Draft Guidance on Engagement of Institutions in Human Subjects Research, 71169-71172 [E6-20849]
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Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Notices
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(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Type of Information Collection
Request: Extension.
Title of Information Collection:
Reference Request for Applicants to the
U.S. Public Health Service
Commissioned Corps.
Form/OMB No.: OS–0937–0025.
Use: These forms will be used by
individuals to apply for appointment in
the U.S. Public Health Service
Commissioned Corps and to obtain
references as part of the application
process. Information supplied on the
forms will be used by appropriate
Department officials to evaluate
candidates for appointments.
Frequency: On Occasion.
Affected Public: Individuals or
Households.
Annual Number of Respondents:
5,000.
Total Annual Responses: 5,000.
Average Burden Per Response: 24
min.
Total Annual Hours: 2,000.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be
received within 30 days of this notice
directly to the Desk Officer at the
address below:
OMB Desk Officer: John Kraemer,
OMB Human Resources and Housing
Branch, Attention: (OMB #0937–0025),
New Executive Office Building, Room
10235, Washington, DC 20503.
Date: November 30, 2006.
Alice Bettencourt,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–0000]
30-Day Notice; Agency Information
Collection Activities: Proposed
Collection; Comment Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Type of Information Collection
Request: New Collection.
Title of Information Collection:
Evaluation of Office on Women’s Health
Publications.
Form/OMB No.: OS–0990–New.
Use: To improve future publications
and to demonstrate accountability of
efforts, the office of Women’s Health
(OWH) will evaluate four health
communications materials. Discussion
groups and web-based or paper-based
surveys will be used from randomly
selected participants and returned
response cards.
Frequency: 1 time.
Affected Public: Individuals or
Households.
Annual Number of Respondents:
1648.
Total Annual Responses: 1648.
Average Burden per Response: 17.2
min.
Total Annual Hours: 472.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
AGENCY:
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information collections must be
received within 30 days of this notice
directly to the Desk Officer at the
address below:
OMB Desk Officer: John Kraemer,
OMB Human Resources and Housing
Branch, Attention: (OMB #0990–New),
New Executive Office Building, Room
10235, Washington, DC 20503.
Date: November 30, 2006.
Alice Bettencourt,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E6–20916 Filed 12–7–06; 8:45 am]
BILLING CODE 4150–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Draft Guidance on Engagement of
Institutions in Human Subjects
Research
Office for Human Research
Protections, Office of Public Health and
Science, Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Office for Human
Research Protections (OHRP), Office of
Public Health and Science, is
announcing the availability of a draft
guidance document entitled, ‘‘OHRP
Guidance on Engagement of Institutions
in Human Subjects Research.’’ The draft
guidance document would revise and
replace two existing OHRP guidance
documents on the engagement of
institutions in human subjects research:
(1) The January 26, 1999 document on
‘‘Engagement of Institutions in
Research, and (2) the December 23, 1999
document on ‘‘Engagement of
Pharmaceutical Companies in HHS
Supported Research.’’ To facilitate
public review of the draft guidance
document, OHRP has developed a table
presenting a side-by-side comparison of
OHRP’s draft revised guidance
document and the current guidance
documents on the engagement of
institution in human subjects research,
which is available on the OHRP Web
site at https://www.hhs.gov/ohrp/
requests/.
OHRP’s current engagement guidance
documents and the proposed draft
guidance document provide examples of
when institutions generally would be
considered to be engaged or not engaged
in human subjects research. The draft
document is intended primarily for
institutional review boards (IRB),
research administrators and other
relevant institutional officials,
investigators, and funding agencies that
may be responsible for the conduct,
review and oversight of human subject
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research that is conducted or supported
by HHS. OHRP will consider comments
received before issuing the final
guidance document.
