Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors; Request for Comments, 21610-21613 [E9-10666]
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Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Proposed Rules
five-county Pennsylvania portion of the
Philadelphia Area does not have tribal
implications as specified by Executive
Order 13175 (65 FR 67249, November 9,
2000), because the SIP is not approved
to apply in Indian country located in the
state, and EPA notes that it will not
impose substantial direct costs on tribal
governments or preempt tribal law.
DATES: To assure consideration,
comments must be received by July 7,
2009.
ADDRESSES: Individuals and
organizations interested in submitting
comments, identified by RIN 0925–
AA53 and Docket Number NIH–2008–
0002, may do so by any of the following
methods:
List of Subjects in 40 CFR Part 52
Electronic Submissions
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Nitrogen dioxide, Ozone, Incorporation
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You may submit electronic comments
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• The Regulations.gov portal: https://
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To ensure timelier processing of
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Authority: 42 U.S.C. 7401 et seq.
Dated: April 28, 2009.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. E9–10675 Filed 5–7–09; 8:45 am]
BILLING CODE 6560–50–P
Written Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 50
45 CFR Part 94
[Docket No. NIH–2008–0002]
RIN 0925–AA53
Responsibility of Applicants for
Promoting Objectivity in Research for
Which Public Health Service Funding
Is Sought and Responsible
Prospective Contractors; Request for
Comments
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AGENCY: Department of Health and
Human Services.
ACTION: Advance notice of proposed
rulemaking.
SUMMARY: On behalf of the Department
of Health and Human Services (HHS)
and the Public Health Service (PHS), a
component of the HHS, the National
Institutes of Health (NIH) seeks
comments from the public on whether
the HHS should amend its regulations
on the responsibility of applicants for
promoting objectivity in research for
which phs funding is sought and on
responsible prospective. We are
interested particularly in receiving
comments on the issues presented
below from the general public,
individual Investigators, scientific
societies and associations, Members of
Congress, other Federal agencies that
support or conduct research, and
institutions that receive PHS funds to
conduct or support biomedical or
behavioral research.
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You may send written submissions in
the following ways:
• Fax: 301–402–0169.
• Mail: Attention: Jerry Moore, NIH
Regulations Officer, NIH, Office of
Management Assessment, 6011
Executive Boulevard, Suite 601, MSC
7669, Rockville, MD 20852–7669.
• Hand Delivery/Courier (for paper,
disk, or CD–ROM submissions):
Attention: Jerry Moore, 6011 Executive
Boulevard, Suite 601, Rockville, MD
20852–7669.
Docket
For access to the docket to read
background documents or comments
received, go to the Regulations.gov
portal and insert the docket number
provided in brackets in the heading on
page one of this document into the
‘‘Search’’ box and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Jerry
Moore at the address above, or
telephone 301–496–4607 (not a toll-free
number) concerning questions about the
rulemaking process; and Sally J. Rockey,
PhD, Deputy Director, Office of
Extramural Research, One Center Drive,
Building 1, Room 142, Bethesda, MD
20892, e-mail FCOI-ANPRM@NIH.GOV
concerning programmatic questions.
SUPPLEMENTARY INFORMATION: Proper
stewardship of Federal funds includes
ensuring objectivity of results by
protecting federally funded research
from compromise by financial conflicts
of interest (FCOI).
In 1995, the PHS and the Office of the
Secretary of Health and Human Services
published the regulations at 42 CFR Part
50 Subpart F and 45 CFR Part 94,
designed to promote objectivity in PHS-
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funded research.1 The regulations are
applicable to Institutions 2 that apply for
PHS funding for research (except for
Small Business Innovation Research
(SBIR)/Small Business Technology
Transfer Research (STTR) Phase I
applications/proposals) and, through
implementation of the regulations by
these Institutions, to each Investigator 3
participating in the research. Generally,
under the regulations:
• The Institution is responsible for
complying with the regulations,
including developing and maintaining a
written and enforced policy; managing,
reducing, or eliminating identified
conflicts; and reporting identified
conflicts to the PHS funding
component. The reports denote the
existence of a conflict and assure that it
has been managed, reduced, or
eliminated.
• The participating Investigators are
responsible for complying with their
Institution’s written Financial Conflict
of Interest (FCOI) policy and for
disclosing their Significant Financial
Interests 4 (SFI) to their Institution.
1 48 CFR Subpart 9.1, ‘‘Responsible Prospective
Contractors,’’ and 48 CFR Subpart 9.5,
‘‘Organizational and Consultant Conflicts of
Interest,’’ also address conflicts of interest in
Federally-funded projects. These provisions apply
only to acquisitions, not to grants or cooperative
agreements.
2 An ‘‘Institution’’ is 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) that (1) 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. See 42 CFR
50.603; 45 CFR 94.3.
