Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors, 53256-53293 [2011-21633]
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Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations
[Docket Number NIH–2010–0001]
e-mail jm40z@nih.gov, concerning
questions about the rulemaking process;
and Dr. Sally Rockey, NIH Deputy
Director for Extramural Research,
concerning substantive questions about
the rule, e-mail
FCOICompliance@mail.nih.gov.
RIN 0925–AA53
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 50
45 CFR Part 94
Responsibility of Applicants for
Promoting Objectivity in Research for
which Public Health Service Funding is
Sought and Responsible Prospective
Contractors
Department of Health and
Human Services.
ACTION: Final rule.
AGENCY:
This final rule implements
changes to the regulations on the
Responsibility of Applicants for
Promoting Objectivity in Research for
which Public Health Service Funding is
Sought and Responsible Prospective
Contractors. Since the promulgation of
the regulations in 1995, biomedical and
behavioral research and the resulting
interactions among government,
research Institutions, and the private
sector have become increasingly
complex. This complexity, as well as a
need to strengthen accountability, led to
changes that expand and add
transparency to Investigators’ disclosure
of Significant Financial Interests (SFIs),
enhance regulatory compliance and
effective institutional oversight and
management of Investigators’ financial
conflicts of interests, as well as increase
the Department of Health and Human
Services’ (HHS) compliance oversight.
DATES: Effective Date: This final rule is
effective as of September 26, 2011.
Compliance Date: An Institution
applying for or receiving PHS funding
from a grant, cooperative agreement, or
contract that is covered by this rule
must be in full compliance with all of
the regulatory requirements herein:
• No later than August 24, 2012; and
• Immediately upon making its
institutional Financial Conflict of
Interest (FCOI) policy publicly
accessible as described herein.
In the interim, Institutions should
continue to comply with the 1995
regulations and report Investigator
FCOIs to the Public Health Service
(PHS) Awarding Component as required
in the 1995 regulations.
FOR FURTHER INFORMATION CONTACT: Jerry
Moore, NIH Regulations Officer, Office
of Management Assessment, National
Institutes of Health, 6011 Executive
Boulevard, Suite 601, MSC 7669,
Rockville, MD 20852–7669, telephone
301–496–4607, fax 301–402–0169,
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SUMMARY:
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I. Background
In 1995, the PHS and the Office of the
Secretary of HHS published regulations
at 42 CFR part 50, subpart F and 45 CFR
part 94 (the 1995 regulations), that are
designed to promote objectivity in PHSfunded research. The 1995 regulations
cover Institutions that apply for or seek
PHS funding for research (except for
Small Business Innovation Research
(SBIR)/Small Business Technology
Transfer Research (STTR) Phase I
applications) and, through
implementation of the regulations by
these Institutions, to each Investigator
participating in the research.
Generally, under the 1995 regulations:
• The Institution 1 is responsible for
complying with the regulations,
including maintaining a written and
enforced FCOI policy; managing,
reducing, or eliminating identified
conflicts; and reporting identified
conflicts to the PHS Awarding
Component. The reports denote the
existence of an FCOI and the
Institution’s assurance that it has been
managed, reduced, or eliminated.
• Investigators 2 are responsible for
complying with their Institution’s
written FCOI policy and for disclosing
their SFIs 3 to the Institution.
1 ‘‘Institution’’ was defined under 42 CFR part 50,
subpart F, as any domestic or foreign, public or
private, entity or organization (excluding a Federal
agency), and under 45 CFR part 94 as any public
or private entity or organization (excluding a
Federal agency) (1) that submits a proposal for a
research contract whether in response to a
solicitation from the PHS or otherwise, or (2) that
assumes the legal obligation to carry out the
research required under the contract. 42 CFR
50.603; 45 CFR 94.3.
2 ‘‘Investigator’’ was defined under the 1995
regulations as the Principal Investigator and any
other person who is responsible for the design,
conduct, or reporting of research (or, in the case of
PHS contracts, a research project) funded by PHS,
or proposed for such funding. For purposes of the
regulatory requirements relating to financial
interests, the term ‘‘Investigator’’ includes the
Investigator’s spouse and dependent children. 42
CFR 50.603; 45 CFR 94.3.
3 ‘‘Significant Financial Interest’’ was defined
under the 1995 regulations as anything of monetary
value, including but not limited to, salary or other
payments for services (e.g., consulting fees or
honoraria); equity interests (e.g., stocks, stock
options or other ownership interests); and
intellectual property rights (e.g., patents, copyrights
and royalties from such rights). The term does not
include: (1) Salary, royalties, or other remuneration
from the applicant Institution; (2) any ownership
interests in the Institution, if the Institution is an
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• Maintaining objectivity in research
requires a commitment from Institutions
and their Investigators to completely
disclose, appropriately review, and
robustly manage identified conflicts.
• The PHS Awarding Components 4
are responsible for overseeing
institutional compliance with the
regulations.
The purpose of the 1995 regulations
was to ensure that there is no reasonable
expectation that the design, conduct, or
reporting of PHS-funded research will
be biased by any Investigator FCOI.
Since the publication of the 1995
regulations, the pace by which new
discoveries are translated from the
research bench into effective treatment
of patients has accelerated significantly,
and the biomedical and behavioral
research enterprise in the United States
has grown in size and complexity. For
example, an analysis of financial
support of biomedical research from
1994 to 2004 5 showed that funding
increased from $37.1 billion in 1994 to
$94.3 billion in 2003. Fifty seven
percent of the funding in 2003 came
from industry sources. At the same time,
relationships between individual
academic researchers and industry have
also increased from 28% in a 1996
survey 6 to 52.8% in a survey conducted
in 2007.7 Researchers frequently work
in multidisciplinary teams to develop
new strategies and approaches for
translating basic research into clinical
application, thus hastening discovery
and advancing human health. In
addition, these newer translational
strategies often involve complex
collaborations between Investigators
and the private sector.
Recent studies from several sources
have also highlighted the increasing
complexity of the financial relationships
applicant under the SBIR/STTR programs; (3)
income from seminars, lectures, or teaching
engagements sponsored by public or nonprofit
entities; (4) income from service on advisory
committees or review panels for public or nonprofit
entities; (5) an equity interest that when aggregated
for the Investigator and the Investigator’s spouse
and dependent children meets both of the following
tests: does not exceed $10,000 in value as
determined through reference to public prices or
other reasonable measures of fair market value, and
does not represent more than a five percent
ownership interest in any single entity; or (6) salary,
royalties, or other payments that when aggregated
for the Investigator and the Investigator’s spouse
and dependent children over the next twelve
months, are not expected (or, in the case of PHS
contracts, are not reasonably expected) to exceed
$10,000. 42 CFR 50.603; 45 CFR 94.3.
4 ‘‘PHS Awarding Component’’ was defined as an
organizational unit of the PHS that funds research
that is subject to these regulations. 42 CFR 50.603,
45 CFR 94.3.
5 Moses H et al., JAMA; 2005;294:1333–1342.
6 Blumenthal D et al., N Engl J Med; 1996;
335:1734–9.
7 Zinner DE et al., Health Aff; 2009;28:1814–25.
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between biomedical researchers and
industry and the possible ramifications
of those relationships. For example, a
2008 report by the Association of
American Medical Colleges and the
Association of American Universities
(AAMC/AAU) 8 states: ‘‘The promises of
translational research, the challenges of
technology transfer, and intense
expectations at all levels of government
that universities and their academic
medical centers function as engines of
socio-economic development generate
new pressures on institutions and their
faculty members to expand their
relationships and deepen their
engagement with industry. These
relationships, now encouraged in many
forms, may involve financial linkages
that are entirely benign but will in other
cases carry the potential to create
serious conflicts of interest. Moreover,
these financial ties are occurring in a
context of dramatically increased public
sensitivity to and concern with
allegations of financial conflicts of
interest more broadly in university
business transactions and across diverse
sectors of industry.’’ A recent study of
the Institute of Medicine (IOM) on
Conflict of Interest in Medical Research,
Education, and Practice states:
‘‘Physicians and researchers must
exercise judgment in complex situations
that are fraught with uncertainty.
Colleagues, patients, students, and the
public need to trust that these
judgments are not compromised by
physicians’ or researchers’ financial ties
to pharmaceutical, medical device, and
biotechnology companies. Ties with
industry are common in medicine.
Some have produced important benefits,
particularly through research
collaborations that improve individual
and public health. At the same time,
widespread relationships with industry
have created significant risks that
individual and institutional financial
interests may unduly influence
professionals’ judgments about the
primary interests or goals of medicine.
Such conflicts of interest threaten the
integrity of scientific investigations, the
objectivity of medical education, and
the quality of patient care. They may
also jeopardize public trust in
medicine.’’ 9 A 2009 report from the
HHS Office of Inspector General (OIG)
8 Protecting Patients, Preserving Integrity,
Advancing Health: Accelerating the Implementation
of COI Policies in Human Subjects Research, A
Report of the AAMC–AAU Advisory Committee on
Financial Conflicts of Interest in Human Subjects
Research, February 2008 p1.
9 Lo, B & Field, M.J. (Eds.). (2009) Conflict of
interest in medical research, education, and
practice. Washington, DC: National Academies
Press. p2.
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stated ‘‘Vulnerabilities exist at grantee
institutions regarding conflicts.’’ 10
The growing complexity of
biomedical and behavioral research; the
increased interaction among
Government, research Institutions, and
the private sector in attaining common
public health goals while meeting
public expectations for research
integrity; as well as increased public
scrutiny, all have raised questions as to
whether a more rigorous approach to
Investigator disclosure, institutional
management of financial conflicts, and
Federal oversight is required. HHS
decided to explore the need for
revisions to the 1995 regulations by
publishing an Advance Notice of
Proposed Rulemaking on May 8, 2009
(74 FR 21610, hereafter ‘‘the ANPRM’’).
After analyzing public comments,
HHS published a Notice of Proposed
Rulemaking (75 FR 28688, hereafter
‘‘the NPRM’’) on May 21, 2010, to
amend the 1995 regulations by
expanding and adding transparency to
Investigators’ disclosure of SFIs,
enhancing regulatory compliance and
effective institutional oversight and
management of Investigators’ financial
conflicts of interests, as well as HHS’
compliance oversight.
Major changes to the 1995 regulations
proposed in the NPRM included:
• Expanding the scope of the
regulations to include SBIR/STTR Phase
I applications.
• Amending the definition of SFI to
include a de minimis threshold of
$5,000 for disclosure that generally
applies to payments and/or equity
interests as well as any equity interest
in non-publicly traded entities.
• Excluding income from government
agencies or Institutions of higher
education for seminars, lectures,
teaching, or service on advisory or
review panels.
• Expanding Investigator disclosure
requirements to include SFIs that are
related to an Investigator’s institutional
responsibilities, with Institutions
responsible for determining whether a
disclosed SFI relates to the research for
which PHS funding is sought and
constitutes an FCOI.
• Enhancing the information on an
FCOI reported by the Institution to the
PHS Awarding Component to include
the information required under the 1995
regulations plus the value of the
financial interest or a statement that a
value cannot be readily determined, the
nature of the FCOI, a description of how
10 HHS OIG report OEI–03–07–00700 ‘‘How
Grantees Manage Financial Conflicts of Interest in
Research Funded by the National Institutes of
Health’’, November 2009 p12.
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the FCOI relates to PHS-funded
research, and key elements of the
Institution’s management plan.
• Requiring that before spending
funds for PHS-supported research, an
Institution shall post on a publicly
accessible Web site information on SFIs
of senior/key personnel that the
Institution determines are related to the
PHS-funded research and constitute an
FCOI.
In addition to these major proposed
changes, the NPRM incorporated minor
proposed changes that reflect technical
updates from the 1995 regulations (e.g.,
in the reference to authority for the
regulations, 42 U.S.C. 299c–4 replaces
42 U.S.C. 299c–3, and, for the
regulations for grants and cooperative
agreements, we added section 219, Title
II, Division D of Public Law 111–117,
the Consolidated Appropriations Act
2010), or that reflect efforts to improve
the overall clarity and accuracy of the
regulations (e.g., the title of the
regulations for grants and cooperative
agreements was changed to ‘‘Promoting
Objectivity in Research,’’ to reinforce
the ongoing nature of the obligations
under this subpart). The final rule also
incorporates such changes.
On July 21, 2010, HHS published a
Notice (75 FR 42362, hereafter ‘‘the
Extension Notice’’) extending the 60 day
comment period for the NPRM by
another 30 days and seeking comment
on whether HHS should clarify its
authority to enforce compliance with
the regulations by Institutions and
Investigators, and whether HHS should
clarify how the regulations apply in
circumstances in which an Investigator
or a PHS-funded research project
transfers from one Institution to another.
II. Discussion of General Public
Comments
During the 90 day comment period
that ended on August 19, 2010, we
received 136 unique comments on the
NPRM and the Extension Notice. Many
respondents were generally supportive
of the overall goal of promoting
objectivity in biomedical research. A
few cited the importance of such
objectivity in maintaining the public’s
and particularly patients’ trust in
treatments, drugs and devices that result
from PHS-funded biomedical research.
Responses to comments in this section
are of a general nature while comments
on specific provisions of the NPRM are
addressed in the next section.
Balancing the Benefits of Relationships
With Industry and Possible Conflicts of
Interest
As stated by several respondents, it is
important to emphasize that translating
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basic research into clinical application
is critical for advancing human health,
and this process requires fruitful
collaborations among government,
academia, and industry. Some
respondents were concerned that the
revisions to the regulations will have a
negative effect on these collaborations
and on the translation of research into
cures. We want to emphasize that the
revisions are not designed to prevent or
hinder relationships among government,
academia, and industry. Rather, the
revisions are aimed at facilitating such
relationships by increasing transparency
and accountability so that the resulting
research is considered objective and in
the interest of the public.
Some respondents were concerned
that there has not been sufficient
research to document an adverse impact
of FCOI on the integrity of PHS-funded
research, which makes it difficult to
substantiate the effectiveness of the
proposed measures, and in particular,
one commenter questioned the citation
of a specific article in the NPRM (‘‘the
Wazana paper’’) in that regard. While
we did not cite a paper by that author
in the NPRM, we understand the
limitations of the research on this topic.
The 1995 regulations were aimed at
preventing bias in PHS-funded research,
and as such, were intended to be
proactive rather than reactive to specific
evidence of bias. Nonetheless, over the
past few years, there have been several
specific allegations of bias among PHSfunded researchers reported in the
press. This has led to increased public
concern, as evidenced by statements
and correspondence from members of
Congress and the language in the
Department of Health and Human
Services Appropriations Act, 2010, to
amend the 1995 regulations ‘‘for the
purpose of strengthening Federal and
institutional oversight and identifying
enhancements * * *.’’ 11 And as
mentioned above, the 2009 OIG report:
How Grantees Manage Financial
Conflicts Of Interest in Research Funded
by the National Institutes of Health
found that ‘‘Vulnerabilities exist in
grantee Institutions’ identification,
management, and oversight of financial
conflicts of interest.’’ It is vital that the
public have confidence in the
objectivity of PHS-funded research. The
revised regulations, with their emphasis
on increasing transparency and
accountability, as well as providing
additional information to the PHS
Awarding Component, are aimed at
doing just that.
Other respondents requested that,
given the complexity of the issues
11 Sec.
219, Tit. II, Div. D, Pub. L. 111–117
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related to management of Investigator
FCOI, HHS fund research to address
issues related to the implementation of
these regulations. As part of our
oversight activities, NIH has developed
and conducted a number of initiatives
and site visits to evaluate institutional
FCOI policies for compliance with the
Federal regulations and has publicized
on-line ‘‘Lessons Learned.’’ NIH found
that the most common compliance
issues center around the appropriate
definition of ‘‘Investigator’’ and
Institutional reporting requirements.
NIH observed that there was some
confusion about receiving disclosures
from Investigators who join a project
after it has begun, and identifying and
reporting FCOI during the project
period. Site visits also reaffirmed that
education is key in ensuring that
Investigators comply with the FCOI
requirements by understanding their
responsibilities in the process.
Therefore, in light of these observations,
the definition of ‘‘Investigator’’ has been
revised in the final rule to emphasize
that Institutions should consider the
roles of those involved in research and
the degree of independence with which
those individuals work.
In addition, the final rule includes a
new requirement for Institutions to
require each Investigator to complete
training related to the FCOI and/or other
FCOI-related requirements at least every
four years or immediately under
designated circumstances. Information
and other resources developed by NIH,
which will be updated as appropriate,
are available as resources for the new
regulatory training requirement and can
be accessed through the NIH Web site’s
Financial Conflict of Interest page at
https://grants.nih.gov/grants/policy/coi/.
Several respondents requested that
the revised regulations apply only to
new or competing PHS awards and
newly identified FCOIs. We note that
many PHS grants, cooperative
agreements, and contracts continue for
several years and, particularly in the
case of grants and cooperative
agreements, a new award can be made
every year. Therefore, the revised
regulations will apply to each grant or
cooperative agreement with an issue
date of the Notice of Award that is
subsequent to the compliance dates of
the final rule (including noncompeting
continuations) and to solicitations
issued and contracts awarded
subsequent to the compliance dates of
the final rule that are for research.
Through their policies, Institutions may
choose to apply the revised regulations
to all active PHS awards. For example,
Institutions may choose, in their FCOI
policy, to implement the regulations on
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a single date on all PHS-funded awards
rather than implementing the
regulations sequentially on the specific
award date of each individual project.
Beyond Financial Conflicts of Interest
A few respondents suggested that the
regulations should also address nonfinancial conflicts of interest. While we
acknowledge that non-financial
conflicts of interest can influence the
scientific process, we chose to retain the
focus of these regulations on FCOIs
because we believe this is a discrete area
in which there is a heightened need to
strengthen management and oversight.
In addition, legal authority for the
regulations references FCOI specifically,
e.g. 42 U.S.C. 289b–1.
One respondent suggested that the
regulations be revised to restrict
recipients of PHS-funded research from
entering into agreements that contain a
provision restricting the Investigator’s
ability to speak, publish, or otherwise
undertake activities contrary to a
company’s commercial interest.
Although we believe this action would
go beyond the scope of these
regulations, we note that as stated in the
HHS and NIH Grants Policy Statements
(https://www.ihs.gov/nonMedical
Programs/gogp/documents/HHS%20
Grants%20Policy%20Statement.pdf and
https://grants.nih.gov/grants/policy/
nihgps_2010/nihgps_ch8.htm#_
Toc271264951, respectively), we believe
that sharing final research data and
other research tools produced or
developed by Investigators under PHSfunded grants, such as cell lines, certain
types of animals (e.g., transgenic mice),
and computer programs, is essential for
expedited translation of research results
into knowledge, products, and
procedures to improve human health.
We endorse the sharing of final research
data and research tools to serve these
and other important scientific goals, and
we support the timely release and
sharing of final research data and
research tools from PHS-supported
studies for use by other researchers.
General Comments on Contracts
One respondent was concerned that
by revising the regulations, it appears
that HHS is modifying the Public Health
Service Act. We want to clarify that,
through this final rule, HHS has revised
regulations promulgated under the
Public Health Service Act, not modified
the Public Health Service Act itself. The
same respondent also believed that ‘‘the
PHS Acquisition Regulations were
abolished and contents (PHSAR 380—
care of lab animals, human subjects and
Indian self determination) were folded
into HHSAR (approx 1998),’’ leading the
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respondent to question whether the
regulations set forth in 45 CFR part 94
remain ‘‘in force.’’ This concern is
unfounded; the regulations at 45 CFR
part 94 remain in effect in addition to,
and not in conflict with, the HHS
Acquisition Regulation (HHSAR)
codified at 48 CFR part 301 et seq.
Additionally, the respondent questioned
the authority of NIH/PHS/HHS ‘‘to set
HHS acquisition policy.’’ As noted in
the final rule promulgating the 1995
regulations, published on July 11, 1995
(60 FR 132), the PHS and the Office of
the Secretary are acting in accordance
with the legislative directive in 42
U.S.C. 289b–1(a). We have also declined
this respondent’s suggestion to place the
revisions to the regulations at 45 CFR
part 94 in the HHSAR; the revisions
expressly pertain to the regulations at 45
CFR part 94 and not to 48 CFR part 301
et seq.
Another respondent suggested that
there is a need to develop a specific
HHSAR provision and/or standard
language in the Request for Proposals
(RFP) regarding the requirement of
certification by the contractor in the
regulations. We disagree; 45 CFR 94.4(k)
provides standard language that is
appropriate for each contract proposal
subject to these regulations.
Another respondent suggested that
contractors should be exempt from the
regulatory requirements to disclose or
report FCOIs, because the respondent
believes that contractors are acting as
independent vendors and the Institution
has no effective means of monitoring
their compliance with the policy. We
disagree with this comment. All Federal
contractors are required to have an
effective means of complying with the
terms and conditions of their contract,
including regulatory obligations
designed to promote objectivity in PHSfunded research. The regulation
specifically provides for enforcement of
these obligations, stating at 94.6(b) that
‘‘* * * the PHS Awarding Component
may decide that a particular financial
conflict of interest will bias the
objectivity of the PHS-funded research
to such an extent that further corrective
action is needed or that the Institution
has not managed the financial conflict
of interest in accordance with this part.
The PHS Awarding Component may
determine that issuance of a Stop Work
Order by the Contracting Officer or
other enforcement action is necessary
until the matter is resolved.’’
One respondent stated that the
language under 45 CFR part 94 is
confusing because it refers to
‘‘applications for research,’’ and
‘‘awarding component’’ which seem
more like grant terms than contract
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terms; additionally, the respondent
noted that the language is inconsistent
with HHS regulations which refer to
OPDIVs or Agencies. We appreciate the
opportunity to clarify that the
regulations at 45 CFR part 94 apply to
Institutions that solicit or receive PHS
research funding by means of a contract
for research, as distinguished from the
regulations at 42 CFR part 50 subpart F
which are applicable to Institutions that
apply for or receive PHS research
funding by means of a grant or
cooperative agreement. The revised
regulations under 45 CFR part 94 do not
include any references to (grant)
applications, but rather to contract
proposals. Furthermore, the references
to ‘‘awarding component’’ in 45 CFR
part 94 are appropriate in the context of
research contracts, and such references
are not inconsistent with references to
‘‘OPDIVs or Agencies’’ in the HHSAR.
These terms have a similar meaning,
though the HHSAR applies to all
operating divisions within HHS,
whereas 45 CFR part 94 only applies to
the Public Health Service of HHS.
Another respondent expressed
concern about inconsistency between
the requirements under 45 CFR part 94
and the treatment of organizational
conflicts of interest (OCIs) by the
Federal Acquisition Regulation (FAR),
Subpart 9.5. We are not aware of any
direct conflict(s) between the two sets of
regulations at this time; 45 CFR part 94
focuses on financial conflicts of interest
of Investigators, whereas Subpart 9.5 of
the FAR focuses on organizational
conflicts of interest. In response to a
related question by the same
respondent, we note that neither 45 CFR
part 94 nor Subpart 9.5 of the FAR
require coordination with legal counsel
on conflict of interest issues. The FAR
provides only in Part 9.504(b) that
‘‘Contracting officers should obtain the
advice of counsel’’ in consideration of
OCIs. The use of the word ‘‘should’’
suggests that this step is a matter of
policy, and not a legal requirement. To
address a final concern by the same
respondent, we note that the de minimis
reporting level of $5,000 does not imply
that no conflict under that amount
exists; as discussed further below, that
amount is used only as a monetary
threshold for the definition of reportable
SFIs under 45 CFR part 94.
General Comments on Cost and Burden
Several respondents suggested that
the analysis of the impact of the
proposed revisions in the NPRM
underestimated the burden and cost of
implementation, particularly regarding
the potential number of Investigators,
SFI disclosures, and FCOI reports. By
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publishing both an ANPRM and an
NPRM, we have endeavored to involve
the community and carefully consider
the public’s concerns. This final rule
incorporates our best efforts to balance
the increased burden that results from
any regulatory action with the need to
respond to demands for greater
transparency and accountability from
the public and Congress, including a
legislative mandate [Pub. L. 111–117,
Div. D, Tit. II, sec. 219, 123 Stat. 3034
(2009)]. We will evaluate the effect of
provisions of the regulations such as the
de minimis and the public accessibility
requirement within three years after
implementation of the final rule.
Our burden estimates were based on
the current pool of PHS-funded
Investigators as well as our experience
with FCOI reports under the 1995
regulations. We note that the revised
definition of Investigator is not
significantly different from that in the
1995 regulations; therefore, the number
of Investigators should not change
substantially. We recognize that the
scope of Investigator SFI disclosures, if
not the actual numbers, will increase
under the revised regulations, and that
the number of FCOI reports may
increase as well. We made a good faith
estimate in the NPRM as to the extent
of these increases. Nonetheless, we have
taken these comments into
consideration as we revised the
Regulatory Impact Analysis in section V
to accommodate the content of this final
rule. Specifically, we have increased the
estimated time for Institutions to adapt
NIH training materials to incorporate
their policies, the time for Investigator
disclosures and updates, and the time
for reviewing disclosures. We also
added an estimated time for completing
a retrospective review, and clarified that
the time estimated for Institutions to
monitor Investigator compliance with a
management plan in the NPRM was
calculated on a monthly rather than
annual basis.
In addition, several respondents
objected to the statement in the NPRM
that the cost of implementing the
amended regulations is an allowable
cost eligible for reimbursement as a
Facilities and Administrative cost on
PHS-supported grants, cooperative
agreements, and contracts, citing
limitations in these reimbursements. We
recognize that in some instances current
cost principles may limit an
Institution’s ability to recover costs
under the Facilities and Administrative
cost mechanism. However, this does not
render those costs ineligible for
recovery.
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Several respondents suggested that
HHS provide assistance to Institutions
for the implementation of new policies
and procedures to comply with the
revised regulations. HHS recognizes the
need to support implementation and is
developing implementation guidance,
which may include, for example,
Frequently Asked Questions and other
updates to NIH’s Financial Conflicts of
Interest Web site, https://grants.nih.gov/
grants/policy/coi/. General inquires
about the FCOI regulations, and requests
to consider additional assistance efforts,
may be directed to:
FCOICompliance@mail.nih.gov.
Many respondents requested that the
implementation of the revised
regulations be staggered and proposed
time periods ranging from one to five
years. In particular, respondents
suggested that the implementation of
the public accessibility requirement in
42 CFR 50.605(a)(5) and 45 CFR
94.5(a)(5) should be postponed to
October 2013 to coincide with the
disclosure provisions under Title VI,
Section 6002, of the recently enacted
Patient Protection and Affordable Care
Act, Public Law 111–148 (hereafter,
Affordable Care Act 12). We agree that it
is important to balance the desire to
implement the revised regulations as
soon as possible with the need to
provide sufficient time for Institutions
and Investigators to comply. We have
done so by providing a compliance date
of up to 365 days from publication of
this final rule, as described in the Dates
section above. We considered a
staggered approach but thought this
would create added burden for
Institutions and Investigators, and
confusion for the public.
One respondent suggested that we
assemble an advisory board of
administrators at Institutions to assist in
our deliberations in drafting the final
rule. We encouraged all stakeholders
including Institutions to submit
comments to the ANPRM and to the
NPRM; such comments have been
instrumental to our deliberations.
Additionally, we convened a committee
of NIH/HHS staff with expertise in
different types of research funded by the
PHS to consider the comments to the
NPRM and the ANPRM.
12 The
Patient Protection and Affordable Care Act
(the Affordable Care Act), Public Law 111–148, was
enacted on March 23, 2010; the Health Care and
Education Reconciliation Act (the Reconciliation
Act), Public Law 111–152, was enacted on March
30, 2010. The Affordable Care Act and the
Reconciliation Act reorganize, amend, and add to
the provisions of part A of title XXVII of the Public
Health Service Act.
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A few respondents suggested that we
postpone revising the regulations and
conduct additional discussion with the
research community. Again, we note
that by publishing both an ANPRM and
an NPRM, and by encouraging public
comment through public outreach
initiatives, we have involved the
community throughout this process, and
we have carefully considered the
comments that have been raised.
III. Discussion of Public Comments
Related to Specific Provisions of the
Revised Regulations
Public comments regarding revisions
to specific provisions of the 1995
regulations are summarized below,
along with a description of HHS’
deliberations and any change made to
the final rule in response to the
comments.
Purpose (42 CFR 50.601; 45 CFR 94.1)
As proposed in the NPRM,13 we have
made minor revisions to this section to
improve internal consistency with
regard to the use of various terms and
phrases throughout the regulations. One
respondent questioned the removal of
the words ‘‘to ensure’’ in the reference
to standards that provide a reasonable
expectation that the design, conduct,
and reporting of research funded under
PHS grants or cooperative agreements is
free from bias resulting from
Investigator FCOI. We have
implemented our proposed language,
which focuses on the phrase
‘‘reasonable expectation,’’ because we
believe it sets a more accurate and
realistic objective for the regulations; as
another respondent noted, it can be
perceived as unrealistic from an
enforcement perspective to ‘‘ensure’’ the
elimination of bias. The respondent also
suggested replacing the phrase ‘‘design,
conduct, or reporting of research’’ with
‘‘design, conduct, analysis,
management, administration, reporting,
and distribution of research’’ throughout
the rule. We have not made this change,
because we believe that ‘‘design,
conduct or reporting’’ covers the major
responsibilities related to the PHSfunded research and that the term
‘‘conduct’’ encompasses many of the
additional terms suggested by the
respondent.
Applicability (42 CFR 50.602, 45 CFR
94.2)
The 1995 regulations were applicable
to each Institution that seeks or receives
PHS funding for research and, through
implementation of the regulations by
each Institution, to each Investigator
13 75
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participating in such research.14
However, the 1995 regulations excluded
SBIR/STTR Phase I applications because
of the expectation that such applications
‘‘are for limited amounts.’’ 15 As we
discussed in the NPRM, since 1995 the
size of these awards has increased, such
that the amounts constitute a significant
expenditure of public funds. For
example, the median amount of an NIH
Phase I award increased from
approximately $99,000 in 1995 to
approximately $182,000 in 2009.
Therefore, we proposed in the NPRM to
include SBIR/STTR Phase I applications
in the revised regulations.
We only received a small number of
comments on this component of the
proposal. While a few respondents
agreed that including these applications
is reasonable, one respondent suggested
that including these applicants in the
final rule ‘‘could present difficulties for
start-up and emerging companies forced
to adhere to the rule’s extensive
requirements for reporting and
managing conflicts of interest
requirements—the same rules with
which large research institutions with
substantially more resources will be
complying.’’
We have taken this comment into
account in our reevaluation of the
proposed inclusion of the SBIR/STTR
Phase I program and we ultimately
determined that this change from the
1995 regulations could indeed create an
undue burden. In particular, SBIR/STTR
companies are small in size (eligible
companies must have fewer than 500
employees, but, for example, the average
NIH SBIR/STTR company has
approximately 20 employees and many
have only 1–3 employees), and these
companies tend to be limited in
resources. Accordingly, we found the
argument to be compelling that the
investment required to comply with the
regulations could create a
disproportionate burden on small
businesses. Moreover, approximately
56% of Phase I awardees will apply for
Phase II funding, at which point they
will be covered by the regulations.
Therefore, the regulations will still
capture the benefits of compliance from
a significant number of these companies
without imposing an undue burden that
could create a disincentive to applicants
14 Consistent with the 1995 regulations, in those
few cases where an individual, rather than an
Institution, is an applicant for PHS grants or
cooperative agreements for research, PHS Awarding
Components will make case-by-case determinations
on the steps to be taken to ensure that the design,
conduct, and reporting of the research will not be
biased by any conflicting financial interest of the
individual.
15 60 FR 35814 (July 11, 1995).
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from the small business community, an
important part of the biomedical
research enterprise. For these reasons,
the final rule retains the exemption of
Phase I SBIR/STTR applications from
the 1995 regulations.
We have also implemented the
NPRM’s proposal to add language in
this section clarifying that the
regulations continue to apply once the
PHS-funded research is underway (i.e.,
after the application process).
Definitions (42 CFR 50.603, 45 CFR
94.3)
In the NPRM we proposed to add
several new definitions, revise some of
the existing definitions, and remove one
definition. Comments and responses
regarding the implementation of those
proposed changes in the final rule
follow:
1. Contractor. We have implemented
the NPRM’s proposal to revise the
definition of ‘‘Contractor,’’ to clarify that
the term applies to an entity that
provides property or services ‘‘under
contract’’ for the direct benefit or use of
the Federal government.
2. Disclosure of significant financial
interests. This definition was not
included in the 1995 regulations but
was proposed in the NPRM to mean an
Investigator’s disclosure of SFIs to an
Institution. We have included this
definition in the final rule—along with
the definition of ‘‘FCOI report’’ below—
because of the confusion that can result
from the use of the terms ‘‘disclosure’’
and (FCOI) ‘‘report.’’ We intend for the
term ‘‘disclosure’’ to capture
communication from an Investigator to
an Institution regarding SFIs, whereas
the term ‘‘report’’ captures
communication from an Institution to
the PHS Awarding Component
regarding FCOI. A few respondents
requested that we switch this definition
with the one stated below (i.e., FCOI
report) in order to align the terminology
with a recent report by the AAMC/
AAU.16 We have not made that change
because we want to minimize public
confusion by keeping our terminology
consistent with that used in the 1995
regulations, to the extent possible.
3. Financial conflict of interest (FCOI).
We proposed this definition in the
NPRM to mean an SFI that could
directly and significantly affect the
design, conduct, or reporting of PHSfunded research. Although this
definition was not listed in the
16 Protecting Patients, Preserving Integrity,
Advancing Health: Accelerating the Implementation
of COI Policies in Human Subjects Research, A
Report of the AAMC–AAU Advisory Committee on
Financial Conflicts of Interest in Human Subjects
Research, February 2008.