DATES: Submit written comments by
February 6, 2007.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled, ‘‘OHRP Guidance on
Engagement of Institutions in Human
Subjects Research,’’ to the Division of
Policy and Assurances, Office for
Human Research Protections, The
Tower Building, 1101 Wootton
Parkway, Suite 200, Rockville, MD
20852. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–402–2071. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written comments to
ENGAGEMENT GUIDANCE
COMMENTS, Office for Human
Research Protections, The Tower
Building, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852. Comments
also may be sent via e-mail to
engagementohrp@hhs.gov. or via
facsimile at 301-402–2071.
FOR FURTHER INFORMATION CONTACT: Mr.
Glen Drew, Office for Human Research
Protections, Department of Health and
Human Services, The Tower Building,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852; 301–496–7005; email glen.drew@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human
Services (HHS), through OHRP,
regulates research involving human
subjects conducted or supported by
HHS in regulations codified at 45 CFR
part 46. The HHS human subject
protection regulations stipulate
substantive and procedural
requirements for the conduct of HHSconducted or -supported research,
including requirements for review and
approval by an IRB before research
involving human subjects may begin,
criteria for IRB approval of research, and
requirements for informed consent or
the waiver of informed consent.
The HHS protection of human
subjects regulations at 45 CFR 46.103(a)
require that each institution ‘‘engaged’’
in human subjects research that is
conducted or supported by HHS provide
OHRP with a satisfactory assurance that
the institution will comply with the
regulations, unless all the research
meets one or more of the categories for
exemption from the regulatory
requirements under 45 CFR 46.101(b).
The Federalwide Assurance (FWA) is
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the only type of assurance currently
accepted by OHRP. The FWA generally
identifies required policies and
procedures for the institution and
describes the activities to which the
regulations apply.
On January 26, 1999, the Office for
Protection from Research Risks (OPRR),
OHRP’s predecessor office, issued
guidance on ‘‘Engagement of
Institutions in Research.’’ OPRR later
issued guidance on ‘‘Engagement of
Pharmaceutical Companies in HHS
Supported Research,’’ dated December
23, 1999.
OHRP is proposing to replace these
two documents with a single document,
‘‘OHRP Guidance on Engagement of
Institutions in Human Subjects
Research,’’ draft dated October 27, 2006.
This guidance is only applicable to
research projects that have been
determined to involve human subjects
and that are not exempt under the HHS
regulations at 45 CFR 46.101(b). Once
an activity is determined to involve
non-exempt human subjects research,
this guidance can be used to determine
whether an institution involved in some
aspect of the research would be
considered ‘‘engaged’’ in human
subjects research, and would thus need
to submit an FWA to OHRP. Like
OHRP’s existing guidance documents on
engagement, this draft document
provides: (1) Examples of activities that,
in general, would result in an institution
being considered engaged in a human
subjects research project; and (2)
examples of activities that, in general,
would result in an institution being
considered not engaged in a human
subjects research project. The draft
guidance document proposes
modifications to the set of examples of
when an institution generally would be
considered engaged or not engaged in
human subjects research. The proposed
modifications include combining,
clarifying, and changing existing
examples, as well as adding further
examples and explanation.
To facilitate public review and
comments, OHRP has created a
comparison table presenting a side-byside display of the text from OHRP’s
draft guidance document matched with
the comparable text from the 1999
guidance documents. This table is
available on the OHRP Web site at
https://www.hhs.gov/ohrp/requests/. The
table is not part of the draft guidance
document.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance document
on OHRP’s Web site at https://
www.hhs.gov/ohrp/requests/.
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III. Request for Comments
OHRP is making its draft guidance
document available for public comment.
OHRP’s revised guidance document on
the engagement of institutions in human
subjects research will be finalized and
issued after the public comments have
been considered.