3 An ‘‘Investigator’’ is defined under the
regulations as the principal investigator and any
other person who is responsible for the design,
conduct, or reporting of research 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. See
42 CFR 50.603; 45 CFR 94.3.
4 A ‘‘Significant Financial Interest’’ is defined
under the regulation as anything of monetary value,
including but not limited to (1) Salary or other
payments for services (e.g., consulting fees or
honoraria); (2) equity interests (e.g., stocks, stock
options or other ownership interests); and (3)
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 institution; (2) any ownership interests in
the institution, if the institution is an applicant
under the SBIR program; (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, 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
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Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Proposed Rules
• The PHS funding components are
responsible for overseeing Institutional
compliance with the regulations.
Ensuring objectivity in research
requires a commitment from Institutions
and their Investigators to complete
disclosure, appropriate review, and
robust management of identified
conflicts consistent with the level of risk
presented. The existing regulations were
designed to provide standards to ensure
that the design, conduct, or and
reporting of PHS-funded research is not
biased by any FCOI.
In the intervening years since the
publication of these regulations, the
pace of translation of new discoveries
from the research bench into effective
treatment of patients has significantly
accelerated. As a result, the biomedical
research enterprise in the United States
is extensive and growing in size and
complexity. Researchers frequently
work in multidisciplinary teams to
develop new strategies and approaches
for translating basic research into
clinical application. In addition, these
newer translational strategies often
involve complex collaborations between
investigators and the private sector.
Together, these factors may generate an
increased potential of investigators to
hold financial interests in multiple
sources which, if not reported and
appropriately managed, reduced, or
eliminated, could introduce bias into
the conduct of their research.
Recognition of the growing complexity
of biomedical research, the increased
interaction between Government and
the private sector in meeting common
public health goals, and recent public
scrutiny have raised the question of
whether a more rigorous approach to
Investigator disclosure, management of
conflicts, and Federal oversight is
required.
Ensuring the objectivity of research
results requires a commitment to
uphold the following principles:
1. Research must be conducted with
transparency and the highest scientific
and ethical standards in a manner that
promotes and respects the rights, safety,
and welfare of all human research
participants.
2. Appropriate interactions and
relationships between government,
academia, and industry, which do not
compromise objectivity in research,
frequently have beneficial outcomes and
should be encouraged.
interest in any single entity; and (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 to exceed $10,000. 42 CFR
50.603; 45 CFR 94.3.
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3. The integrity of the scientific record
is critical to the conduct of science.
4. Risk management is essential in
evaluating and managing conflict of
interest; risk management should be
commensurate with the level of risk of
the research.
5. Complete and timely disclosure of
financial interests and effective
management of conflicts of interest are
essential to ensuring objectivity in
research.
For the reasons cited above, we are
considering whether to revise the
current regulations to provide
Institutions with a more comprehensive
set of guidelines based on these five
principles. The complex and
controversial issues surrounding FCOI
warrant a carefully considered, open
dialogue with all affected parties.
Consequently, we invite public
comments on all aspects of potential
regulation in this area, and particularly
on the following issues:
I. Expanding the Scope of the
Regulation & Disclosure of Interests
The regulations are applicable to
Institutions that apply for PHS funding
for research and, through
implementation of the regulations by
each Institution, to each Investigator
participating in such research. However,
the regulations do not apply to Phase I
SBIR/STTR applications (42 CFR
50.602, 45 CFR 94.2).
The regulations require that
Investigators disclose to the Institution
only those Significant Financial
Interests (SFI) (1) that would reasonably
appear to be affected by the research for
which funding is sought from the PHS;
and (2) in entities whose financial
interests would reasonably appear to be
affected by the research (42CFR
50.604(c)(1); 45 CFR 94.4(c)(1)).
a. Should the regulations be expanded
so that they also apply to Phase I SBIR/
STTR research applications/proposals
for PHS funding?
b. In May 2004, HHS issued a
guidance document entitled, ‘‘Financial
Relationships and Interests in Research
Involving Human Subjects: Guidance for
Human Subject Protection’’ that raises
points to consider in determining
whether specific financial interests,
including Institutional financial
interests, in research affect the rights
and welfare of human subjects and if so,
what actions could be considered to
protect those subjects. In February 2008,
the Association of American Medical
Colleges (AAMC) and the Association of
American Universities (AAU) Advisory
Committee on Financial Conflicts of
Interest in Human Subjects Research
issued a report, ‘‘Protecting Patients,
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Preserving Integrity, Advancing Health:
Accelerating the Implementation of COI
Policies in Human Subjects Research,’’
which offered a number of
recommendations designed to enhance
Institutional conflict of interest policies.