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Definitions sections of the 1995
regulations, it is consistent with
language contained in other provisions
of the 1995 regulations.17 One
respondent suggested that the definition
be revised to mean an SFI that could
directly or indirectly affect the design,
conduct, or reporting of PHS-funded
research. We have considered this
suggestion and believe that including
the term ‘‘indirectly’’ could create
ambiguity and extend the definition
beyond the scope of the regulations. The
term ‘‘significantly’’ in this context
means that the financial interest would
have a material effect on the research,
which we believe appropriately fulfills
the intent of the regulations, i.e., to
maintain objectivity in PHS-funded
research.
Some respondents requested the
inclusion of specific examples to
illustrate SFIs that could be considered
FCOIs. Because conflicts of interest can
vary according to the specific context
and Institutional policy, we are
concerned that providing examples
could create public confusion, so we
have not made that change to the final
rule. Other respondents suggested that
Institutions should consider specific
criteria, including the stage of the
research and its commercial potential,
the proximity to possible U.S. Food and
Drug Administration (FDA) review, and
the magnitude of the potential risk,
when determining whether an SFI is an
FCOI. Although we disagree that this
suggestion should be implemented in
the regulations, we note that Institutions
may include a variety of criteria in the
review of Investigators’ SFIs and the
determination of whether they
constitute an FCOI with the PHS-funded
research, including those suggested by
respondents.
4. Financial Conflict of Interest (FCOI)
report. This definition was not included
in the 1995 regulations but was
proposed in the NPRM to mean an
Institution’s report of an FCOI to a PHS
Awarding Component. We have
included this definition in the final rule
for the same reasons we have included
the ‘‘disclosure of SFIs’’ definition
discussed above.
5. Financial interest. We proposed
this definition in the NPRM, as a
companion to the revision of the ‘‘SFI’’
definition, described below, to mean
anything of monetary value or potential
monetary value. Some respondents
agreed with this definition, while others
suggested that the phrase ‘‘or potential
monetary value’’ is too broad and
suggested the stated purpose could be
achieved by the phrase: ‘‘anything of
17 42
PO 00000
CFR 50.605(a) and 45 CFR 94.5(a).
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53261
monetary value, whether or not the
value is readily ascertainable.’’ We agree
and have changed the language in the
final rule accordingly. Another
respondent asked if anything of
‘‘potential monetary value’’ would
include patents or patent applications.
As discussed below in the definition of
SFI, patents and patent applications are
included in the definition.
6. Institution. Consistent with our
proposal in the NPRM, we have revised
the definition of ‘‘Institution’’ to refer
specifically to an Institution that is
applying for, or that receives, PHS
research funding. A few respondents
questioned whether Federal agencies
should be excluded from this definition,
as this would exclude Federal
researchers such as NIH scientists. One
requested that HHS evaluate the revised
regulations after a period of time to
assess whether Federal researchers
(‘‘intramural investigators’’) should be
included. Federal agencies and their
employees are subject to conflicts of
interest requirements, including
disclosure by employees and review by
agencies, pursuant to Federal criminal
statutes, the Ethics in Government Act
as amended, and supplemental agency
regulations. Accordingly, we have
retained the exclusion of Federal
agencies in this definition.
7. Institutional responsibilities. We
proposed this definition in the NPRM to
mean an Investigator’s professional
responsibilities on behalf of the
Institution including, but not limited to,
activities such as research, research
consultation, teaching, professional
practice, institutional committee
memberships, and service on panels
such as Institutional Review Boards or
Data and Safety Monitoring Boards.
Some respondents requested that this
definition be clarified to specify that the
Investigator’s responsibilities are
defined by the Institution. We agree and
have modified the definition
accordingly to make clear that the
Institution defines the Investigator’s
responsibilities in its policy on financial
conflicts of interests. One respondent
suggested that the list of examples
should be expanded. In light of the
change to the regulatory text noted
above, and because the definition
indicates that the list is not exhaustive,
we have not made further changes.
8. Investigator. Consistent with our
proposal in the NPRM, we have revised
the definition of ‘‘Investigator’’ to clarify
that it means the Project Director/
Principal Investigator (PD/PI) as well as
any other person, regardless of title or
position, who is responsible for the
design, conduct, or reporting of research
funded by the PHS, or proposed for
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such funding, which may include, for
example, collaborators or consultants..
Several respondents suggested that this
definition is overly broad and will result
in disclosures from people who are only
peripherally associated with the PHSfunded research. We note that the
definition is not substantially different
from the definition in the 1995
regulations 18 and is consistent with
regulatory guidance that NIH has issued
(e.g., see ‘‘Investigator-Specific
Questions’’ section of NIH’s ‘‘Frequently
Asked Questions’’ resource at https://
grants.nih.gov/grants/policy/
coifaq.htm). In response to questions
about whether this definition includes
unfunded collaborators, we note that the
definition refers to the function of the
individual on the PHS-funded project;
i.e., his/her responsibility for the design,
conduct, or reporting of the PHS-funded
research, and not to his/her title or the
amount or source of remuneration.
Other respondents suggested the
definition should be expanded to
include other types of activities, or to
include people in a position to
influence the design, conduct, or
reporting of the research. We have
retained the focus of the definition on
Investigators who are responsible for the
design, conduct, or reporting of research
for the reasons discussed above.
Consistent with our proposal in the
NPRM, we have also eliminated the
reference to the Investigator’s spouse
and dependent children in this
definition, as we believe that such
reference is more appropriate to include
in the SFI definition, below.
9. Key personnel. In parallel to the use
of the term ‘‘senior/key personnel’’ in
making FCOI information publicly
accessible for research grants and
cooperative agreements under 42 CFR
50.605, the term ‘‘key personnel’’ is
used for research contracts under 45
CFR 94.5. Therefore, we thought it
would be useful to include a separate
definition for this term in the final rule,
to clarify the exact meaning: the PD/PI
and any other personnel considered to
be essential to work performance in
accordance with HHSAR subpart
352.242–70 and identified as key
personnel in the contract proposal and
contract.
10. Manage. We proposed this
definition in the NPRM to mean taking
action to address an FCOI, which
includes reducing or eliminating the
FCOI, to ensure that the design,
conduct, and reporting of research will
be free from bias or the appearance of
bias. Consistent with our discussion in
the NPRM, we have included a modified
18 42
CFR 50.603 and 45 CFR 94.3.
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version of this definition in the final
rule as part of a wider reconsideration
of the concepts of managing, reducing,
and eliminating an FCOI. In the 1995
regulations, these concepts were
typically listed separately; 19 suggesting
that reducing or eliminating an FCOI
may not be the same as managing an
FCOI. We believe that it is more
appropriate to consider the reduction or
elimination of an FCOI as alternate
means of managing an FCOI, depending
on the circumstances.
This revision is not intended, as
suggested by one respondent, to imply
that reduction or elimination is the only
acceptable means of managing an FCOI.
To address this concern, we have
changed the definition in the final rule
to read ‘‘* * * to take action to
address a financial conflict of interest,
which can include reducing or
eliminating the financial conflict of
interest * * *’’ Another respondent
agreed with the definition, while a third
thought it should be expanded to
include activities beyond the design,
conduct, or reporting of research and to
state that the ultimate goal is
elimination. Another respondent
thought that certain types of SFIs should
be specified as requiring elimination or
reduction. In response to these related
comments, we want to clarify that we do
not intend to imply that every FCOI
must be eliminated; the goal of the
regulations is to ensure appropriate
management so as to maintain
objectivity of the research. Additionally,
as discussed above, we believe ‘‘design,
conduct, or reporting’’ covers the major
responsibilities related to the PHSfunded research, so we have not
expanded the scope of the definition.
One respondent suggested that ‘‘ensure’’
is impossible to enforce. To address this
concern, we have included the phrase
‘‘to the extent possible’’ in the
definition. Finally, respondents
suggested the deletion of the phrase
‘‘appearance of bias.’’ We have made
this change, as we agree that this phrase
can be interpreted as overly broad and
ambiguous.
11. PD/PI. We proposed this
definition in the NPRM to mean a
Project Director or Principal Investigator
of a PHS-funded research project. In the
final rule, to improve clarity, we have
noted that the PD/PI is included in the
definition of senior/key personnel in 42
CFR 50.603, and in the definition of key
personnel in 45 CFR 94.3.
12. PHS. Consistent with our proposal
in the NPRM, we have revised the
definition of ‘‘PHS’’ to include a specific
reference to NIH in order to clarify that
19 42
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Institutions applying for, or receiving,
research funding from NIH are subject to
the regulations. This language remains
unchanged from that proposed in the
NPRM; however, as a technical
correction to improve clarity and
accuracy, we have deleted the reference
to ‘‘an operating division.’’
13. Research. Consistent with our
proposal in the NPRM, we have revised
the definition of ‘‘research’’ to include
a non-exhaustive list of examples of
different types of PHS funding
mechanisms to which the definition
applies. As revised, the definition under
42 CFR 50.603 includes any activity for
which research funding is available
from a PHS Awarding Component
through a grant or cooperative
agreement, whether authorized under
the PHS Act or other statutory authority,
such as a research grant, career
development award, center grant,
individual fellowship award,
infrastructure award, institutional
training grant, program project, or
research resources award. The
definition under 45 CFR 94.3 includes
any activity for which research funding
is available from a PHS Awarding
Component through a contract, whether
authorized under the PHS Act or other
statutory authority. We also added the
terms ‘‘study or experiment’’ to enhance
clarity. A few respondents requested
that the definition exclude certain types
of grants such as those for educational
activities, training, or construction. We
note that PHS funds a wide variety of
award types and there may be some
research components within award
types that are not specifically labeled
‘‘research’’ awards. It is important that
the information on SFI related to such
activities be provided to the Institution
for evaluation of the relatedness to PHSfunded research and the possibility of
an FCOI. Therefore, we believe it would
not be prudent to limit the types of PHSfunded research activities that are
subject to these regulations and we did
not make this change.
One respondent suggested the
addition of examples for the term
‘‘product development’’ in the
definition. We agree that this is useful
and have added the examples of product
development (a diagnostic test or drug)
and of products of basic and applied
research (a published article, book, or
book chapter). Another respondent
suggested that reference to the
regulations be included in specific
Requests for Applications or Requests
for Proposals to clarify exactly when the
regulations are applicable. We believe
this comment is addressed by the
general provision of Web links to and
citations of applicable policy
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requirements and terms and conditions
of awards on Notices of Award for all
PHS funded grants and cooperative
agreements and in all contracts awarded
by the PHS that are for research.
14. Senior/key personnel. The NPRM
uses this term in the proposal and
discussion of the management and
posting of FCOI under 42 CFR 50.605.
Therefore, we thought it would be
useful to include a separate definition
for this term in the final rule, to clarify
the exact meaning: the PD/PI and any
other person who the Institution
identifies as senior/key personnel in the
grant application progress report, and
any other report submitted to the PHS
by the Institution under this subpart.
This definition is in parallel to that of
the term ‘‘key personnel’’ used in
making FCOI information publicly
accessible for research contracts under
45 CFR 94.5.
15. Significant Financial Interest. In
the NPRM, we proposed to revise
substantially the SFI definition,20
incorporating the proposed definitions
of ‘‘financial interest’’ and ‘‘institutional
responsibilities’’ described above.
Below is a discussion of public
comments related to the implementation
of these changes, using the categories
referenced in the NPRM to highlight
differences from the 1995 regulations.21
Institutional responsibilities: Some
respondents suggested that the
disclosure requirement in the 1995
regulations,22 i.e., SFIs that Investigators
deem related to the PHS-funded
research, is sufficient. We note that the
NPRM’s proposal to expand the
definition of SFI was influenced by the
suggestions of many respondents to the
20 75
FR 28705 (May 21, 2010).
the 1995 regulations, an SFI means
anything of monetary value, including but not
limited to, salary or other payments for services
(e.g., consulting fees or honoraria); equity interests
(e.g., stocks, stock options or other ownership
interests); and intellectual property rights (e.g.,
patents, copyrights and royalties from such rights).
The term does not include: (1) Salary, royalties, or
other remuneration from the applicant Institution;
(2) any ownership interests in the Institution, if the
Institution is an applicant under the SBIR/STTR
programs; (3) income from seminars, lectures, or
teaching engagements sponsored by public or
nonprofit entities; (4) income from service on
advisory committees or review panels for public or
nonprofit entities; (5) an equity interest that when
aggregated for the Investigator and the Investigator’s
spouse and dependent children meets both of the
following tests: does not exceed $10,000 in value
as determined through reference to public prices or
other reasonable measures of fair market value, and
does not represent more than a five percent
ownership interest in any single entity; or (6) salary,
royalties, or other payments that when aggregated
for the Investigator and the Investigator’s spouse
and dependent children over the next 12 months,
are not expected (or, in the case of PHS contracts,
are not reasonably expected) to exceed $10,000.
22 42 CFR 50.604(c)(1) and 45 CFR 94.4(c)(1)
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21 Under
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ANPRM who supported this change. A
few respondents agreed that expanding
SFIs subject to disclosure by an
Investigator to an Institution to include
those that reasonably appear to be
related to the Investigator’s
‘‘institutional responsibilities’’ is
warranted. Many others, however,
suggested that the SFIs to be disclosed
should be limited to those that
reasonably appear to be related to the
Investigator’s ‘‘research
responsibilities.’’ We have considered
this suggestion and believe that since
the definition of ‘‘research
responsibilities’’ is not clear-cut, this
change would once again place the
responsibility on the Investigator for
deciding which SFIs should be
disclosed to the Institution (similar to
the 1995 regulations) and may not
provide the Institutions with the full
complement of information needed to
evaluate the potential for FCOI. For
example, an Investigator is on the board
of a pharmaceutical company and
believes that this service draws on the
Investigator’s clinical expertise rather
than research knowledge. If the SFI
definition is confined to ‘‘research
responsibilities’’, the Investigator may
not disclose the income from this
activity to the Investigator’s Institution.
Such income definitely would fall
under ‘‘institutional responsibilities’’,
however, as the Investigator is on the
clinical faculty of the Institution.
Moreover, we note that the scope of
activities that need to be disclosed by
the Investigator is limited by the fact
that the SFI definition excludes income
from seminars, lectures, or teaching
engagements sponsored by a Federal,
state, or local government agency, an
Institution of higher education as
defined at 20 U.S.C. 1001(a), an
academic teaching hospital, a medical
center, or a research institute that is
affiliated with an Institution of higher
education; or income from service on
advisory committees or review panels
for a Federal, state, or local government
agency, an Institution of higher
education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education.
One respondent proposed that the
regulations specify particular
relationships and types of interests that
should be disclosed. We have
considered this suggestion and believe
that limiting the scope of SFIs that an
Investigator is required to disclose to his
or her Institution may exclude SFIs in
activities that have the potential to
affect the objectivity of PHS-funded
PO 00000
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53263
research. Therefore, we have retained
the language proposed in the NPRM.
One respondent suggested that PHS
funding could change an Investigator’s
institutional responsibilities and
suggested that SFI disclosures should be
based on the anticipated responsibilities
if funding is awarded. We have not
changed the regulations in this regard,
because we believe this concern would
be addressed by the Institution’s FCOI
policy; i.e., any time there is a
significant change in an Investigator’s
institutional responsibilities (whether in
relation to PHS funding or not),
Institutions should consider whether
this would require the Investigator to
update his or her SFI disclosures.
Other respondents questioned
whether specific types of income, such
as clinical work within private or
university practice or teaching a craft,
would need to be disclosed. Income
from any activity that is related to the
Investigator’s institutional
responsibilities as defined by the
Institution that meets the monetary
threshold must be disclosed. Another
suggested that payment related to the
accrual of patients to clinical trials
should be included in the definition. If
the individual receiving the payment
meets the definition of ‘‘Investigator’’
under the regulations, such payment
would be included in the SFI definition
and should be disclosed.23
Monetary threshold: Respondents
submitted a wide range of comments on
the monetary threshold proposed in the
NPRM. Some supported the $5,000
threshold; others suggested that the
threshold of $10,000 in the 1995
regulations should be retained; and
many suggested that the threshold be
lowered even further to $100 or zero.
We have considered all the comments
and we believe that the $5,000 threshold
proposed in the NPRM provides the
appropriate balance between the
administrative burden associated with
disclosure and review of SFIs and the
intended benefit in promoting
objectivity in research.
Some respondents requested that the
disclosure thresholds be harmonized
with those of other Federal agencies
such as the FDA and the National
Science Foundation or with the
disclosure provisions of the Affordable
Care Act. While there may be some
similarity in intent, the numerous
disclosure requirements of other Federal
laws, regulations, or policies are not
necessarily comparable to those
23 Alternatively, if the commenter is concerned
about (improper) payment to an Institution under
these circumstances, we note that institutional
conflicts of interest are addressed in section IV of
this final rule.
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specified in these regulations. For
example, Title VI, Section 6002 of the
Affordable Care Act requires disclosure
by the entities providing the payment.
FDA, for purposes of financial
disclosure by clinical investigators, has
defined significant payment of other
sorts as payments made by the sponsor
of a covered study to the investigator or
the institution to support activities of
the investigator that have a monetary
value of more than $25,000, exclusive of
the costs of conducting the clinical
study or other clinical studies.24 Due to
the extent of potential differences in the
nature, scope, and applicability of
Federal disclosure requirements, we do
not agree that it is feasible to harmonize
all requirements at this time, although
we believe these regulations could serve
as a basis for ongoing collaboration and
coordination regarding the topic of
conflicts of interest.
Other respondents suggested that
different disclosure thresholds should
be instituted for research depending on
whether it involves human participants,
drugs, or devices. As discussed in the
NPRM, we posed a number of questions
in the ANPRM on the issue of whether
the regulations should be amended to
require specific approaches related to
certain types of research or
alternatively, specific types of financial
interests or FCOI.25 The majority of the
respondents to the ANPRM thought that
this approach would not account for the
full range of research projects as well as
the large variation in circumstances in
which FCOI may arise. We agree and
note that the monetary threshold is the
same regardless of the type of research,
financial interest, or identified FCOI at
issue.
Timing: The NPRM proposed to
change the timing for determining
whether remuneration represents an
SFI. The 1995 regulations excluded
aggregated payments (including salary
and royalties) that are ‘‘not expected to
exceed’’ (or, in the case of PHS
contracts, are ‘‘not reasonably expected
to exceed’’) the monetary threshold
‘‘over the next 12 months.’’ Under the
revised definition proposed in the
NPRM, at issue is remuneration
(including salary and any payment for
services not otherwise identified as
salary) received from an entity ‘‘in the
12 months preceding the disclosure.’’
We have included this change in the
final rule; we believe it will help
Institutions and Investigators to
determine more accurately whether or
not a financial interest represents an SFI
because the payments have already
24 21
25 74
CFR 54.2(f).
FR 21612 (May 8, 2009).
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occurred and are likely to have been
documented. Moreover, to the extent an
Investigator receives additional
remuneration from an entity after
completing an initial SFI disclosure,
such remuneration would be subject to
the Investigator’s ongoing disclosure
obligations assuming the monetary
threshold was met or exceeded.
Several respondents suggested that
the 1995 regulations’ disclosure period
is more consistent with the aim of
maintaining objectivity in research.
Some suggested that the time period for
disclosure include both the preceding
and the next 12 months, and one
suggested that the period cover the
duration of the award. We do not agree
with these suggestions. In addition to
disclosing SFIs received in the 12
months preceding the disclosure,
Investigators are required to disclose
new SFIs to the Institution within 30
days, and if payments received after the
initial disclosure give rise to an SFI that
is determined to be an FCOI by the
institutional official(s), the Institution is
required to submit an FCOI report to the
PHS Awarding Component. Consistent
with our proposal in the NPRM, the
final rule also includes a requirement
for annual updates. We believe this
combination of provisions provides
reasonable coverage of an Investigator’s
SFIs related to the PHS-funded research
project, and allows a more accurate
listing of SFIs by Investigators.
Institutions are free to expand upon
these requirements in their institutional
policies and when considering whether
an SFI is an FCOI with regard to the
PHS-funded research.
Some respondents inquired how a
payment or reimbursement that
occurred before a PHS award should be
reviewed in relation to the PHS-funded
research. Although such considerations
are dependent on the context of the SFI,
the regulations do not prevent
Institutions from taking into account
whether the Investigator has an ongoing
financial relationship with the entity
providing the payment or
reimbursement or whether the payment
or reimbursement was limited in
duration.
One respondent suggested that
different disclosure periods should be
instituted for different types of research.
As discussed in the NPRM and above,
we posed a number of questions in the
ANPRM on the issue of whether the
regulations should be amended to
require specific approaches related to
certain types of research or
alternatively, specific types of financial
interests or FCOI. The majority of the
respondents to the ANPRM thought that
this approach would not account for the
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full range of research projects as well as
the large variation in circumstances in
which FCOI may arise. As a result, the
regulations impose uniform
requirements, regardless of the type of
research, financial interest, or identified
FCOI at issue.
Examples of payment for services:
The definition of SFI under the 1995
regulations referenced as examples of
payments for services, receipt of
consulting fees, or honoraria. In the
NPRM, we proposed to add ‘‘paid
authorship’’ and ‘‘travel
reimbursement’’ as additional
examples.26
With regard to ‘‘paid authorship,’’
although it should be clear that receipt
of payment from an entity in exchange
for drafting a publication constitutes
payment for services, we believe it is
important to reference this form of
payment specifically in the regulations.
We are particularly concerned about
situations in which Investigators may
have accepted payment from private
entities, in return for allowing their
names to be used as authors on
publications for which they had very
limited input. This practice has come
under increasing scrutiny in recent
years and we wish to make it clear to
Institutions and Investigators that such
activity may be subject to the disclosure
and reporting requirements depending
on the circumstances of a given case,
such as the amount of payment. One
respondent noted that remuneration
from authorship of textbooks is not
considered an FCOI at their Institution.
We note that the regulations only
require disclosure of such SFI by the
Investigator to his or her Institution. The
Institution makes the determination as
to whether the SFI constitutes an FCOI,
based on its review of the specific
circumstances. Another respondent
suggested that payments to faculty
authors from publishers should be
excluded from the SFI definition while
payments from companies not engaged
primarily in publishing should be
included. We do not agree with this
suggestion, because we believe that it
may be difficult to draw a distinction
between companies engaged primarily
in publishing (i.e., ‘‘publishers’’) and
those that are not, leading to
inconsistent disclosures. Therefore, we
retained the ‘‘paid authorship’’ example
in the definition, as proposed in the
NPRM.
With regard to ‘‘travel
reimbursement,’’ while one respondent
agreed that this should be included in
the SFI definition, many objected to its
inclusion on the grounds that such
26 75
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payments do not constitute income to
the Investigator and requiring their
disclosure would constitute a burden, as
in many cases the Investigator is not
aware of the value of the
reimbursement. We have considered
these comments carefully and
appreciate that for Investigators, travel
to scientific meetings and to present his/
her research to colleagues and other
interested parties is an integral part of
the scientific research enterprise and
affords many important opportunities
for forging relationships and
collaborations among researchers. The
provisions in the revised regulations are
not intended to discourage this type of
travel. We also appreciate that requiring
Investigators to disclose the value of
travel reimbursements could be
difficult, particularly in the case of
sponsored travel, which is paid on
behalf of the Investigator and not
reimbursed to the Investigator, so that
the exact monetary value may not be
readily available. Nonetheless,
depending on the source of funding and
other circumstances (e.g., destination,
duration) of specific travel, the
Institution may consider whether that
sponsored travel could affect the design,
conduct, or reporting of PHS-funded
research. In order to minimize the
burden on the Investigator while
providing the Institution with the
appropriate level of information, we
have added another category (paragraph
2) to the SFI definition that addresses
the disclosure of reimbursed and
sponsored travel. The Institution’s FCOI
policy will specify the details of this
disclosure, which will include, at a
minimum, the purpose of the trip, the
identity of the sponsor/organizer, the
destination, and the duration. Although
the regulations do not require disclosure
of the monetary value of the sponsored
or reimbursed travel, in accordance with
the Institution’s FCOI policy, the
Institutional official(s) can determine if
further information is needed, including
a determination or disclosure of
monetary value, in order to establish
whether the travel constitutes an FCOI
with the PHS-funded research. In
addition, travel that is reimbursed or
sponsored by a Federal, state, or local
government agency, an Institution of
higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education is not subject to this
disclosure requirement.
We considered the alternative of
revising the rule to exclude ‘‘reasonable
and customary’’ travel. We did not
revise the rule in this manner because
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we believe that this puts the
responsibility for defining ‘‘reasonable
and customary’’ onto the Investigator,
which may lead to inconsistency in
disclosure.
Royalties & Intellectual Property:
Under the 1995 regulations, royalties are
included among the ‘‘payments’’ subject
to the $10,000 threshold. Under the
revisions proposed in the NPRM, which
we have implemented, the $5,000
threshold would apply to equity
interests and ‘‘payment for services,’’
which would include salary but not
royalties. Royalties nevertheless are
potentially subject to disclosure, as are
other interests related to intellectual
property. Specifically, the revised
definition applies to any of the
following: intellectual property rights
(e.g., patents, copyrights), royalties from
such rights, and agreements to share in
royalties related to intellectual property
rights. As discussed further below,
however, royalties received by the
Investigator from the Institution would
still be excluded from the SFI definition
if the Investigator is currently employed
or otherwise appointed by the
Institution.
One respondent inquired whether
Investigators should disclose
intellectual property interests when a
patent application is submitted or only
when the patent is granted. Since
income related to an intellectual
property interest may be received before
a patent is issued we would expect
institutional policies to require
disclosure upon the filing of a patent
application or the receipt of income
related to the intellectual property
interest, whichever is earlier. We have
also clarified our intent that the
disclosure requirements include
intellectual property interests by adding
a specific reference to ‘‘interests’’ to the
existing reference to ‘‘rights.’’
Many respondents requested further
clarification as to the thresholds
associated with these intellectual
property interests. The threshold of
$5,000 applies to licensed intellectual
property rights (e.g., patents,
copyrights), royalties from such rights,
and agreements to share in royalties
related to licensed intellectual property
rights. Several respondents suggested
that in the rare cases when unlicensed
intellectual property is held by the
Investigator instead of flowing through
the Institution, it should be excluded
from the definition as it is difficult to
determine the value of such interests.
We agree that it is difficult to determine
the value of such interests, and have
revised the SFI definition to include
intellectual property rights and interests
(e.g., patents, copyrights) upon receipt
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of income related to such rights and
interests. Therefore unlicensed
intellectual property that does not
generate income is excluded.
Nonetheless, such interests have the
potential to become significant and
generate income, at which point they
would become subject to the
regulations.
Exclusions: Consistent with the
NPRM, we have modified the types of
interests that are specifically excluded
from the SFI definition. For example,
the NPRM definition only excludes
income from seminars, lectures, and
teaching engagements, if sponsored by a
Federal, state, or local government
agency, or an Institution of higher
education as defined at 20 U.S.C.
1001(a). Similarly, in the NPRM we
proposed that income from service on
advisory committees or review panels
would only be excluded if from a
Federal, state, or local government
agency, or an Institution of higher
education as defined at 20 U.S.C.
1001(a). We proposed this change due to
the growth of non-profit entities that
sponsor such activities since the 1995
regulations were promulgated. Some of
these non-profit entities receive funding
from for-profit entities that may have an
interest in the outcome of the
Investigators’ research (e.g., foundations
supported by pharmaceutical
companies). One respondent suggested
that all income should be included in
the SFI definition. We believe that the
final rule strikes an appropriate balance
regarding the income that must be
disclosed as an SFI. On the other hand,
we received many suggestions for
additional types of non-profit
Institutions for which income from
seminars, lectures, or teaching
engagements and from service on
advisory committees or review panels
could be excluded, e.g., professional or
engineering societies, Institutions that
provide competitive research grants,
academic medical centers, and
Institutions that meet the standards of
the Accreditation Council for
Continuing Medical Education. Other
respondents suggested that disclosure
be limited to income from non-profit
organizations that are primarily
supported by for-profit companies.
Another suggested the definition
exclude activities that primarily support
higher education. We have not adopted
all these suggestions because we believe
that difficulties in identifying the
funding sources of many non-profit
organizations would pose a greater
obstacle to Investigators when deciding
which SFI to disclose to their Institution
than they would to the Institution when
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evaluating such SFI. Therefore, it would
seem preferable for the Institution to
receive and evaluate the information.
Nonetheless, we agree with
respondents that limiting exclusions
from disclosure to income from Federal,
state, or local government agencies, and
Institutions of higher education as
defined at 20 U.S.C. 1001(a) is
unnecessarily narrow. Therefore, we
have revised the SFI definition in the
final rule to exclude salary, royalties, or
other remuneration paid by the
Institution to the Investigator if the
Investigator is currently employed or
otherwise appointed by the Institution;
any ownership interest in the Institution
held by the Investigator, if the
Institution is a commercial or for-profit
organization; income from seminars,
lectures, or teaching engagements
sponsored by a Federal, state, or local
government agency, an Institution of
higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education; or income from
service on advisory committees or
review panels for a Federal, state, or
local government agency, an Institution
of higher education as defined at 20
U.S.C. 1001(a), an academic teaching
hospital, a medical center, or a research
institute that is affiliated with an
Institution of higher education.
One respondent inquired whether
income received from seminars,
lectures, or teaching engagements
sponsored by a Federal, state, or local
government agency; or income from
service on advisory committees or
review panels for a Federal, state, or
local government agency, but paid by a
private contract organization acting for
that government agency, is excluded
from the SFI definition. If a private
organization is acting as a contractor to
the Federal, state, or local government
agency, for the purposes of these
regulations, such income is excluded
from the definition.
The 1995 regulations excluded from
the SFI definition any ownership
interests in the Institution, if the
Institution is an applicant under the
SBIR Program. As proposed in the
NPRM, we have broadened the
exclusion to cover any ownership
interests in the Institution if the
Institution is a commercial or for-profit
organization (whether or not the
Institution is an applicant under the
SBIR Program). A few respondents
requested further clarification, of
situations in which an Investigator is
employed by an Institution and also has
equity in a for-profit company. In those
cases, his or her equity would only be
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excluded from disclosure requirements
when the for-profit company is the
Institution that is applying for, or that
receives, the PHS research funding in
which the Investigator is participating.
As proposed in the NPRM, we have
also limited the exclusion in the 1995
regulations for salary, royalties, or other
remuneration paid by the Institution to
the Investigator to circumstances in
which the Investigator is currently
employed or otherwise appointed by the
Institution. In response to questions
from a number of respondents, we have
also clarified that intellectual property
rights assigned to the Institution and
agreements to share in royalties related
to such rights are also excluded from the
SFI definition. Other respondents
suggested that royalties and intellectual
property rights that are provided by the
Institution should not be excluded from
the definition as they could affect the
objectivity of the PHS-funded research.
We do not believe it would be useful to
increase the disclosure burden on the
Investigator by requiring disclosure to
the Institution of information the
Institution already has available.
However, we note that Institutions have
the flexibility to require such
disclosures in their own policies. One
respondent suggested that such royalties
continue to be excluded from the SFI
definition if an Investigator transfers to
another Institution. In that case,
however, the new Institution is not the
source of the royalties and the exclusion
would not apply; therefore such
royalties would be included in the SFI
definition.
Many respondents requested that
income from mutual funds and
retirement accounts be explicitly
excluded from Investigator disclosure
requirements, to the extent that
Investigators do not control the
investment decisions made in these
vehicles. We have provided guidance in
the form of Frequently Asked Questions
on the NIH Web site recognizing that
interests in a pooled fund such as a
diversified mutual fund may be
sufficiently remote that it would not
reasonably be expected to create a
conflict of interest for a PHS-funded
Investigator.27 We have revised the
regulations in accordance with this
guidance to exclude income from
27 https://grants.nih.gov/grants/policy/
coifaq.htm#427.
Am I required to disclose interests in mutual
funds?
Please refer to your Institution’s policy. An
interest in a pooled fund such as a diversified
mutual fund may be sufficiently remote that it
would not reasonably be expected to create a
conflict of interest for an Investigator funded by the
NIH.
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investment vehicles, such as mutual
funds and retirement accounts, as long
as the Investigator does not directly
control the investment decisions made
in these vehicles.
One respondent requested that the
definition cover any ‘‘security,’’ as
defined by reference to the Securities
Act of 1933, as amended, and suggested
that there is no reason to exclude debt
instruments. Although we have not
implemented this suggestion in the final
rule, we note that our definition
addresses stock, a specific element of
the definition of ‘‘security’’ under the
Securities Act of 1933, 15 U.S.C. 77a et
seq., and that the regulations do not
expressly exclude debt instruments. A
few respondents suggested that the
definition should go beyond the
Investigator’s spouse and dependent
children to include interests held by
more distant family members and/or
friends. We have not made this change,
because we believe that it would expand
the scope of the regulations
unnecessarily and create ambiguity.
Some respondents suggested that the
SFI definition include payments from
individuals, as well as entities. We have
not made this change because we
typically would expect individual
payors to be acting on behalf of or in
connection to entities, and because the
source of payment is not the primary
focus of the SFI definition.
Several respondents requested that we
revise the SFI definition to include
‘‘domestic partners.’’ Although we
appreciate the interest in identifying
individuals who share assets with, or
control assets on behalf of, the
Investigator through civil unions,
powers of attorney, or other
arrangements, we have not made that
specific change to the final rule because
we believe it is beyond the scope of
these regulations to define the term
‘‘domestic partners.’’ However, we note
that Institutions have the flexibility to
incorporate this suggestion into their
policies.