OHRP is particularly interested in the
public’s comments on two examples of
activities which would not result in the
institution being considered engaged in
a human subjects research project under
OHRP’s current draft guidance
document:
1 Example B(1): Institutions whose
employees or agents release to the
investigators at another institution
identifiable private information or
identifiable biological specimens
pertaining to the subjects of the
research; and,
2 Example B(7): Institutions
(including private practices) not
selected as research sites whose
employees or agents administer clinical
trial-related medical services if all of the
following conditions are met:
(a) The institution’s employees or
agents do not enroll subjects, or obtain
the informed consent of any subject for
research participation;
(b) The institution’s employees or
agents do not administer the primary
study interventions being tested under
the protocol;
(c) The institution’s employees or
agents provide only services that either
are clinically indicated, or are dictated
by the protocol but not clinically
indicated, and would typically be
performed as part of routine clinical
monitoring and/or follow-up of subjects
enrolled at a study site by clinical trial
investigators, such as a blood test, chest
X-ray, CT scan, medical history and
physical examination, or an assessment
and reporting of an adverse event;
(d) The investigator(s) from an
institution engaged in the research
retain responsibility for oversight of all
protocol-related activities and assure
that appropriate arrangements are made
for any safety monitoring and adverse
event reporting required under the IRBapproved protocol;
(e) When appropriate, the informed
consent document states that follow-up
data are to be provided to the
investigators by the institution’s
employees or agents; and,
(f) When providing follow-up data to
the investigators, the institution’s
employees or agents provide such data
to the investigators in accord with the
procedures described in the informed
consent.
Proposed example (B)(1) would
represent a modification in OHRP
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policy. OHRP’s current guidance
document issued in 1999 states that an
institution whose employees or agents
release individually identifiable private
information about subjects, for research
purposes, without the subjects’ explicit
written permission is considered to be
engaged in human subjects research.
The proposed modification in guidance
is based on the definition of human
subject at 45 CFR 46.102(f), which states
in part, ‘‘human subject means a living
individual about whom an investigator
* * * conducting research obtains
* * * identifiable private information.’’
(emphasis added). OHRP has concluded
that releasing identifiable private
information for research purposes is not
equivalent to obtaining identifiable
private information; thus, an institution
releasing such identifiable private
information is not involved in an
activity including a ‘‘human subject’’ as
defined by the HHS protection of
human subjects regulations. Therefore,
the revised example would clarify that
an institution, whose employees or
agents release to the investigators at
another institution identifiable private
information about living individuals or
identifiable biological specimens that
came from living individuals, is not
considered engaged in human subjects
research.
Proposed example (B)(7) would
represent another modification in OHRP
policy. OHRP’s current guidance
document states that an institution (or
private practitioner) whose clinical staff
provide protocol-related care and/or
follow-up to subjects enrolled at distant
sites by clinical trial investigators in
OHRP-recognized Cooperative Protocol
Research Programs (CPRPs) (e.g., the
oncology group clinical trials sponsored
by the National Cancer Institute) is not
considered to be engaged in human
subjects research provided certain
specified conditions are met. OHRP is
proposing two key modifications to this
current example: (1) That the example
not be limited to scenarios involving
human subjects research at OHRPrecognized CPRPs; and (2) that the
example exclude an institution whose
employees or agents administer the
primary study intervention being tested
in the research. OHRP is proposing to
broaden the example beyond OHRPrecognized CPRPs because OHRP does
not believe that the conditions specified
in example (B)(7) of the current draft
guidance document are unique to
clinical trials conducted under CPRPs.
In addition, to better protect human
subjects involved in research, OHRP
believes that an institution whose
employees or agents administer the
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primary study intervention being tested
in the study should be required: (1) To
obtain an OHRP-approved FWA, and (2)
to certify to the HHS agency conducting
or supporting the research that the
application of proposal for research has
been reviewed and approved by an IRB
designated in the FWA, and will be
subject to continuing review by an IRB.
Therefore, through example (B)(7) in the
current draft engagement guidance
document, OHRP is proposing to clarify
that institutions whose employees or
agents administer the primary study
intervention being tested in the study
would be engaged in human subjects
research. OHRP does not believe the
requirement for an FWA will be unduly
burdensome for such institutions since
OHRP has simplified the assurance
process with the implementation of the
FWA, and now permits an institution
holding an OHRP-approved FWA to
extend the applicability of its FWA to
cover collaborating independent
investigators and collaborating
institutional investigators through an
Individual Investigator Agreement (IIA)
(see https://www.hhs.gov/ohrp/
humansubjects/assurance/
guidanceonalternativetofwa.htm).