One recommendation was that
investigators conducting human
subjects research should be required to
report all of their outside financial
interests directly or indirectly related to
their professional responsibilities to
their Institution, regardless of dollar
amount and regardless of whether or not
the investigator believes that the
reported financial interests might
reasonably appear to be affected by his
or her current or anticipated research. In
light of the above, should Investigators
be required to disclose to their
Institutions all Significant Financial
Interests that are related to their
Institutional responsibilities? Would
this expanded disclosure allow the
Institution to better determine which of
these Significant Financial Interests
constitute a FCOI?
II. Definition of ‘‘Significant Financial
Interest’’
A ‘‘Significant Financial Interest’’ is
defined by the current 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);
• Intellectual property rights (e.g.,
patents, copyrights and royalties from
such rights).
The term does not include the
following types of financial interests:
• Salary, royalties, or other
remuneration from the Institution;
• Any ownership interests in the
Institution, if the Institution is an
applicant under the SBIR/STTR
program;
• Income from seminars, lectures, or
teaching engagements sponsored by
public or nonprofit entities;
• Income from service on advisory
committees or review panels for public
or nonprofit entities;
• An equity interest that, when
aggregated for the Investigator and the
Investigator’s spouse and dependent
children, 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;
• Salary, royalties or other payments
that when aggregated for the Investigator
and the Investigator’s spouse and
dependent children over the next twelve
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months, are not expected to exceed
$10,000. (42 CFR 50.603; 45 CFR 94.3).
a. Should the current exemptions be
maintained?
• If so, are the current de minimis
thresholds ($10,000 and 5 percent
ownership interest in any single entity)
reasonable? If not, how should the de
minimis thresholds be changed? Should
these thresholds be the same for all
types of research?
• If not, which exemptions should be
reconsidered, and why?
b. Should certain Significant
Financial Interests (i.e., Significant
Financial Interests received from
specific sources or related to certain
types of research) automatically be
considered a FCOI under the
regulations? If so, what types of
Significant Financial Interests?
III. Identification and Management of
Conflicts by Institutions
The regulations require that an
official(s) designated by the Institution
review all financial disclosures;
determine whether a financial conflict
of interest exists; and, if so, determine
what actions the Institution should take
to manage, reduce, or eliminate the
conflict of interest (42 CFR. 50.605; 45
CFR 94.5). The regulations provide that
a conflict of interest exists when the
designated official(s) reasonably
determines that a Significant Financial
Interest could directly and significantly
affect the design, conduct, or reporting
of the research funded by the PHS (42
CFR 50.605; 45 CFR 94.5). The
regulations currently do not define the
term ‘‘designated Institutional
official(s)’’, or mandate specific actions
that Institutions must take to manage,
reduce or eliminate particular types of
FCOIs.
a. Should large Institutions (defined
as greater than 50 employees) be
required to establish an independent
committee to review financial
disclosures, and require that committee
to report to an organizational level
within the Institution that is not
conflicted by the short-term financial
interests of the Investigator or
Institution? Would a 50 employee
threshold reasonably balance the risk of
a more relaxed requirement for smaller
Institutions against the burden imposed
by requiring an independent panel for
these evaluations?
b. For certain types of research,
should the Institution be required to
develop a conflict management plan
when the Institution decides to manage
or reduce, rather than eliminate, the
conflict? If so, for which types of
research? Should there be prescribed
standards for the conflict management
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plans? Should the Institution be
required to submit this plan to the PHS
funding component when it reports the
existence of a conflict to the
component?
c. Should Investigators who are
involved in participant selection, the
informed consent process, and clinical
management of a trial, be prohibited
from having a Significant Financial
Interest in any company whose interests
could be affected by their research or
clinical trial? If so, what special
circumstances would justify waiving
this condition, if any?
d. Should the regulations prescribe
specific approaches for the
management, reduction, or elimination
of particular types of FCOI? If so, for
which types of FCOI? Which
approaches?
e. Should specific requirements
related to the identification,
management, and reporting of FCOI be
established for subrecipients (i.e.,
subgrantees, contractors, subcontractors,
collaborators)?
f. Should amounts received by
Investigators from certain kinds of
organizations be limited to certain
maximum thresholds if an Investigator
is supported with PHS research funds?
If so, which kinds of organizations? At
what thresholds?
IV. Assuring Institutional Compliance
Under the current regulations, the
PHS funding component may at any
time inquire into the Institutional
procedures and actions regarding
conflicting financial interests in PHSfunded research, including a
requirement for submission, or review
on site, of all records pertinent to
compliance with the regulation (42 CFR
50.606; 45 CFR 94.6). On the basis of its
review of records and/or other
information that may be available, the
PHS funding component may decide
that a particular conflict of interest will
bias the objectivity of the research it
funds to such an extent that further
corrective action is needed or that the
Institution has not managed, reduced, or
eliminated the conflict of interest in
accordance with the regulation(s) (42
CFR 50.606; 45 CFR 94.6). The PHS
funding component may determine that
suspension of funding/the issuance of a
Stop Work order is necessary until the
matter is resolved(42 CFR 50.606; 45
CFR 94.6).
a. Should the regulations enhance
existing enforcement options in the
event of noncompliance?
b. Should Investigators be required
under the regulations to complete
routine FCOI training?