Finally, as a technical correction to
the language proposed in the NPRM, we
have deleted the reference to ‘‘except as
otherwise specified in this definition,’’
to improve the overall clarity of the SFI
definition.
16. Small Business Innovation
Research (SBIR) Program. In the NPRM
we removed the definition in the 1995
regulations for the SBIR Program since,
in the proposed regulations this
program was no longer excluded, and
we had not separately defined other
HHS research programs that were
subject to the proposed regulations. As
the SBIR Phase I applications are
excluded from the final rule (see
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discussion above), we are including the
definition in the final rule.
Responsibilities of Institutions
Regarding Investigator Financial
Conflicts of Interest (42 CFR 50.604, 45
CFR 94.4)
Consistent with the NPRM, we have
substantially revised the responsibilities
of Institutions regarding Investigator
FCOI.
The 1995 regulations provided that
each Institution must maintain an
appropriate written, enforced policy on
conflicts of interest that complies with
the regulations.28 In the NPRM we
proposed revising this provision to
require an Institution not only to
maintain an up-to-date, written,
enforced FCOI policy that complies
with the regulations, but also to make
such policy available via a publicly
accessible Web site. We have included
this requirement in the revised
regulations at 42 CFR 50.604(a) and 45
CFR 94.4(a), because we believe that it
fosters greater transparency and
accountability with regard to
institutional policies. Moreover, we
have clarified that if an Institution does
not have a current presence on a
publicly accessible Web site (and only
in those cases), the Institution may
make the information available in
writing within five business days of any
request. If, however, the Institution
acquires a presence on a publicly
accessible Web site during the time of
the PHS award, the requirement to post
the information on that Web site will
apply within 30 calendar days.
One respondent suggested that
Institutions’ policies should be filed
with the PHS. We believe the
requirement to make the policies
publicly available renders this
suggestion unnecessary. One respondent
suggested that Institutions should be
required to ‘‘prominently’’ post their
FCOI policy on the Institution’s Web
site so that it would be easily accessible.
We have not revised the regulations to
include this requirement, because we
understand that term could create
ambiguity. We have used the term
‘‘publicly accessible’’ to communicate
our intention that the public can readily
obtain the information required under
these regulations. In the event of any
questions, we encourage members of the
public to contact Institutions for
instructions as to the location of their
policy, and to report any enforcement
concerns to the PHS Awarding
Component. One respondent inquired as
to whether this provision applies to
subrecipients. We note that
28 42
CFR 50.604(a) and 45 CFR 94.4(a).
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subrecipients that rely on their own
policies would be subject to this
requirement. However, if the
subrecipient is relying on the policies of
the awardee Institution, that Institution
would be responsible for posting the
policy.
Consistent with the NPRM, we have
also revised this section to clarify that
if an Institution’s policy on FCOI
includes standards that are more
stringent than the regulations, the
Institution shall adhere to its policy and
shall provide FCOI reports regarding
identified FCOI to the PHS Awarding
Component in accordance with the
Institution’s own standards within the
time periods required in the regulations.
Many respondents indicated that this
provision would provide a substantial
disincentive to Institutions to adopt
more stringent standards than those set
forth in the regulations, and could lead
to a lack of consistency in reporting and
increased confusion.
We appreciate the concerns raised
and discussed them carefully before
making the final decision to retain this
language in the final rule because of
several mitigating factors. For example,
the 1995 regulations indicated that the
regulations constituted a minimum
standard; i.e., the Institution retained
flexibility to add requirements to those
in the regulations, as long as such
requirements are consistent with the
regulations. Specifically, 42 CFR 50.605
and 45 CFR 94.5 state: ‘‘In addition to
the types of conflicting financial
interests described in this paragraph
that must be managed, reduced, or
eliminated, an Institution may require
the management of other conflicting
financial interests in its policy on
financial conflicts of interest, as the
Institution deems appropriate.’’
Moreover, in regulatory guidance on
this issue with regard to grants and
cooperative agreements, NIH stated that
Institutions could impose more
stringent requirements than those in the
regulation as long as the Institution’s
policies meet the minimum
requirements of the regulation and each
Investigator is informed of the
Institution’s policies; of the
Investigator’s disclosure
responsibilities; and of the regulation.29
In addition, the principle that an
Institution must follow its own policies,
even if they go beyond—but as long as
they are consistent with—Federal
policies and regulations, is an
established standard of NIH grants
policies and applies to the
implementation of all terms and
29 NIH ‘‘Frequently Asked Question’’ B.4 at
https://grants.nih.gov/grants/policy/coifaq.htm.
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conditions of award for grants and
cooperative agreements. Finally, we
weighed the possible inconsistency in
reporting resulting from implementation
of this provision against the possible
ramifications of the PHS Awarding
Component being unaware of an FCOI
related to PHS-funded research that was
identified by the Institution. We
concluded that full reporting of all
Institution-identified FCOIs related to
PHS-funded research is necessary for
appropriate accountability by the
Institution and for robust oversight by
the PHS Awarding Component.
Although the regulations do not specify
a standardized Federal reporting form,
as suggested by one respondent, the
regulations identify necessary elements
of the report (e.g., 42 CFR 50.605(b)(3)
and 45 CFR 94.5(b)(3)), and NIH
provides a framework for reporting
those elements through its online
reporting system.
Also consistent with the NPRM, we
are incorporating the requirement in the
1995 regulations that each Institution
must inform each Investigator of its
policy on conflicts of interest, of the
Investigator’s disclosure
responsibilities, and of these
regulations. This requirement is
addressed as a new paragraph (b), and,
as proposed in the NPRM, it includes an
Investigator training requirement.
However, we have modified the training
requirement to accommodate
suggestions raised in public comments.
Specifically, the NPRM proposed that
Institutions require Investigators to
complete training regarding the
Institution’s FCOI policy, the
Investigator’s responsibilities regarding
disclosure of SFI, and the regulations,
prior to engaging in PHS-funded
research and, thereafter, at least once
every two years.
Although some respondents agreed
with the training requirements as
proposed, many other respondents
raised reasonable alternatives. For
example, most of the respondents on
this topic agreed with the requirement
for initial training of Investigators prior
to engaging in PHS-funded research but
thought that the Institution should
determine the training frequency
thereafter or that a period longer than
two years should be specified. We
considered the comments carefully and
agree that every two years may be too
frequent; however, we believe it is
important to ensure that Investigators
receive training beyond the initial
period in order to maintain objectivity
in PHS-funded research over the long
term. Therefore, we have revised the
provision in 42 CFR 50.604(b) and 45
CFR 94.4(b) to require Institutions to
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train Investigators prior to engaging in
research related to any PHS-funded
grant or contract, and at least every four
years (a typical period of a PHS-funded
research grant), and immediately when
any of the following circumstances
apply: (1) The Institution revises its
financial conflicts of interest policies or
procedures in any manner that affects
the requirements of Investigators; (2) an
Investigator moves to a new Institution;
or (3) an Institution finds that an
Investigator is not in compliance with
the regulations or with the Institution’s
financial conflicts of interest policy or
management plan.
One respondent proposed that
training be required only of those PHSfunded Investigators who have FCOIs.
We disagree with this suggestion, as this
change would not fulfill the purpose of
the training requirement, which is to
inform all Investigators conducting
PHS-funded research of the Institution’s
FCOI policy, their responsibilities
regarding disclosure of SFI, and the
regulations. A few respondents
suggested that the mandated training
include a discussion of ethical issues
surrounding FCOI. We note that as long
as the training covers the Institution’s
FCOI policy, the Investigator’s
responsibilities regarding disclosure of
SFI, and the regulations, Institutions are
free to adopt this suggestion, and to
include any other issues they deem
essential to accomplishing the stated
objective of the training. One
respondent suggested that the
Institution’s training materials be
submitted to the PHS Awarding
Component and that Investigators be
required to certify completion of
training to the PHS Awarding
Component. We believe that this
suggestion is addressed by the existing
HHS requirement that institutional
officials are responsible for ensuring
compliance with all applicable Federal
laws and regulations, including required
certifications and assurances; such
officials must provide a certification
regarding compliance with the
regulation—including the training
requirement—with each application for
funding.
Finally, several respondents requested
that HHS provide training materials that
Institutions can use to fulfill this
requirement, as well as seminars or
workshops that address implementation
of the revised regulations. As in the
past, NIH/HHS will continue to engage
in outreach activities to promote
compliance with the regulations, and
will make resources available online,
including guidance on policy
development and a regulatory training
module for Institutions and
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Investigators. Institutions should adapt
these resources to incorporate
information related to their specific
policies and procedures, as needed.
Consistent with the NPRM, we have
also implemented clarifications to the
requirement in the 1995 regulations
that, if the Institution carries out the
PHS-funded research through
subrecipients (e.g., subcontractors or
consortium members), the Institution
must take reasonable steps to ensure
that Investigators working for
subrecipients comply with the
regulations, either by requiring those
Investigators to comply with the
Institution’s policy or by requiring the
subrecipients to provide assurances to
the Institution that will enable the
Institution to comply with the
regulations. As proposed in the NPRM,
we are addressing these changes in a
new subsection (c), though we are
implementing minor changes to the
proposed language to improve overall
clarity as follows: An Institution that
carries out the PHS-funded research
through a subrecipient must incorporate
as part of a written agreement with the
subrecipient terms that establish
whether the FCOI policy of the awardee
Institution or that of the subrecipient
will apply to the subrecipient’s
Investigators. If the subrecipient’s
Investigator must comply with the
subrecipient’s FCOI policy, the
subrecipient shall certify as part of the
agreement referenced above that its
policy complies with the regulations. If
the subrecipient cannot provide such
certification, the agreement shall state
that subrecipient Investigators are
subject to the FCOI policy of the
awardee Institution for significant
financial interests that are directly
related to the subrecipient’s work for the
awardee Institution.
Additionally, if the subrecipient’s
Investigators must comply with the
subrecipient’s FCOI policy, the
agreement referenced above shall
specify time period(s) for the
subrecipient to report all identified
FCOI to the awardee Institution. Such
time period(s) shall be sufficient to
enable the awardee Institution to
provide timely FCOI reports, as
necessary, to the PHS as required by the
regulations. Alternatively, if the
subrecipient’s Investigators must
comply with the awardee Institution’s
FCOI policy, the agreement referenced
above shall specify time period(s) for
the subrecipient to submit all
Investigator disclosures of SFIs to the
awardee Institution. Such time period(s)
shall be sufficient to enable the awardee
Institution to comply timely with its
review, management, and reporting
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obligations under the regulations.
Subsection (c) also requires that the
Institution provide FCOI reports to the
PHS regarding all FCOIs of all
subrecipient Investigators consistent
with the regulations. We believe these
changes will clarify for Institutions and
their subrecipients the requirements of
both parties, which will promote greater
compliance with the regulations.
Many respondents were concerned
that these provisions would be difficult
to operationalize as written in the
NPRM, particularly in the case of
foreign organizations. They suggested
that awardee Institutions would not
reasonably be able to evaluate the FCOI
policies of the subrecipient Institution.
We believe that this concern is
alleviated by the requirement of a
written agreement to reinforce a clear
understanding of the expectations of the
subrecipient and awardee Institution,30
depending on whose policy will apply.
To address a concern raised by another
respondent, we have also added
language to limit the SFI reported to the
awardee Institution to those that are
directly related to the subrecipient’s
work for the awardee Institution.
Some respondents suggested that the
subrecipients report FCOIs identified for
their Investigators directly to the PHS
Awarding Component. Others proposed
that subrecipients that are the direct
recipients of other awards from the PHS
Awarding Component be exempt from
the certification process. We disagree
with both suggestions. The PHS
Awarding Component has a direct
relationship only with the awardee
Institution. Therefore, the awardee
Institution is responsible for providing
FCOI reports to the PHS regarding all
financial conflicts of interest of all
subrecipient Investigators, consistent
with the regulations. These expectations
apply whether or not the subrecipient
serves as an awardee Institution to the
PHS Awarding Component on other
awards, as each award is considered
separately for purposes of compliance
with the regulations.
One respondent noted that there is no
timeline specified for Institutions to
provide the PHS all FCOI reports of all
subrecipient Investigators. We have
clarified our expectation that
Institutions report subrecipientidentified FCOIs prior to the
expenditure of funds and within 60
days of any subsequently identified
FCOI by adding this language to
subsection (c)(2).
One respondent proposed that the
agreement between the awardee and
30 The term ‘‘awardee Institution’’ is used here to
distinguish it from the subrecipient Institution.
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subrecipient Institutions, and the
subrecipients’ FCOI policies should be
filed with the PHS. We believe that the
submission of this information is not
necessary unless specifically requested
by the PHS Awarding Component since
applicable HHS policy requires
Institutions to certify compliance with
the requirements of this and other
regulations in each application or
solicitation for funding. An Institution’s
failure to comply with the terms and
conditions of award, including this
regulation, may cause HHS to take one
or more enforcement actions, depending
on the severity and duration of the
noncompliance.
Paragraph (d) of the NPRM required
that an Institution designate an
institutional official(s) to solicit and
review disclosures of SFIs from each
Investigator who is planning to
participate in PHS-funded research. A
few respondents suggested that the
regulations be revised to stipulate the
requirements for the designated
official(s) and how the Institution
should ensure that the designated
official(s) do not themselves have
conflicts of interest. We have not
implemented those changes because we
believe that the Institution is in the best
position to determine the qualifications
and characteristics of the designated
official(s) in the Institution’s policy.
The 1995 regulations required that, by
the time an application or contract
proposal is submitted to the PHS, each
Investigator who is planning to
participate in the PHS-funded research
has submitted to the designated
official(s) a listing of his/her known
SFIs (and those of his/her spouse and
dependent children): (i) That would
reasonably appear to be affected by the
research for which PHS funding is
sought; and (ii) in entities whose
financial interests would reasonably
appear to be affected by the research.
All financial disclosures must be
updated during the period of award,
either on an annual basis or as new
reportable SFIs are obtained. As
discussed above, the revised SFI
definition includes SFIs that reasonably
appear related to the Investigator’s
‘‘institutional responsibilities.’’
Therefore, the requirement in the 1995
regulations to disclose SFIs, which we
have adopted in paragraph (e) of the
final rule, incorporates this revised
definition, such that the scope of
Investigator disclosures is no longer
project specific, but rather pertains to
the Investigator’s institutional
responsibilities. In response to a
suggestion from a respondent, we have
clarified that Investigators who have not
previously disclosed their SFIs to the
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Institution’s designated official(s) must
do so no later than the time of
application or date of contract proposal
submitted for PHS-funded research.
One respondent suggested that
Institutions should establish an internal
database for disclosures of Investigator
SFI which could be easily updated. We
have not included this requirement
because we are concerned that it could
impose an unnecessary administrative
burden and expense to Institutions. As
long as Institutions have a process in
place to comply fully with all regulatory
requirements, they may collect
disclosures from Investigators in the
manner that is most appropriate for
their policies and procedures.
Consistent with our proposal in the
NPRM, as part of paragraph (e), we have
also revised and clarified an
Investigator’s annual and ongoing,
including ad hoc, disclosure
obligations. Specifically, in addition to
requiring that each Investigator who is
planning to participate in the PHSfunded research disclose to the
Institution’s designated official(s) the
Investigator’s SFIs (and those of the
Investigator’s spouse and dependent
children), the Institution must also
require each Investigator who is
participating in the PHS-funded
research to submit an updated SFI
disclosure:
(1) At least annually during the period
of the award, including disclosure of
any information that was not disclosed
initially to the Institution or in a
subsequent SFI disclosure, and
disclosure of updated information
regarding any previously disclosed SFI
(e.g., the updated value of a previously
disclosed equity interest). A number of
respondents agreed that annual
disclosure by Investigators is necessary
but suggested that the Institution should
be free to determine the specific timing.
We have revised paragraph (e)(2) to
adopt this suggestion. Because of this
change, we have declined the suggestion
of another respondent to link the annual
disclosure period to the Fiscal Year
calendar. Another respondent suggested
that the disclosure period should be
event-driven, rather than annual. While
we continue to believe that annual
disclosure is appropriate, we note that
the requirement for disclosing updated
SFIs in subsection (e)(3), as described
below, should address this concern by
providing Institutions with information
about Investigator SFIs that arise
between the annual disclosure periods.
(2) Within 30 days of discovering or
acquiring (e.g., through purchase,
marriage, or inheritance) a new SFI. A
few respondents suggested that 30 days
is too short a period for disclosure of
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53269
new SFIs, and one respondent suggested
that this requirement be changed to 60
days, consistent with the time-period
specified in other parts of the
regulations. After carefully considering
the appropriate balance between
affording Investigators sufficient time to
disclose new SFIs as they arise and the
need to review SFIs related to PHSfunded research in a timely manner, we
have retained the 30 day period in
subsection (e)(3).
A respondent suggested that requiring
disclosure when an Investigator is
planning to participate in PHS-funded
research is too imprecise and requested
that this phrase be revised. We have
revised subsection (e)(1) to specify that
disclosures must occur no later than the
time of application or date of contract
proposal submitted for PHS-funded
research.
The 1995 regulations required an
Institution to provide guidelines
consistent with the regulations for the
designated official(s) to identify
conflicting interests and take such
actions as necessary to ensure that such
conflicting interests will be managed,
reduced, or eliminated. Consistent with
our proposal in the NPRM, we have
reorganized and expanded this
requirement in a re-designated
paragraph (f), to clarify an Institution’s
obligations. First, the guidelines must
address two related tasks, specifically,
determination of whether an
Investigator’s SFI is related to the PHSfunded research and, if so related,
whether the SFI is an FCOI. Under the
1995 regulations, the Investigator bore
the responsibility for determining the
relatedness of an SFI to the PHS-funded
research as part of the disclosure
process.
As discussed above, however, we
have revised the definition of SFI to
address ‘‘institutional responsibilities’’;
consistent with this change, we have
shifted the responsibility for
determining whether an Investigator’s
SFI is related to PHS-funded research to
the Institution. Specifically, an
Investigator’s SFI is related to PHSfunded research when the Institution,
through its designated official(s),
reasonably determines that the SFI:
could be affected by the PHS-funded
research; or is in an entity whose
financial interest could be affected by
the research. Although one respondent
suggested that this definition is not
sufficiently inclusive, we believe it
encompasses the range of relationships
between an Investigator’s SFI and PHSfunded research. We note that this
definition has been in effect since the
1995 regulations and remains consistent
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with the guidance that NIH/HHS has
offered on this issue since that time.
Many respondents agreed that the
responsibility for determining whether
an Investigator’s SFI is related to the
PHS-funded research should ultimately
rest with the Institution; however, they
were concerned that the proposed
revisions in the NPRM did not allow
Institutions to involve the Investigator
in this process. They suggested that
requiring Institutions to make this
determination without the input of the
Investigator would make the decisionmaking process more challenging.
Because this was not the intent of the
proposed language, we have revised
paragraph (f) to explicitly state that the
Institution may involve the Investigator
in the designated official(s)’s
determination of whether an SFI is
related to the PHS-funded research. A
few respondents suggested this
responsibility should remain with the
Investigator. We have weighed this
suggestion and believe that the revised
language strikes the appropriate balance
between the Institution’s ultimate
responsibility for reviewing Investigator
disclosures and the Investigator’s
responsibility to disclose all SFIs related
to his or her institutional
responsibilities.
In the Extension Notice, we requested
comment as to whether the regulations
should further clarify that, as part of the
Institution’s FCOI determination
process, institutional officials must
consider whether an Investigator’s SFI
was previously determined to be an
FCOI at another Institution and subject
to a management plan with regard to
other PHS-funded research project(s).
Many respondents suggested that
requiring institutional officials to
consider information on an FCOI from
another Institution is unnecessary, as
information regarding FCOIs would be
available on a public Web site, as per
the proposed revisions in the NPRM.
They suggested that Institutions should
be free to use their own policies and
procedures to comply with the
regulations. We have considered these
comments and agree. With the
expansion of Investigator disclosure to
include all SFIs related to their
institutional responsibilities and the
requirement to ensure public
accessibility of information about FCOIs
of senior/key personnel for research
grants and cooperative agreements and
key personnel for research contracts, the
likelihood of an Institution not receiving
information about a particular SFI or
FCOI is minimized.
One respondent suggested the
following alternative approach: in a case
where an Investigator moves from one
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Institution to another, the PHS
Awarding Component would mediate
the transfer of information related to any
identified FCOI from the previous
Institution to the new one, and the
receiving Institution, while not bound
by any previous management plan,
would have to advise the PHS Awarding
Component of its decision regarding
that FCOI. Another suggested that
Institutions should be required to notify
the PHS Awarding Component of the
imposition of a penalty on Investigators
that limits their participation in PHSfunded research, and that the PHS
Awarding Component should create a
registry of these Investigators. In light of
these comments, we have specified that
updated disclosures should include any
FCOI identified on a PHS-funded
project that was transferred from
another Institution. We also note that, as
specified in 42 CFR 50.606(b) and 45
CFR 94.6(b), the HHS may inquire at
any time (before, during, or after award)
into any Investigator disclosure of
financial interests and the Institution’s
review of, and response to, such
disclosure, whether or not the
disclosure resulted in the Institution’s
determination of an FCOI. This would
include situations in which an
Investigator moves from one Institution
to another.
To provide clarification regarding the
determination of whether an
Investigator’s SFI is an FCOI, the redesignated paragraph (f) incorporates
modified language moved from
paragraph (a)(1) of the 1995 regulations,
consistent with the NPRM. Specifically,
this paragraph provides that an FCOI
exists when the Institution, through its
designated official(s), reasonably
determines that the SFI could directly
and significantly affect the design,
conduct, or reporting of the PHS-funded
research. As discussed above, the
regulations also incorporate a revised
definition of FCOI that is based on this
language.
Consistent with our proposal in the
NPRM, we have included the
requirement in the 1995 regulations
regarding FCOI management
responsibilities in a separate paragraph
(g), in which we clarified that the
requirement includes management of
any financial conflicts of a subrecipient
Investigator pursuant to paragraph (c) of
the revised regulations described above.
We have also cross-referenced the
Institution’s revised management
responsibilities specified in 42 CFR
50.605(a) and 45 CFR 94.5(a), including
the development and implementation of
a management plan and, if necessary, a
retrospective review and a mitigation
report regarding how any identified bias
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was addressed, as discussed in further
detail below. As a related matter, we
have included a new paragraph (h) that
cross-references the Institution’s revised
and expanded reporting requirements in
the new paragraphs 42 CFR 50.605(b)
and 45 CFR 94.5(b).
Consistent with our proposal in the
NPRM, we have retained, but redesignated, the requirement of
paragraph (e) of the 1995 regulations,
i.e., Institutions must maintain records
of all financial disclosures and all
actions taken by the Institution with
respect to each FCOI for at least three
years from the date of submission of the
final expenditures report or final
payment, or where applicable, for the
other time periods specified in 45 CFR
74.53(b) or 48 CFR part 4, subpart 4.7.
Specifically, in paragraph (i) of 42 CFR
50.604 and 45 CFR 94.4, we have
included a responsibility to maintain
records relating to all Investigator
disclosures of financial interests and the
Institution’s review of, and response to,
such disclosures (whether or not a
disclosure resulted in the Institution’s
determination of an FCOI) and actions
under the Institution’s policy or
retrospective review, if applicable, for
that time period. We believe that this
revision helps clarify for Institutions our
intent for the record retention obligation
to apply not only in cases in which the
Institution has identified an FCOI, but
to all Investigator SFI disclosures,
whether or not such disclosure
generated a response by the Institution.
One respondent suggested that
retaining records for three years is
insufficient. We disagree; this
requirement is not substantially
different from the requirement in the
1995 regulations, and is consistent with
the PHS record retention policy.
Another suggested that, since some
awards continue for many years and
disclosures now relate to the
institutional responsibilities of
Investigator, all records would have to
be retained indefinitely. We disagree; as
described in the NIH grants policy
statement (https://grants.nih.gov/grants/
policy/nihgps_2010/
nihgps_ch8.htm#_Toc271264975),
records relating to all Investigator
disclosures of financial interests and the
Institution’s review of, and response to,
such disclosures, do not need to be
retained indefinitely. Instead, the
information must be retained for each
competitive segment for a period of
three years following the date the final
expenditures report or final invoice is
submitted to the PHS Awarding
Component. In response to another
comment, we also note that the record
retention requirements in this paragraph
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apply to records of all financial
disclosures and actions under the
Institution’s policy, even if the policy is
more stringent than the regulations.
Additionally, the 1995 regulations
required at paragraph (f) that
Institutions establish adequate
enforcement mechanisms and provide
for sanctions where appropriate.
Consistent with our proposal in the
NPRM, we have revised this obligation
in a re-designated paragraph (j) to
require an Institution not only to
establish adequate enforcement
mechanisms and provide for employee
sanctions, but also to provide for other
administrative actions to ensure
Investigator compliance as appropriate.
One respondent suggested that the
choice of enforcement mechanisms be
left to the discretion of each Institution,
and that the PHS should not prescribe
specific enforcement mechanisms for
use in any type of situation. We note
that the revised language strikes a
balance between preserving the
Institution’s discretion in this regard
and in enabling the PHS Awarding
Component to exercise proper oversight;
e.g., the language does not specify
particular actions as ‘‘adequate’’ or
‘‘appropriate,’’ implicitly recognizing
that the Institution and the PHS
Awarding Component make those
judgments on a case-by-case basis.
Another respondent suggested that we
consider revising the regulations to
specify that FCOI committees, i.e.,
institutional official(s), can disapprove
or suspend PHS funding of Investigators
who are not in compliance with these
regulations. While this example may
indeed account for appropriate action(s)
under this provision and/or under the
Remedies sections, we have not
specified any one action in this
particular context because of the need
for discretion by the Institutions and the
PHS Awarding Components, to account
for the specific circumstances at issue.
Additionally, providing this example in
the regulatory text could create
confusion between the suspension of an
Investigator by an Institution under
these regulations and the suspension or
debarment of an Investigator by the PHS
Awarding Component under 2 CFR part
376.
One respondent suggested that the
PHS/HHS should be given enforcement
power over any disclosure of significant
financial interest that, although in
technical compliance with the
regulations is part of a plan or scheme
to avoid the disclosure requirements,
and referenced the Securities Act of
1933, as amended. We have not
implemented this suggestion because
we believe this concern is mitigated by
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the aforementioned revisions to this
section and by the ability of the HHS to
inquire at any time (before, during, or
after award) into any Investigator
disclosure of financial interests and the
Institution’s review of, and response to,
such disclosure, whether or not the
disclosure resulted in the Institution’s
determination of an FCOI.
Finally, consistent with the NPRM,
we have revised the certification
requirement that was set forth in
paragraph (g) of the 1995 regulations.
Re-designated paragraph (k) requires an
Institution to certify that the Institution
(1) Has in effect at that Institution an upto-date, written, and enforced
administrative process to identify and
manage FCOI with respect to all
research projects for which funding is
sought or received from the PHS; (2)
shall promote and enforce Investigator
compliance with the regulations’
requirements including those pertaining
to disclosure of SFIs; (3) shall manage
FCOI and provide initial and ongoing
FCOI reports to the PHS consistent with
the regulations; (4) agrees to make
information available, promptly upon
request, to the HHS relating to any
Investigator disclosure of financial
interests and the Institution’s review of,
and response to, such disclosure,
whether or not the disclosure resulted
in the Institution’s determination of an
FCOI; and (5) shall fully comply with
the requirements of the regulations.
Notably, this revised paragraph
eliminates much of the certification
language in the 1995 regulations
regarding an Institution’s reporting
obligations. This change is consistent
with other critical changes to the
regulations that we have implemented;
specifically, we have substantially
revised and expanded the reporting
requirements, and included a discussion
of such requirements in the revisions to
42 CFR 50.605(b) and 45 CFR 94.5(b), as
discussed below.
Management and Reporting of Financial
Conflicts of Interest (42 CFR 50.605, 45
CFR 94.5)
Consistent with the NPRM, we have
revised and expanded substantially the
provisions of the 1995 regulations
regarding management of FCOI to
address requirements for both
management and reporting of FCOI.
The 1995 regulations require at
paragraph (a), that an Institution’s
designated official(s) review all
financial disclosures and determine
whether a conflict of interest exists; i.e.,
the designated official(s) reasonably
determines that an SFI could directly
and significantly affect the design,
conduct, or reporting of the PHS-funded
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53271
research. If a conflict is identified, the
official(s) must determine what actions
should be taken by the Institution to
manage, reduce, or eliminate it.
Paragraph (a) also provides examples of
conditions or restrictions that might be
imposed to manage conflicts of interest,
specifically public disclosure of SFIs,
monitoring of research by independent
reviewers, modification of the research
plan, disqualification from participation
in all or a portion of the research funded
by the PHS, divestiture of SFIs, or
severance of relationships that create
actual or potential conflicts.
Per our proposal in the NPRM, we
have revised the above language as part
of a re-designated paragraph (a)(1) to
require that, prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the designated
official(s) of an Institution shall,
consistent with paragraph (f) of the
preceding section (42 CFR 50.604 or 45
CFR 94.4): review all Investigator
disclosures of SFIs; determine whether
any SFIs relate to PHS-funded research;
determine whether an FCOI exists; and,
if so, develop and implement a
management plan that shall specify the
actions that have been, and shall be,
taken to manage such FCOI. As noted in
the preceding section, the Institution
may involve the Investigator in
determining whether an SFI is related to
PHS-funded research.
One respondent suggested that this
provision would require an Institution
to identify and manage FCOI in advance
of the Notice of Award and suggested a
transition period of 60 days after award
for the implementation of this
provision, with an interim management
plan in place during that time. In
response, we note that this requirement
refers to actions that need to be taken
prior to expenditure of funds, not
necessarily in advance of the award
itself. In addition, development and
implementation of an interim
management plan for all identified
FCOIs (instead of only those identified
after the retrospective review discussed
below) would seem to place an
additional burden on the process of
managing an identified FCOI, so we
have declined that suggestion.
Some respondents suggested that the
PHS Awarding Component or some
other outside agency, but not
Institutions, should have the
responsibility for reviewing Investigator
SFIs and identifying and managing
FCOI, citing possible conflicts of
interest of the designated institutional
official(s), or the Institutions
themselves. After considering this, we
believe that the revisions that we have
made to the regulations strike the
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appropriate balance between the
responsibilities of the Institution for
determining and managing Investigator
FCOI and the oversight responsibilities
of the PHS Awarding Component. We
believe that our revisions will
strengthen the roles of all involved in
this process. Additionally, we have
included a discussion of institutional
conflicts of interest in section IV of this
final rule.
The most significant change that we
have made to this section is the
management plan requirement that we
introduced in the NPRM. Although the
1995 regulations required Institutions to
manage FCOI, the term ‘‘management
plan’’ was not used. As we noted in the
NPRM, many Institutions already have
been developing and implementing
management plans as a means of
fulfilling their FCOI management
responsibilities; explicitly incorporating
this requirement in the regulations
acknowledges the value of this practice
as an important means to maintain
objectivity in PHS-funded research
across the research community. As
indicated in the discussion of paragraph
(b) below, the expanded reporting
requirements include an obligation to
report, at a minimum, a description of
‘‘key elements’’ of the Institution’s
management plan in certain FCOI
reports.
As discussed in the NPRM, and for
reasons explained above, we also have
deleted the sentence in this section from
the 1995 regulations that describes
when an FCOI exists. A modified
version of this sentence has been moved
to the re-designated paragraph (f) of 42
CFR 50.604 and 45 CFR 94.4, as well as
incorporated into a definition of FCOI in
42 CFR 50.603 and 45 CFR 94.3.
In the revised paragraph (a)(1), we
have also included the following
updated and expanded list of examples
of conditions or restrictions that might
be imposed to manage an FCOI: public
disclosure of FCOI (e.g., when
presenting or publishing the research);
disclosure of FCOI directly to
participants in research projects
involving human subjects research;
appointment of an independent monitor
capable of taking measures to protect
the design, conduct, or reporting of the
research against bias resulting from the
FCOI; modification of the research plan;
change of personnel or personnel
responsibilities, or disqualification of
personnel from participation in all or a
portion of the research; reduction or
elimination of a financial interest (e.g.,
sale of an equity interest); or severance
of relationships that create financial
conflicts.
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One respondent suggested that
disclosure alone is not sufficient for
management of FCOI. Others suggested
that the regulations should define a
specific standard for acceptable conduct
of research when an FCOI with PHSfunded research has been identified
(e.g., adopting the guidelines for
conducting medical research published
by AAMC and AAU), which could
include defining the SFI that would
preclude an Investigator from being a
PD/PI on PHS-funded projects or
requiring the Institution to consider the
interests of patients explicitly. Another
suggested that the risk of advancing
potentially conflicted research should
be weighed against the risk of not
advancing the research. Given the wide
range of contexts in which a conflict
with PHS-funded research may arise, we
believe that specifying particular
standards or specific criteria may not
cover all types of FCOI. Therefore, we
have declined these suggestions, though
we note that Institutions may choose a
variety of measures, including those
proposed by the respondents, in their
evaluation of SFIs and in any specific
management plan. In addition, as
discussed in the NPRM and above, we
posed a number of questions in the
ANPRM on the issue of whether the
regulations should be amended to
require specific approaches to
management of FCOI related to certain
types of research or alternatively,
specific types of financial interests or
FCOI. Many of the respondents to the
ANPRM thought that this approach
would not account for the full range of
research projects as well as the large
variation in circumstances in which
FCOI may arise. Moreover, the
regulations do not include specific
provisions related to the type of
research, financial interest, or identified
FCOI at issue.