In addition, OHRP wants to highlight
three other proposed changes in the
current draft guidance document:
1. The draft guidance document does
not include examples regarding when
‘‘statistical centers,’’ ‘‘operations
centers,’’ or ‘‘coordinating centers’’ for
multi-site research would be engaged in
human subjects research. The existing
January 26, 1999 guidance document
includes examples of when such entities
would be engaged in human subjects
research (see the January 26, 1999
document on ‘‘Engagement of
Institutions in Research, examples
(A)(6) and (A)(7)). OHRP is proposing to
delete these examples in the new
engagement guidance document since
OHRP believes that these entities’
activities are subsumed under example
(A)(5) in the draft engagement guidance
document, which states that an
institution would be engaged in human
subjects research if the institution’s
employees or agents ‘‘* * * obtain for
research purposes identifiable private
information or identifiable biological
specimens from any source * * * .’’ In
addition, the January 26, 1999
document provided guidance on what
component(s) of the study would
require review by the IRB for the
statistical, operations, or coordinating
centers. Because this issue of IRB review
could apply to any institution engaged
in a component of a cooperative
research project, OHRP’s draft guidance
document addressed this general issue
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separately at the end of the section III.
A.
2. OHRP is proposing that an
institution be considered not engaged in
human subjects research in the event
the institution’s employees or agents
consult or collaborate on the human
subjects research by obtaining coded
private information or human biological
specimens from an institution engaged
in the research that retains a link to
individually identifying information
(such as name or social security
number), if one of several specified
conditions is met (see example (B)(2) in
the draft engagement guidance
document). OHRP believes this
additional example helps to clarify the
distinction and relationship between:
(1) Determining when a research study
involving coded private information or
human biological specimens involves
human subjects (see OHRP’s August 10,
2004, Guidance on Research Involving
Coded Private Information or Biological
Specimens at https://www.hhs.gov/ohrp/
humansubjects/guidance/cdebiol.pdf),
and (2) determining whether an
institution is engaged in human subjects
research if it receives coded private
information or human biological
specimens for a research study that
already has been determined to involve
human subjects.
3. OHRP is proposing that an
institution be considered not engaged in
human subjects research if the
institution’s employees or agents author
a paper, journal article, or presentation
describing a human subjects research
study (see example (B)(8) in the current
draft engagement guidance document).
This is in contrast to the January 26,
1999 guidance document, which
suggests that such authorship would
make an institution engaged in human
subjects research (see example (B)(2) in
the January 26, 1999 guidance
document). OHRP is proposing this
clarification because OHRP believes that
for an institution to be engaged in
human subjects research, an
institution’s employees or agents must
obtain: (1) Data about the subjects of the
research through intervention or
interaction with them; or (2) identifiable
private information about the subjects of
the research. If the institution’s
employees or agents do not obtain such
information, the portion of the activity
conducted by the institution does not
involve human subjects, as defined by
45 CFR 46.102(f). Because authorship
does not always involve obtaining such
data or information about the subjects of
the research, OHRP does not believe
that it is helpful to consider authorship
as a factor in determining whether an
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institution is engaged in human subjects
research.
All of the modifications and
clarifications proposed in OHRP’s draft
guidance document, including those
discussed above, are reflected in the
comparison table of the previous
guidance documents and the new draft
guidance document on OHRP’s Web site
at https://www.hhs.gov/ohrp/requests/.
OHRP welcomes comments on its draft
guidance.
Dated: December 1, 2006.
Melody Lin,
Deputy Director, Office for Human Research
Protections.
[FR Doc. E6–20849 Filed 12–7–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
(2) that any institution which submits
an application for PHS support for a
research project on which Mr.