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c. Should independent confirmation
of an Institution’s compliance with the
regulation be required? If so, what
should this confirmation look like (e.g.,
accreditation by an outside body, an
independent audit)?
V. Requiring Institutions to Provide
Additional Information to the PHS
Under the current regulations, prior to
spending any funds under an award, the
Institution must report to the PHS
funding component the existence of any
conflicting financial interest found by
the Institution and assure that the
interest has been managed, reduced, or
eliminated in accordance with the
regulation(s) (42 CFR 50.604(g)(2), 45
CFR 94.4(g)(2)). The regulations do not
require the Institution to report to PHS
officials the nature of the interest or
other details (42 CFR 50.604(g)(2), 45
CFR 94.4(g)(2)).
a. Should Institutions be required to
submit to the PHS funding component
additional information on any identified
conflict? If they should not be required
to submit additional information for all
identified conflicts, should they be
required to submit additional
information for identified conflicts
involving certain types of research? If
so, for which types of research? What
kind of information would provide
valuable data to the PHS funding
component in evaluating these reports
and the potential risk of bias in conduct
of research?
VI. Institutional Conflict of Interest
Institutional conflict of interest is
currently not addressed by the
regulations, although there has been
movement in the research community
toward incorporating Institutional
standards in conflict of interest policies
(see, for example, the February 2008
AAMC/AAU report, ‘‘Protecting
Patients, Preserving Integrity, Advancing
Health: Accelerating the
Implementation of COI Policies in
Human Subjects Research’’), and some
Institutions have adopted such
standards. This is an area of increasing
concern. If the regulation were to be
amended to address Institutional
conflict of interest, how should it
address the following issues?
a. How would Institutional conflict of
interest be defined?
b. What would an Institutional
conflict of Interest policy address in
order to assure the PHS of objectivity in
research?
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Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Proposed Rules
Dated: February 2, 2009.
Raynard S. Kington,
Acting Director, National Institutes of Health.
Approved: April 9, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9–10666 Filed 5–7–09; 8:45 am]
BILLING CODE 4140–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[DA 09–904; WT Docket No. 08–61, WT
Docket No. 03–187]
Petition for Expedited Rulemaking and
Other Relief on Behalf of American
Bird Conservancy, Defenders of
Wildlife and National Audubon Society
AGENCY: Federal Communications
Commission.
ACTION: Proposed rule.
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SUMMARY: In this document, comment is
sought on a petition for Expedited
Rulemaking and Other Relief on Behalf
of American Bird Conservancy,
Defenders of Wildlife and National
Audubon Society (Petitioners).
Petitioners request that the Commission
adopt new rules on an expedited basis
to comply with the National
Environmental Policy Act (NEPA), the
Endangered Species Act (ESA), and the
Migratory Bird Treaty Act (MBTA), and
their implementing regulations, and to
carry out the mandate of the U.S. Court
of Appeals for the District of Columbia
Circuit in American Bird Conservancy,
Inc. v. FCC, 516 F.3d 1027 (DC Cir.
2008).
DATES: Interested parties may file
comments on or before May 29, 2009,
and reply comments on or before June
15, 2009.
ADDRESSES: You may submit comments,
identified by WT Docket No. 08–61 and
WT Docket 03–187, by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Federal Communications
Commission’s Web site: https://
www.fcc.gov/cgb/ecfs/. Follow the
instructions for submitting comments.
• Mail: Filings can be sent by hand or
messenger delivery, by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail
(although we continue to experience
delays in receiving U.S. Postal Service
mail). All filings must be addressed to
the Commission’s Secretary, Office of
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17:31 May 07, 2009
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the Secretary, Federal Communications
Commission.
• People with Disabilities: Contact the
FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by e-mail: FCC504@fcc.gov
or phone: 202–418–0530 or TTY: 202–
418–0432.
For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Aaron Goldschmidt, Spectrum and
Competition Policy Division, Wireless
Telecommunications Bureau at (202)
418–7146 or
Aaron.Goldschmidt@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s public
notice released on April 29, 2009. The
full text of the public notice is available
for public inspection and copying
during business hours in the FCC
Reference Information Center, Portals II,
445 12th Street, SW., Room CY–A257,
Washington, DC 20554. It also may be
purchased from the Commission’s
duplicating contractor at Portals II, 445
12th Street, SW., Room CY–B402,
Washington, DC 20554; the contractor’s
Web site, https://www.bcpiweb.com; or
by calling (800) 378–3160, facsimile
(202) 488–5563, or e-mail
FCC@BCPIWEB.com. Copies of the
public notice also may be obtained via
the Commission’s Electronic Comment
Filing System (ECFS) by entering the
docket number, WT Docket No. 08–61
or WT Docket No. 03–187. Additionally,
the complete item is available on the
Federal Communications Commission’s
Web site at https://www.fcc.gov.
