[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]


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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Draft Guidance on Institutional Review Board Approval of Research 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.

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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Public Health and Science, is announcing the availability of a draft 
guidance document entitled ``Guidance on IRB Approval of Research with 
Conditions,'' and is seeking comment on the draft guidance. The draft 
guidance document, when finalized, would provide OHRP's first formal 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance on IRB Approval of Research with 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to the draft guidance document.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]
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