Finally, respondents were concerned
that the flexibility afforded to
Institutions in determining how to
manage SFIs that were determined to be
FCOIs will lead to a lack of consistency
across Institutions in the evaluation and
management of Investigator FCOIs.
Given the wide variety of contexts in
which FCOIs can arise and the
differences among Institutions, some
variation across Institutions is expected.
We believe that Institutions are in the
best position to evaluate the
circumstances and determine the most
appropriate management strategies for
specific cases.
Additionally, we have included the
two paragraphs that we introduced in
the NPRM (paragraphs (a)(2) and (a)(3)),
with modifications, to clarify an
Institution’s obligations in situations in
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which an Institution becomes aware of
an SFI after the PHS-funded research is
already underway. Specifically,
paragraph (a)(2) states that whenever, in
the course of an ongoing PHS-funded
research project, a new Investigator
participating in the research project
discloses an SFI or an existing
Investigator discloses a new SFI to the
Institution, the designated official(s) of
the Institution shall, within 60 days:
Review the SFI disclosure; determine
whether it is related to PHS-funded
research; determine whether an FCOI
exists; and, if so, implement, on at least
an interim basis, a management plan
that shall specify the actions that have
been, and will be, taken to manage the
FCOI. Depending on the nature of the
SFI, an Institution may determine that
additional interim measures are
necessary with regard to the
Investigator’s participation in the PHSfunded research project between the
date of disclosure and the completion of
the Institution’s review.
Paragraph (a)(3) states that whenever
an Institution identifies an SFI that was
not disclosed timely by an Investigator
or, for whatever reason, was not
previously reviewed by the Institution
during an ongoing PHS-funded research
project (e.g., was not timely reviewed or
reported by a subrecipient), the
designated official(s) shall, within 60
days: review the SFI; determine whether
it is related to PHS-funded research;
determine whether an FCOI exists; and,
if so: (i) Implement, on at least an
interim basis, a management plan that
shall specify the actions that have been,
and will be, taken to manage such FCOI
going forward; and (ii) In addition,
whenever an FCOI is not identified or
managed timely including:
• Failure by the Investigator to
disclose an SFI that is determined by
the Institution to constitute an FCOI;
• Failure by the Institution to review
or manage such an FCOI; or
• Failure by the Investigator to
comply with an FCOI management plan;
the Institution shall, within 120 days of
the Institution’s determination of
noncompliance, complete a
retrospective review of the Investigator’s
activities and the PHS-funded research
project to determine whether any PHSfunded research, or portion thereof,
conducted during the time period of the
noncompliance, was biased in the
design, conduct, or reporting of such
research.
The Institution is required to
document the retrospective review; such
documentation shall include, but not
necessarily be limited to, all of the
following key elements:
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1. Project number;
2. Project title;
3. PD/PI or contact PD/PI if a multiple
PD/PI model is used;
4. Name of the Investigator with the
FCOI;
5. Entity with which the Investigator
has a financial conflict of interest;
6. Reason(s) for the retrospective
review;
7. Detailed methodology used for the
retrospective review (e.g., methodology
of the review process, composition of
the review panel, documents reviewed);
8. Findings of the review (i.e., facts
and observations); and
9. Conclusions of the review (i.e.,
determination and recommended
actions).
If bias is found, the Institution is
required to notify the PHS Awarding
Component promptly and submit a
mitigation report to the PHS Awarding
Component. The mitigation report must
include, at a minimum, the key
elements documented in the
retrospective review above and a
description of the impact of the bias on
the research project and the Institution’s
plan of action or actions taken to
eliminate or mitigate the effect of the
bias (e.g., impact on the research
project; extent of harm done, including
any qualitative and quantitative data to
support any actual or future harm;
analysis of whether the research project
is salvageable). Thereafter, the
Institution will submit FCOI reports
annually, as specified elsewhere in the
regulations. Depending on the nature of
the FCOI, an Institution may determine
that additional interim measures are
necessary with regard to the
Investigator’s participation in the PHSfunded research project between the
date that the FCOI or the Investigator’s
noncompliance is determined and the
completion of the Institution’s
retrospective review.
As we explained in the NPRM,31 these
revisions are based, at least in part, on
our experience working with
Institutions and our observation that
some Institutions may be more diligent
about addressing potential FCOI at the
onset of a PHS-funded research project
than after the work is already underway.
We also believe it is important to
address in the regulations circumstances
in which an Institution, for whatever
reason, has not timely reviewed an SFI,
particularly when such SFI is later
determined to be an FCOI. In such
circumstances, it is of course important
for an Institution to manage the FCOI
going forward; however, there is also a
critical need to review and determine
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whether any bias was introduced into
the research during the period of time
prior to review and management of the
FCOI. In the NPRM we proposed to
address this need in paragraph (a)(3) by
the introduction of a ‘‘mitigation plan’’
requirement,32 which we have clarified
in the revised regulations as a
‘‘retrospective review’’ and ‘‘mitigation
report,’’ as provided above.
While one respondent agreed with the
requirement for a mitigation plan in the
case of a newly identified SFI that the
Institution determines is an FCOI, many
suggested that the proposed requirement
for a mitigation plan was unnecessary.
They thought that the goal of such a
plan would be achieved by the review
and management plan that Institutions
are required to implement when they
determine that an Investigator’s SFI
constitutes an FCOI, and that
determining if there was bias in the
design, conduct, or reporting of the
PHS-funded research would be very
difficult. Some respondents agreed,
however, that it seems reasonable to
expect the Institution to determine
whether a mitigation plan is necessary.
We have considered the comments and
agree that the requirement for a
mitigation plan may have been stated
too broadly in the NPRM. Mitigation
reports should only be used in cases
where the Institution determines that a
newly identified FCOI has resulted in
bias in the design, conduct, or reporting
of PHS-funded research. Respondents
also suggested that the elements of the
mitigation plan in the NPRM were
unclear and requested additional
guidance. To address these comments,
we have revised the requirement, as
provided above.
Paragraph (a)(4) requires the
Institution to monitor Investigator
compliance with the management plan
on an ongoing basis until the
completion of the PHS-funded research
project. This paragraph dovetails with
the new paragraphs (a)(2) and (a)(3),
described above, by ensuring that the
management actions taken by an
Institution at the time an FCOI is
identified continue to be followed by
the Investigator(s) involved for the
duration of the project.
In the NPRM we proposed to
introduce at paragraph (a)(5) a new
requirement to help the biomedical and
behavioral research community as well
as the public, Congress, and other
interested parties monitor the integrity
and credibility of PHS-funded research,
and underscore our commitment to
fostering transparency, accountability,
and public trust. Specifically, we
32 75
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53273
proposed a new requirement that, prior
to the Institution’s expenditure of any
funds under a PHS-funded research
project, the Institution shall make
available via a publicly accessible Web
site information concerning any SFI that
meets the following three criteria: (A)
The SFI was disclosed and is still held
by the PD/PI or any other Investigator
who has been identified by the
Institution as senior/key personnel for
the PHS-funded research project in the
grant application, contract proposal,
contract, progress report, or other
required report submitted to the PHS;
(B) the Institution determines that the
SFI is related to the PHS-funded
research; and (C) the Institution
determines that the SFI is an FCOI.
We proposed to require that the
information posted include, at a
minimum, the following:
• The Investigator’s name;
• The Investigator’s position with
respect to the research project;
• The nature of the SFI;
• And the approximate dollar value
of the SFI (dollar ranges would be
permissible; less than $20,000; less than
$50,000; less than $100,000; less than or
equal to $250,000; greater than
$250,000), or a statement that the
interest is one whose value cannot be
readily determined through reference to
public prices or other reasonable
measures of fair market value.
We proposed a requirement that the
Institution update the posted
information at least annually, and
update the Web site within 60 days of
the Institution’s receipt or identification
of information concerning any
additional SFI that was not previously
disclosed by the senior/key personnel
for the PHS-funded research project, or
upon the disclosure of an SFI by new
senior/key personnel, if the Institution
determines that the SFI is related to the
PHS-funded research and is an FCOI.
We proposed that information
concerning the SFIs of an individual
subject to this requirement shall remain
available via the Institution’s publicly
accessible Web site for at least five years
from the date that the information was
most recently updated.
We received many comments on this
proposed requirement. Some
respondents did not support this
requirement, as they were concerned
about privacy issues. A few respondents
suggested that posting information
about Investigator FCOI without the
appropriate context would foster a
negative perception of FCOI, and a
couple of comments indicated that the
requirements might conflict with state
laws. Others suggested this requirement
is unnecessary, given the disclosure
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provisions required under the recently
enacted Affordable Care Act. One
respondent proposed that this
information should be included in
applications or proposals for PHSfunded research but not posted on a
publicly accessible Web site. Several
suggested that additional discussion of
this provision is needed and requested
that this requirement be omitted from
the final rule at this time.
We are strongly committed to the
value of transparency to the public, and
we also appreciate the concerns raised
by these respondents. In keeping with
the increasing number and range of
public disclosure initiatives, including
those in the aforementioned Affordable
Care Act, we believe it is important to
make available to the public critical
information affecting PHS-funded
research. Consistent with statutory goals
and Executive Order 13563, we believe
the language that we have finalized in
this rule strikes a reasonable balance of
the public and private interests at issue.
Some respondents suggested that the
information be made available upon
request, rather than posted on a publicly
available Web site. We carefully
considered this suggestion and agree
that making the information available
upon request is in accordance with the
overall goal of enhanced transparency.
The chosen approach promotes such
transparency without imposing undue
burdens. Therefore, we have revised the
regulations to state that the Institution
must make the information publicly
accessible and may do so by posting the
information on a public Web site or by
making the information available in
writing within five business days of any
request.
Several respondents thought that the
requirement would constitute a
substantial burden and cited the
necessity of setting up a database
structure. We note that the final rule
does not require the information to be
provided in a specific format. Therefore,
an Institution could choose to provide
the information as a simple document or
spreadsheet.
A few respondents suggested that all
Investigator SFIs or all payments from
pharmaceutical companies, not only
those that were determined to constitute
an FCOI with PHS-funded research,
should be provided. We disagree; we
continue to believe that providing
information on only those SFIs
determined to be FCOIs with PHSfunded research provides the
appropriate level of transparency,
particularly as not all SFIs are
determined to relate to PHS-funded
research. However, Institutions are free
to expand upon this requirement by
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providing information on all SFIs of
their Investigators. One respondent
suggested that there should be a grading
system to denote levels of conflicts of
interest. We note that the determination
of an FCOI by an Institution requires an
assessment of how an SFI may cause an
FCOI with the PHS-funded research,
and how any such FCOI must be
managed. It is at that point the
Institution is judging the SFI and its
potential to create an FCOI; there is no
gradient associated with an FCOI itself.
Additionally, we are concerned that this
suggestion would undermine the
premise that an Investigator’s FCOI with
PHS-funded research is not necessarily
negative or prohibitive; the intent of the
regulations is to ensure the appropriate
management of such FCOIs in order to
protect the objectivity of the research.
Other respondents supported the
requirement for making information
about Investigator’s SFIs that were
determined to be FCOIs with PHSfunded research publicly accessible.
Many suggested that the PHS should
host the information on a central Web
site. Although we considered this
suggestion at length, we continue to
believe that Institutions are in a better
position to provide and maintain this
information. For example, the
Institution will be able to put the
information into context, as suggested
by some respondents, e.g., by relating
the information to the Institution’s FCOI
policies or to other information about
the Investigator, as the Institution deems
appropriate.
Several respondents requested that
the regulations provide additional
guidance as to exactly which
Investigators are covered by this
provision. Consistent with our proposal
in the NPRM, we have applied the
requirement to senior/key personnel for
research grants and cooperative
agreements and key personnel for
research contracts. To provide further
clarity, we also have included a new
definition of senior/key personnel in 42
CFR 50.603 and of key personnel in 45
CFR 94.3. Because these definitions of
‘‘senior/key personnel’’ and ‘‘key
personnel’’ include the PD/PI, we have
limited the references in this section to
‘‘senior/key personnel’’ or ‘‘key
personnel’’ to avoid confusion and
redundancy. Others requested that this
provision apply only to Investigators
and not to their spouse or dependent
children, or at least that the names of
the spouse and dependent children not
be posted. We note that, consistent with
the proposal in the NPRM, the
information provided must include the
name of the Investigator and the nature
of the SFI. Any SFIs of the Investigator’s
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spouse and dependent children will be
attributed to the Investigator, such that
only the Investigator’s name would be
provided.
Some respondents suggested that the
dollar ranges included in this provision
be the same as those required in reports
of FCOI to the PHS Awarding
Component. We agree with this
suggestion and have revised the
language accordingly. Although one
respondent requested that no dollar
amounts should be provided, while
another suggested that the top range of
$250,000 is too low, we believe that the
revised ranges provide the appropriate
level of information. Respondents made
several suggestions as to the length of
time the information should remain
available, ranging from two to three
years. We agree with the specific
comments that it would be useful to
align the duration of the requirement for
providing this information with the PHS
records retention policy. Accordingly,
we have revised the regulations to
require that information concerning the
SFIs that were determined to constitute
FCOIs shall remain available for at least
three years from the date that the
information was most recently updated.
One respondent asked for clarification
of how the criterion for providing
information on an SFI that is still held
by the Investigator would apply to
payments or reimbursements. We note
that the requirements for making
information publicly accessible relate to
those SFIs that were determined to be
FCOIs. The regulations do not prevent
Institutions from taking into account,
during that evaluation process, whether
the Investigator has an ongoing financial
relationship with the entity providing
the payment or reimbursement or
whether the payment or reimbursement
was limited in duration.
Finally, several respondents suggested
that time is needed to allow Institutions
to set up systems required to comply
with the requirements in this paragraph.
In particular, many suggested that
implementation should be delayed to
October 2013 to coincide with the
implementation of the disclosure
provisions of the Affordable Care Act.
As specified in the ‘‘Compliance Date’’
paragraph in the Dates section above,
we have provided time for
implementation of the revised
regulations such that 365 days after
publication of the final rule, Institutions
receiving PHS funding will be required
to ensure public accessibility of
information on FCOIs of senior/key
personnel on research grants and
cooperative agreements and of key
personnel on research contracts via a
publicly accessible Web site or by
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making the information available in
writing within five business days of any
request, as required by 42 CFR 50.605
(a)(5) and 45 CFR 94.5 (a)(5).
Additionally, as proposed in the
NPRM and discussed above, we have
maintained the requirement of
paragraph (b) of the 1995 regulations but
restated it as follows: ‘‘In addition to the
types of conflicting financial interests as
defined in this subpart that must be
managed pursuant to this section, an
Institution may require the management
of other financial conflicts of interests in
its policy on financial conflicts of
interest, as the Institution deems
appropriate.’’
As we also proposed in the NPRM, we
have included a substantial revision and
expansion of Institutions’ existing FCOI
reporting requirements. Specifically,
paragraph (b)(1) discusses the timing of
initial FCOI reports and references the
proposed management plan
requirements addressed in the above
discussion of paragraph (a): Prior to the
Institution’s expenditure of any funds
under a PHS-funded research project,
the Institution shall provide to the PHS
Awarding Component an FCOI report
regarding any Investigator’s SFI found
by the Institution to be an FCOI and
ensure that the Institution has
implemented a management plan in
accordance with this subpart. We have
clarified that, in cases in which the
Institution identifies an FCOI and
eliminates it prior to the expenditure of
PHS-awarded funds, the Institution
shall not submit an FCOI report to the
PHS Awarding Component.
Similarly, paragraph (b)(2) discusses
the timing of follow-up FCOI reports,
with examples of when such reports
may be required as well as references to
the proposed management plan and
retrospective review requirements
addressed above in the discussion of
paragraph (a): for any SFI that the
Institution identifies as conflicting
subsequent to the Institution’s initial
FCOI report during an ongoing PHSfunded research project (e.g., upon the
participation of an Investigator who is
new to the research project), the
Institution shall provide to the PHS
Awarding Component, within 60 days,
a report regarding the FCOI and ensure
that the Institution has implemented a
management plan in accordance with
the regulations. Where such an FCOI
report involves an SFI that was not
disclosed timely by an Investigator or,
for whatever reason, was not previously
reviewed by the Institution (e.g., was
not timely reviewed or reported by a
subrecipient), the Institution also is
required to complete a retrospective
review to determine whether any PHS-
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funded research, or portion thereof,
conducted prior to the identification
and management of the FCOI was biased
in the design, conduct, or reporting of
such research. Additionally, if bias is
found, the Institution is required to
notify the PHS Awarding Component
promptly and submit a mitigation report
to the PHS Awarding Component.
Consistent with our proposal in the
NPRM, paragraph (b)(3) discusses
information that must be included in
the FCOI reports required under
paragraphs (b)(1) and (b)(2), described
above. Specifically, such FCOI reports
must include sufficient information to
enable the PHS Awarding Component to
understand the nature and extent of the
financial conflict, and to assess the
appropriateness of the Institution’s
management plan. In addition to the
minimum specific elements of the FCOI
report that we proposed in the NPRM,33
we have included a requirement to
name the entity with which the
Investigator has a financial conflict of
interest, to enhance transparency and
accountability.
The majority of respondents
supported the requirement that
Institutions provide this additional
information to the PHS Awarding
Component, although one respondent
thought this was unnecessary. Another
respondent thought that requiring
Institutions to report key elements of the
management plan would include
information that Investigators might
want to keep private. We have retained
this requirement because we believe
that receiving information on specific
aspects of the management plan is
necessary to ensure appropriate
oversight by the PHS Awarding
Component. We note that the
regulations state under 42 CFR 50.606(b)
and 45 CFR 94.6(b) that to the extent
permitted by law, HHS will maintain
the confidentiality of all records of
financial interests. Another suggested
the regulations require reporting of the
exact dollar amount of the financial
interest, rather than ranges. We did not
make this change; the exact amount of
some types of financial interests, such
as equity, may change frequently, which
could create ambiguity and intensify the
administrative burden.
One respondent inquired as to
whether the rationale for including the
conflicted Investigator in the research
project should include application of
the ‘‘rebuttable presumption standard as
articulated by AAMC’’ (i.e.,
‘‘Institutional policies should establish
the rebuttable presumption that an
individual who holds a significant
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53275
financial interest in research involving
human subjects may not conduct such
research.’’ 34) We note that Institutions
have the flexibility to use this standard
in their evaluations of Investigator SFI,
as long as they comply with the
regulations. Other respondents
questioned why the FCOI report should
contain a rationale for including the
conflicted Investigator in the research
project since the credentials of the
Investigator are included in the research
application or proposal and were
considered during the peer review
process. Although our intent was to
include the justification for permitting
the Investigator with an FCOI to remain
on the project, as opposed to the
scientific rationale for the Investigator’s
involvement in the project, we have
removed this element from the
minimum requirements of the FCOI
report to minimize confusion.
One respondent suggested it would be
more efficient for Institutions to
describe their monitoring measures
annually for all FCOI reports rather than
on a report-specific basis. We disagree;
because the monitoring measures may
differ depending on the requirements of
the specific management plan, we
believe that retaining that element in
each report is important. Several
respondents recommended deleting the
requirement for a description of how the
management plan will safeguard
objectivity in the research project, as
that is inherent in the management plan
and should be apparent from the other
information provided. We believe that
documenting this element is important
to ensure proper oversight; however, to
address this comment, we have clarified
this element to describe how the
management plan is designed to
safeguard objectivity in PHS-funded
research.
One respondent suggested that this
requirement be retained only for
research involving human participants.
As discussed in the NPRM and above,
we posed a number of questions in the
ANPRM on the issue of whether the
regulations should be amended to
require specific approaches to
management of FCOI related to certain
types of research or alternatively,
specific types of financial interests or
FCOI. The majority of the respondents
to the ANPRM thought that this
approach would not account for the full
range of research projects as well as the
34 AAMC Task Force on Financial Conflicts of
Interest in Clinical Research: Protecting Subjects,
Preserving Trust, Promoting Progress—Policy and
Guidelines for the Oversight of Individual Financial
Interests in Human Subjects Research, December
2001 https://www.aamc.org/download/75302/data/
firstreport.pdf.
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large variation in circumstances in
which FCOIs may arise. As a result, the
regulations, including the provisions in
this paragraph, impose uniform FCOI
management responsibilities, regardless
of the type of research, financial
interest, or identified FCOI at issue.
Nonetheless, we note that Institutions
are free to differentially manage FCOI
depending on the nature of the research
as long as they remain in full
compliance with the regulations.
A few respondents requested that the
regulations include additional examples
of appropriate elements of a
management plan, such as the use of
independent monitors or a description
of circumstances in which eliminating
an FCOI is necessary. Given the wide
range of circumstances in which FCOI
may occur and the importance of
tailoring institutional review and
determination to each specific case, we
believe that including additional
examples may be interpreted as
prescriptive and may be misconstrued
as the only means of managing a
particular type of conflict. Nonetheless,
as described above, a list of examples of
conditions or restrictions that might be
imposed to manage an FCOI is
described in 42 CFR 50.605(a)(1) and 45
CFR 94.5(a)(1). One respondent
requested that the HHS develop
templates for reporting FCOIs to the
PHS Awarding Component. Because the
regulations describe the basic
information required in these reports,
we believe that templates are
unnecessary.
One respondent noted that the
regulations do not state how the PHS
Awarding Component will respond to
the FCOI reports submitted by
Institutions and recommended that HHS
establish a policy on the responsibilities
of the PHS Awarding Component, while
another requested that agency staff
receive training in the review of FCOI
reports submitted to the PHS Awarding
Component to ensure consistency. In
response to these comments, we want to
assure stakeholders that we have in
place procedures and guidance on how
staff should respond to FCOI reports
submitted by Institutions, and we
provide training on the evaluation of
information that we receive from
Institutions about FCOIs with PHSfunded research. We have taken and are
continuing to take steps to increase
oversight of the FCOI regulations. For
example, NIH has:
• Conducted a thorough review of its
system of oversight and compliance
with respect to the FCOI regulations
with the purpose of ensuring that a
vigorous and effective oversight system
is in place.
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• Developed an FCOI Reporting
Module as a tool for Institutions to
electronically manage and submit FCOI
reports to NIH. This module provides
consistent reporting of FCOIs to the
NIH. The system interfaces with the
Web-based reporting tool for NIH staff
already in use and will provide a full
spectrum of tracking and oversight
capabilities for NIH extramural staff.
Mandatory use of the FCOI Module
went into effect during FY 2009.35
• Developed an FCOI review protocol
for use by staff in evaluating
institutional FCOI reports and
conducted mandatory training for
extramural program and grants
management staff on the use of the
protocol and other FCOI issues.
• Routinely conduct in-depth reviews
of cases of alleged FCOI involving
extramural grantees and will continue to
do so as new allegations arise.
• Evaluate and analyze grantee
Institutions’ FCOI policies and practices
on an ongoing basis.
• Formed an FCOI Liaison group
consisting of representatives from each
of the NIH Institutes and/or Centers (IC)
to discuss FCOI issues and guide FCOI
activities in their respective ICs, with
assistance from the Office of Extramural
Research.
• Developed and included new
language for NIH’s ‘‘Notice of Award’’
template that highlights FCOI
requirements.
• Developed and conducted a number
of initiatives and site visits to evaluate
institutional FCOI policies for
compliance with the regulation. These
initiatives include:
Æ NIH Pilot Compliance Program on
FCOI.
Æ NIH Targeted Site Reviews.
• Following evaluation of the
institutional FCOI policies, publicized
on-line ‘‘Lessons Learned’’ to encourage
enhanced compliance in the grantee
community.
• Issued a number of communications
to remind extramural grant recipients of
their FCOI compliance responsibilities.
These communications include:
Æ Articles (NIH OER ‘‘Nexus’’
newsletter).
Æ NIH Guide Notices.
Æ E-mails to Institutional officials.
• Continue to respond to grantee
questions directed to the OER FCOI
mailbox concerning compliance with
the Federal regulation.
• Provide education and outreach
activities aimed at raising awareness of
the issues surrounding FCOI at the
institutional and Investigator levels
(e.g., NIH Regional Seminars;
35 OMB
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No. 0925–0417.
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presentations at professional
organizations and meetings).
These policies and guidance will be
updated to incorporate all revisions
implemented in this final rule, and we
will continue to train the relevant staff,
as necessary.
As proposed in the NPRM, paragraph
(b)(4) includes a requirement to provide
follow-up reports in cases in which an
FCOI has been previously identified and
reported. Specifically, for any FCOI
previously reported by the Institution
with regard to an ongoing PHS-funded
research project, the Institution shall
provide to the PHS Awarding
Component an annual FCOI report that
addresses the status of the FCOI and any
changes to the management plan for the
duration of the PHS-funded research
project. The annual FCOI report must
specify whether the financial conflict is
still being managed or explain why the
FCOI no longer exists. The Institution
must provide annual FCOI reports to the
PHS Awarding Component for the
duration of the project period (including
extensions with or without funds) in the
time and manner specified by the PHS
Awarding Component.
A few respondents suggested that
providing a report annually when there
has been no change to the FCOI or its
management is unnecessary. We have
considered this suggestion but believe
that annual notification, even if there
are no changes, is necessary to provide
appropriate assurance to the PHS
Awarding Component that an identified
FCOI continues to be managed
throughout the period of the PHSfunded research. One respondent
suggested that the regulations allow the
Institution to determine the frequency of
reporting on identified FCOIs,
depending on the type of PHS-funded
research and the nature of the conflict.
As discussed above, the regulations
impose uniform FCOI management
responsibilities, regardless of the type of
research, financial interest, or identified
FCOI at issue to account for the full
range of circumstances in which FCOI
may arise. Finally, while several
respondents requested that the timing of
the annual reports be determined by the
Institution rather than the PHS
Awarding Component, we have
determined that the reports need to be
provided in the time and manner
specified by the PHS Awarding
Component in order to facilitate
appropriate and efficient oversight.
Finally, as proposed in the NPRM,
paragraph (b)(5) includes language with
regard to FCOI reporting that is similar
to the language for FCOI management in
the re-designated paragraph (a)(6),
described above. Namely, in addition to
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the types of financial conflicts of
interest that must be reported pursuant
to this section, an Institution may
require the reporting of other FCOI in its
policy on financial conflicts of interest,
as the Institution deems appropriate.
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Remedies (42 CFR 50.606, 45 CFR 94.6)
In both the NPRM and the Extension
Notice, we welcomed public comments
regarding the need to further revise and
clarify this section, with respect to PHS’
enforcement authority in the event of
noncompliance with the regulations.
Although we did not receive a high
volume of comments on this topic, we
took all feedback into consideration
when finalizing the rule. We appreciate
this opportunity to emphasize our
commitment to effective oversight,
which requires a partnership between
the PHS Awarding Components and the
Institutions. The regulations make clear
that Institutions are responsible for
ensuring Investigator compliance with
institutional policies and procedures,
and it is necessary for Institutions to
establish appropriate consequences for
noncompliance. However, it is equally
essential that the PHS Awarding
Components consider appropriate
enforcement action. We believe that the
revised regulations strike an appropriate
balance of responsibilities in this regard.
In general, several respondents
supported our proposal to refine the
discussion of remedies in the 1995
regulations. Although one respondent
expressed concern that the regulations
seem to lack meaningful enforcement
mechanisms and remedies, we believe
that the Remedies section supports a
range of possible corrective and
remedial actions for the PHS Awarding
Components and the Institutions to
consider. Additionally, we believe it is
important to weigh the specific
circumstances of each particular case
when pursuing such action(s) and to
retain a full range of available options.
For that reason, we have declined to
incorporate some of the additional
‘‘penalties’’ that a few respondents
suggested, such as monetary fines,
dismissals, or jail times for
Investigators; fines for Institutions; or,
as one respondent suggested, ‘‘referrals
to the FDA * * * to bar participation by
the individual in any clinical study
designed to seek marketing approval.’’
Likewise for that reason, we have not
incorporated the suggestion of another
respondent to include a specific
requirement that if an Institution takes
enforcement action against an
Investigator, PHS should automatically
‘‘impose penalties directly on an
Investigator.’’
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We did, however, agree with one
respondent that it would be helpful to
clarify, in the grants context in
particular, that institutional sanctions
against an Investigator can travel with
the Investigator upon his or her transfer
to another Institution. Specifically, we
have revised 42 CFR 50.606, paragraph
(a), as follows: ‘‘If the failure of an
Investigator to comply with an
Institution’s financial conflicts of
interest policy or a financial conflict of
interest management plan appears to
have biased the design, conduct, or
reporting of the PHS-funded research,
the Institution shall promptly notify the
PHS Awarding Component of the
corrective action taken or to be taken.
The PHS Awarding Component will
consider the situation and, as necessary,
take appropriate action, or refer the
matter to the Institution for further
action, which may include directions to
the Institution on how to maintain
appropriate objectivity in the PHSfunded research project. The PHS may,
for example, require Institutions
employing such an Investigator to
enforce any applicable corrective
actions prior to a PHS award or when
the transfer of a PHS grant(s) involves
such an Investigator.’’
This revision is intended to reference
the range of options for the PHS
Awarding Component to consider,
depending on the specific
circumstances at issue. For example,
PHS may decide to initiate governmentwide suspension or debarment of the
Investigator under 2 CFR part 376; or to
use enforcement measures under 45
CFR 74.62, e.g., perhaps to make the
approval of a transfer contingent upon
the former Institution’s disclosure of the
corrective action—including the specific
sanctions against the Investigator—to
the new Institution; and/or to use
special award conditions under 45 CFR
74.14, e.g., perhaps to make the new
Institution agree to take the same or
similar action against that Investigator
or explain to the PHS Awarding
Component in writing why such action
was not taken and what alternative
measures will be used to ensure
compliance.
One respondent suggested that the
regulations include a description of a
process to resolve differences of opinion
between the PHS Awarding Component
and the Institution regarding evaluation
and management of FCOIs. We declined
that change, as we believe it would be
unnecessary and overly prescriptive to
impose a particular process as a
regulatory requirement; we will
continue to work collaboratively with
Institutions to resolve any such
differences on a case by case basis,
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53277
taking into consideration the specific
circumstances of each disagreement. We
note, however, that the Institution may
have an opportunity for a hearing,
appeal, or other administrative process
or proceeding to which it is entitled
under any applicable statute or
regulation, in the event that the PHS
Awarding Component takes
enforcement action against the
Institution.
As we proposed in NPRM, we also
have revised paragraph (b) to clarify that
the HHS may inquire at any time (i.e.,
before, during, or after award) into any
Investigator disclosure of financial
interests and the Institution’s review of,
and response to, such disclosure,
whether or not the disclosure resulted
in the Institution’s determination of an
FCOI. Consistent with the 1995
regulations, an Institution must submit,
or permit on site review of, all records
pertinent to compliance with the
regulations. One respondent suggested
that the regulations restrict the period
during which HHS may inquire to a
defined number of years after the end of
the award period. We have not made
this change because the effects of
compromising objectivity in PHSfunded research may continue for some
time after the award period. Another
suggested that the regulations state that
HHS may request information not
deemed relevant to a finding of FCOI
only for the purpose of investigating an
allegation of noncompliance with these
rules. Although we agree that an
allegation of noncompliance is one
circumstance that could trigger this
provision, we disagree that it would be
appropriate to limit HHS’ oversight
authority to this specific event.36
In paragraph (b), we also have
retained the statement in the 1995
regulations that, to the extent permitted
by law, HHS will maintain the
confidentiality of all records of financial
interests. In response to a question from
a respondent, we note that this includes
the information required under 42 CFR
50.605(b) and 45 CFR 94.5(b).
As we proposed in the NPRM, we
have revised paragraph (c) to add that in
any case in which the HHS determines
that a PHS-funded project of clinical
research whose purpose is to evaluate
the safety or effectiveness of a drug,
36 Among other examples of HHS’ oversight
authority, we note that with regard to grants or
cooperative agreements from HHS to Institution of
higher education, hospitals, other non-profit
organizations, and commercial organizations, HHS
awarding agencies have the right of timely and
unrestricted access to any books, documents,
papers, or other records of recipients that are
pertinent to its awards, to make audits,
examinations, excerpts, transcripts and copies of
such documents. See 45 CFR 74.53(4)(e).
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medical device, or treatment has been
designed, conducted, or reported by an
Investigator with an FCOI that was not
managed or reported by the Institution
as required by the regulations, the
Institution must not only require the
Investigator involved to disclose the
FCOI in each public presentation of the
results of the research, but also to
request an addendum to previously
published presentations. One
respondent suggested that this
requirement may not achieve the
desired aim, as Investigators could
refrain from publicly presenting their
results and publishers could refuse to
publish the addendum or could publish
it in an inconspicuous manner. We have
implemented the proposed language
from the NPRM because we believe the
disclosure requirements as modified
further the objective of the regulations
to promote objectivity in research.
Institutions are in the position to
identify other actions that may be
appropriate in such instances,
depending on the specific case. We also
note that the provision regarding public
presentations has been in place since
the 1995 regulations and that the
revision merely expands the potential
venues in which the FCOI must be
disclosed, which is intended to
strengthen transparency and
accountability.
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Other HHS Regulations That Apply (42
CFR 50.607)
As we proposed in the NPRM, we
have revised the list of other HHS
regulations that apply, to update
changes that have been made in the CFR
location or title of the references in this
section since 1995. In the NPRM, we
asked for comment on whether the
regulations should be further revised to
delete this section. Only one respondent
suggested deleting this section; we have
retained it as a useful point of reference.
