[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63150-63152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Final 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.
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SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, is announcing the availability of a guidance
document entitled, ``OHRP Guidance on Engagement of Institutions in
Human Subjects Research.'' The guidance document describes: (1)
Scenarios that, in general, would result in an institution being
considered engaged in a human subjects research project; (2) scenarios
that would result in an institution being considered not engaged in a
human subjects research project; and (3) IRB review considerations for
cooperative research in which multiple institutions are engaged in the
same non-exempt human subjects research project. The guidance document
is intended primarily for institutional review boards (IRBs), research
administrators and other relevant institutional officials,
investigators, and funding agencies that may be responsible for the
conduct, review and oversight of human subject research that is
conducted or supported by the Department of Health and Human Services
(HHS).
The guidance document announced in this notice finalizes the draft
guidance with the same title that was made available for public comment
in the Federal Register on December 8,
[[Page 63151]]
2006 (71 FR 71169). OHRP received twenty-four comments on the draft
guidance document, and those comments were considered as the guidance
was finalized. The final guidance document replaces 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.''
DATES: Comments on OHRP guidance documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the 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, 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 240-453-
6909. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance document. Submit written comments to
ENGAGEMENT GUIDANCE COMMENTS, Office for Human Research Protections,
1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may
be sent via e-mail to [email protected] or via facsimile at 240-453-6909.
FOR FURTHER INFORMATION CONTACT: Ms. Julie Kaneshiro, Office for Human
Research Protections, Department of Health and Human Services, 1101
Wootton Parkway, Suite 200, Rockville, MD 20852; 240-453-6900; e-mail
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
OHRP, Office of Public Health and Science, is announcing the
availability of a guidance document entitled, ``OHRP Guidance on
Engagement of Institutions in Human Subjects Research.'' 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) and (b) require that each institution ``engaged'' in human
subjects research that is conducted or supported by HHS (1) provide
OHRP with a satisfactory assurance that the institution will comply
with the regulations, and (2) certify to the HHS agency conducting or
supporting the research that the research has been reviewed and
approved by an IRB designated in the assurance and will be subject to
continuing review by an IRB, 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.
In the Federal Register of December 8, 2006 (71 FR 71169), OHRP
announced the availability of a draft guidance document entitled,
``OHRP Guidance on Engagement of Institutions in Human Subjects
Research,'' dated October 27, 2006, which OHRP proposed would replace
the two guidance documents that had been issued in 1999. OHRP received
twenty-four comments on the draft guidance and those comments were
considered as the guidance was finalized. See section II. Discussion of
Public Comments for a summary of the main comments received and OHRP's
responses.
This guidance is only applicable to HHS-conducted or -supported
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 (1) hold or obtain
an applicable OHRP-approved FWA, and (2) certify to the HHS agency
conducting or supporting the research that the research has been
reviewed and approved by an IRB designated in the assurance and will be
subject to continuing review by an IRB.
II. Discussion of Public Comments
Most of the comments expressed general support for OHRP's draft
guidance document. Some comments suggested clarifying changes and
others recommended more substantive changes to the scenarios described
in the draft guidance. All of the comments received were considered as
the guidance was finalized. A discussion of the main comments follows.
Institutions Engaged in Human Subjects Research
Awardee Institutions
OHRP's draft guidance document proposed that institutions that
receive an award through a grant, contract, or cooperative agreement
directly from HHS for non-exempt human subjects research (i.e., awardee
institutions) would generally be considered engaged in human subjects
research, even where all activities involving human subjects are
carried out by agents of another institution. A few of the commenters
urged OHRP to reconsider its view that such awardee institutions should
generally be considered engaged in human subjects research when all
activities involving human subjects are carried out by agents of
another institution. The commenters noted that considering such awardee
institutions to be engaged in human subjects research often results in
duplicative review by IRBs and administrative burden for awardee
institutions that choose to modify their FWAs to rely on another
institution's IRB to satisfy the regulatory requirements under 45 CFR
part 46. These commenters questioned whether human subjects were
offered greater protections by considering such awardee institutions to
be engaged in human subjects research.
OHRP believes that institutions that receive an award directly from
HHS for non-exempt human subjects research should generally be
considered engaged in human subjects research. However, the office
understands these commenters' concerns and agrees that in some
circumstances, institutions that receive an award for non-exempt human
subjects research, but that do not carry out any of the activities
involving human subjects, should not be considered engaged in the human
subjects research. OHRP will continue to consider this issue in
consultation with the HHS funding agencies.
[[Page 63152]]
Institutions Not Engaged in Human Subjects Research
Release of Identifiable Private Information or Biological Specimens
In the Federal Register of December 8, 2006 (71 FR 71169), OHRP
noted that the office was particularly interested in the public's
comments on the proposal that institutions whose employees or agents
release to investigators at another institution identifiable private
information or identifiable biological specimens pertaining to the
subjects of the research, not be considered engaged in human subjects
research.
The public comments supported this proposed scenario. OHRP retained
this scenario in the final guidance document, with only minor
clarifying changes (see scenario B.(6) in the final guidance).
Administration of Clinical Trial-Related Medical Services
In the Federal Register of December 8, 2006 (71 FR 71169), OHRP
also noted that the office was particularly interested in the public's
comments on the proposal that institutions (including private
practices) not selected as research sites whose employees or agents
administer clinical trial-related medical services, not be considered
engaged in human subjects research provided that specified conditions
were met. One of the proposed conditions was that the institution's
employees or agents do not administer the primary study interventions
being tested under the protocol.
The public comments on this proposed scenario were generally
supportive, but several commenters sought clarifications on some of the
proposed conditions. In addition, a few of the commenters recommended
that OHRP expand the scenario to permit the employees or agents of an
institution not selected as a research site to administer the study
intervention being tested or evaluated under the protocol, and still
not consider such an institution to be engaged in human subjects
research.
In the final guidance, OHRP retained the proposed scenario, with
minor changes in response to the public comments (see scenario B.(2) in
the final guidance). However, OHRP also has included another scenario
in the final guidance that would allow employees or agents of an
institution not initially selected as a research site to administer the
study interventions being tested or evaluated under the protocol,
provided that this occurs on a one-time or short-term basis, and
specified conditions are met (see scenario B.(3) in the final
guidance). OHRP believes this is responsive to the concern raised in a
public comment that research subjects are sometimes unexpectedly
hospitalized or otherwise unexpectedly unable to receive a study
intervention being tested or evaluated in a protocol from an
institution that had previously been designated as a research site.
III. Comments
Interested persons may submit comments regarding this guidance
document to OHRP at any time. Please see the ADDRESSES section for
information on where to submit written comments.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance
document on OHRP's Web site at http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.htm.
Dated: October 16, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections.
[FR Doc. E8-25177 Filed 10-22-08; 8:45 am]
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