McMaster’s participation is proposed or
which uses him in any capacity on PHS
supported research, or that submits a
report of PHS-funded research in which
he is involved, must concurrently
submit a plan for supervision of his
duties to the funding agency for
approval. The supervisory plan must be
designed to ensure the scientific
integrity of his research contribution.
Mr. McMaster also agrees to ensure that
the institution submits a copy of the
supervisory plan to ORI. He further
agrees that he will not participate in any
PHS-supported research until such a
supervisory plan is submitted to ORI.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
AGENCY:
ACTION:
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E6–20927 Filed 12–7–06; 8:45 am]
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Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
Nicholas McMaster, University of
Chicago: Based on a College Discipline
Hearing report and on additional
analysis conducted by ORI in its
oversight review, the U.S. Public Health
Service (PHS) found that Mr. Nicholas
McMaster, undergraduate student,
Biological Sciences Collegiate Division
in the Departments of Psychology and
Comparative Human Development at
the University of Chicago (UC), engaged
in research misconduct supported by
National Institute of Environmental
Health Sciences (NIEHS), National
Institutes of Health (NIH), grant P50
ES12382 and National Institute on
Aging (NIA), NIH, grant P01 AG018911.
Specifically, PHS found that Mr.
McMaster fabricated data in recording
the score for the lordosis reflex and in
recording the cell types present in
vaginal epithelium from rats in two
experimental psychology protocols.
Mr. McMaster has entered into a
Voluntary Exclusion Agreement in
which he has voluntarily agreed, for a
period of three (3) years, beginning on
November 14, 2006:
(1) To exclude himself from serving in
any advisory capacity to PHS, including
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant;
and
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Alzheimer’s
Disease Demonstration Grants to
States Program Standardized Data
Collection
Administration on Aging, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: The Administration on Aging
(AoA) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
agency. Under the Paperwork Reduction
Act of 1995 (the PRA), Federal agencies
are required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements relating to
Alzheimer’s Disease Demonstration
Grants to States Program
DATES: Submit written or electronic
comments on the collection of
information by February 6, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to:
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Lori.Stalbaum@aoa.hhs.gov. Submit
written comments on the collection of
information to Administration on Aging,
Washington, DC 20201, ATTN: Lori
Stalbaum.
FOR FURTHER INFORMATION CONTACT: Lori
Stalbaum at 202–357–3452 or e-mail:
lori.stalbaum@aoa.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency request
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, AoA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, AoA invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of AoA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
AoA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
when appropriate, and other forms of
information technology.
The Alzheimer’s Disease
Demonstration Grants to States
(ADDGS) Program is authorized through
Sections 398, 399 and 399A of the
Public Health Service (PHS) Act, as
amended by Public Law 101–557 Home
Health Care and Alzheimer’s Disease
Amendments of 1990. The ADDGS
program funded through AoA helps
states extend family support services
provided by subgrantees to underserved
populations, including those in rural
communities.
The PHS Act requires AoA to
‘‘provide for an evaluation of each
demonstration project for which a grant
is made.’’ The PHS Act further states
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[Federal Register Volume 71, Number 236 (Friday, December 8, 2006)]
[Notices]
[Pages 71169-71172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20849]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Draft Guidance on Engagement of Institutions in Human Subjects
Research
AGENCY: Office for Human Research Protections, Office of Public Health
and Science, Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, is announcing the availability of a draft
guidance document entitled, ``OHRP Guidance on Engagement of
Institutions in Human Subjects Research.'' The draft guidance document
would revise and replace two existing OHRP guidance documents on the
engagement of institutions in human subjects research: (1) The January
26, 1999 document on ``Engagement of Institutions in Research, and (2)
the December 23, 1999 document on ``Engagement of Pharmaceutical
Companies in HHS Supported Research.'' To facilitate public review of
the draft guidance document, OHRP has developed a table presenting a
side-by-side comparison of OHRP's draft revised guidance document and
the current guidance documents on the engagement of institution in
human subjects research, which is available on the OHRP Web site at
https://www.hhs.gov/ohrp/requests/.