IV. Institutional Conflict of Interest
Institutional conflict of interest is a
subject that is not specifically addressed
in the 1995 regulations for reasons
stated in the 1995 final rule.37 Because
this is a topic of increasing interest to
HHS as well as in the research
community, we invited comment in the
ANPRM on the possible revision of the
regulations to address institutional
conflict of interest. In particular, we
asked (a) How ‘‘institutional conflict of
interest’’ would be defined, and (b) what
an institutional conflict of interest
policy would address in order to assure
the PHS of objectivity in research.38
37 60
38 74
FR 35813 (July 11, 1995).
FR 21612 (May 8, 2009).
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Consistent with the public comments
that we received on this topic, we
continue to believe that further careful
consideration is necessary before PHS
regulations could be formulated that
would address the subject of
institutional conflict of interest in the
same comprehensive manner as the
1995 regulations address Investigator
FCOI. Because we believe it is important
to revise the 1995 regulations in a
timely manner, specific revisions that
we proposed in the NPRM were limited
to the subject of Investigator FCOI.
In the NPRM, we asked for public
comments on whether the regulations
should be further revised to require
Institutions, at a minimum, to adopt
some type of policy on institutional
conflict of interest, even if the scope and
elements of the policy remain undefined
in the regulations. We received a wide
range of responses to this question, with
some respondents stating that the
regulations should include a basic
provision requiring Institutions to have
a policy on institutional conflict of
interest without specifying the nature or
scope of such a policy, and others
suggesting that it would be premature to
include such a provision in the
regulations. Respondents in both groups
urged HHS to engage the biomedical
research community in discussions on
the definition of institutional conflict of
interest and how it should be addressed.
One respondent suggested that the
regulations should include a definition
of institutional conflict of interest and
specific provisions for policies
addressing the issue.
We have considered all the comments
and believe that requiring Institutions to
have a policy on institutional conflict of
interest without providing additional
guidance as to the nature and scope of
that policy would lead to confusion and
inconsistencies across Institutions. We
also believe that substantial additional
information and deliberations are
needed to formulate such guidance.
Therefore, we have limited the final rule
to Investigator conflict of interest. HHS
will continue to consider the issue of
institutional conflict of interest together
with the biomedical research
community, including the question of
whether it is appropriate to propose
specific regulations to address this
subject.
V. Regulatory Impact Analyses (RIA)
The following is provided as public
information.
Analysis of Impacts
We have examined the impacts of the
amendments to 42 CFR part 50 subpart
F and 45 CFR part 94 under Executive
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Order 12866, Executive Order 13563,
the Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This rule
has been designated a ‘‘significant
regulatory action’’ although not
economically significant, under section
3(f) of Executive Order 12866.
Accordingly, the rule has been reviewed
by the Office of Management and
Budget.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of the rule on small
entities. For the purposes of this
analysis, small entities include small
business concerns as defined by the
SBA, usually businesses with fewer
than 500 employees. Approximately
2,800 such organizations 39 apply to NIH
for research funding annually, of which
approximately 1,300 Institutions 40 are
awarded funds. These regulations do
not cover SBIR/STTR Program Phase I
applications or awards. Therefore, the
provisions of the regulations apply to
the approximately 800 applicants to the
SBIR/STTR Phase II program annually,
of which approximately 300 Institutions
receive funding. There is no change to
the 1995 regulations that pertain
specifically to applicant organizations.
Rather, all changes to the regulations
apply only to the approximately 300
small business concerns that receive
Phase II SBIR/STTR PHS funding. The
cost of implementing the amended
regulations is an allowable cost that may
be eligible for reimbursement as a
Facilities and Administrative cost on
PHS-supported grants, cooperative
agreements and contracts. This could
offset the cost burdens of
implementation. Therefore, we do not
believe that the changes to the
regulations will have a significant
economic impact on a substantial
number of small entities. Our analysis is
39 All applicant Institution numbers are based on
the number of Institutions that applied for NIH
funding in FY 2008.
40 All applicant Institution numbers are based on
the number of Institutions that applied for NIH
funding in FY 2008.
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further supported by the small number
of FCOI reports submitted by small
business concerns; for example, ten
reports by small business concerns were
submitted to NIH in FY 2009 and eleven
in FY 2010. We also considered the
impact of the requirement for
Investigator training on small entities
and have lowered the frequency of
training required from every two years
as proposed in the NPRM to every four
yours. We believe this expanded
timeframe will decrease the burden on
Institutions, including small businesses.
In addition, for the 1995 regulations,
NIH developed training materials that
Institutions can use which are available
on the NIH Web site at https://
grants.nih.gov/grants/policy/coi/
index.htm. NIH will continue to update
the training materials to ameliorate the
burden on Institutions, including small
businesses.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation
with base year of 1995) in any one
year.’’ The current inflation-adjusted
statutory threshold is approximately
$143.5 million.41 The agency does not
expect that the amendments to the
regulations will result in any 1-year
expenditure that would meet or exceed
this amount.
Benefits
The amendments to the regulations
will expand and add transparency to
Investigator disclosure of Significant
Section of 42 CFR
part 50 subpart F or
45 CFR part 94
50.602 or 94.2 .......
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50.604 or 94.4
(a) ...................
(b) ...................
( c)(1) ..............
(c)(2) ...............
(d) ...................
(e)(1) ...............
41 Bureau
Financial Interests as well as enhance
regulatory compliance and effective
oversight of financial conflicts of
interest. Specifically, the revisions will
provide Institutions with additional
information on Investigator financial
interests so they can make a more
informed evaluation of whether the
disclosed SFI constitutes an FCOI with
PHS-funded research. Also, the
revisions will provide HHS with
additional information on an identified
FCOI to enable improved oversight.
Finally, the revised regulations will
provide interested stakeholders such as
Congress and the public with
information about Investigator financial
interests that were identified as an FCOI
with research funded by PHS, enabling
increased transparency and
accountability, with the goal of
preserving and strengthening public
trust in the output of the Federal
investment in biomedical research.
Costs
Approximately 3000 Institutions that
apply for PHS funding annually are
subject to the regulations. As there are
no changes to the regulations in the
requirements for Institutions that are
applying for PHS-funding, the
amendments will affect the
approximately 2000 organizations
(including small businesses but
excluding those that receive funding
through the SBIR/STTR Phase I
program) that are awarded PHS funding
annually and, through the
implementation of the regulations by
the Institutions, to the estimated 38,000
Investigators (using the definition of
Investigator in the regulations)
participating in PHS-funded research
that have SFIs. Many of the revisions
expand requirements that already
existed in the regulations. For instance,
the number of Investigators who would
be required to disclose their SFI is
unchanged under the revised
regulations as the definition of
Investigator is not changed
substantially. That said, however,
Investigators would be required to
disclose a larger number of financial
interests due to the revisions to the SFI
definition (e.g., changing the de minimis
from $10,000 to $5,000, and including
income from a subset of non-profit
Institutions). Also, Institutions are
already required to report any identified
FCOI to the PHS Awarding Component
under the 1995 regulations. The revised
regulations will require these reports to
contain additional information. Several
new requirements are included in the
revised regulations, including the
requirement for making information
available upon request and the
requirement for a retrospective review
in those rare cases in which an
Institution identifies noncompliance
with the regulations. We discuss the
rationale for each of these requirements
in the preamble. In sum, the estimated
burden for current implementation of
the 1995 regulations is approximately
80% of the burden estimated for
implementing the revised regulations.
The cost of implementing the
amended regulations is an allowable
cost that may be eligible for
reimbursement as a Facilities and
Administrative cost on PHS supported
grants, cooperative agreements and
contracts. This could offset some
portion of the cost burdens of
implementation for the affected
Institutions and through their
implementation of the regulations, to
the Investigators. Nonetheless, we are
including a description of the estimated
costs of the amendments to the
regulations for general information.
Number of respondents
Frequency of
response (annual)
Estimated cost per
response 42
Total: approximately 3,000 applicant
Institutions and 2,000 awardee Institutions (based on FY 2008 numbers) and an estimated 38,000 Investigators.
NA .........................
NA.
3,000 44 ................................................
Institutions: 2,000 45 ............................
Investigators: 38,000 46 .......................
1 ............................
Institutions: 1 ........
Investigators
0.25 47.
$8,505,000.
Institutions: $420,000.
Investigators: $665,000.
Total: $1,085,000.
500 49 ...................................................
Included in the cost estimate in
50.605/94.5(b)(3).
3,000 50 ................................................
38,000 51 ..............................................
1 ............................
NA .........................
$2,835 ...................
Institutions: $210 ..
Investigators:
$17.5 48.
Total: $227.5.
$35.00 ...................
NA.
1 ............................
1 ............................
$35 ........................
$140 ......................
$105,000.
$5,320,000.
Estimated annual cost 43
$17,500.
of Labor Statistics inflation calculator.
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Section of 42 CFR
part 50 subpart F or
45 CFR part 94
(e)(2) ...............
(e)(3) ...............
(f) ....................
(g) ...................
(h) ...................
(i) .....................
(j) .....................
(k) ....................
50.605 or 94.5
(a)(1) ...............
(a)(2) ...............
(a)(3) ...............
(a)(3)(i) ............
(a)(3)(ii) ...........
(a)(3)(iii) ..........
(a)(4) ...............
(a)(5) ...............
(b)(1) ...............
(b)(2) ...............
mstockstill on DSK4VPTVN1PROD with RULES3
(b)(3) ...............
(b)(4) ...............
50.606 or 94.6
(a) 65 ................
(c) ....................
Number of respondents
Frequency of
response (annual)
Estimated cost per
response 42
38,000 52 ..............................................
950 53 ...................................................
2,000 awardee Institutions ..................
Included in the cost estimate in
50.605/94.5(a)(1).
Included in the cost estimate in
50.605/94.5(b)(3).
2,000 awardee Institutions ..................
Included in the cost estimate in
50.604/94.4(a).
Included in the cost estimate in
50.604/94.4(a).
1 ............................
1 ............................
1 ............................
NA .........................
$35.00 ...................
$17.50 ...................
$35.00 ...................
NA.
NA .........................
NA.
1 ............................
NA .........................
$140 ......................
NA.
NA .........................
NA.
2,000 awardee Institutions 54 ..............
1 ............................
950 55 ...................................................
The cost is included in 50.605/
94.5(b)(2) below.
500 56 ...................................................
50 57 .....................................................
50 58 .....................................................
50 .........................................................
950 59 ...................................................
2,000 60 ................................................
Cost
included
in
50.605(b)(3)/
94.5(b)(3) below.
50 FCOI reports as in a(3)(ii) above 61
5 mitigation reports 62 ..........................
NA .........................
$70 for review and
$2,800 for developing management plan.
Total: $2,870 ........
NA .........................
$2,660,000 for review of all disclosures plus $2,660,000 for developing management plans of those
identified as FCOI.
Total: $5,320,000.
NA.
1 ............................
1 ............................
1 ............................
1 ............................
1 ............................
1 ............................
NA .........................
$105 ......................
$2,800 ...................
$2,800 ...................
$35 ........................
$420 ......................
$175 ......................
NA .........................
$52,500.
$140,000.
$140,000.
$1,750.
$399,000.
$350,000.
NA.
$70 for FCOI report and $70 for
mitigation report.
$70 × 50 = $3,500 for FCOI report
and $70 × 5 = $350 for mitigation
report.
Total = $3,850.
950 63 ...................................................
950 64 ...................................................
1 for reporting
FCOI and 1 for
mitigation reports in the case
bias was determined during the
retrospective review.
1 ............................
1 ............................
$70 ........................
$35.00 ...................
$66,500.
$33,250.
20 66 .....................................................
50 67 .....................................................
1 ............................
3 68 ........................
$350 ......................
$31.50 ...................
$7,000.
$1,575.
Estimated annual cost 43
$1,330,000.
$8,313.
$70,000.
$280,000.
Total annual cost: $23,236,238.
42 Average burden hours × $35/hour based on recent NIH cost analyses.
43 Number of respondents × estimated cost per response.
44 Assumes 3,000 applicant Institutions and 80 hours per Institution for formulating and maintaining the policy. Also assumes that most Institutions already maintain a public Web site. Therefore, posting the policy to the Web site or providing it upon request is an incremental cost—estimated at 1 hour annually.
45 Assumes that 2,000 awardee Institutions: 1. Inform Investigators about the policy on an annual basis by sending a notification to all Investigators = 1 hour and 2. Annually adapt NIH-provided training materials to institutional needs = 5 hours.
46 Assumes 38,000 Investigators undergo 2 hours of training every four years. This refers to FCOI training only and is based on the use of
training materials developed by the NIH and adapted to the Institution’s needs.
47 Once every 4 years.
48 $70 every 4 years.
49 An estimated maximum 25% of Institutions may have subrecipients in any one year—assuming 1 hour per Institution to incorporate the requirement of the regulations into an already existing written agreement. Includes burden on subrecipients.
50 Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators.
51 The financial disclosure burden estimate is based upon an Investigator figure of 38,000 with an average response time of 4 hours.
52 Assuming that updating a disclosure takes less time/effort than creating a new one—1 hour.
53 Assuming that only a small number of the 38,000 Investigators will have a new SFI in any year.
54 Although an estimated 950 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial
disclosures associated with PHS-funded awards to determine whether any conflicts of interest exist. Thus, the review burden of 76,000 hours is
based upon estimates that it will take on the average 2 hours for an institutional official(s) to review each of 38,000 financial disclosures associated with PHS funded awards. The burden for developing a management plan for identified FCOI is estimated at 80 hours × 950 cases = 76,000
hours.
55 Based on 50.604/94.4(e)(3) above.
56 Assuming that this is a rare occurrence, based on prior experience.
57 Assuming only a fraction of the newly identified SFIs will constitute FCOI.
58 Assuming only a fraction of the newly identified SFIs will constitute FCOI.
59 Based on previous assumption of 950 FCOI reports annually—estimated 12 hours annually, which may consist of 1 hour monthly or any
other division the Institution deems appropriate.
60 Since the information could be provided as a simple document or spreadsheet, providing the required information to multiple requestors or
adding it to an existing Web site is an incremental cost. Updating annually does have an additional cost.
61 The burden for subsequent reports of conflicts is significantly less, because we do not expect many additional reportable conflicts and there
will be only a limited number of disclosures to review.
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53281
62 After retrospective review—the cost of which is accounted for in a(3)(ii) above—we estimate that bias will be found in only a fraction of
cases.
63 Assumes 950 FCOI reports annually × 2 hours to prepare the report/complete an NIH-provided Web form.
64 Assumes it takes less time to update a report than to create a new one—1 hour per update.
65 This estimate includes inquiries by the PHS Awarding Component as described in 50.606.(b) and 94.6(b) and in accordance with 50.604(k)
and 94.4(k).
66 This burden was originally estimated in the 1995 Final Rule to be no more than 5 instances that the failure of an Investigator to comply with
the Institution’s conflict of interest policy has biased the design, conduct or reporting of the research. ‘‘Objectivity in Research, Final Rule’’ 60
Fed. Reg. 132 (July 11, 1995) pps. 35810–35819. This burden estimate, and others was increased in 2002 ‘‘due to increased numbers of Institutions and Investigators.’’ Although there has been an increase in the number of cases of noncompliance in the past few years, the number has
not approached this estimate so we believe it is still reasonable.
67 Based on 50.605/94.5(a)(3)(i)—of those only a fraction will relate to a project of clinical research whose purpose is to evaluate the safety or
effectiveness of a drug, medical device, or treatment, but we are calculating the maximum estimated cost.
68 Assuming an average of 3 publications annually.
Alternatives
The key alternative to the amendment
of these regulations would be to
continue to operate under the 1995
regulations. In the intervening years
since the regulations were promulgated,
Investigator collaborations have become
more complex and public scrutiny has
increased significantly creating an
environment that would benefit from
regulation with more effective means for
management and oversight. If we
continue to operate under the 1995
regulations, we would then lose the
opportunity to implement enhanced
Institutional management of Investigator
FCOIs related to PHS-funded research,
increased oversight by the PHS
Awarding Component, and enhanced
transparency. In addition, Congress has
expressly directed and supported the
ongoing regulation of FCOI (42 U.S.C.
216, 289b–1, 299c–4; Sec. 219, Tit. II,
Div. D, Pub. L. 111–117, 123 Stat. 3034),
and we agree that strengthening such
regulation is necessary to enhance
public trust and ensure the responsible
stewardship of Federal funds.
Paperwork Reduction Act
This final rule contains requirements
that are subject to OMB approval under
the Paperwork Reduction Act of 1995,
as amended (44 U.S.C. chapter 35).
Sections 50.604(a), 50.604(b),
50.604(c)(1), 50.604(d), 50.604(e)(1),
50.604(e)(2), 50.604(e)(3), 50.604(f),
50.605(a)(1), 50.605(a)(3),
50.605(a)(3)(i), 50.605(a)(3)(ii),
50.605(a)(4), 50.605(a)(5), 50.605(b)(1),
50.605(b)(2), 50.605(b)(3), 50.605(b)(4),
50.606(a), 50.606(c); 94.4(a), 94.4(b),
94.4(c)(1), 94.4(d), 94.4(e)(1), 94.4(e)(2),
94.4(e)(3), 94.4(f), 94.5(a)(1), 94.5(a)(3),
94.5(a)(3)(i), 94.5(a)(3)(ii), 94.5(a)(4),
94.5(a)(5), 94.5(b)(1), 94.5(b)(2),
94.5(b)(3), 94.5(b)(4), 94.6(a), and 94.6(c)
contain reporting and information
collection requirements that are subject
to OMB approval under the Paperwork
Reduction Act.
42 CFR 50.604(i), and 45 CFR 94.4(i)
contain recordkeeping requirements that
are subject to OMB review under the
Section of 42 CFR
part 50 subpart F or
45 CFR part 94
50.602 or 94.2 .......
50.604 or 94.4
(a) ...................
(b) ...................
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( c)(1) ..............
(c)(2) ...............
(d) ...................
(e)(1) ...............
(e)(2) ...............
(e)(3) ...............
(f) ....................
(g) ...................
(h) ...................
(i) .....................
(j) .....................
VerDate Mar<15>2010
Paperwork Reduction Act. The title,
description, and respondent description
of the information collection and
recordkeeping requirements contained
in this revised rule have been submitted
to OMB for review. Other organizations
and individuals desiring to submit
comments on the information collection
and recordkeeping requirements should
send their comments to: (1) Mikia
Currie, Project Clearance Officer,
National Institutes of Health, Rockledge
Center 1, 6705 Rockledge Drive, Room
3509, Bethesda, MD 20817, telephone
301–594–7949 (not a toll-free number);
and (2) the Office of Information and
Regulatory Affairs, OMB,
OIRA_submission@omb.eop or by fax to
202–395–6974, and mark ‘‘Attention:
Desk Officer for the National Institutes
of Health, Department of Health and
Human Services.’’ After we obtain OMB
approval, we will publish the OMB
control number in the Federal Register.
Following are details of the estimated
burden of implementing the revised
regulations.
Number of respondents
Frequency of
response (annual)
Total: approximately 3,000 applicant
Institutions and 2,000 awardee Institutions (based on FY2008 numbers)
and an estimated 38,000 Investigators.
NA .........................
NA.
3,000 70 ................................................
Institutions: 2,000 72 ............................
Investigators: 38,000 73 .......................
1 ............................
Institutions: 1 ........
Investigators
0.25 74.
1 ............................
NA .........................
81 71 ......................
Institutions: 6 ........
Investigators:
0.5 75.
1 ............................
NA .........................
243,000.
Institutions: 12,000.
Investigators: 19,000.
Total: 31,000.
500.
NA.
1 ............................
1 ............................
1 ............................
1 ............................
1 ............................
NA .........................
1 ............................
4 ............................
1 ............................
0.5 .........................
1 ............................
NA .........................
3,000.
152,000.
38,000.
475.
2,000.
NA.
NA .........................
NA .........................
NA.
1 ............................
NA .........................
4 ............................
NA .........................
8,000.
NA.
E:\FR\FM\25AUR3.SGM
25AUR3
500 76 ...................................................
Included in the burden estimate in
50.605/94.5 (b)(3).
3,000 77 ................................................
38,000 78 ..............................................
38,000 79 ..............................................
950 80 ...................................................
2,000 awardee Institutions ..................
Included in the burden estimate in
50.605/94.5 (a)(1).
Included in the burden estimate in
50.605/94.5 (b)(3).
2,000 awardee Institutions ..................
Included in the burden estimate in
50.604/94.4 (a).
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Average burden
hours
Annual burden hours 69
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Section of 42 CFR
part 50 subpart F or
45 CFR part 94
Number of respondents
Frequency of
response (annual)
Average burden
hours
(k) ....................
Included in the burden estimate in
50.604/94.4 (a).
NA .........................
NA .........................
NA.
50.605 or 94.5
(a)(1) ...............
2,000 awardee Institutions 81 ..............
1 ............................
76,000 for reviewing disclosures from
38,000 Investigators plus 76,000 for
developing management plans for
950 identified FCOIs = 152,000.
950 82 ...................................................
The burden is included in 50.605/94.5
(b)(2) below.
500 83 ...................................................
50 84 .....................................................
50 85 .....................................................
50 .........................................................
950 86 ...................................................
2,000 87 ................................................
Included in 50.605(b)(3)/94.5 (b)(3)
below.
50 FCOI reports as in a(3)(ii) above 88
5 mitigation reports 89 ..........................
NA .........................
2 hours per disclosure to review
plus 80 hours
per identified
FCOI to develop
management
plan.
NA .........................
NA.
1 ............................
1 ............................
1 ............................
1 ............................
1 ............................
1 ............................
NA .........................
3 ............................
80 ..........................
80 ..........................
1 ............................
12 ..........................
5 ............................
NA .........................
1,500.
4,000.
4,000.
50.
11,400.
10,000.
NA.
2 for FCOI report
and 2 for mitigation report.
50×2 = 100 for FCOI report and
5×2=10 for mitigation report.
Total =110.
950 90 ...................................................
950 91 ...................................................
1 for reporting
FCOI and 1 for
mitigation reports in the case
bias was determined during the
retrospective review.
1 ............................
1 ............................
2 ............................
1 ............................
1,900.
950.
20 93 .....................................................
50 94 .....................................................
1 ............................
3 95 ........................
10 ..........................
0.3 .........................
200.
45.
(a)(2) ...............
(a)(3) ...............
(a)(3)(i) ............
(a)(3)(ii) ...........
(a)(3)(iii) ..........
(a)(4) ...............
(a)(5) ...............
(b)(1) ...............
(b)(2) ...............
mstockstill on DSK4VPTVN1PROD with RULES3
(b)(3) ...............
(b)(4) ...............
50.606 or 94.6
(a) 92 ................
(c) ....................
Annual burden hours 69
Total burden hours: 664,130.
69 Number of respondents × average burden hours × frequency of response.
70 Assumes 3,000 applicant Institutions and 80 hours per Institution for formulating and maintaining the policy. Also assumes that most Institutions already maintain a public Web site. Therefore, posting the policy to the Web site or providing it upon request is an incremental burden—estimated at 1 hour annually.
71 80 h for policy formulation and maintenance; 1h for posting the policy or providing it upon request.
72 Assumes that 2,000 awardee Institutions: 1. inform Investigators about the policy on an annual basis by sending a notification to all Investigators = 1 hour and 2. annually adapt NIH-provided training materials to institutional needs = 5 hours.
73 Assumes 38,000 Investigators undergo 2 hours of training every four years. This refers to FCOI training only and is based on the use of
training materials developed by the NIH and adapted to the Institution’s needs.
74 Once every 4 years.
75 2 hours every 4 years.
76 An estimated maximum 25% of Institutions may have subrecipients in any one year—assuming 1 hour per Institution to incorporate the requirement of the regulations into an already existing written agreement. Includes burden on subrecipients.
77 Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators.
78 The financial disclosure burden estimate is based upon an Investigator figure of 38,000 with an average response time of 4 hours.
79 Assuming that updating a disclosure takes less time/effort than creating a new one—1 hour.
80 Assuming that only a small number of the 38,000 Investigators will have a new SFI in any year.
81 Although an estimated 950 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial
disclosures associated with PHS-funded awards to determine whether any conflicts of interest exist. Thus, the review burden of 76,000 hours is
based upon estimates that it will take on the average 2 hours for an institutional official(s) to review each of 38,000 financial disclosures associated with PHS funded awards. The burden for developing a management plan for identified FCOI is estimated at 80 hours × 950 cases = 76,000
hours.
82 Based on 50.604/94.4 (e)(3) above.
83 Assuming that this is a rare occurrence based on prior experience.
84 Assuming only a fraction of the newly identified SFIs will constitute FCOI.
85 Assuming only a fraction of the newly identified SFIs will constitute FCOI.
86 Based on previous assumption of 950 FCOI reports annually—estimated 12 hours annually, which may consist of 1 hour monthly or any
other division the Institution deems appropriate.
87 Since the information could be provided as a simple document or spreadsheet, providing the required information to multiple requestors or
adding it to an existing Web site is an incremental burden. Updating annually does have an additional burden.
88 The burden for subsequent reports of conflicts is significantly less, because we do not expect many additional reportable conflicts and there
will be only a limited number of disclosures to review.
89 After retrospective review—the burden of which is accounted for in a(3)(ii) above—we estimate that bias will be found in only a fraction of
cases.
90 Assumes 950 FCOI reports annually × 2 hours to prepare the report/complete an NIH-provided Web form.
91 Assumes it takes less time to update a report than to create a new one—1 hour per update.
92 This estimate includes inquiries by the PHS Awarding Component as described in 50.606.(b) and 94.6(b) and in accordance with 50.604(k)
and 94.4(k).
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53283
93 This burden was originally estimated in the 1995 Final Rule to be no more than 5 instances that the failure of an Investigator to comply with
the Institution’s conflict of interest policy has biased the design, conduct or reporting of the research. ‘‘Objectivity in Research, Final Rule’’ 60 FR
132 (July 11, 1995) pps. 35810–35819. This burden estimate, and others was increased in 2002 ‘‘due to increased numbers of Institutions and
Investigators.’’ Although there has been an increase in the number of cases of noncompliance in the past few years, the number has not approached this estimate so we believe it is still reasonable.
94 Number based on 50.605/94.5 (a)(3)(i)—of those only a fraction will relate to a project of clinical research whose purpose is to evaluate the
safety or effectiveness of a drug, medical device, or treatment, but we are calculating the maximum estimated burden.
95 Assuming an average of 3 publications annually.
Environmental Impact
We have determined that this action
is of a type that does not individually
or cumulatively have a significant effect
on the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Catalogue of Federal Domestic
Assistance
mstockstill on DSK4VPTVN1PROD with RULES3
The Catalogue of Federal Domestic
Assistance numbered programs
applicable to this revised rule are:
93.113—Environmental Health
93.121—Oral Diseases and Disorders
Research
93.142—NIEHS Hazardous Waste Worker
Health and Safety Training
93.143—NIEHS Superfund Hazardous
Substances—Basic Research and
Education
93.172—Human Genome Research
93.173—Research Related to Deafness and
Communication Disorders
93.187—Undergraduate Scholarship Program
for Individuals from Disadvantaged
Backgrounds
93.213—Research and Training in
Complementary and Alternative
Medicine
93.233—National Center on Sleep Disorders
Research
93.242—Mental Health Research Grants
93.271—Alcohol Research Career
Development Awards for Scientists and
Clinicians
93.272—Alcohol National Research Service
Awards for Research Training
93.273—Alcohol Research Programs
93.279—Drug Abuse and Addiction Research
Programs
93.281—Mental Health Research Career/
Scientist Development Awards
93.282—Mental Health National Research
Service Awards for Research Training
93.286—Discovery and Applied Research for
Technological Innovations to Improve
Human Health
93.307—Minority Health and Health
Disparities Research
93.310—Trans-NIH Research Support
93.361—Nursing Research
93.389—National Center for Research
Resources
93.393—Cancer Cause and Prevention
Research
93.394—Cancer Detection and Diagnosis
Research
93.395—Cancer Treatment Research
93.396—Cancer Biology Research
93.397—Cancer Centers Support Grants
93.398—Cancer Research Manpower
93.399—Cancer Control
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93.701—Trans-NIH Recovery Act Research
Support RECOVERY
93.702—National Center for Research
Resources, Recovery Act Construction
Support RECOVERY
93.837—Cardiovascular Diseases Research
93.838—Lung Diseases Research
93.839—Blood Diseases and Resources
Research
93.846—Arthritis, Musculoskeletal and Skin
Diseases Research
93.847—Diabetes, Digestive, and Kidney
Diseases Extramural Research
93.853—Extramural Research Programs in
the Neurosciences and Neurological
Disorders
93.855—Allergy, Immunology and
Transplantation Research
93.856—Microbiology and Infectious
Diseases Research
93.859—Biomedical Research and Research
Training
93.865—Child Health and Human
Development Extramural Research
93.866—Aging Research
93.867—Vision Research
93.879—Medical Library Assistance
93.891—Alcohol Research Center Grants
93.989—International Research and Research
Training
List of Subjects in 42 CFR Part 50 and
45 CFR Part 94
Colleges and universities, Conflict of
interests, Contracts, Financial
disclosure, Grants—health, Grants
programs, Non-profit organizations,
Research, Scientists, Small businesses.
For the reasons set forth in the
preamble, HHS is amending 42 CFR
chapter I, subchapter D, part 50, and 45
CFR subtitle A, subchapter A, part 94 as
follows:
TITLE 42—PUBLIC HEALTH
1. Revise Subpart F to read as follows:
Subpart F—Promoting Objectivity in
Research
Sec.
50.601 Purpose.
50.602 Applicability.
50.603 Definitions.
50.604 Responsibilities of Institutions
regarding Investigator financial conflicts
of interest.
50.605 Management and reporting of
financial conflicts of interest.
50.606 Remedies.
50.607 Other HHS regulations that apply.
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Authority: 42 U.S.C. 216, 289b–1, 299c–4;
Sec. 219, Tit. II, Div. D, Pub. L. 111–117, 123
Stat. 3034.
§ 50.601
Purpose.
This subpart promotes objectivity in
research by establishing standards that
provide a reasonable expectation that
the design, conduct, and reporting of
research funded under Public Health
Service (PHS) grants or cooperative
agreements will be free from bias
resulting from Investigator financial
conflicts of interest.
§ 50.602
Applicability.
This subpart is applicable to each
Institution that is applying for, or that
receives, PHS research funding by
means of a grant or cooperative
agreement and, through the
implementation of this subpart by the
Institution, to each Investigator who is
planning to participate in, or is
participating in, such research;
provided, however, that this subpart
does not apply to SBIR Program Phase
I applications. In those few cases where
an individual, rather than an Institution,
is applying for, or receives, PHS
research funding, PHS Awarding
Components will make case-by-case
determinations on the steps to be taken,
consistent with this subpart, to provide
a reasonable expectation that the design,
conduct, and reporting of the research
will be free from bias resulting from a
financial conflict of interest of the
individual.
§ 50.603
PART 50—POLICIES OF GENERAL
APPLICABILITY
■
Subpart F—Promoting Objectivity in
Research
Definitions.
As used in this subpart:
Disclosure of significant financial
interests means an Investigator’s
disclosure of significant financial
interests to an Institution.
Financial conflict of interest (FCOI)
means a significant financial interest
that could directly and significantly
affect the design, conduct, or reporting
of PHS-funded research.
FCOI report means an Institution’s
report of a financial conflict of interest
to a PHS Awarding Component.
Financial interest means anything of
monetary value, whether or not the
value is readily ascertainable.
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HHS means the United States
Department of Health and Human
Services, and any components of the
Department to which the authority
involved may be delegated.
Institution means any domestic or
foreign, public or private, entity or
organization (excluding a Federal
agency) that is applying for, or that
receives, PHS research funding.
Institutional responsibilities means an
Investigator’s professional
responsibilities on behalf of the
Institution, and as defined by the
Institution in its policy on financial
conflicts of interest, which may include
for example: activities such as research,
research consultation, teaching,
professional practice, institutional
committee memberships, and service on
panels such as Institutional Review
Boards or Data and Safety Monitoring
Boards.
Investigator means the project director
or principal Investigator and any other
person, regardless of title or position,
who is responsible for the design,
conduct, or reporting of research funded
by the PHS, or proposed for such
funding, which may include, for
example, collaborators or consultants.
Manage means taking action to
address a financial conflict of interest,
which can include reducing or
eliminating the financial conflict of
interest, to ensure, to the extent
possible, that the design, conduct, and
reporting of research will be free from
bias.
PD/PI means a project director or
principal Investigator of a PHS-funded
research project; the PD/PI is included
in the definitions of senior/key
personnel and Investigator under this
subpart.
PHS means the Public Health Service
of the U.S. Department of Health and
Human Services, and any components
of the PHS to which the authority
involved may be delegated, including
the National Institutes of Health (NIH).
PHS Awarding Component means the
organizational unit of the PHS that
funds the research that is subject to this
subpart.
Public Health Service Act or PHS Act
means the statute codified at 42 U.S.C.
201 et seq.
Research means a systematic
investigation, study or experiment
designed to develop or contribute to
generalizable knowledge relating
broadly to public health, including
behavioral and social-sciences research.
The term encompasses basic and
applied research (e.g., a published
article, book or book chapter) and
product development (e.g., a diagnostic
test or drug). As used in this subpart,
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the term includes any such activity for
which research funding is available
from a PHS Awarding Component
through a grant or cooperative
agreement, whether authorized under
the PHS Act or other statutory authority,
such as a research grant, career
development award, center grant,
individual fellowship award,
infrastructure award, institutional
training grant, program project, or
research resources award.
