[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57486-57487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26830]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Draft Guidance on Institutional Review Board Approval of Research
With Conditions
AGENCY: Office for Human Research Protections, Office of Public Health
and Science, Office of the Secretary, Department of Health and Human
Services.
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Public Health and Science, is announcing the availability of a draft
guidance document entitled ``Guidance on IRB Approval of Research with
Conditions,'' and is seeking comment on the draft guidance. The draft
guidance document, when finalized, would provide OHRP's first formal
guidance on this topic. The draft document, which is available on the
OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended
primarily for institutional review boards (IRBs), investigators,
Department of Health and Human Services (HHS) funding agencies, and
others that may be responsible for the review, conduct, or oversight of
human subject research conducted or supported by HHS. OHRP will
consider comments received before issuing the final guidance document.
DATES: Submit written comments by January 5, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance on IRB Approval of Research with
Conditions'' 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 301-402-2071. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the draft guidance document.
You may submit comments, identified by docket ID number HHS-OPHS-
2009-0017, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Enter the above docket ID number in the ``Enter Keyword or ID'' field
and click on ``Search.'' On the next Web page, click on the ``Submit a
Comment'' action and follow the instructions.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health
Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Comments received, including any personal information, will be
posted without change to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S.
Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, 240-453-6900; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Overview
OHRP is announcing the availability of a draft guidance document
entitled ``Guidance on IRB Approval of Research with Conditions.'' The
draft guidance document, when finalized, will represent OHRP's current
thinking on this topic and will provide OHRP's first formal guidance on
this topic. The draft document is intended primarily for IRBs,
investigators, HHS funding agencies, and others that may be responsible
for the review, conduct, or oversight of human subject research
conducted or supported by HHS. The guidance document would apply to
non-exempt human subjects research conducted or supported by HHS. It
provides guidance on the authority of IRBs to approve research with
conditions. In particular, OHRP offers guidance on the following
topics:
(1) What actions can an IRB take when reviewing research?
(2) What does IRB approval with conditions mean?
(3) What circumstances preclude the IRB from approving research?
(4) What circumstances permit the IRB to approve research with
conditions?
(5) How should the IRB handle changes to research that are proposed
after the IRB has approved the research with conditions?
(6) How do conditions on IRB approval at the time of initial review
affect the initiation of research?
(7) How do conditions on IRB approval at the time of continuing
review, or at the time of review of proposed changes in previously
approved research, affect ongoing research?
(8) What must the IRB records include regarding the documentation
of conditions of IRB approval of research?
B. Pertinent Recommendations by the Secretary's Advisory Committee on
Human Research Protections (SACHRP) Related to Continuing Review and
Expedited Review
In a March 14, 2007 letter, SACHRP transmitted to the Secretary of
Health and Human Services recommendations regarding IRB continuing
review and expedited review of research. Two of these recommendations
are addressed by the draft guidance document. The following discussion
describes OHRP's response to these SACHRP recommendations and
identifies the
[[Page 57487]]
section(s) of the draft guidance document that address each
recommendation.
(1) SACHRP Recommendation: OHRP and the Food and Drug
Administration should issue expanded guidance (a) clarifying that final
approval of stipulations from convened meeting review (i.e.,
``contingent approval'') is not a form of expedited review; and (b)
permitting IRBs to describe in their written policies and procedures
``stipulation mechanisms'' for verifying changes required for approval
of proposed research under which (i) the IRB Chairperson, or designated
member-reviewer, may exercise reasonable judgment in verifying that the
stipulations of the convened IRB have been satisfied; and (ii) a
qualified IRB administrator may verify that the investigator has
implemented specific language (e.g., in the protocol, informed consent
document, or advertisements) dictated by the convened IRB (and
requiring no subjective judgment on the part of the administrator).
OHRP's Response: OHRP agrees with this recommendation. Sections B
and D of the draft guidance document in particular reflect OHRP's
implementation of SACHRP's recommendation.
(2) SACHRP Recommendation: OHRP should modify its guidance on
continuing review so that, when the study has been reviewed by the IRB
(at a convened meeting or through an expedited process, as appropriate)
and the IRB finds that there are no substantive concerns in terms of
the risk-benefit relationship, informed consent, or other key
protections, suspension of all research activity is not required when
the expiration date passes, provided that IRB review is completed
within 30 days past the expiration date.
OHRP's Response: OHRP agrees in general with the intent of this
recommendation. OHRP has addressed this recommendation through its
discussion of conditional approval by the IRB at the time of continuing
review in section G of the draft guidance document.
II. Electronic Access
The draft guidance document is available on OHRP's Web site at
http://www.hhs.gov/ohrp/requests/.
III. Request for Comments
OHRP requests comments on its draft guidance document. OHRP will
consider all comments before issuing a final guidance document.
Dated: November 3, 2009.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. E9-26830 Filed 11-5-09; 8:45 am]
BILLING CODE 4150-36-P