OHRP's current engagement guidance documents and the proposed draft
guidance document provide examples of when institutions generally would
be considered to be engaged or not engaged in human subjects research.
The draft document is intended primarily for institutional review
boards (IRB), research administrators and other relevant institutional
officials, investigators, and funding agencies that may be responsible
for the conduct, review and oversight of human subject
[[Page 71170]]
research that is conducted or supported by HHS. OHRP will consider
comments received before issuing the final guidance document.
DATES: Submit written comments by February 6, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled, ``OHRP Guidance on Engagement of
Institutions in Human Subjects Research,'' to the Division of Policy
and Assurances, Office for Human Research Protections, The Tower
Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to 301-402-2071. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance. Submit written comments to ENGAGEMENT GUIDANCE
COMMENTS, Office for Human Research Protections, The Tower Building,
1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may
be sent via e-mail to engagementohrp@hhs.gov. or via facsimile at 301-
402-2071.
FOR FURTHER INFORMATION CONTACT: Mr. Glen Drew, Office for Human
Research Protections, Department of Health and Human Services, The
Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852;
301-496-7005; e-mail glen.drew@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human Services (HHS), through OHRP,
regulates research involving human subjects conducted or supported by
HHS in regulations codified at 45 CFR part 46. The HHS human subject
protection regulations stipulate substantive and procedural
requirements for the conduct of HHS-conducted or -supported research,
including requirements for review and approval by an IRB before
research involving human subjects may begin, criteria for IRB approval
of research, and requirements for informed consent or the waiver of
informed consent.
The HHS protection of human subjects regulations at 45 CFR
46.103(a) require that each institution ``engaged'' in human subjects
research that is conducted or supported by HHS provide OHRP with a
satisfactory assurance that the institution will comply with the
regulations, unless all the research meets one or more of the
categories for exemption from the regulatory requirements under 45 CFR
46.101(b). The Federalwide Assurance (FWA) is the only type of
assurance currently accepted by OHRP. The FWA generally identifies
required policies and procedures for the institution and describes the
activities to which the regulations apply.
On January 26, 1999, the Office for Protection from Research Risks
(OPRR), OHRP's predecessor office, issued guidance on ``Engagement of
Institutions in Research.'' OPRR later issued guidance on ``Engagement
of Pharmaceutical Companies in HHS Supported Research,'' dated December
23, 1999.
OHRP is proposing to replace these two documents with a single
document, ``OHRP Guidance on Engagement of Institutions in Human
Subjects Research,'' draft dated October 27, 2006. This guidance is
only applicable to research projects that have been determined to
involve human subjects and that are not exempt under the HHS
regulations at 45 CFR 46.101(b). Once an activity is determined to
involve non-exempt human subjects research, this guidance can be used
to determine whether an institution involved in some aspect of the
research would be considered ``engaged'' in human subjects research,
and would thus need to submit an FWA to OHRP. Like OHRP's existing
guidance documents on engagement, this draft document provides: (1)
Examples of activities that, in general, would result in an institution
being considered engaged in a human subjects research project; and (2)
examples of activities that, in general, would result in an institution
being considered not engaged in a human subjects research project. The
draft guidance document proposes modifications to the set of examples
of when an institution generally would be considered engaged or not
engaged in human subjects research. The proposed modifications include
combining, clarifying, and changing existing examples, as well as
adding further examples and explanation.
To facilitate public review and comments, OHRP has created a
comparison table presenting a side-by-side display of the text from
OHRP's draft guidance document matched with the comparable text from
the 1999 guidance documents. This table is available on the OHRP Web
site at https://www.hhs.gov/ohrp/requests/. The table is not part of the
draft guidance document.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidance
document on OHRP's Web site at https://www.hhs.gov/ohrp/requests/.
III. Request for Comments
OHRP is making its draft guidance document available for public
comment. OHRP's revised guidance document on the engagement of
institutions in human subjects research will be finalized and issued
after the public comments have been considered.