Senior/key personnel means the PD/PI
and any other person identified as
senior/key personnel by the Institution
in the grant application, progress report,
or any other report submitted to the PHS
by the Institution under this subpart.
Significant financial interest means:
(1) A financial interest consisting of
one or more of the following interests of
the Investigator (and those of the
Investigator’s spouse and dependent
children) that reasonably appears to be
related to the Investigator’s institutional
responsibilities:
(i) With regard to any publicly traded
entity, a significant financial interest
exists if the value of any remuneration
received from the entity in the twelve
months preceding the disclosure and
the value of any equity interest in the
entity as of the date of disclosure, when
aggregated, exceeds $5,000. For
purposes of this definition,
remuneration includes salary and any
payment for services not otherwise
identified as salary (e.g., consulting fees,
honoraria, paid authorship); equity
interest includes any stock, stock
option, or other ownership interest, as
determined through reference to public
prices or other reasonable measures of
fair market value;
(ii) With regard to any non-publicly
traded entity, a significant financial
interest exists if the value of any
remuneration received from the entity
in the twelve months preceding the
disclosure, when aggregated, exceeds
$5,000, or when the Investigator (or the
Investigator’s spouse or dependent
children) holds any equity interest (e.g.,
stock, stock option, or other ownership
interest); or
(iii) Intellectual property rights and
interests (e.g., patents, copyrights), upon
receipt of income related to such rights
and interests.
(2) Investigators also must disclose
the occurrence of any reimbursed or
sponsored travel (i.e., that which is paid
on behalf of the Investigator and not
reimbursed to the Investigator so that
the exact monetary value may not be
readily available), related to their
institutional responsibilities; provided,
however, that this disclosure
requirement does not apply to travel
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that is reimbursed or sponsored by a
Federal, state, or local government
agency, an Institution of higher
education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education. The Institution’s FCOI
policy will specify the details of this
disclosure, which will include, at a
minimum, the purpose of the trip, the
identity of the sponsor/organizer, the
destination, and the duration. In
accordance with the Institution’s FCOI
policy, the institutional official(s) will
determine if further information is
needed, including a determination or
disclosure of monetary value, in order to
determine whether the travel constitutes
an FCOI with the PHS-funded research.
(3) The term significant financial
interest does not include the following
types of financial interests: salary,
royalties, or other remuneration paid by
the Institution to the Investigator if the
Investigator is currently employed or
otherwise appointed by the Institution,
including intellectual property rights
assigned to the Institution and
agreements to share in royalties related
to such rights; any ownership interest in
the Institution held by the Investigator,
if the Institution is a commercial or forprofit organization; income from
investment vehicles, such as mutual
funds and retirement accounts, as long
as the Investigator does not directly
control the investment decisions made
in these vehicles; income from
seminars, lectures, or teaching
engagements sponsored by a Federal,
state, or local government agency, an
Institution of higher education as
defined at 20 U.S.C. 1001(a), an
academic teaching hospital, a medical
center, or a research institute that is
affiliated with an Institution of higher
education; or income from service on
advisory committees or review panels
for a Federal, state, or local government
agency, an Institution of higher
education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education.
Small Business Innovation Research
(SBIR) Program means the extramural
research program for small businesses
that is established by the Awarding
Components of the Public Health
Service and certain other Federal
agencies under Public Law 97–219, the
Small Business Innovation Development
Act, as amended. For purposes of this
subpart, the term SBIR Program also
includes the Small Business Technology
Transfer (STTR) Program, which was
established by Public Law 102–564.
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§ 50.604 Responsibilities of Institutions
regarding Investigator financial conflicts of
interest.
Each Institution shall:
(a) Maintain an up-to-date, written,
enforced policy on financial conflicts of
interest that complies with this subpart,
and make such policy available via a
publicly accessible Web site. If the
Institution does not have any current
presence on a publicly accessible Web
site (and only in those cases), the
Institution shall make its written policy
available to any requestor within five
business days of a request. If, however,
the Institution acquires a presence on a
publicly accessible Web site during the
time of the PHS award, the requirement
to post the information on that Web site
will apply within 30 calendar days. If an
Institution maintains a policy on
financial conflicts of interest that
includes standards that are more
stringent than this subpart (e.g., that
require a more extensive disclosure of
financial interests), the Institution shall
adhere to its policy and shall provide
FCOI reports regarding identified
financial conflicts of interest to the PHS
Awarding Component in accordance
with the Institution’s own standards and
within the timeframe prescribed by this
subpart.
(b) Inform each Investigator of the
Institution’s policy on financial
conflicts of interest, the Investigator’s
responsibilities regarding disclosure of
significant financial interests, and of
these regulations, and require each
Investigator to complete training
regarding the same prior to engaging in
research related to any PHS-funded
grant and at least every four years, and
immediately when any of the following
circumstances apply:
(1) The Institution revises its financial
conflict of interest policies or
procedures in any manner that affects
the requirements of Investigators;
(2) An Investigator is new to an
Institution; or
(3) An Institution finds that an
Investigator is not in compliance with
the Institution’s financial conflict of
interest policy or management plan.
(c) If the Institution carries out the
PHS-funded research through a
subrecipient (e.g., subcontractors or
consortium members), the Institution
(awardee Institution) must take
reasonable steps to ensure that any
subrecipient Investigator complies with
this subpart by:
(1) Incorporating as part of a written
agreement with the subrecipient terms
that establish whether the financial
conflicts of interest policy of the
awardee Institution or that of the
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subrecipient will apply to the
subrecipient’s Investigators.
(i) If the subrecipient’s Investigators
must comply with the subrecipient’s
financial conflicts of interest policy, the
subrecipient shall certify as part of the
agreement referenced above that its
policy complies with this subpart. If the
subrecipient cannot provide such
certification, the agreement shall state
that subrecipient Investigators are
subject to the financial conflicts of
interest policy of the awardee
Institution for disclosing significant
financial interests that are directly
related to the subrecipient’s work for the
awardee Institution;
(ii) Additionally, if the subrecipient’s
Investigators must comply with the
subrecipient’s financial conflicts of
interest policy, the agreement
referenced above shall specify time
period(s) for the subrecipient to report
all identified financial conflicts of
interest to the awardee Institution. Such
time period(s) shall be sufficient to
enable the awardee Institution to
provide timely FCOI reports, as
necessary, to the PHS as required by this
subpart;
(iii) Alternatively, if the subrecipient’s
Investigators must comply with the
awardee Institution’s financial conflicts
of interest policy, the agreement
referenced above shall specify time
period(s) for the subrecipient to submit
all Investigator disclosures of significant
financial interests to the awardee
Institution. Such time period(s) shall be
sufficient to enable the awardee
Institution to comply timely with its
review, management, and reporting
obligations under this subpart.
(2) Providing FCOI reports to the PHS
Awarding Component regarding all
financial conflicts of interest of all
subrecipient Investigators consistent
with this subpart, i.e., prior to the
expenditure of funds and within 60
days of any subsequently identified
FCOI.
(d) Designate an institutional
official(s) to solicit and review
disclosures of significant financial
interests from each Investigator who is
planning to participate in, or is
participating in, the PHS-funded
research.
(e)(1) Require that each Investigator
who is planning to participate in the
PHS-funded research disclose to the
Institution’s designated official(s) the
Investigator’s significant financial
interests (and those of the Investigator’s
spouse and dependent children) no later
than the time of application for PHSfunded research.
(2) Require each Investigator who is
participating in the PHS-funded
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research to submit an updated
disclosure of significant financial
interests at least annually, in accordance
with the specific time period prescribed
by the Institution, during the period of
the award. Such disclosure shall
include any information that was not
disclosed initially to the Institution
pursuant to paragraph (e)(1) of this
section, or in a subsequent disclosure of
significant financial interests (e.g., any
financial conflict of interest identified
on a PHS-funded project that was
transferred from another Institution),
and shall include updated information
regarding any previously disclosed
significant financial interest (e.g., the
updated value of a previously disclosed
equity interest).
(3) Require each Investigator who is
participating in the PHS-funded
research to submit an updated
disclosure of significant financial
interests within thirty days of
discovering or acquiring (e.g., through
purchase, marriage, or inheritance) a
new significant financial interest.
(f) Provide guidelines consistent with
this subpart for the designated
institutional official(s) to determine
whether an Investigator’s significant
financial interest is related to PHSfunded research and, if so related,
whether the significant financial interest
is a financial conflict of interest. An
Investigator’s significant financial
interest is related to PHS-funded
research when the Institution, through
its designated official(s), reasonably
determines that the significant financial
interest: could be affected by the PHSfunded research; or is in an entity
whose financial interest could be
affected by the research. The Institution
may involve the Investigator in the
designated official(s)’s determination of
whether a significant financial interest
is related to the PHS-funded research. A
financial conflict of interest exists when
the Institution, through its designated
official(s), reasonably determines that
the significant financial interest could
directly and significantly affect the
design, conduct, or reporting of the
PHS-funded research.
(g) Take such actions as necessary to
manage financial conflicts of interest,
including any financial conflicts of a
subrecipient Investigator pursuant to
paragraph (c) of this section.
Management of an identified financial
conflict of interest requires development
and implementation of a management
plan and, if necessary, a retrospective
review and a mitigation report pursuant
to § 50.605(a).
(h) Provide initial and ongoing FCOI
reports to the PHS as required pursuant
to § 50.605(b).
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(i) Maintain records relating to all
Investigator disclosures of financial
interests and the Institution’s review of,
and response to, such disclosures
(whether or not a disclosure resulted in
the Institution’s determination of a
financial conflict of interest) and all
actions under the Institution’s policy or
retrospective review, if applicable, for at
least three years from the date the final
expenditures report is submitted to the
PHS or, where applicable, from other
dates specified in 45 CFR 74.53(b) and
92.42 (b) for different situations.
(j) Establish adequate enforcement
mechanisms and provide for employee
sanctions or other administrative
actions to ensure Investigator
compliance as appropriate.
(k) Certify, in each application for
funding to which this subpart applies,
that the Institution:
(1) Has in effect at that Institution an
up-to-date, written, and enforced
administrative process to identify and
manage financial conflicts of interest
with respect to all research projects for
which funding is sought or received
from the PHS;
(2) Shall promote and enforce
Investigator compliance with this
subpart’s requirements including those
pertaining to disclosure of significant
financial interests;
(3) Shall manage financial conflicts of
interest and provide initial and ongoing
FCOI reports to the PHS Awarding
Component consistent with this subpart;
(4) Agrees to make information
available, promptly upon request, to the
HHS relating to any Investigator
disclosure of financial interests and the
Institution’s review of, and response to,
such disclosure, whether or not the
disclosure resulted in the Institution’s
determination of a financial conflict of
interest; and
(5) Shall fully comply with the
requirements of this subpart.
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§ 50.605 Management and reporting of
financial conflicts of interest.
(a) Management of financial conflicts
of interest.
(1) Prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the designated
official(s) of an Institution shall,
consistent with § 50.604(f): review all
Investigator disclosures of significant
financial interests; determine whether
any significant financial interests relate
to PHS-funded research; determine
whether a financial conflict of interest
exists; and, if so, develop and
implement a management plan that
shall specify the actions that have been,
and shall be, taken to manage such
financial conflict of interest. Examples
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of conditions or restrictions that might
be imposed to manage a financial
conflict of interest include, but are not
limited to:
(i) Public disclosure of financial
conflicts of interest (e.g., when
presenting or publishing the research);
(ii) For research projects involving
human subjects research, disclosure of
financial conflicts of interest directly to
participants;
(iii) Appointment of an independent
monitor capable of taking measures to
protect the design, conduct, and
reporting of the research against bias
resulting from the financial conflict of
interest;
(iv) Modification of the research plan;
(v) Change of personnel or personnel
responsibilities, or disqualification of
personnel from participation in all or a
portion of the research;
(vi) Reduction or elimination of the
financial interest (e.g., sale of an equity
interest); or
(vii) Severance of relationships that
create financial conflicts.
(2) Whenever, in the course of an
ongoing PHS-funded research project,
an Investigator who is new to
participating in the research project
discloses a significant financial interest
or an existing Investigator discloses a
new significant financial interest to the
Institution, the designated official(s) of
the Institution shall, within sixty days:
review the disclosure of the significant
financial interest; determine whether it
is related to PHS-funded research;
determine whether a financial conflict
of interest exists; and, if so, implement,
on at least an interim basis, a
management plan that shall specify the
actions that have been, and will be,
taken to manage such financial conflict
of interest. Depending on the nature of
the significant financial interest, an
Institution may determine that
additional interim measures are
necessary with regard to the
Investigator’s participation in the PHSfunded research project between the
date of disclosure and the completion of
the Institution’s review.
(3) Whenever an Institution identifies
a significant financial interest that was
not disclosed timely by an Investigator
or, for whatever reason, was not
previously reviewed by the Institution
during an ongoing PHS-funded research
project (e.g., was not timely reviewed or
reported by a subrecipient), the
designated official(s) shall, within sixty
days: review the significant financial
interest; determine whether it is related
to PHS-funded research; determine
whether a financial conflict of interest
exists; and, if so:
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(i) Implement, on at least an interim
basis, a management plan that shall
specify the actions that have been, and
will be, taken to manage such financial
conflict of interest going forward;
(ii)(A) In addition, whenever a
financial conflict of interest is not
identified or managed in a timely
manner including failure by the
Investigator to disclose a significant
financial interest that is determined by
the Institution to constitute a financial
conflict of interest; failure by the
Institution to review or manage such a
financial conflict of interest; or failure
by the Investigator to comply with a
financial conflict of interest
management plan, the Institution shall,
within 120 days of the Institution’s
determination of noncompliance,
complete a retrospective review of the
Investigator’s activities and the PHSfunded research project to determine
whether any PHS-funded research, or
portion thereof, conducted during the
time period of the noncompliance, was
biased in the design, conduct, or
reporting of such research.
(B) The Institution is required to
document the retrospective review; such
documentation shall include, but not
necessarily be limited to, all of the
following key elements:
(1) Project number;
(2) Project title;
(3) PD/PI or contact PD/PI if a
multiple PD/PI model is used;
(4) Name of the Investigator with the
FCOI;
(5) Name of the entity with which the
Investigator has a financial conflict of
interest;
(6) Reason(s) for the retrospective
review;
(7) Detailed methodology used for the
retrospective review (e.g., methodology
of the review process, composition of
the review panel, documents reviewed);
(8) Findings of the review; and
(9) Conclusions of the review.
(iii) Based on the results of the
retrospective review, if appropriate, the
Institution shall update the previously
submitted FCOI report, specifying the
actions that will be taken to manage the
financial conflict of interest going
forward. If bias is found, the Institution
is required to notify the PHS Awarding
Component promptly and submit a
mitigation report to the PHS Awarding
Component. The mitigation report must
include, at a minimum, the key
elements documented in the
retrospective review above and a
description of the impact of the bias on
the research project and the Institution’s
plan of action or actions taken to
eliminate or mitigate the effect of the
bias (e.g., impact on the research
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project; extent of harm done, including
any qualitative and quantitative data to
support any actual or future harm;
analysis of whether the research project
is salvageable). Thereafter, the
Institution will submit FCOI reports
annually, as specified elsewhere in this
subpart. Depending on the nature of the
financial conflict of interest, an
Institution may determine that
additional interim measures are
necessary with regard to the
Investigator’s participation in the PHSfunded research project between the
date that the financial conflict of
interest or the Investigator’s
noncompliance is determined and the
completion of the Institution’s
retrospective review.
(4) Whenever an Institution
implements a management plan
pursuant to this subpart, the Institution
shall monitor Investigator compliance
with the management plan on an
ongoing basis until the completion of
the PHS-funded research project.
(5)(i) Prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the Institution
shall ensure public accessibility, via a
publicly accessible Web site or written
response to any requestor within five
business days of a request, of
information concerning any significant
financial interest disclosed to the
Institution that meets the following
three criteria:
(A) The significant financial interest
was disclosed and is still held by the
senior/key personnel as defined by this
subpart;
(B) The Institution determines that the
significant financial interest is related to
the PHS-funded research; and
(C) The Institution determines that the
significant financial interest is a
financial conflict of interest.
(ii) The information that the
Institution makes available via a
publicly accessible Web site or written
response to any requestor within five
business days of a request, shall
include, at a minimum, the following:
the Investigator’s name; the
Investigator’s title and role with respect
to the research project; the name of the
entity in which the significant financial
interest is held; the nature of the
significant financial interest; and the
approximate dollar value of the
significant financial interest (dollar
ranges are permissible: $0–$4,999;
$5,000–$9,999; $10,000–$19,999;
amounts between $20,000–$100,000 by
increments of $20,000; amounts above
$100,000 by increments of $50,000), or
a statement that the interest is one
whose value cannot be readily
determined through reference to public
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prices or other reasonable measures of
fair market value.
(iii) If the Institution uses a publicly
accessible Web site for the purposes of
this subsection, the information that the
Institution posts shall be updated at
least annually. In addition, the
Institution shall update the Web site
within sixty days of the Institution’s
receipt or identification of information
concerning any additional significant
financial interest of the senior/key
personnel for the PHS-funded research
project that was not previously
disclosed, or upon the disclosure of a
significant financial interest of senior/
key personnel new to the PHS-funded
research project, if the Institution
determines that the significant financial
interest is related to the PHS-funded
research and is a financial conflict of
interest. The Web site shall note that the
information provided is current as of the
date listed and is subject to updates, on
at least an annual basis and within 60
days of the Institution’s identification of
a new financial conflict of interest. If the
Institution responds to written requests
for the purposes of this subsection, the
Institution will note in its written
response that the information provided
is current as of the date of the
correspondence and is subject to
updates, on at least an annual basis and
within 60 days of the Institution’s
identification of a new financial conflict
of interest, which should be requested
subsequently by the requestor.
(iv) Information concerning the
significant financial interests of an
individual subject to paragraph (a)(5) of
this section shall remain available, for
responses to written requests or for
posting via the Institution’s publicly
accessible Web site for at least three
years from the date that the information
was most recently updated.
(6) In addition to the types of
financial conflicts of interest as defined
in this subpart that must be managed
pursuant to this section, an Institution
may require the management of other
financial conflicts of interest in its
policy on financial conflicts of interest,
as the Institution deems appropriate.
(b) Reporting of financial conflicts of
interest.
(1) Prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the Institution
shall provide to the PHS Awarding
Component an FCOI report regarding
any Investigator’s significant financial
interest found by the Institution to be
conflicting and ensure that the
Institution has implemented a
management plan in accordance with
this subpart. In cases in which the
Institution identifies a financial conflict
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53287
of interest and eliminates it prior to the
expenditure of PHS-awarded funds, the
Institution shall not submit an FCOI
report to the PHS Awarding Component.
(2) For any significant financial
interest that the Institution identifies as
conflicting subsequent to the
Institution’s initial FCOI report during
an ongoing PHS-funded research project
(e.g., upon the participation of an
Investigator who is new to the research
project), the Institution shall provide to
the PHS Awarding Component, within
sixty days, an FCOI report regarding the
financial conflict of interest and ensure
that the Institution has implemented a
management plan in accordance with
this subpart. Pursuant to paragraph
(a)(3)(ii) of this section, where such
FCOI report involves a significant
financial interest that was not disclosed
timely by an Investigator or, for
whatever reason, was not previously
reviewed or managed by the Institution
(e.g., was not timely reviewed or
reported by a subrecipient), the
Institution also is required to complete
a retrospective review to determine
whether any PHS-funded research, or
portion thereof, conducted prior to the
identification and management of the
financial conflict of interest was biased
in the design, conduct, or reporting of
such research. Additionally, pursuant to
paragraph (a)(3)(iii) of this section, if
bias is found, the Institution is required
to notify the PHS Awarding Component
promptly and submit a mitigation report
to the PHS Awarding Component.
(3) Any FCOI report required under
paragraphs (b)(1) or (b)(2) of this section
shall include sufficient information to
enable the PHS Awarding Component to
understand the nature and extent of the
financial conflict, and to assess the
appropriateness of the Institution’s
management plan. Elements of the FCOI
report shall include, but are not
necessarily limited to the following:
(i) Project number;
(ii) PD/PI or Contact PD/PI if a
multiple PD/PI model is used;
(iii) Name of the Investigator with the
financial conflict of interest;
(iv) Name of the entity with which the
Investigator has a financial conflict of
interest;
(v) Nature of the financial interest
(e.g., equity, consulting fee, travel
reimbursement, honorarium);
(vi) Value of the financial interest
(dollar ranges are permissible: $0–
$4,999; $5,000–$9,999; $10,000–
$19,999; amounts between $20,000–
$100,000 by increments of $20,000;
amounts above $100,000 by increments
of $50,000), or a statement that the
interest is one whose value cannot be
readily determined through reference to
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public prices or other reasonable
measures of fair market value;
(vii) A description of how the
financial interest relates to the PHSfunded research and the basis for the
Institution’s determination that the
financial interest conflicts with such
research; and
(viii) A description of the key
elements of the Institution’s
management plan, including:
(A) Role and principal duties of the
conflicted Investigator in the research
project;
(B) Conditions of the management
plan;
(C) How the management plan is
designed to safeguard objectivity in the
research project;
(D) Confirmation of the Investigator’s
agreement to the management plan;
(E) How the management plan will be
monitored to ensure Investigator
compliance; and
(F) Other information as needed.
(4) For any financial conflict of
interest previously reported by the
Institution with regard to an ongoing
PHS-funded research project, the
Institution shall provide to the PHS
Awarding Component an annual FCOI
report that addresses the status of the
financial conflict of interest and any
changes to the management plan for the
duration of the PHS-funded research
project. The annual FCOI report shall
specify whether the financial conflict is
still being managed or explain why the
financial conflict of interest no longer
exists. The Institution shall provide
annual FCOI reports to the PHS
Awarding Component for the duration
of the project period (including
extensions with or without funds) in the
time and manner specified by the PHS
Awarding Component.
(5) In addition to the types of
financial conflicts of interest as defined
in this subpart that must be reported
pursuant to this section, an Institution
may require the reporting of other
financial conflicts of interest in its
policy on financial conflicts of interest,
as the Institution deems appropriate.
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§ 50.606
Remedies.
(a) If the failure of an Investigator to
comply with an Institution’s financial
conflicts of interest policy or a financial
conflict of interest management plan
appears to have biased the design,
conduct, or reporting of the PHS-funded
research, the Institution shall promptly
notify the PHS Awarding Component of
the corrective action taken or to be
taken. The PHS Awarding Component
will consider the situation and, as
necessary, take appropriate action, or
refer the matter to the Institution for
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further action, which may include
directions to the Institution on how to
maintain appropriate objectivity in the
PHS-funded research project. PHS may,
for example, require Institutions
employing such an Investigator to
enforce any applicable corrective
actions prior to a PHS award or when
the transfer of a PHS grant(s) involves
such an Investigator.
(b) The PHS Awarding Component
and/or HHS may inquire at any time
before, during, or after award into any
Investigator disclosure of financial
interests and the Institution’s review
(including any retrospective review) of,
and response to, such disclosure,
regardless of whether the disclosure
resulted in the Institution’s
determination of a financial conflict of
interest. An Institution is required to
submit, or permit on site review of, all
records pertinent to compliance with
this subpart. To the extent permitted by
law, HHS will maintain the
confidentiality of all records of financial
interests. On the basis of its review of
records or other information that may be
available, the PHS Awarding
Component may decide that a particular
financial conflict of interest will bias the
objectivity of the PHS-funded research
to such an extent that further corrective
action is needed or that the Institution
has not managed the financial conflict
of interest in accordance with this
subpart. The PHS Awarding Component
may determine that imposition of
special award conditions under 45 CFR
74.14 and 92.12, or suspension of
funding or other enforcement action
under 45 CFR 74.62 and 92.43, is
necessary until the matter is resolved.
(c) In any case in which the HHS
determines that a PHS-funded project of
clinical research whose purpose is to
evaluate the safety or effectiveness of a
drug, medical device, or treatment has
been designed, conducted, or reported
by an Investigator with a financial
conflict of interest that was not managed
or reported by the Institution as
required by this subpart, the Institution
shall require the Investigator involved to
disclose the financial conflict of interest
in each public presentation of the
results of the research and to request an
addendum to previously published
presentations.
§ 50.607
Other HHS regulations that apply.
Several other regulations and policies
apply to this subpart. They include, but
are not necessarily limited to:
2 CFR part 376—Nonprocurement
debarment and suspension (HHS)
42 CFR part 50, subpart D—Public
Health Service grant appeals
procedure
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45 CFR part 16—Procedures of the
Departmental Grant Appeals Board
45 CFR part 74—Uniform administrative
requirements for awards and
subawards to institutions of higher
education, hospitals, other
nonprofit organizations, and
commercial organizations
45 CFR part 79—Program fraud civil
remedies
45 CFR part 92—Uniform administrative
requirements for grants and
cooperative agreements to State,
local, and tribal governments
TITLE 45—PUBLIC WELFARE
■
2. Revise Part 94 to read as follows:
PART 94—RESPONSIBLE
PROSPECTIVE CONTRACTORS
Sec.
94.1
94.2
94.3
94.4
Purpose.
Applicability.
Definitions.
Responsibilities of Institutions
regarding Investigator financial conflicts
of interest.
94.5 Management and reporting of financial
conflicts of interest.
94.6 Remedies.
Authority: 42 U.S.C. 216, 289b–1, 299c–
4.
§ 94.1
Purpose.
This part promotes objectivity in
research by establishing standards that
provide a reasonable expectation that
the design, conduct, and reporting of
research performed under PHS contracts
will be free from bias resulting from
Investigator financial conflicts of
interest.
§ 94.2
Applicability.
This part is applicable to each
Institution that submits a proposal, or
that receives, Public Health Service
(PHS) research funding by means of a
contract and, through the
implementation of this part by the
Institution, to each Investigator who is
planning to participate in, or is
participating in such research; provided,
however, that this part does not apply
to SBIR Program Phase I applications.
§ 94.3
Definitions.
As used in this part:
Contractor means an entity that
provides property or services under
contract for the direct benefit or use of
the Federal Government.
Disclosure of significant financial
interests means an Investigator’s
disclosure of significant financial
interests to an Institution.
Financial conflict of interest (FCOI)
means a significant financial interest
that could directly and significantly
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affect the design, conduct, or reporting
of PHS-funded research.
FCOI report means an Institution’s
report of a financial conflict of interest
to a PHS Awarding Component.
Financial interest means anything of
monetary value, whether or not the
value is readily ascertainable.
HHS means the United States
Department of Health and Human
Services, and any components of the
Department to which the authority
involved may be delegated.
Institution means any domestic or
foreign, public or private, entity or
organization (excluding a Federal
agency) that submits a proposal, or that
receives, PHS research funding.
Institutional responsibilities means an
Investigator’s professional
responsibilities on behalf of the
Institution, and as defined by the
Institution in its policy on financial
conflicts of interest, which may include
for example: activities such as research,
research consultation, teaching,
professional practice, institutional
committee memberships, and service on
panels such as Institutional Review
Boards or Data and Safety Monitoring
Boards.
Investigator means the project director
or principal Investigator and any other
person, regardless of title or position,
who is responsible for the design,
conduct, or reporting of research funded
by the PHS, or proposed for such
funding, which may include, for
example, collaborators or consultants.
Key personnel includes the PD/PI and
any other personnel considered to be
essential to work performance in
accordance with HHSAR subpart
352.242–70 and identified as key
personnel in the contract proposal and
contract.
Manage means taking action to
address a financial conflict of interest,
which can include reducing or
eliminating the financial conflict of
interest, to ensure, to the extent
possible, that the design, conduct, and
reporting of research will be free from
bias.
PD/PI means a project director or
principal Investigator of a PHS-funded
research project; the PD/PI is included
in the definitions of key personnel and
Investigator under this part.
PHS means the Public Health Service
of the U.S. Department of Health and
Human Services, and any components
of the PHS to which the authority
involved may be delegated, including
the National Institutes of Health (NIH).
PHS Awarding Component means the
organizational unit of the PHS that
funds the research that is subject to this
part.
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Public Health Service Act or PHS Act
means the statute codified at 42 U.S.C.
201 et seq.
Research means a systematic
investigation, study or experiment
designed to develop or contribute to
generalizable knowledge relating
broadly to public health, including
behavioral and social-sciences research.
The term encompasses basic and
applied research (e.g., a published
article, book or book chapter) and
product development (e.g., a diagnostic
test or drug). As used in this part, the
term includes any such activity for
which research funding is available
from a PHS Awarding Component
through a contract, whether authorized
under the PHS Act or other statutory
authority.
Significant financial interest means:
(1) A financial interest consisting of
one or more of the following interests of
the Investigator (and those of the
Investigator’s spouse and dependent
children) that reasonably appears to be
related to the Investigator’s institutional
responsibilities:
(i) With regard to any publicly traded
entity, a significant financial interest
exists if the value of any remuneration
received from the entity in the twelve
months preceding the disclosure and
the value of any equity interest in the
entity as of the date of disclosure, when
aggregated, exceeds $5,000. For
purposes of this definition,
remuneration includes salary and any
payment for services not otherwise
identified as salary (e.g., consulting fees,
honoraria, paid authorship); equity
interest includes any stock, stock
option, or other ownership interest, as
determined through reference to public
prices or other reasonable measures of
fair market value;
(ii) With regard to any non-publicly
traded entity, a significant financial
interest exists if the value of any
remuneration received from the entity
in the twelve months preceding the
disclosure, when aggregated, exceeds
$5,000, or when the Investigator (or the
Investigator’s spouse or dependent
children) holds any equity interest (e.g.,
stock, stock option, or other ownership
interest); or
(iii) Intellectual property rights and
interests (e.g., patents, copyrights), upon
receipt of income related to such rights
and interests.
(2) Investigators also must disclose
the occurrence of any reimbursed or
sponsored travel (i.e., that which is paid
on behalf of the Investigator and not
reimbursed to the Investigator so that
the exact monetary value may not be
readily available), related to their
Institutional responsibilities; provided,
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however, that this disclosure
requirement does not apply to travel
that is reimbursed or sponsored by a
Federal, state, or local government
agency, an Institution of higher
education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education. The Institution’s FCOI
policy will specify the details of this
disclosure, which will include, at a
minimum, the purpose of the trip, the
identity of the sponsor/organizer, the
destination, and the duration. In
accordance with the Institution’s FCOI
policy, the Institutional official(s) will
determine if further information is
needed, including a determination or
disclosure of monetary value, in order to
determine whether the travel constitutes
an FCOI with the PHS-funded research.
(3) The term significant financial
interest does not include the following
types of financial interests: salary,
royalties, or other remuneration paid by
the Institution to the Investigator if the
Investigator is currently employed or
otherwise appointed by the Institution,
including intellectual property rights
assigned to the Institution and
agreements to share in royalties related
to such rights; any ownership interest in
the Institution held by the Investigator,
if the Institution is a commercial or forprofit organization; income from
investment vehicles, such as mutual
funds and retirement accounts, as long
as the Investigator does not directly
control the investment decisions made
in these vehicles; income from
seminars, lectures, or teaching
engagements sponsored by a Federal,
state, or local government agency, an
Institution of higher education as
defined at 20 U.S.C. 1001(a), an
academic teaching hospital, a medical
center, or a research institute that is
affiliated with an Institution of higher
education; or income from service on
advisory committees or review panels
for a Federal, state, or local government
agency, an Institution of higher
education as defined at 20 U.S.C.
1001(a), an academic teaching hospital,
a medical center, or a research institute
that is affiliated with an Institution of
higher education.
Small Business Innovation Research
(SBIR) Program means the extramural
research program for small businesses
that is established by the Awarding
Components of the Public Health
Service and certain other Federal
agencies under Public Law 97–219, the
Small Business Innovation Development
Act, as amended. For purposes of this
part, the term SBIR Program also
includes the Small Business Technology
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Transfer (STTR) Program, which was
established by Public Law 102–564.
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§ 94.4 Responsibilities of Institutions
regarding Investigator financial conflicts of
interest.
Each Institution shall:
(a) Maintain an up-to-date, written,
enforced policy on financial conflicts of
interest that complies with this part,
and make such policy available via a
publicly accessible Web site. If the
Institution does not have any current
presence on a publicly accessible Web
site (and only in those cases), the
Institution shall make its written policy
available to any requestor within five
business days of a request. If, however,
the Institution acquires a presence on a
publicly accessible Web site during the
time of the PHS award, the requirement
to post the information on that Web site
will apply within 30 calendar days. If an
Institution maintains a policy on
financial conflicts of interest that
includes standards that are more
stringent than this part (e.g., that require
a more extensive disclosure of financial
interests), the Institution shall adhere to
its policy and shall provide FCOI
reports regarding identified financial
conflicts of interest to the PHS
Awarding Component in accordance
with the Institution’s own standards and
within the timeframe prescribed by this
part.
(b) Inform each Investigator of the
Institution’s policy on financial
conflicts of interest, the Investigator’s
responsibilities regarding disclosure of
significant financial interests, and of
these regulations, and require each
Investigator to complete training
regarding the same prior to engaging in
research related to any PHS-funded
contract and at least every four years,
and immediately when any of the
following circumstances apply:
(1) The Institution revises its financial
conflict of interest policies or
procedures in any manner that affects
the requirements of Investigators;
(2) An Investigator is new to an
Institution; or
(3) An Institution finds that an
Investigator is not in compliance with
the Institution’s financial conflict of
interest policy or management plan.