On April 14, 2009, American Bird
Conservancy, Defenders of Wildlife and
National Audubon Society (Petitioners)
filed a petition requesting that the
Federal Communications Commission
(Commission) adopt new rules on an
expedited basis to comply with the
National Environmental Policy Act
(NEPA), the Endangered Species Act
(ESA), and the Migratory Bird Treaty
Act (MBTA), and their implementing
regulations, and to carry out the
mandate of the U.S. Court of Appeals for
the District of Columbia Circuit in
American Bird Conservancy, Inc. v.
FCC, 516 F.3d 1027 (DC Cir. 2008).1
Specifically, Petitioners request that
the FCC undertake the following
1 In the Matter of Amendment of Part 1 of the
Commission’s Rules Regarding Environmental
Compliance Procedures for Processing Antenna
Structure Registration Applications, WT Docket No.
08–61, filed April 14, 2009 (Petition).
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21613
actions: Amend the Commission’s
regulations that implement NEPA,
‘‘consistent with Council on
Environmental Quality regulations and
guidance,’’ to ‘‘cure deficiencies’’ and to
ensure that only Commission actions
that have no significant environmental
effects individually or cumulatively are
categorically excluded; Prepare a
programmatic environmental impact
statement addressing the environmental
consequences of its Antenna Structure
Registration (ASR) program on
migratory birds, their habitats, and the
environment; Promulgate rules to clarify
the roles, responsibilities and
obligations of the Commission,
applicants, and non-federal
representatives in complying with the
ESA; Consult with the U.S. Fish and
Wildlife Service on the ASR program
regarding all effects of towers and
antenna structures on endangered and
threatened species; and complete the
proposed rulemaking in WT Docket No.
03–187 to adopt measures to reduce
migratory bird deaths in compliance
with the MBTA.2
Procedural Matters: This proceeding
has been designated as a ‘‘permit-butdisclose’’ proceeding in accordance
with the Commission’s ex parte rules.3
Parties making oral ex parte
presentations in this proceeding are
reminded that memoranda summarizing
the presentation must contain the
presentation’s substance and not merely
list the subjects discussed.4 More than a
one- or two-sentence description of the
views and arguments presented is
generally required.5
Pursuant to §§ 1.415 and 1.419 of the
Commission’s rules, 47 CFR 1.415 and
1.419, interested parties may file
comments on or before May 29, 2009
and reply comments on or before June
15, 2009. Comments may be filed using:
(1) The Commission’s Electronic
Comment Filing System (ECFS), (2) the
Federal Government’s eRulemaking
Portal, or (3) by filing paper copies. See
Electronic Filing of Documents in
Rulemaking Proceedings, 63 FR 24121
(May 1, 1998).
Electronic Filers: Comments may be
filed electronically using the Internet by
accessing the ECFS: https://www.fcc.gov/
cgb/ecfs/or the Federal eRulemaking
Portal: https://www.regulations.gov.
Filers should follow the instructions
2 Petition
at iv–v.
47 CFR 1.1200(a), 1.1206.
4 See Commission Emphasizes the Public’s
Responsibilities in Permit-But-Disclose
Proceedings, Public Notice, 15 FCC Rcd 19945
(2000).
5 See 47 CFR 1.1206(b)(2). Other rules pertaining
to oral and written presentations are also set forth
in 1.1206(b). See 47 CFR 1.1206(b).
3 See
E:\FR\FM\08MYP1.SGM
08MYP1
]]>Agencies
[Federal Register Volume 74, Number 88 (Friday, May 8, 2009)]
[Proposed Rules]
[Pages 21610-21613]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10666]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 50
45 CFR Part 94
[Docket No. NIH-2008-0002]
RIN 0925-AA53
Responsibility of Applicants for Promoting Objectivity in
Research for Which Public Health Service Funding Is Sought and
Responsible Prospective Contractors; Request for Comments
AGENCY: Department of Health and Human Services.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: On behalf of the Department of Health and Human Services (HHS)
and the Public Health Service (PHS), a component of the HHS, the
National Institutes of Health (NIH) seeks comments from the public on
whether the HHS should amend its regulations on the responsibility of
applicants for promoting objectivity in research for which phs funding
is sought and on responsible prospective. We are interested
particularly in receiving comments on the issues presented below from
the general public, individual Investigators, scientific societies and
associations, Members of Congress, other Federal agencies that support
or conduct research, and institutions that receive PHS funds to conduct
or support biomedical or behavioral research.
DATES: To assure consideration, comments must be received by July 7,
2009.