OHRP is particularly interested in the public's comments on two
examples of activities which would not result in the institution being
considered engaged in a human subjects research project under OHRP's
current draft guidance document:
1 Example B(1): Institutions whose employees or agents release to
the investigators at another institution identifiable private
information or identifiable biological specimens pertaining to the
subjects of the research; and,
2 Example B(7): Institutions (including private practices) not
selected as research sites whose employees or agents administer
clinical trial-related medical services if all of the following
conditions are met:
(a) The institution's employees or agents do not enroll subjects,
or obtain the informed consent of any subject for research
participation;
(b) The institution's employees or agents do not administer the
primary study interventions being tested under the protocol;
(c) The institution's employees or agents provide only services
that either are clinically indicated, or are dictated by the protocol
but not clinically indicated, and would typically be performed as part
of routine clinical monitoring and/or follow-up of subjects enrolled at
a study site by clinical trial investigators, such as a blood test,
chest X-ray, CT scan, medical history and physical examination, or an
assessment and reporting of an adverse event;
(d) The investigator(s) from an institution engaged in the research
retain responsibility for oversight of all protocol-related activities
and assure that appropriate arrangements are made for any safety
monitoring and adverse event reporting required under the IRB-approved
protocol;
(e) When appropriate, the informed consent document states that
follow-up data are to be provided to the investigators by the
institution's employees or agents; and,
(f) When providing follow-up data to the investigators, the
institution's employees or agents provide such data to the
investigators in accord with the procedures described in the informed
consent.
Proposed example (B)(1) would represent a modification in OHRP
[[Page 71171]]
policy. OHRP's current guidance document issued in 1999 states that an
institution whose employees or agents release individually identifiable
private information about subjects, for research purposes, without the
subjects' explicit written permission is considered to be engaged in
human subjects research. The proposed modification in guidance is based
on the definition of human subject at 45 CFR 46.102(f), which states in
part, ``human subject means a living individual about whom an
investigator * * * conducting research obtains * * * identifiable
private information.'' (emphasis added). OHRP has concluded that
releasing identifiable private information for research purposes is not
equivalent to obtaining identifiable private information; thus, an
institution releasing such identifiable private information is not
involved in an activity including a ``human subject'' as defined by the
HHS protection of human subjects regulations. Therefore, the revised
example would clarify that an institution, whose employees or agents
release to the investigators at another institution identifiable
private information about living individuals or identifiable biological
specimens that came from living individuals, is not considered engaged
in human subjects research.
Proposed example (B)(7) would represent another modification in
OHRP policy. OHRP's current guidance document states that an
institution (or private practitioner) whose clinical staff provide
protocol-related care and/or follow-up to subjects enrolled at distant
sites by clinical trial investigators in OHRP-recognized Cooperative
Protocol Research Programs (CPRPs) (e.g., the oncology group clinical
trials sponsored by the National Cancer Institute) is not considered to
be engaged in human subjects research provided certain specified
conditions are met. OHRP is proposing two key modifications to this
current example: (1) That the example not be limited to scenarios
involving human subjects research at OHRP-recognized CPRPs; and (2)
that the example exclude an institution whose employees or agents
administer the primary study intervention being tested in the research.
OHRP is proposing to broaden the example beyond OHRP-recognized CPRPs
because OHRP does not believe that the conditions specified in example
(B)(7) of the current draft guidance document are unique to clinical
trials conducted under CPRPs. In addition, to better protect human
subjects involved in research, OHRP believes that an institution whose
employees or agents administer the primary study intervention being
tested in the study should be required: (1) To obtain an OHRP-approved
FWA, and (2) to certify to the HHS agency conducting or supporting the
research that the application of proposal for research has been
reviewed and approved by an IRB designated in the FWA, and will be
subject to continuing review by an IRB. Therefore, through example
(B)(7) in the current draft engagement guidance document, OHRP is
proposing to clarify that institutions whose employees or agents
administer the primary study intervention being tested in the study
would be engaged in human subjects research. OHRP does not believe the
requirement for an FWA will be unduly burdensome for such institutions
since OHRP has simplified the assurance process with the implementation
of the FWA, and now permits an institution holding an OHRP-approved FWA
to extend the applicability of its FWA to cover collaborating
independent investigators and collaborating institutional investigators
through an Individual Investigator Agreement (IIA) (see https://
www.hhs.gov/ohrp/humansubjects/assurance/
guidanceonalternativetofwa.htm).