(c) If the Institution carries out the
PHS-funded research through a
subrecipient (e.g., subcontractors, or
consortium members), the Institution
(awardee Institution) must take
reasonable steps to ensure that any
subrecipient Investigator complies with
this part by
(1) Incorporating as part of a written
agreement with the subrecipient terms
that establish whether the financial
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conflicts of interest policy of the
awardee Institution or that of the
subrecipient will apply to the
subrecipient’s Investigators.
(i) If the subrecipient’s Investigators
must comply with the subrecipient’s
financial conflicts of interest policy, the
subrecipient shall certify as part of the
agreement referenced above that its
policy complies with this part. If the
subrecipient cannot provide such
certification, the agreement shall state
that subrecipient Investigators are
subject to the financial conflicts of
interest policy of the awardee
Institution for disclosing significant
financial interests that are directly
related to the subrecipient’s work for the
awardee Institution;
(ii) Additionally, if the subrecipient’s
Investigators must comply with the
subrecipient’s financial conflicts of
interest policy, the agreement
referenced above shall specify time
period(s) for the subrecipient to report
all identified financial conflicts of
interest to the awardee Institution. Such
time period(s) shall be sufficient to
enable the awardee Institution to
provide timely FCOI reports, as
necessary, to the PHS as required by this
part;
(iii) Alternatively, if the subrecipient’s
Investigators must comply with the
awardee Institution’s financial conflicts
of interest policy, the agreement
referenced above shall specify time
period(s) for the subrecipient to submit
all Investigator disclosures of significant
financial interests to the awardee
Institution. Such time period(s) shall be
sufficient to enable the awardee
Institution to comply timely with its
review, management, and reporting
obligations under this part.
(2) Providing FCOI reports to the PHS
Awarding Component regarding all
financial conflicts of interest of all
subrecipient Investigators consistent
with this part, i.e., prior to the
expenditure of funds and within 60
days of any subsequently identified
FCOI.
(d) Designate an institutional
official(s) to solicit and review
disclosures of significant financial
interests from each Investigator who is
planning to participate in, or is
participating in, the PHS-funded
research.
(e)(1) Require that each Investigator
who is planning to participate in the
PHS-funded research disclose to the
Institution’s designated official(s) the
Investigator’s significant financial
interests (and those of the Investigator’s
spouse and dependent children) no later
than date of submission of the
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Institution’s proposal for PHS-funded
research.
(2) Require each Investigator who is
participating in the PHS-funded
research to submit an updated
disclosure of significant financial
interests at least annually, in accordance
with the specific time period prescribed
by the Institution, during the period of
the award. Such disclosure shall
include any information that was not
disclosed initially to the Institution
pursuant to paragraph (e)(1) of this
section, or in a subsequent disclosure of
significant financial interests (e.g., any
financial conflict of interest identified
on a PHS-funded project that was
transferred from another Institution),
and shall include updated information
regarding any previously disclosed
significant financial interest (e.g., the
updated value of a previously disclosed
equity interest).
(3) Require each Investigator who is
participating in the PHS-funded
research to submit an updated
disclosure of significant financial
interests within thirty days of
discovering or acquiring (e.g., through
purchase, marriage, or inheritance) a
new significant financial interest.
(f) Provide guidelines consistent with
this part for the designated institutional
official(s) to determine whether an
Investigator’s significant financial
interest is related to PHS-funded
research and, if so related, whether the
significant financial interest is a
financial conflict of interest. An
Investigator’s significant financial
interest is related to PHS-funded
research when the Institution, through
its designated official(s), reasonably
determines that the significant financial
interest: Could be affected by the PHSfunded research; or is in an entity
whose financial interest could be
affected by the research. The Institution
may involve the Investigator in the
designated official(s)’s determination of
whether a significant financial interest
is related to the PHS-funded research. A
financial conflict of interest exists when
the Institution, through its designated
official(s), reasonably determines that
the significant financial interest could
directly and significantly affect the
design, conduct, or reporting of the
PHS-funded research.
(g) Take such actions as necessary to
manage financial conflicts of interest,
including any financial conflicts of a
subrecipient Investigator pursuant to
paragraph (c) of this section.
Management of an identified financial
conflict of interest requires development
and implementation of a management
plan and, if necessary, a retrospective
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review and mitigation report pursuant
to § 94.5(a).
(h) Provide initial and ongoing FCOI
reports to the PHS as required pursuant
to § 94.5(b).
(i) Maintain records relating to all
Investigator disclosures of financial
interests and the Institution’s review of,
and response to, such disclosures
(whether or not a disclosure resulted in
the Institution’s determination of a
financial conflict of interest), and all
actions under the Institution’s policy or
retrospective review, if applicable, for at
least three years from the date of final
payment or, where applicable, for the
time periods specified in 48 CFR part 4,
subpart 4.7.
(j) Establish adequate enforcement
mechanisms and provide for employee
sanctions or other administrative
actions to ensure Investigator
compliance as appropriate.
(k) Certify, in each contract proposal
to which this part applies, that the
Institution:
(1) Has in effect at that Institution an
up-to-date, written, and enforced
administrative process to identify and
manage financial conflicts of interest
with respect to all research projects for
which funding is sought or received
from the PHS;
(2) Shall promote and enforce
Investigator compliance with this part’s
requirements including those pertaining
to disclosure of significant financial
interests;
(3) Shall manage financial conflicts of
interest and provide initial and ongoing
FCOI reports to the PHS Awarding
Component consistent with this part;
(4) Agrees to make information
available, promptly upon request, to the
HHS relating to any Investigator
disclosure of financial interests and the
Institution’s review of, and response to,
such disclosure, whether or not the
disclosure resulted in the Institution’s
determination of a financial conflict of
interest; and
(5) Shall fully comply with the
requirements of this part.
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§ 94.5 Management and reporting of
financial conflicts of interest.
(a) Management of financial conflicts
of interest.
(1) Prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the designated
official(s) of an Institution shall,
consistent with § 94.4(f): review all
Investigator disclosures of significant
financial interests; determine whether
any significant financial interests relate
to PHS-funded research; determine
whether a financial conflict of interest
exists; and, if so, develop and
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implement a management plan that
shall specify the actions that have been,
and shall be, taken to manage such
financial conflict of interest. Examples
of conditions or restrictions that might
be imposed to manage a financial
conflict of interest include, but are not
limited to:
(i) Public disclosure of financial
conflicts of interest (e.g., when
presenting or publishing the research);
(ii) For research projects involving
human subjects research, disclosure of
financial conflicts of interest directly to
participants;
(iii) Appointment of an independent
monitor capable of taking measures to
protect the design, conduct, and
reporting of the research against bias,
resulting from the financial conflict of
interest;
(iv) Modification of the research plan;
(v) Change of personnel or personnel
responsibilities, or disqualification of
personnel from participation in all or a
portion of the research;
(vi) Reduction or elimination of the
financial interest (e.g., sale of an equity
interest); or
(vii) Severance of relationships that
create financial conflicts.
(2) Whenever, in the course of an
ongoing PHS-funded research project,
an Investigator who is new to
participating in the research project
discloses a significant financial interest
or an existing Investigator discloses a
new significant financial interest to the
Institution, the designated official(s) of
the Institution shall, within sixty days:
review the disclosure of the significant
financial interest; determine whether it
is related to PHS-funded research;
determine whether a financial conflict
of interest exists; and, if so, implement,
on at least an interim basis, a
management plan that shall specify the
actions that have been, and will be,
taken to manage such financial conflict
of interest. Depending on the nature of
the significant financial interest, an
Institution may determine that
additional interim measures are
necessary with regard to the
Investigator’s participation in the PHSfunded research project between the
date of disclosure and the completion of
the Institution’s review.
(3) Whenever an Institution identifies
a significant financial interest that was
not disclosed timely by an Investigator
or, for whatever reason, was not
previously reviewed by the Institution
during an ongoing PHS-funded research
project (e.g., was not timely reviewed or
reported by a subrecipient), the
designated official(s) shall, within sixty
days: review the significant financial
interest; determine whether it is related
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to PHS-funded research; determine
whether a financial conflict of interest
exists; and, if so:
(i) Implement, on at least an interim
basis, a management plan that shall
specify the actions that have been, and
will be, taken to manage such financial
conflict of interest going forward;
(ii) (A) In addition, whenever a
financial conflict of interest is not
identified or managed in a timely
manner including failure by the
Investigator to disclose a significant
financial interest that is determined by
the Institution to constitute a financial
conflict of interest; failure by the
Institution to review or manage such a
financial conflict of interest; or failure
by the Investigator to comply with a
financial conflict of interest
management plan, the Institution shall,
within 120 days of the Institution’s
determination of noncompliance,
complete a retrospective review of the
Investigator’s activities and the PHSfunded research project to determine
whether any PHS-funded research, or
portion thereof, conducted during the
time period of the noncompliance, was
biased in the design, conduct, or
reporting of such research.
(B) The Institution is required to
document the retrospective review; such
documentation shall include, but not
necessarily be limited to, all of the
following key elements:
(1) Project number;
(2) Project title;
(3) PD/PI or contact PD/PI if a
multiple PD/PI model is used;
(4) Name of the Investigator with the
FCOI;
(5) Name of the entity with which the
Investigator has a financial conflict of
interest;
(6) Reason(s) for the retrospective
review;
(7) Detailed methodology used for the
retrospective review (e.g., methodology
of the review process, composition of
the review panel, documents reviewed);
(8) Findings of the review; and
(9) Conclusions of the review.
(iii) Based on the results of the
retrospective review, if appropriate, the
Institution shall update the previously
submitted FCOI report, specifying the
actions that will be taken to manage the
financial conflict of interest going
forward. If bias is found, the Institution
is required to notify the PHS Awarding
Component promptly and submit a
mitigation report to the PHS Awarding
Component. The mitigation report must
include, at a minimum, the key
elements documented in the
retrospective review above and a
description of the impact of the bias on
the research project and the Institution’s
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plan of action or actions taken to
eliminate or mitigate the effect of the
bias (e.g., impact on the research
project; extent of harm done, including
any qualitative and quantitative data to
support any actual or future harm;
analysis of whether the research project
is salvageable). Thereafter, the
Institution will submit FCOI reports
annually, as specified elsewhere in this
part. Depending on the nature of the
financial conflict of interest, an
Institution may determine that
additional interim measures are
necessary with regard to the
Investigator’s participation in the PHSfunded research project between the
date that the financial conflict of
interest or the Investigator’s
noncompliance is determined and the
completion of the Institution’s
retrospective review.
(4) Whenever an Institution
implements a management plan
pursuant to this part, the Institution
shall monitor Investigator compliance
with the management plan on an
ongoing basis until the completion of
the PHS-funded research project.
(5)(i) Prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the Institution
shall ensure public accessibility, via a
publicly accessible Web site or written
response to any requestor within five
business days of a request, of
information concerning any significant
financial interest disclosed to the
Institution that meets the following
three criteria:
(A) The significant financial interest
was disclosed and is still held by key
personnel as defined in this part;
(B) The Institution determines that the
significant financial interest is related to
the PHS-funded research; and
(C) The Institution determines that the
significant financial interest is a
financial conflict of interest.
(ii) The information that the
Institution makes available via a
publicly accessible Web site or written
response to any requestor within five
business days of a request, shall
include, at a minimum, the following:
The Investigator’s name; the
Investigator’s title and role with respect
to the research project; the name of the
entity in which the significant financial
interest is held; the nature of the
significant financial interest; and the
approximate dollar value of the
significant financial interest (dollar
ranges are permissible: $0–$4,999;
$5,000–$9,999; $10,000–$19,999;
amounts between $20,000–$100,000 by
increments of $20,000; amounts above
$100,000 by increments of $50,000), or
a statement that the interest is one
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whose value cannot be readily
determined through reference to public
prices or other reasonable measures of
fair market value.
(iii) If the Institution uses a publicly
accessible Web site for the purposes of
this subsection, the information that the
Institution posts shall be updated at
least annually. In addition, the
Institution shall update the Web site
within sixty days of the Institution’s
receipt or identification of information
concerning any additional significant
financial interest of the senior/key
personnel for the PHS-funded research
project that was not previously
disclosed, or upon the disclosure of a
significant financial interest of senior/
key personnel new to the PHS-funded
research project, if the Institution
determines that the significant financial
interest is related to the PHS-funded
research and is a financial conflict of
interest. The Web site shall note that the
information provided is current as of the
date listed and is subject to updates, on
at least an annual basis and within 60
days of the Institution’s identification of
a new financial conflict of interest. If the
Institution responds to written requests
for the purposes of this subsection, the
Institution will note in its written
response that the information provided
is current as of the date of the
correspondence and is subject to
updates, on at least an annual basis and
within 60 days of the Institution’s
identification of a new financial conflict
of interest, which should be requested
subsequently by the requestor.
(iv) Information concerning the
significant financial interests of an
individual subject to paragraph (a)(5) of
this section shall remain available, for
responses to written requests or for
posting via the Institution’s publicly
accessible Web site for at least three
years from the date that the information
was most recently updated.
(6) In addition to the types of
financial conflicts of interest as defined
in this part that must be managed
pursuant to this section, an Institution
may require the management of other
financial conflicts of interest in its
policy on financial conflicts of interest,
as the Institution deems appropriate.
(b) Reporting of financial conflicts of
interest.
(1) Prior to the Institution’s
expenditure of any funds under a PHSfunded research project, the Institution
shall provide to the PHS Awarding
Component an FCOI report regarding
any Investigator’s significant financial
interest found by the Institution to be
conflicting and ensure that the
Institution has implemented a
management plan in accordance with
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this part. In cases in which the
Institution identifies a financial conflict
of interest and eliminates it prior to the
expenditure of PHS-awarded funds, the
Institution shall not submit an FCOI
report to the PHS Awarding Component.
(2) For any significant financial
interest that the Institution identifies as
conflicting subsequent to the
Institution’s initial FCOI report during
an ongoing PHS-funded research project
(e.g., upon the participation of an
Investigator who is new to the research
project), the Institution shall provide to
the PHS Awarding Component, within
sixty days, an FCOI report regarding the
financial conflict of interest and ensure
that the Institution has implemented a
management plan in accordance with
this part. Pursuant to paragraph (a)(3)(ii)
of this section, where such FCOI report
involves a significant financial interest
that was not disclosed timely by an
Investigator or, for whatever reason, was
not previously reviewed or managed by
the Institution (e.g., was not timely
reviewed or reported by a subrecipient),
the Institution also is required to
complete a retrospective review to
determine whether any PHS-funded
research, or portion thereof, conducted
prior to the identification and
management of the financial conflict of
interest was biased in the design,
conduct, or reporting of such research.
Additionally, pursuant to paragraph
(a)(3)(iii) of this section, if bias is found,
the Institution is required to notify the
PHS Awarding Component promptly
and submit a mitigation report to the
PHS Awarding Component.
(3) Any FCOI report required under
paragraphs (b)(1) or (b)(2) of this section
shall include sufficient information to
enable the PHS Awarding Component to
understand the nature and extent of the
financial conflict, and to assess the
appropriateness of the Institution’s
management plan. Elements of the FCOI
report shall include, but are not
necessarily limited to the following:
(i) Project/Contract number;
(ii) PD/PI or Contact PD/PI if a
multiple PD/PI model is used;
(iii) Name of the Investigator with the
financial conflict of interest;
(iv) Name of the entity with which the
Investigator has a financial conflict of
interest;
(v) Nature of the financial interest
(e.g., equity, consulting fee, travel
reimbursement, honorarium);
(vi) Value of the financial interest
(dollar ranges are permissible: $0–
$4,999; $5,000–$9,999; $10,000–
$19,999; amounts between $20,000–
$100,000 by increments of $20,000;
amounts above $100,000 by increments
of $50,000), or a statement that the
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interest is one whose value cannot be
readily determined through reference to
public prices or other reasonable
measures of fair market value;
(vii) A description of how the
financial interest relates to the PHSfunded research and the basis for the
Institution’s determination that the
financial interest conflicts with such
research; and
(viii) A description of the key
elements of the Institution’s
management plan, including:
(A) Role and principal duties of the
conflicted Investigator in the research
project;
(B) Conditions of the management
plan;
(C) How the management plan is
designed to safeguard objectivity in the
research project;
(D) Confirmation of the Investigator’s
agreement to the management plan;
(E) How the management plan will be
monitored to ensure Investigator
compliance; and
(F) Other information as needed.
(4) For any financial conflict of
interest previously reported by the
Institution with regard to an ongoing
PHS-funded research project, the
Institution shall provide to the PHS
Awarding Component an annual FCOI
report that addresses the status of the
financial conflict of interest and any
changes to the management plan for the
duration of the PHS-funded research
project. The annual FCOI report shall
specify whether the financial conflict is
still being managed or explain why the
financial conflict of interest no longer
exists. The Institution shall provide
annual FCOI reports to the PHS
Awarding Component for the duration
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of the project period (including
extensions with or without funds) in the
time and manner specified by the PHS
Awarding Component.
(5) In addition to the types of
financial conflicts of interest as defined
in this part that must be reported
pursuant to this section, an Institution
may require the reporting of other
financial conflicts of interest in its
policy on financial conflicts of interest,
as the Institution deems appropriate.
§ 94.6
Remedies.
(a) If the failure of an Investigator to
comply with an Institution’s financial
conflicts of interest policy or a financial
conflict of interest management plan
appears to have biased the design,
conduct, or reporting of the PHS-funded
research, the Institution shall promptly
notify the PHS Awarding Component of
the corrective action taken or to be
taken. The PHS Awarding Component
will consider the situation and, as
necessary, take appropriate action, or
refer the matter to the Institution for
further action, which may include
directions to the Institution on how to
maintain appropriate objectivity in the
PHS-funded research project.
(b) The PHS Awarding Component
and/or HHS may inquire at any time
(before, during, or after award) into any
Investigator disclosure of financial
interests and the Institution’s review of,
and response to, such disclosure,
regardless of whether or not the
disclosure resulted in the Institution’s
determination of a financial conflict of
interest. An Institution is required to
submit, or permit on site review of, all
records pertinent to compliance with
this part. To the extent permitted by
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53293
law, HHS will maintain the
confidentiality of all records of financial
interests. On the basis of its review of
records or other information that may be
available, the PHS Awarding
Component may decide that a particular
financial conflict of interest will bias the
objectivity of the PHS-funded research
to such an extent that further corrective
action is needed or that the Institution
has not managed the financial conflict
of interest in accordance with this part.
The PHS Awarding Component may
determine that issuance of a Stop Work
Order by the Contracting Officer or
other enforcement action is necessary
until the matter is resolved.
(c) In any case in which the HHS
determines that a PHS-funded project of
clinical research whose purpose is to
evaluate the safety or effectiveness of a
drug, medical device, or treatment has
been designed, conducted, or reported
by an Investigator with a financial
conflict of interest that was not managed
or reported by the Institution as
required by this part, the Institution
shall require the Investigator involved to
disclose the financial conflict of interest
in each public presentation of the
results of the research and to request an
addendum to previously published
presentations.
Dated: February 24, 2011.
Francis S. Collins,
Director, National Institutes of Health.
Approved: March 2, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–21633 Filed 8–23–11; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 76, Number 165 (Thursday, August 25, 2011)]
[Rules and Regulations]
[Pages 53256-53293]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21633]
[[Page 53255]]
Vol. 76
Thursday,
No. 165
August 25, 2011
Part IV
Department of Health and Human Services
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42 CFR Part 50
45 CFR Part 94
Responsibility of Applicants for Promoting Objectivity in Research for
Which Public Health Service Funding Is Sought and Responsible
Prospective Contractors; Final Rule
Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 /
Rules and Regulations
[[Page 53256]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 50
45 CFR Part 94
[Docket Number NIH-2010-0001]
RIN 0925-AA53
Responsibility of Applicants for Promoting Objectivity in
Research for which Public Health Service Funding is Sought and
Responsible Prospective Contractors
AGENCY: Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: This final rule implements changes to the regulations on the
Responsibility of Applicants for Promoting Objectivity in Research for
which Public Health Service Funding is Sought and Responsible
Prospective Contractors. Since the promulgation of the regulations in
1995, biomedical and behavioral research and the resulting interactions
among government, research Institutions, and the private sector have
become increasingly complex. This complexity, as well as a need to
strengthen accountability, led to changes that expand and add
transparency to Investigators' disclosure of Significant Financial
Interests (SFIs), enhance regulatory compliance and effective
institutional oversight and management of Investigators' financial
conflicts of interests, as well as increase the Department of Health
and Human Services' (HHS) compliance oversight.
DATES: Effective Date: This final rule is effective as of September 26,
2011.
Compliance Date: An Institution applying for or receiving PHS
funding from a grant, cooperative agreement, or contract that is
covered by this rule must be in full compliance with all of the
regulatory requirements herein:
No later than August 24, 2012; and
Immediately upon making its institutional Financial
Conflict of Interest (FCOI) policy publicly accessible as described
herein.
In the interim, Institutions should continue to comply with the
1995 regulations and report Investigator FCOIs to the Public Health
Service (PHS) Awarding Component as required in the 1995 regulations.
FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, National Institutes of Health, 6011
Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669,
telephone 301-496-4607, fax 301-402-0169, e-mail jm40z@nih.gov,
concerning questions about the rulemaking process; and Dr. Sally
Rockey, NIH Deputy Director for Extramural Research, concerning
substantive questions about the rule, e-mail
FCOICompliance@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In 1995, the PHS and the Office of the Secretary of HHS published
regulations at 42 CFR part 50, subpart F and 45 CFR part 94 (the 1995
regulations), that are designed to promote objectivity in PHS-funded
research. The 1995 regulations cover Institutions that apply for or
seek PHS funding for research (except for Small Business Innovation
Research (SBIR)/Small Business Technology Transfer Research (STTR)
Phase I applications) and, through implementation of the regulations by
these Institutions, to each Investigator participating in the research.
Generally, under the 1995 regulations:
The Institution \1\ is responsible for complying with the
regulations, including maintaining a written and enforced FCOI policy;
managing, reducing, or eliminating identified conflicts; and reporting
identified conflicts to the PHS Awarding Component. The reports denote
the existence of an FCOI and the Institution's assurance that it has
been managed, reduced, or eliminated.
---------------------------------------------------------------------------
\1\ ``Institution'' was defined under 42 CFR part 50, subpart F,
as any domestic or foreign, public or private, entity or
organization (excluding a Federal agency), and under 45 CFR part 94
as any public or private entity or organization (excluding a Federal
agency) (1) that submits a proposal for a research contract whether
in response to a solicitation from the PHS or otherwise, or (2) that
assumes the legal obligation to carry out the research required
under the contract. 42 CFR 50.603; 45 CFR 94.3.
---------------------------------------------------------------------------
Investigators \2\ are responsible for complying with their
Institution's written FCOI policy and for disclosing their SFIs \3\ to
the Institution.
---------------------------------------------------------------------------
\2\ ``Investigator'' was defined under the 1995 regulations as
the Principal Investigator and any other person who is responsible
for the design, conduct, or reporting of research (or, in the case
of PHS contracts, a research project) funded by PHS, or proposed for
such funding. For purposes of the regulatory requirements relating
to financial interests, the term ``Investigator'' includes the
Investigator's spouse and dependent children. 42 CFR 50.603; 45 CFR
94.3.
\3\ ``Significant Financial Interest'' was defined under the
1995 regulations as anything of monetary value, including but not
limited to, salary or other payments for services (e.g., consulting
fees or honoraria); equity interests (e.g., stocks, stock options or
other ownership interests); and intellectual property rights (e.g.,
patents, copyrights and royalties from such rights). The term does
not include: (1) Salary, royalties, or other remuneration from the
applicant Institution; (2) any ownership interests in the
Institution, if the Institution is an applicant under the SBIR/STTR
programs; (3) income from seminars, lectures, or teaching
engagements sponsored by public or nonprofit entities; (4) income
from service on advisory committees or review panels for public or
nonprofit entities; (5) an equity interest that when aggregated for
the Investigator and the Investigator's spouse and dependent
children meets both of the following tests: does not exceed $10,000
in value as determined through reference to public prices or other
reasonable measures of fair market value, and does not represent
more than a five percent ownership interest in any single entity; or
(6) salary, royalties, or other payments that when aggregated for
the Investigator and the Investigator's spouse and dependent
children over the next twelve months, are not expected (or, in the
case of PHS contracts, are not reasonably expected) to exceed
$10,000. 42 CFR 50.603; 45 CFR 94.3.
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Maintaining objectivity in research requires a commitment
from Institutions and their Investigators to completely disclose,
appropriately review, and robustly manage identified conflicts.
The PHS Awarding Components \4\ are responsible for
overseeing institutional compliance with the regulations.
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\4\ ``PHS Awarding Component'' was defined as an organizational
unit of the PHS that funds research that is subject to these
regulations. 42 CFR 50.603, 45 CFR 94.3.
---------------------------------------------------------------------------
The purpose of the 1995 regulations was to ensure that there is no
reasonable expectation that the design, conduct, or reporting of PHS-
funded research will be biased by any Investigator FCOI. Since the
publication of the 1995 regulations, the pace by which new discoveries
are translated from the research bench into effective treatment of
patients has accelerated significantly, and the biomedical and
behavioral research enterprise in the United States has grown in size
and complexity. For example, an analysis of financial support of
biomedical research from 1994 to 2004 \5\ showed that funding increased
from $37.1 billion in 1994 to $94.3 billion in 2003. Fifty seven
percent of the funding in 2003 came from industry sources. At the same
time, relationships between individual academic researchers and
industry have also increased from 28% in a 1996 survey \6\ to 52.8% in
a survey conducted in 2007.\7\ Researchers frequently work in
multidisciplinary teams to develop new strategies and approaches for
translating basic research into clinical application, thus hastening
discovery and advancing human health. In addition, these newer
translational strategies often involve complex collaborations between
Investigators and the private sector.
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\5\ Moses H et al., JAMA; 2005;294:1333-1342.
\6\ Blumenthal D et al., N Engl J Med; 1996; 335:1734-9.
\7\ Zinner DE et al., Health Aff; 2009;28:1814-25.
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Recent studies from several sources have also highlighted the
increasing complexity of the financial relationships
[[Page 53257]]
between biomedical researchers and industry and the possible
ramifications of those relationships. For example, a 2008 report by the
Association of American Medical Colleges and the Association of
American Universities (AAMC/AAU) \8\ states: ``The promises of
translational research, the challenges of technology transfer, and
intense expectations at all levels of government that universities and
their academic medical centers function as engines of socio-economic
development generate new pressures on institutions and their faculty
members to expand their relationships and deepen their engagement with
industry. These relationships, now encouraged in many forms, may
involve financial linkages that are entirely benign but will in other
cases carry the potential to create serious conflicts of interest.
Moreover, these financial ties are occurring in a context of
dramatically increased public sensitivity to and concern with
allegations of financial conflicts of interest more broadly in
university business transactions and across diverse sectors of
industry.'' A recent study of the Institute of Medicine (IOM) on
Conflict of Interest in Medical Research, Education, and Practice
states: ``Physicians and researchers must exercise judgment in complex
situations that are fraught with uncertainty. Colleagues, patients,
students, and the public need to trust that these judgments are not
compromised by physicians' or researchers' financial ties to
pharmaceutical, medical device, and biotechnology companies. Ties with
industry are common in medicine. Some have produced important benefits,
particularly through research collaborations that improve individual
and public health. At the same time, widespread relationships with
industry have created significant risks that individual and
institutional financial interests may unduly influence professionals'
judgments about the primary interests or goals of medicine. Such
conflicts of interest threaten the integrity of scientific
investigations, the objectivity of medical education, and the quality
of patient care. They may also jeopardize public trust in medicine.''
\9\ A 2009 report from the HHS Office of Inspector General (OIG) stated
``Vulnerabilities exist at grantee institutions regarding conflicts.''
\10\
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\8\ Protecting Patients, Preserving Integrity, Advancing Health:
Accelerating the Implementation of COI Policies in Human Subjects
Research, A Report of the AAMC-AAU Advisory Committee on Financial
Conflicts of Interest in Human Subjects Research, February 2008 p1.
\9\ Lo, B & Field, M.J. (Eds.). (2009) Conflict of interest in
medical research, education, and practice. Washington, DC: National
Academies Press. p2.
\10\ HHS OIG report OEI-03-07-00700 ``How Grantees Manage
Financial Conflicts of Interest in Research Funded by the National
Institutes of Health'', November 2009 p12.
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The growing complexity of biomedical and behavioral research; the
increased interaction among Government, research Institutions, and the
private sector in attaining common public health goals while meeting
public expectations for research integrity; as well as increased public
scrutiny, all have raised questions as to whether a more rigorous
approach to Investigator disclosure, institutional management of
financial conflicts, and Federal oversight is required. HHS decided to
explore the need for revisions to the 1995 regulations by publishing an
Advance Notice of Proposed Rulemaking on May 8, 2009 (74 FR 21610,
hereafter ``the ANPRM'').
After analyzing public comments, HHS published a Notice of Proposed
Rulemaking (75 FR 28688, hereafter ``the NPRM'') on May 21, 2010, to
amend the 1995 regulations by expanding and adding transparency to
Investigators' disclosure of SFIs, enhancing regulatory compliance and
effective institutional oversight and management of Investigators'
financial conflicts of interests, as well as HHS' compliance oversight.
Major changes to the 1995 regulations proposed in the NPRM
included:
Expanding the scope of the regulations to include SBIR/
STTR Phase I applications.
Amending the definition of SFI to include a de minimis
threshold of $5,000 for disclosure that generally applies to payments
and/or equity interests as well as any equity interest in non-publicly
traded entities.
Excluding income from government agencies or Institutions
of higher education for seminars, lectures, teaching, or service on
advisory or review panels.
Expanding Investigator disclosure requirements to include
SFIs that are related to an Investigator's institutional
responsibilities, with Institutions responsible for determining whether
a disclosed SFI relates to the research for which PHS funding is sought
and constitutes an FCOI.
Enhancing the information on an FCOI reported by the
Institution to the PHS Awarding Component to include the information
required under the 1995 regulations plus the value of the financial
interest or a statement that a value cannot be readily determined, the
nature of the FCOI, a description of how the FCOI relates to PHS-funded
research, and key elements of the Institution's management plan.
Requiring that before spending funds for PHS-supported
research, an Institution shall post on a publicly accessible Web site
information on SFIs of senior/key personnel that the Institution
determines are related to the PHS-funded research and constitute an
FCOI.
In addition to these major proposed changes, the NPRM incorporated
minor proposed changes that reflect technical updates from the 1995
regulations (e.g., in the reference to authority for the regulations,
42 U.S.C. 299c-4 replaces 42 U.S.C. 299c-3, and, for the regulations
for grants and cooperative agreements, we added section 219, Title II,
Division D of Public Law 111-117, the Consolidated Appropriations Act
2010), or that reflect efforts to improve the overall clarity and
accuracy of the regulations (e.g., the title of the regulations for
grants and cooperative agreements was changed to ``Promoting
Objectivity in Research,'' to reinforce the ongoing nature of the
obligations under this subpart). The final rule also incorporates such
changes.
On July 21, 2010, HHS published a Notice (75 FR 42362, hereafter
``the Extension Notice'') extending the 60 day comment period for the
NPRM by another 30 days and seeking comment on whether HHS should
clarify its authority to enforce compliance with the regulations by
Institutions and Investigators, and whether HHS should clarify how the
regulations apply in circumstances in which an Investigator or a PHS-
funded research project transfers from one Institution to another.
II. Discussion of General Public Comments
During the 90 day comment period that ended on August 19, 2010, we
received 136 unique comments on the NPRM and the Extension Notice. Many
respondents were generally supportive of the overall goal of promoting
objectivity in biomedical research. A few cited the importance of such
objectivity in maintaining the public's and particularly patients'
trust in treatments, drugs and devices that result from PHS-funded
biomedical research. Responses to comments in this section are of a
general nature while comments on specific provisions of the NPRM are
addressed in the next section.
Balancing the Benefits of Relationships With Industry and Possible
Conflicts of Interest
As stated by several respondents, it is important to emphasize that
translating
[[Page 53258]]
basic research into clinical application is critical for advancing
human health, and this process requires fruitful collaborations among
government, academia, and industry. Some respondents were concerned
that the revisions to the regulations will have a negative effect on
these collaborations and on the translation of research into cures. We
want to emphasize that the revisions are not designed to prevent or
hinder relationships among government, academia, and industry. Rather,
the revisions are aimed at facilitating such relationships by
increasing transparency and accountability so that the resulting
research is considered objective and in the interest of the public.
Some respondents were concerned that there has not been sufficient
research to document an adverse impact of FCOI on the integrity of PHS-
funded research, which makes it difficult to substantiate the
effectiveness of the proposed measures, and in particular, one
commenter questioned the citation of a specific article in the NPRM
(``the Wazana paper'') in that regard. While we did not cite a paper by
that author in the NPRM, we understand the limitations of the research
on this topic. The 1995 regulations were aimed at preventing bias in
PHS-funded research, and as such, were intended to be proactive rather
than reactive to specific evidence of bias. Nonetheless, over the past
few years, there have been several specific allegations of bias among
PHS-funded researchers reported in the press. This has led to increased
public concern, as evidenced by statements and correspondence from
members of Congress and the language in the Department of Health and
Human Services Appropriations Act, 2010, to amend the 1995 regulations
``for the purpose of strengthening Federal and institutional oversight
and identifying enhancements * * *.'' \11\ And as mentioned above, the
2009 OIG report: How Grantees Manage Financial Conflicts Of Interest in
Research Funded by the National Institutes of Health found that
``Vulnerabilities exist in grantee Institutions' identification,
management, and oversight of financial conflicts of interest.'' It is
vital that the public have confidence in the objectivity of PHS-funded
research. The revised regulations, with their emphasis on increasing
transparency and accountability, as well as providing additional
information to the PHS Awarding Component, are aimed at doing just
that.