ADDRESSES: Individuals and organizations interested in submitting
comments, identified by RIN 0925-AA53 and Docket Number NIH-2008-0002,
may do so by any of the following methods:
Electronic Submissions
You may submit electronic comments in the following way:
The Regulations.gov portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
To ensure timelier processing of comments, NIH is no longer
accepting comments submitted to the agency by e-mail. The NIH
encourages you to continue to submit electronic comments by using the
Regulations.gov portal: https://www.regulations.gov.
Written Submissions
You may send written submissions in the following ways:
Fax: 301-402-0169.
Mail: Attention: Jerry Moore, NIH Regulations Officer,
NIH, Office of Management Assessment, 6011 Executive Boulevard, Suite
601, MSC 7669, Rockville, MD 20852-7669.
Hand Delivery/Courier (for paper, disk, or CD-ROM
submissions): Attention: Jerry Moore, 6011 Executive Boulevard, Suite
601, Rockville, MD 20852-7669.
Docket
For access to the docket to read background documents or comments
received, go to the Regulations.gov portal and insert the docket number
provided in brackets in the heading on page one of this document into
the ``Search'' box and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Jerry Moore at the address above, or
telephone 301-496-4607 (not a toll-free number) concerning questions
about the rulemaking process; and Sally J. Rockey, PhD, Deputy
Director, Office of Extramural Research, One Center Drive, Building 1,
Room 142, Bethesda, MD 20892, e-mail FCOI-ANPRM@NIH.GOV concerning
programmatic questions.
SUPPLEMENTARY INFORMATION: Proper stewardship of Federal funds includes
ensuring objectivity of results by protecting federally funded research
from compromise by financial conflicts of interest (FCOI).
In 1995, the PHS and the Office of the Secretary of Health and
Human Services published the regulations at 42 CFR Part 50 Subpart F
and 45 CFR Part 94, designed to promote objectivity in PHS-funded
research.\1\ The regulations are applicable to Institutions \2\ that
apply for PHS funding for research (except for Small Business
Innovation Research (SBIR)/Small Business Technology Transfer Research
(STTR) Phase I applications/proposals) and, through implementation of
the regulations by these Institutions, to each Investigator \3\
participating in the research. Generally, under the regulations:
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\1\ 48 CFR Subpart 9.1, ``Responsible Prospective Contractors,''
and 48 CFR Subpart 9.5, ``Organizational and Consultant Conflicts of
Interest,'' also address conflicts of interest in Federally-funded
projects. These provisions apply only to acquisitions, not to grants
or cooperative agreements.
\2\ An ``Institution'' is 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) that (1) 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. See 42 CFR 50.603; 45 CFR 94.3.
\3\ An ``Investigator'' is defined under the regulations as the
principal investigator and any other person who is responsible for
the design, conduct, or reporting of research 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. See 42 CFR 50.603; 45 CFR 94.3.
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The Institution is responsible for complying with the
regulations, including developing and maintaining a written and
enforced policy; managing, reducing, or eliminating identified
conflicts; and reporting identified conflicts to the PHS funding
component. The reports denote the existence of a conflict and assure
that it has been managed, reduced, or eliminated.
The participating Investigators are responsible for
complying with their Institution's written Financial Conflict of
Interest (FCOI) policy and for disclosing their Significant Financial
Interests \4\ (SFI) to their Institution.
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\4\ A ``Significant Financial Interest'' is defined under the
regulation as anything of monetary value, including but not limited
to (1) Salary or other payments for services (e.g., consulting fees
or honoraria); (2) equity interests (e.g., stocks, stock options or
other ownership interests); and (3) 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 institution; (2) any ownership interests in the institution, if
the institution is an applicant under the SBIR program; (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, 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; and (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 to
exceed $10,000. 42 CFR 50.603; 45 CFR 94.3.
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[[Page 21611]]
The PHS funding components are responsible for overseeing
Institutional compliance with the regulations.
Ensuring objectivity in research requires a commitment from
Institutions and their Investigators to complete disclosure,
appropriate review, and robust management of identified conflicts
consistent with the level of risk presented. The existing regulations
were designed to provide standards to ensure that the design, conduct,
or and reporting of PHS-funded research is not biased by any FCOI.
In the intervening years since the publication of these
regulations, the pace of translation of new discoveries from the
research bench into effective treatment of patients has significantly
accelerated. As a result, the biomedical research enterprise in the
United States is extensive and growing in size and complexity.
Researchers frequently work in multidisciplinary teams to develop new
strategies and approaches for translating basic research into clinical
application. In addition, these newer translational strategies often
involve complex collaborations between investigators and the private
sector. Together, these factors may generate an increased potential of
investigators to hold financial interests in multiple sources which, if
not reported and appropriately managed, reduced, or eliminated, could
introduce bias into the conduct of their research. Recognition of the
growing complexity of biomedical research, the increased interaction
between Government and the private sector in meeting common public
health goals, and recent public scrutiny have raised the question of
whether a more rigorous approach to Investigator disclosure, management
of conflicts, and Federal oversight is required.