In addition, OHRP wants to highlight three other proposed changes
in the current draft guidance document:
1. The draft guidance document does not include examples regarding
when ``statistical centers,'' ``operations centers,'' or ``coordinating
centers'' for multi-site research would be engaged in human subjects
research. The existing January 26, 1999 guidance document includes
examples of when such entities would be engaged in human subjects
research (see the January 26, 1999 document on ``Engagement of
Institutions in Research, examples (A)(6) and (A)(7)). OHRP is
proposing to delete these examples in the new engagement guidance
document since OHRP believes that these entities' activities are
subsumed under example (A)(5) in the draft engagement guidance
document, which states that an institution would be engaged in human
subjects research if the institution's employees or agents ``* * *
obtain for research purposes identifiable private information or
identifiable biological specimens from any source * * * .'' In
addition, the January 26, 1999 document provided guidance on what
component(s) of the study would require review by the IRB for the
statistical, operations, or coordinating centers. Because this issue of
IRB review could apply to any institution engaged in a component of a
cooperative research project, OHRP's draft guidance document addressed
this general issue separately at the end of the section III. A.
2. OHRP is proposing that an institution be considered not engaged
in human subjects research in the event the institution's employees or
agents consult or collaborate on the human subjects research by
obtaining coded private information or human biological specimens from
an institution engaged in the research that retains a link to
individually identifying information (such as name or social security
number), if one of several specified conditions is met (see example
(B)(2) in the draft engagement guidance document). OHRP believes this
additional example helps to clarify the distinction and relationship
between: (1) Determining when a research study involving coded private
information or human biological specimens involves human subjects (see
OHRP's August 10, 2004, Guidance on Research Involving Coded Private
Information or Biological Specimens at https://www.hhs.gov/ohrp/
humansubjects/guidance/cdebiol.pdf), and (2) determining whether an
institution is engaged in human subjects research if it receives coded
private information or human biological specimens for a research study
that already has been determined to involve human subjects.
3. OHRP is proposing that an institution be considered not engaged
in human subjects research if the institution's employees or agents
author a paper, journal article, or presentation describing a human
subjects research study (see example (B)(8) in the current draft
engagement guidance document). This is in contrast to the January 26,
1999 guidance document, which suggests that such authorship would make
an institution engaged in human subjects research (see example (B)(2)
in the January 26, 1999 guidance document). OHRP is proposing this
clarification because OHRP believes that for an institution to be
engaged in human subjects research, an institution's employees or
agents must obtain: (1) Data about the subjects of the research through
intervention or interaction with them; or (2) identifiable private
information about the subjects of the research. If the institution's
employees or agents do not obtain such information, the portion of the
activity conducted by the institution does not involve human subjects,
as defined by 45 CFR 46.102(f). Because authorship does not always
involve obtaining such data or information about the subjects of the
research, OHRP does not believe that it is helpful to consider
authorship as a factor in determining whether an
[[Page 71172]]
institution is engaged in human subjects research.
All of the modifications and clarifications proposed in OHRP's
draft guidance document, including those discussed above, are reflected
in the comparison table of the previous guidance documents and the new
draft guidance document on OHRP's Web site at https://www.hhs.gov/ohrp/
requests/. OHRP welcomes comments on its draft guidance.
Dated: December 1, 2006.
Melody Lin,
Deputy Director, Office for Human Research Protections.
[FR Doc. E6-20849 Filed 12-7-06; 8:45 am]
BILLING CODE 4150-36-P