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\11\ Sec. 219, Tit. II, Div. D, Pub. L. 111-117
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Other respondents requested that, given the complexity of the
issues related to management of Investigator FCOI, HHS fund research to
address issues related to the implementation of these regulations. As
part of our oversight activities, NIH has developed and conducted a
number of initiatives and site visits to evaluate institutional FCOI
policies for compliance with the Federal regulations and has publicized
on-line ``Lessons Learned.'' NIH found that the most common compliance
issues center around the appropriate definition of ``Investigator'' and
Institutional reporting requirements. NIH observed that there was some
confusion about receiving disclosures from Investigators who join a
project after it has begun, and identifying and reporting FCOI during
the project period. Site visits also reaffirmed that education is key
in ensuring that Investigators comply with the FCOI requirements by
understanding their responsibilities in the process. Therefore, in
light of these observations, the definition of ``Investigator'' has
been revised in the final rule to emphasize that Institutions should
consider the roles of those involved in research and the degree of
independence with which those individuals work.
In addition, the final rule includes a new requirement for
Institutions to require each Investigator to complete training related
to the FCOI and/or other FCOI-related requirements at least every four
years or immediately under designated circumstances. Information and
other resources developed by NIH, which will be updated as appropriate,
are available as resources for the new regulatory training requirement
and can be accessed through the NIH Web site's Financial Conflict of
Interest page at https://grants.nih.gov/grants/policy/coi/.
Several respondents requested that the revised regulations apply
only to new or competing PHS awards and newly identified FCOIs. We note
that many PHS grants, cooperative agreements, and contracts continue
for several years and, particularly in the case of grants and
cooperative agreements, a new award can be made every year. Therefore,
the revised regulations will apply to each grant or cooperative
agreement with an issue date of the Notice of Award that is subsequent
to the compliance dates of the final rule (including noncompeting
continuations) and to solicitations issued and contracts awarded
subsequent to the compliance dates of the final rule that are for
research. Through their policies, Institutions may choose to apply the
revised regulations to all active PHS awards. For example, Institutions
may choose, in their FCOI policy, to implement the regulations on a
single date on all PHS-funded awards rather than implementing the
regulations sequentially on the specific award date of each individual
project.
Beyond Financial Conflicts of Interest
A few respondents suggested that the regulations should also
address non-financial conflicts of interest. While we acknowledge that
non-financial conflicts of interest can influence the scientific
process, we chose to retain the focus of these regulations on FCOIs
because we believe this is a discrete area in which there is a
heightened need to strengthen management and oversight. In addition,
legal authority for the regulations references FCOI specifically, e.g.
42 U.S.C. 289b-1.
One respondent suggested that the regulations be revised to
restrict recipients of PHS-funded research from entering into
agreements that contain a provision restricting the Investigator's
ability to speak, publish, or otherwise undertake activities contrary
to a company's commercial interest. Although we believe this action
would go beyond the scope of these regulations, we note that as stated
in the HHS and NIH Grants Policy Statements (https://www.ihs.gov/nonMedicalPrograms/gogp/documents/HHS%20Grants%20Policy%20Statement.pdf
and https://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch8.htm#_Toc271264951, respectively), we believe that sharing final research
data and other research tools produced or developed by Investigators
under PHS-funded grants, such as cell lines, certain types of animals
(e.g., transgenic mice), and computer programs, is essential for
expedited translation of research results into knowledge, products, and
procedures to improve human health. We endorse the sharing of final
research data and research tools to serve these and other important
scientific goals, and we support the timely release and sharing of
final research data and research tools from PHS-supported studies for
use by other researchers.
General Comments on Contracts
One respondent was concerned that by revising the regulations, it
appears that HHS is modifying the Public Health Service Act. We want to
clarify that, through this final rule, HHS has revised regulations
promulgated under the Public Health Service Act, not modified the
Public Health Service Act itself. The same respondent also believed
that ``the PHS Acquisition Regulations were abolished and contents
(PHSAR 380--care of lab animals, human subjects and Indian self
determination) were folded into HHSAR (approx 1998),'' leading the
[[Page 53259]]
respondent to question whether the regulations set forth in 45 CFR part
94 remain ``in force.'' This concern is unfounded; the regulations at
45 CFR part 94 remain in effect in addition to, and not in conflict
with, the HHS Acquisition Regulation (HHSAR) codified at 48 CFR part
301 et seq. Additionally, the respondent questioned the authority of
NIH/PHS/HHS ``to set HHS acquisition policy.'' As noted in the final
rule promulgating the 1995 regulations, published on July 11, 1995 (60
FR 132), the PHS and the Office of the Secretary are acting in
accordance with the legislative directive in 42 U.S.C. 289b-1(a). We
have also declined this respondent's suggestion to place the revisions
to the regulations at 45 CFR part 94 in the HHSAR; the revisions
expressly pertain to the regulations at 45 CFR part 94 and not to 48
CFR part 301 et seq.
Another respondent suggested that there is a need to develop a
specific HHSAR provision and/or standard language in the Request for
Proposals (RFP) regarding the requirement of certification by the
contractor in the regulations. We disagree; 45 CFR 94.4(k) provides
standard language that is appropriate for each contract proposal
subject to these regulations.
Another respondent suggested that contractors should be exempt from
the regulatory requirements to disclose or report FCOIs, because the
respondent believes that contractors are acting as independent vendors
and the Institution has no effective means of monitoring their
compliance with the policy. We disagree with this comment. All Federal
contractors are required to have an effective means of complying with
the terms and conditions of their contract, including regulatory
obligations designed to promote objectivity in PHS-funded research. The
regulation specifically provides for enforcement of these obligations,
stating at 94.6(b) that ``* * * the PHS Awarding Component may decide
that a particular financial conflict of interest will bias the
objectivity of the PHS-funded research to such an extent that further
corrective action is needed or that the Institution has not managed the
financial conflict of interest in accordance with this part. The PHS
Awarding Component may determine that issuance of a Stop Work Order by
the Contracting Officer or other enforcement action is necessary until
the matter is resolved.''
One respondent stated that the language under 45 CFR part 94 is
confusing because it refers to ``applications for research,'' and
``awarding component'' which seem more like grant terms than contract
terms; additionally, the respondent noted that the language is
inconsistent with HHS regulations which refer to OPDIVs or Agencies. We
appreciate the opportunity to clarify that the regulations at 45 CFR
part 94 apply to Institutions that solicit or receive PHS research
funding by means of a contract for research, as distinguished from the
regulations at 42 CFR part 50 subpart F which are applicable to
Institutions that apply for or receive PHS research funding by means of
a grant or cooperative agreement. The revised regulations under 45 CFR
part 94 do not include any references to (grant) applications, but
rather to contract proposals. Furthermore, the references to ``awarding
component'' in 45 CFR part 94 are appropriate in the context of
research contracts, and such references are not inconsistent with
references to ``OPDIVs or Agencies'' in the HHSAR. These terms have a
similar meaning, though the HHSAR applies to all operating divisions
within HHS, whereas 45 CFR part 94 only applies to the Public Health
Service of HHS.
Another respondent expressed concern about inconsistency between
the requirements under 45 CFR part 94 and the treatment of
organizational conflicts of interest (OCIs) by the Federal Acquisition
Regulation (FAR), Subpart 9.5. We are not aware of any direct
conflict(s) between the two sets of regulations at this time; 45 CFR
part 94 focuses on financial conflicts of interest of Investigators,
whereas Subpart 9.5 of the FAR focuses on organizational conflicts of
interest. In response to a related question by the same respondent, we
note that neither 45 CFR part 94 nor Subpart 9.5 of the FAR require
coordination with legal counsel on conflict of interest issues. The FAR
provides only in Part 9.504(b) that ``Contracting officers should
obtain the advice of counsel'' in consideration of OCIs. The use of the
word ``should'' suggests that this step is a matter of policy, and not
a legal requirement. To address a final concern by the same respondent,
we note that the de minimis reporting level of $5,000 does not imply
that no conflict under that amount exists; as discussed further below,
that amount is used only as a monetary threshold for the definition of
reportable SFIs under 45 CFR part 94.
General Comments on Cost and Burden
Several respondents suggested that the analysis of the impact of
the proposed revisions in the NPRM underestimated the burden and cost
of implementation, particularly regarding the potential number of
Investigators, SFI disclosures, and FCOI reports. By publishing both an
ANPRM and an NPRM, we have endeavored to involve the community and
carefully consider the public's concerns. This final rule incorporates
our best efforts to balance the increased burden that results from any
regulatory action with the need to respond to demands for greater
transparency and accountability from the public and Congress, including
a legislative mandate [Pub. L. 111-117, Div. D, Tit. II, sec. 219, 123
Stat. 3034 (2009)]. We will evaluate the effect of provisions of the
regulations such as the de minimis and the public accessibility
requirement within three years after implementation of the final rule.
Our burden estimates were based on the current pool of PHS-funded
Investigators as well as our experience with FCOI reports under the
1995 regulations. We note that the revised definition of Investigator
is not significantly different from that in the 1995 regulations;
therefore, the number of Investigators should not change substantially.
We recognize that the scope of Investigator SFI disclosures, if not the
actual numbers, will increase under the revised regulations, and that
the number of FCOI reports may increase as well. We made a good faith
estimate in the NPRM as to the extent of these increases. Nonetheless,
we have taken these comments into consideration as we revised the
Regulatory Impact Analysis in section V to accommodate the content of
this final rule. Specifically, we have increased the estimated time for
Institutions to adapt NIH training materials to incorporate their
policies, the time for Investigator disclosures and updates, and the
time for reviewing disclosures. We also added an estimated time for
completing a retrospective review, and clarified that the time
estimated for Institutions to monitor Investigator compliance with a
management plan in the NPRM was calculated on a monthly rather than
annual basis.
In addition, several respondents objected to the statement in the
NPRM that the cost of implementing the amended regulations is an
allowable cost eligible for reimbursement as a Facilities and
Administrative cost on PHS-supported grants, cooperative agreements,
and contracts, citing limitations in these reimbursements. We recognize
that in some instances current cost principles may limit an
Institution's ability to recover costs under the Facilities and
Administrative cost mechanism. However, this does not render those
costs ineligible for recovery.
[[Page 53260]]
General Comments on Implementation
Several respondents suggested that HHS provide assistance to
Institutions for the implementation of new policies and procedures to
comply with the revised regulations. HHS recognizes the need to support
implementation and is developing implementation guidance, which may
include, for example, Frequently Asked Questions and other updates to
NIH's Financial Conflicts of Interest Web site, https://grants.nih.gov/grants/policy/coi/. General inquires about the FCOI regulations, and
requests to consider additional assistance efforts, may be directed to:
FCOICompliance@mail.nih.gov.
Many respondents requested that the implementation of the revised
regulations be staggered and proposed time periods ranging from one to
five years. In particular, respondents suggested that the
implementation of the public accessibility requirement in 42 CFR
50.605(a)(5) and 45 CFR 94.5(a)(5) should be postponed to October 2013
to coincide with the disclosure provisions under Title VI, Section
6002, of the recently enacted Patient Protection and Affordable Care
Act, Public Law 111-148 (hereafter, Affordable Care Act \12\). We agree
that it is important to balance the desire to implement the revised
regulations as soon as possible with the need to provide sufficient
time for Institutions and Investigators to comply. We have done so by
providing a compliance date of up to 365 days from publication of this
final rule, as described in the Dates section above. We considered a
staggered approach but thought this would create added burden for
Institutions and Investigators, and confusion for the public.
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\12\ The Patient Protection and Affordable Care Act (the
Affordable Care Act), Public Law 111-148, was enacted on March 23,
2010; the Health Care and Education Reconciliation Act (the
Reconciliation Act), Public Law 111-152, was enacted on March 30,
2010. The Affordable Care Act and the Reconciliation Act reorganize,
amend, and add to the provisions of part A of title XXVII of the
Public Health Service Act.
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One respondent suggested that we assemble an advisory board of
administrators at Institutions to assist in our deliberations in
drafting the final rule. We encouraged all stakeholders including
Institutions to submit comments to the ANPRM and to the NPRM; such
comments have been instrumental to our deliberations. Additionally, we
convened a committee of NIH/HHS staff with expertise in different types
of research funded by the PHS to consider the comments to the NPRM and
the ANPRM.
A few respondents suggested that we postpone revising the
regulations and conduct additional discussion with the research
community. Again, we note that by publishing both an ANPRM and an NPRM,
and by encouraging public comment through public outreach initiatives,
we have involved the community throughout this process, and we have
carefully considered the comments that have been raised.
III. Discussion of Public Comments Related to Specific Provisions of
the Revised Regulations
Public comments regarding revisions to specific provisions of the
1995 regulations are summarized below, along with a description of HHS'
deliberations and any change made to the final rule in response to the
comments.
Purpose (42 CFR 50.601; 45 CFR 94.1)
As proposed in the NPRM,\13\ we have made minor revisions to this
section to improve internal consistency with regard to the use of
various terms and phrases throughout the regulations. One respondent
questioned the removal of the words ``to ensure'' in the reference to
standards that provide a reasonable expectation that the design,
conduct, and reporting of research funded under PHS grants or
cooperative agreements is free from bias resulting from Investigator
FCOI. We have implemented our proposed language, which focuses on the
phrase ``reasonable expectation,'' because we believe it sets a more
accurate and realistic objective for the regulations; as another
respondent noted, it can be perceived as unrealistic from an
enforcement perspective to ``ensure'' the elimination of bias. The
respondent also suggested replacing the phrase ``design, conduct, or
reporting of research'' with ``design, conduct, analysis, management,
administration, reporting, and distribution of research'' throughout
the rule. We have not made this change, because we believe that
``design, conduct or reporting'' covers the major responsibilities
related to the PHS-funded research and that the term ``conduct''
encompasses many of the additional terms suggested by the respondent.
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\13\ 75 FR 28689 (May 21, 2010).
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Applicability (42 CFR 50.602, 45 CFR 94.2)
The 1995 regulations were applicable to each Institution that seeks
or receives PHS funding for research and, through implementation of the
regulations by each Institution, to each Investigator participating in
such research.\14\ However, the 1995 regulations excluded SBIR/STTR
Phase I applications because of the expectation that such applications
``are for limited amounts.'' \15\ As we discussed in the NPRM, since
1995 the size of these awards has increased, such that the amounts
constitute a significant expenditure of public funds. For example, the
median amount of an NIH Phase I award increased from approximately
$99,000 in 1995 to approximately $182,000 in 2009. Therefore, we
proposed in the NPRM to include SBIR/STTR Phase I applications in the
revised regulations.
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\14\ Consistent with the 1995 regulations, in those few cases
where an individual, rather than an Institution, is an applicant for
PHS grants or cooperative agreements for research, PHS Awarding
Components will make case-by-case determinations on the steps to be
taken to ensure that the design, conduct, and reporting of the
research will not be biased by any conflicting financial interest of
the individual.
\15\ 60 FR 35814 (July 11, 1995).
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We only received a small number of comments on this component of
the proposal. While a few respondents agreed that including these
applications is reasonable, one respondent suggested that including
these applicants in the final rule ``could present difficulties for
start-up and emerging companies forced to adhere to the rule's
extensive requirements for reporting and managing conflicts of interest
requirements--the same rules with which large research institutions
with substantially more resources will be complying.''
We have taken this comment into account in our reevaluation of the
proposed inclusion of the SBIR/STTR Phase I program and we ultimately
determined that this change from the 1995 regulations could indeed
create an undue burden. In particular, SBIR/STTR companies are small in
size (eligible companies must have fewer than 500 employees, but, for
example, the average NIH SBIR/STTR company has approximately 20
employees and many have only 1-3 employees), and these companies tend
to be limited in resources. Accordingly, we found the argument to be
compelling that the investment required to comply with the regulations
could create a disproportionate burden on small businesses. Moreover,
approximately 56% of Phase I awardees will apply for Phase II funding,
at which point they will be covered by the regulations. Therefore, the
regulations will still capture the benefits of compliance from a
significant number of these companies without imposing an undue burden
that could create a disincentive to applicants
[[Page 53261]]
from the small business community, an important part of the biomedical
research enterprise. For these reasons, the final rule retains the
exemption of Phase I SBIR/STTR applications from the 1995 regulations.
We have also implemented the NPRM's proposal to add language in
this section clarifying that the regulations continue to apply once the
PHS-funded research is underway (i.e., after the application process).
Definitions (42 CFR 50.603, 45 CFR 94.3)
In the NPRM we proposed to add several new definitions, revise some
of the existing definitions, and remove one definition. Comments and
responses regarding the implementation of those proposed changes in the
final rule follow:
1. Contractor. We have implemented the NPRM's proposal to revise
the definition of ``Contractor,'' to clarify that the term applies to
an entity that provides property or services ``under contract'' for the
direct benefit or use of the Federal government.
2. Disclosure of significant financial interests. This definition
was not included in the 1995 regulations but was proposed in the NPRM
to mean an Investigator's disclosure of SFIs to an Institution. We have
included this definition in the final rule--along with the definition
of ``FCOI report'' below--because of the confusion that can result from
the use of the terms ``disclosure'' and (FCOI) ``report.'' We intend
for the term ``disclosure'' to capture communication from an
Investigator to an Institution regarding SFIs, whereas the term
``report'' captures communication from an Institution to the PHS
Awarding Component regarding FCOI. A few respondents requested that we
switch this definition with the one stated below (i.e., FCOI report) in
order to align the terminology with a recent report by the AAMC/
AAU.\16\ We have not made that change because we want to minimize
public confusion by keeping our terminology consistent with that used
in the 1995 regulations, to the extent possible.
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\16\ Protecting Patients, Preserving Integrity, Advancing
Health: Accelerating the Implementation of COI Policies in Human
Subjects Research, A Report of the AAMC-AAU Advisory Committee on
Financial Conflicts of Interest in Human Subjects Research, February
2008.
---------------------------------------------------------------------------
3. Financial conflict of interest (FCOI). We proposed this
definition in the NPRM to mean an SFI that could directly and
significantly affect the design, conduct, or reporting of PHS-funded
research. Although this definition was not listed in the Definitions
sections of the 1995 regulations, it is consistent with language
contained in other provisions of the 1995 regulations.\17\ One
respondent suggested that the definition be revised to mean an SFI that
could directly or indirectly affect the design, conduct, or reporting
of PHS-funded research. We have considered this suggestion and believe
that including the term ``indirectly'' could create ambiguity and
extend the definition beyond the scope of the regulations. The term
``significantly'' in this context means that the financial interest
would have a material effect on the research, which we believe
appropriately fulfills the intent of the regulations, i.e., to maintain
objectivity in PHS-funded research.
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\17\ 42 CFR 50.605(a) and 45 CFR 94.5(a).
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Some respondents requested the inclusion of specific examples to
illustrate SFIs that could be considered FCOIs. Because conflicts of
interest can vary according to the specific context and Institutional
policy, we are concerned that providing examples could create public
confusion, so we have not made that change to the final rule. Other
respondents suggested that Institutions should consider specific
criteria, including the stage of the research and its commercial
potential, the proximity to possible U.S. Food and Drug Administration
(FDA) review, and the magnitude of the potential risk, when determining
whether an SFI is an FCOI. Although we disagree that this suggestion
should be implemented in the regulations, we note that Institutions may
include a variety of criteria in the review of Investigators' SFIs and
the determination of whether they constitute an FCOI with the PHS-
funded research, including those suggested by respondents.
4. Financial Conflict of Interest (FCOI) report. This definition
was not included in the 1995 regulations but was proposed in the NPRM
to mean an Institution's report of an FCOI to a PHS Awarding Component.
We have included this definition in the final rule for the same reasons
we have included the ``disclosure of SFIs'' definition discussed above.
5. Financial interest. We proposed this definition in the NPRM, as
a companion to the revision of the ``SFI'' definition, described below,
to mean anything of monetary value or potential monetary value. Some
respondents agreed with this definition, while others suggested that
the phrase ``or potential monetary value'' is too broad and suggested
the stated purpose could be achieved by the phrase: ``anything of
monetary value, whether or not the value is readily ascertainable.'' We
agree and have changed the language in the final rule accordingly.
Another respondent asked if anything of ``potential monetary value''
would include patents or patent applications. As discussed below in the
definition of SFI, patents and patent applications are included in the
definition.
6. Institution. Consistent with our proposal in the NPRM, we have
revised the definition of ``Institution'' to refer specifically to an
Institution that is applying for, or that receives, PHS research
funding. A few respondents questioned whether Federal agencies should
be excluded from this definition, as this would exclude Federal
researchers such as NIH scientists. One requested that HHS evaluate the
revised regulations after a period of time to assess whether Federal
researchers (``intramural investigators'') should be included. Federal
agencies and their employees are subject to conflicts of interest
requirements, including disclosure by employees and review by agencies,
pursuant to Federal criminal statutes, the Ethics in Government Act as
amended, and supplemental agency regulations. Accordingly, we have
retained the exclusion of Federal agencies in this definition.
7. Institutional responsibilities. We proposed this definition in
the NPRM to mean an Investigator's professional responsibilities on
behalf of the Institution including, but not limited to, activities
such as research, research consultation, teaching, professional
practice, institutional committee memberships, and service on panels
such as Institutional Review Boards or Data and Safety Monitoring
Boards. Some respondents requested that this definition be clarified to
specify that the Investigator's responsibilities are defined by the
Institution. We agree and have modified the definition accordingly to
make clear that the Institution defines the Investigator's
responsibilities in its policy on financial conflicts of interests. One
respondent suggested that the list of examples should be expanded. In
light of the change to the regulatory text noted above, and because the
definition indicates that the list is not exhaustive, we have not made
further changes.
8. Investigator. Consistent with our proposal in the NPRM, we have
revised the definition of ``Investigator'' to clarify that it means the
Project Director/Principal Investigator (PD/PI) as well as any other
person, regardless of title or position, who is responsible for the
design, conduct, or reporting of research funded by the PHS, or
proposed for
[[Page 53262]]
such funding, which may include, for example, collaborators or
consultants.. Several respondents suggested that this definition is
overly broad and will result in disclosures from people who are only
peripherally associated with the PHS-funded research. We note that the
definition is not substantially different from the definition in the
1995 regulations \18\ and is consistent with regulatory guidance that
NIH has issued (e.g., see ``Investigator-Specific Questions'' section
of NIH's ``Frequently Asked Questions'' resource at https://grants.nih.gov/grants/policy/coifaq.htm). In response to questions
about whether this definition includes unfunded collaborators, we note
that the definition refers to the function of the individual on the
PHS-funded project; i.e., his/her responsibility for the design,
conduct, or reporting of the PHS-funded research, and not to his/her
title or the amount or source of remuneration.
---------------------------------------------------------------------------
\18\ 42 CFR 50.603 and 45 CFR 94.3.
---------------------------------------------------------------------------
Other respondents suggested the definition should be expanded to
include other types of activities, or to include people in a position
to influence the design, conduct, or reporting of the research. We have
retained the focus of the definition on Investigators who are
responsible for the design, conduct, or reporting of research for the
reasons discussed above.
Consistent with our proposal in the NPRM, we have also eliminated
the reference to the Investigator's spouse and dependent children in
this definition, as we believe that such reference is more appropriate
to include in the SFI definition, below.
9. Key personnel. In parallel to the use of the term ``senior/key
personnel'' in making FCOI information publicly accessible for research
grants and cooperative agreements under 42 CFR 50.605, the term ``key
personnel'' is used for research contracts under 45 CFR 94.5.
Therefore, we thought it would be useful to include a separate
definition for this term in the final rule, to clarify the exact
meaning: the PD/PI and any other personnel considered to be essential
to work performance in accordance with HHSAR subpart 352.242-70 and
identified as key personnel in the contract proposal and contract.
10. Manage. We proposed this definition in the NPRM to mean taking
action to address an FCOI, which includes reducing or eliminating the
FCOI, to ensure that the design, conduct, and reporting of research
will be free from bias or the appearance of bias. Consistent with our
discussion in the NPRM, we have included a modified version of this
definition in the final rule as part of a wider reconsideration of the
concepts of managing, reducing, and eliminating an FCOI. In the 1995
regulations, these concepts were typically listed separately; \19\
suggesting that reducing or eliminating an FCOI may not be the same as
managing an FCOI. We believe that it is more appropriate to consider
the reduction or elimination of an FCOI as alternate means of managing
an FCOI, depending on the circumstances.
---------------------------------------------------------------------------
\19\ 42 CFR 50.605(a) and 45 CFR 94.5(a).
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This revision is not intended, as suggested by one respondent, to
imply that reduction or elimination is the only acceptable means of
managing an FCOI. To address this concern, we have changed the
definition in the final rule to read ``* * * to take action to address
a financial conflict of interest, which can include reducing or
eliminating the financial conflict of interest * * *'' Another
respondent agreed with the definition, while a third thought it should
be expanded to include activities beyond the design, conduct, or
reporting of research and to state that the ultimate goal is
elimination. Another respondent thought that certain types of SFIs
should be specified as requiring elimination or reduction. In response
to these related comments, we want to clarify that we do not intend to
imply that every FCOI must be eliminated; the goal of the regulations
is to ensure appropriate management so as to maintain objectivity of
the research. Additionally, as discussed above, we believe ``design,
conduct, or reporting'' covers the major responsibilities related to
the PHS-funded research, so we have not expanded the scope of the
definition. One respondent suggested that ``ensure'' is impossible to
enforce. To address this concern, we have included the phrase ``to the
extent possible'' in the definition. Finally, respondents suggested the
deletion of the phrase ``appearance of bias.'' We have made this
change, as we agree that this phrase can be interpreted as overly broad
and ambiguous.
11. PD/PI. We proposed this definition in the NPRM to mean a
Project Director or Principal Investigator of a PHS-funded research
project. In the final rule, to improve clarity, we have noted that the
PD/PI is included in the definition of senior/key personnel in 42 CFR
50.603, and in the definition of key personnel in 45 CFR 94.3.
12. PHS. Consistent with our proposal in the NPRM, we have revised
the definition of ``PHS'' to include a specific reference to NIH in
order to clarify that Institutions applying for, or receiving, research
funding from NIH are subject to the regulations. This language remains
unchanged from that proposed in the NPRM; however, as a technical
correction to improve clarity and accuracy, we have deleted the
reference to ``an operating division.''
13. Research. Consistent with our proposal in the NPRM, we have
revised the definition of ``research'' to include a non-exhaustive list
of examples of different types of PHS funding mechanisms to which the
definition applies. As revised, the definition under 42 CFR 50.603
includes any activity for which research funding is available from a
PHS Awarding Component through a grant or cooperative agreement,
whether authorized under the PHS Act or other statutory authority, such
as a research grant, career development award, center grant, individual
fellowship award, infrastructure award, institutional training grant,
program project, or research resources award. The definition under 45
CFR 94.3 includes any activity for which research funding is available
from a PHS Awarding Component through a contract, whether authorized
under the PHS Act or other statutory authority. We also added the terms
``study or experiment'' to enhance clarity. A few respondents requested
that the definition exclude certain types of grants such as those for
educational activities, training, or construction. We note that PHS
funds a wide variety of award types and there may be some research
components within award types that are not specifically labeled
``research'' awards. It is important that the information on SFI
related to such activities be provided to the Institution for
evaluation of the relatedness to PHS-funded research and the
possibility of an FCOI. Therefore, we believe it would not be prudent
to limit the types of PHS-funded research activities that are subject
to these regulations and we did not make this change.
One respondent suggested the addition of examples for the term
``product development'' in the definition. We agree that this is useful
and have added the examples of product development (a diagnostic test
or drug) and of products of basic and applied research (a published
article, book, or book chapter). Another respondent suggested that
reference to the regulations be included in specific Requests for
Applications or Requests for Proposals to clarify exactly when the
regulations are applicable. We believe this comment is addressed by the
general provision of Web links to and citations of applicable policy
[[Page 53263]]
requirements and terms and conditions of awards on Notices of Award for
all PHS funded grants and cooperative agreements and in all contracts
awarded by the PHS that are for research.
14. Senior/key personnel. The NPRM uses this term in the proposal
and discussion of the management and posting of FCOI under 42 CFR
50.605. Therefore, we thought it would be useful to include a separate
definition for this term in the final rule, to clarify the exact
meaning: the PD/PI and any other person who the Institution identifies
as senior/key personnel in the grant application progress report, and
any other report submitted to the PHS by the Institution under this
subpart. This definition is in parallel to that of the term ``key
personnel'' used in making FCOI information publicly accessible for
research contracts under 45 CFR 94.5.
15. Significant Financial Interest. In the NPRM, we proposed to
revise substantially the SFI definition,\20\ incorporating the proposed
definitions of ``financial interest'' and ``institutional
responsibilities'' described above. Below is a discussion of public
comments related to the implementation of these changes, using the
categories referenced in the NPRM to highlight differences from the
1995 regulations.\21\
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\20\ 75 FR 28705 (May 21, 2010).
\21\ Under the 1995 regulations, an SFI means anything of
monetary value, including but not limited to, salary or other
payments for services (e.g., consulting fees or honoraria); equity
interests (e.g., stocks, stock options or other ownership
interests); and intellectual property rights (e.g., patents,
copyrights and royalties from such rights). The term does not
include: (1) Salary, royalties, or other remuneration from the
applicant Institution; (2) any ownership interests in the
Institution, if the Institution is an applicant under the SBIR/STTR
programs; (3) income from seminars, lectures, or teaching
engagements sponsored by public or nonprofit entities; (4) income
from service on advisory committees or review panels for public or
nonprofit entities; (5) an equity interest that when aggregated for
the Investigator and the Investigator's spouse and dependent
children meets both of the following tests: does not exceed $10,000
in value as determined through reference to public prices or other
reasonable measures of fair market value, and does not represent
more than a five percent ownership interest in any single entity; or
(6) salary, royalties, or other payments that when aggregated for
the Investigator and the Investigator's spouse and dependent
children over the next 12 months, are not expected (or, in the case
of PHS contracts, are not reasonably expected) to exceed $10,000.
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Institutional responsibilities: Some respondents suggested that the
disclosure requirement in the 1995 regulations,\22\ i.e., SFIs that
Investigators deem related to the PHS-funded research, is sufficient.
We note that the NPRM's proposal to expand the definition of SFI was
influenced by the suggestions of many respondents to the ANPRM who
supported this change. A few respondents agreed that expanding SFIs
subject to disclosure by an Investigator to an Institution to include
those that reasonably appear to be related to the Investigator's
``institutional responsibilities'' is warranted. Many others, however,
suggested that the SFIs to be disclosed should be limited to those that
reasonably appear to be related to the Investigator's ``research
responsibilities.'' We have considered this suggestion and believe that
since the definition of ``research responsibilities'' is not clear-cut,
this change would once again place the responsibility on the
Investigator for deciding which SFIs should be disclosed to the
Institution (similar to the 1995 regulations) and may not provide the
Institutions with the full complement of information needed to evaluate
the potential for FCOI. For example, an Investigator is on the board of
a pharmaceutical company and believes that this service draws on the
Investigator's clinical expertise rather than research knowledge. If
the SFI definition is confined to ``research responsibilities'', the
Investigator may not disclose the income from this activity to the
Investigator's Institution. Such income definitely would fall under
``institutional responsibilities'', however, as the Investigator is on
the clinical faculty of the Institution.
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\22\ 42 CFR 50.604(c)(1) and 45 CFR 94.4(c)(1)
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Moreover, we note that the scope of activities that need to be
disclosed by the Investigator is limited by the fact that the SFI
definition excludes income from seminars, lectures, or teaching
engagements sponsored by a Federal, state, or local government agency,
an Institution of higher education as defined at 20 U.S.C. 1001(a), an
academic teaching hospital, a medical center, or a research institute
that is affiliated with an Institution of higher education; or income
from service on advisory committees or review panels for a Federal,
state, or local government agency, an Institution of higher education
as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a
medical center, or a research institute that is affiliated with an
Institution of higher education.
One respondent proposed that the regulations specify particular
relationships and types of interests that should be disclosed. We have
considered this suggestion and believe that limiting the scope of SFIs
that an Investigator is required to disclose to his or her Institution
may exclude SFIs in activities that have the potential to affect the
objectivity of PHS-funded research. Therefore, we have retained the
language proposed in the NPRM.
One respondent suggested that PHS funding could change an
Investigator's institutional responsibilities and suggested that SFI
disclosures should be based on the anticipated responsibilities if
funding is awarded. We have not changed the regulations in this regard,
because we believe this concern would be addressed by the Institution's
FCOI policy; i.e., any time there is a significant change in an
Investigator's institutional responsibilities (whether in relation to
PHS funding or not), Institutions should consider whether this would
require the Investigator to update his or her SFI disclosures.
Other respondents questioned whether specific types of income, such
as clinical work within private or university practice or teaching a
craft, would need to be disclosed. Income from any activity that is
related to the Investigator's institutional responsibilities as defined
by the Institution that meets the monetary threshold must be disclosed.
Another suggested that payment related to the accrual of patients to
clinical trials should be included in the definition. If the individual
receiving the payment meets the definition of ``Investigator'' under
the regulations, such payment would be included in the SFI definition
and should be disclosed.\23\
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\23\ Alternatively, if the commenter is concerned about
(improper) payment to an Institution under these circumstances, we
note that institutional conflicts of interest are addressed in
section IV of this final rule.
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Monetary threshold: Respondents submitted a wide ra