Ensuring the objectivity of research results requires a commitment
to uphold the following principles:
1. Research must be conducted with transparency and the highest
scientific and ethical standards in a manner that promotes and respects
the rights, safety, and welfare of all human research participants.
2. Appropriate interactions and relationships between government,
academia, and industry, which do not compromise objectivity in
research, frequently have beneficial outcomes and should be encouraged.
3. The integrity of the scientific record is critical to the
conduct of science.
4. Risk management is essential in evaluating and managing conflict
of interest; risk management should be commensurate with the level of
risk of the research.
5. Complete and timely disclosure of financial interests and
effective management of conflicts of interest are essential to ensuring
objectivity in research.
For the reasons cited above, we are considering whether to revise
the current regulations to provide Institutions with a more
comprehensive set of guidelines based on these five principles. The
complex and controversial issues surrounding FCOI warrant a carefully
considered, open dialogue with all affected parties. Consequently, we
invite public comments on all aspects of potential regulation in this
area, and particularly on the following issues:
I. Expanding the Scope of the Regulation & Disclosure of Interests
The regulations are applicable to Institutions that apply for PHS
funding for research and, through implementation of the regulations by
each Institution, to each Investigator participating in such research.
However, the regulations do not apply to Phase I SBIR/STTR applications
(42 CFR 50.602, 45 CFR 94.2).
The regulations require that Investigators disclose to the
Institution only those Significant Financial Interests (SFI) (1) that
would reasonably appear to be affected by the research for which
funding is sought from the PHS; and (2) in entities whose financial
interests would reasonably appear to be affected by the research (42CFR
50.604(c)(1); 45 CFR 94.4(c)(1)).
a. Should the regulations be expanded so that they also apply to
Phase I SBIR/STTR research applications/proposals for PHS funding?
b. In May 2004, HHS issued a guidance document entitled,
``Financial Relationships and Interests in Research Involving Human
Subjects: Guidance for Human Subject Protection'' that raises points to
consider in determining whether specific financial interests, including
Institutional financial interests, in research affect the rights and
welfare of human subjects and if so, what actions could be considered
to protect those subjects. In February 2008, the Association of
American Medical Colleges (AAMC) and the Association of American
Universities (AAU) Advisory Committee on Financial Conflicts of
Interest in Human Subjects Research issued a report, ``Protecting
Patients, Preserving Integrity, Advancing Health: Accelerating the
Implementation of COI Policies in Human Subjects Research,'' which
offered a number of recommendations designed to enhance Institutional
conflict of interest policies. One recommendation was that
investigators conducting human subjects research should be required to
report all of their outside financial interests directly or indirectly
related to their professional responsibilities to their Institution,
regardless of dollar amount and regardless of whether or not the
investigator believes that the reported financial interests might
reasonably appear to be affected by his or her current or anticipated
research. In light of the above, should Investigators be required to
disclose to their Institutions all Significant Financial Interests that
are related to their Institutional responsibilities? Would this
expanded disclosure allow the Institution to better determine which of
these Significant Financial Interests constitute a FCOI?
II. Definition of ``Significant Financial Interest''
A ``Significant Financial Interest'' is defined by the current
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);
Intellectual property rights (e.g., patents, copyrights
and royalties from such rights).
The term does not include the following types of financial
interests:
Salary, royalties, or other remuneration from the
Institution;
Any ownership interests in the Institution, if the
Institution is an applicant under the SBIR/STTR program;
Income from seminars, lectures, or teaching engagements
sponsored by public or nonprofit entities;
Income from service on advisory committees or review
panels for public or nonprofit entities;
An equity interest that, when aggregated for the
Investigator and the Investigator's spouse and dependent children, 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;
Salary, royalties or other payments that when aggregated
for the Investigator and the Investigator's spouse and dependent
children over the next twelve
[[Page 21612]]
months, are not expected to exceed $10,000. (42 CFR 50.603; 45 CFR
94.3).
a. Should the current exemptions be maintained?
If so, are the current de minimis thresholds ($10,000 and
5 percent ownership interest in any single entity) reasonable? If not,
how should the de minimis thresholds be changed? Should these
thresholds be the same for all types of research?
If not, which exemptions should be reconsidered, and why?
b. Should certain Significant Financial Interests (i.e.,
Significant Financial Interests received from specific sources or
related to certain types of research) automatically be considered a
FCOI under the regulations? If so, what types of Significant Financial
Interests?
III. Identification and Management of Conflicts by Institutions
The regulations require that an official(s) designated by the
Institution review all financial disclosures; determine whether a
financial conflict of interest exists; and, if so, determine what
actions the Institution should take to manage, reduce, or eliminate the
conflict of interest (42 CFR. 50.605; 45 CFR 94.5). The regulations
provide that a conflict of interest exists when the designated
official(s) reasonably determines that a Significant Financial Interest
could directly and significantly affect the design, conduct, or
reporting of the research funded by the PHS (42 CFR 50.605; 45 CFR
94.5). The regulations currently do not define the term ``designated
Institutional official(s)'', or mandate specific actions that
Institutions must take to manage, reduce or eliminate particular types
of FCOIs.
a. Should large Institutions (defined as greater than 50 employees)
be required to establish an independent committee to review financial
disclosures, and require that committee to report to an organizational
level within the Institution that is not conflicted by the short-term
financial interests of the Investigator or Institution? Would a 50
employee threshold reasonably balance the risk of a more relaxed
requirement for smaller Institutions against the burden imposed by
requiring an independent panel for these evaluations?
b. For certain types of research, should the Institution be
required to develop a conflict management plan when the Institution
decides to manage or reduce, rather than eliminate, the conflict? If
so, for which types of research? Should there be prescribed standards
for the conflict management plans? Should the Institution be required
to submit this plan to the PHS funding component when it reports the
existence of a conflict to the component?
c. Should Investigators who are involved in participant selection,
the informed consent process, and clinical management of a trial, be
prohibited from having a Significant Financial Interest in any company
whose interests could be affected by their research or clinical trial?
If so, what special circumstances would justify waiving this condition,
if any?
d. Should the regulations prescribe specific approaches for the
management, reduction, or elimination of particular types of FCOI? If
so, for which types of FCOI? Which approaches?
e. Should specific requirements related to the identification,
management, and reporting of FCOI be established for subrecipients
(i.e., subgrantees, contractors, subcontractors, collaborators)?
f. Should amounts received by Investigators from certain kinds of
organizations be limited to certain maximum thresholds if an
Investigator is supported with PHS research funds? If so, which kinds
of organizations? At what thresholds?
IV. Assuring Institutional Compliance
Under the current regulations, the PHS funding component may at any
time inquire into the Institutional procedures and actions regarding
conflicting financial interests in PHS-funded research, including a
requirement for submission, or review on site, of all records pertinent
to compliance with the regulation (42 CFR 50.606; 45 CFR 94.6). On the
basis of its review of records and/or other information that may be
available, the PHS funding component may decide that a particular
conflict of interest will bias the objectivity of the research it funds
to such an extent that further corrective action is needed or that the
Institution has not managed, reduced, or eliminated the conflict of
interest in accordance with the regulation(s) (42 CFR 50.606; 45 CFR
94.6). The PHS funding component may determine that suspension of
funding/the issuance of a Stop Work order is necessary until the matter
is resolved(42 CFR 50.606; 45 CFR 94.6).
a. Should the regulations enhance existing enforcement options in
the event of noncompliance?
b. Should Investigators be required under the regulations to
complete routine FCOI training?
c. Should independent confirmation of an Institution's compliance
with the regulation be required? If so, what should this confirmation
look like (e.g., accreditation by an outside body, an independent
audit)?
V. Requiring Institutions to Provide Additional Information to the PHS
Under the current regulations, prior to spending any funds under an
award, the Institution must report to the PHS funding component the
existence of any conflicting financial interest found by the
Institution and assure that the interest has been managed, reduced, or
eliminated in accordance with the regulation(s) (42 CFR 50.604(g)(2),
45 CFR 94.4(g)(2)). The regulations do not require the Institution to
report to PHS officials the nature of the interest or other details (42
CFR 50.604(g)(2), 45 CFR 94.4(g)(2)).
a. Should Institutions be required to submit to the PHS funding
component additional information on any identified conflict? If they
should not be required to submit additional information for all
identified conflicts, should they be required to submit additional
information for identified conflicts involving certain types of
research? If so, for which types of research? What kind of information
would provide valuable data to the PHS funding component in evaluating
these reports and the potential risk of bias in conduct of research?
VI. Institutional Conflict of Interest
Institutional conflict of interest is currently not addressed by
the regulations, although there has been movement in the research
community toward incorporating Institutional standards in conflict of
interest policies (see, for example, the February 2008 AAMC/AAU report,
``Protecting Patients, Preserving Integrity, Advancing Health:
Accelerating the Implementation of COI Policies in Human Subjects
Research''), and some Institutions have adopted such standards. This is
an area of increasing concern. If the regulation were to be amended to
address Institutional conflict of interest, how should it address the
following issues?
a. How would Institutional conflict of interest be defined?
b. What would an Institutional conflict of Interest policy address
in order to assure the PHS of objectivity in research?
[[Page 21613]]
Dated: February 2, 2009.
Raynard S. Kington,
Acting Director, National Institutes of Health.
Approved: April 9, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9-10666 Filed 5-7-09; 8:45 am]
BILLING CODE 4140-01-P
