[Federal Register Volume 75, Number 230 (Wednesday, December 1, 2010)]
[Notices]
[Pages 74734-74735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Guidance on Institutional Review Board Continuing Review of 
Research

AGENCY: Department of Health and Human Services, Office for Human 
Research Protections, Office of the Assistant Secretary for Health, 
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 
the Assistant Secretary for Health, is announcing the availability of a 
guidance document entitled ``Guidance on IRB Continuing Review of 
Research.'' The guidance document supersedes OHRP's January 15, 2007 
guidance entitled ``Guidance on Continuing Review.'' The document, 
which is available on OHRP's Web site at http://www.hhs.gov/ohrp/policy/continuingreview2010.html or http://www.hhs.gov/ohrp/policy/continuingreview2010.pdf, is intended primarily for institutional 
review boards (IRB), 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

[[Page 74735]]

conducted or supported by HHS. The guidance document announced in this 
notice finalizes the draft guidance that was made available for public 
comment through a notice in the Federal Register on November 6, 2009 
(74 FR 57487). OHRP received comments on the draft guidance document 
from 18 individuals and organizations, and those comments were 
considered as the guidance was finalized.

DATES: Comments on OHRP guidance documents are welcome at any time.

ADDRESSES: Submit written requests for a single copy of the guidance 
document entitled, ``Guidance on IRB Continuing Review of 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 301-402-2071. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance document.
    Submit written comments to Comments on Continuing Review Guidance, 
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 240-402-2071.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for 
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
MD 20852, 240-453-6900; e-mail [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    OHRP is announcing the availability of a guidance document entitled 
``Guidance on IRB Continuing Review of Research.'' The guidance 
document supersedes OHRP's January 15, 2007 guidance entitled 
``Guidance on Continuing Review.'' The 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 applies 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, the guidance 
addresses the following 11 topics:
    (1) Key IRB Considerations When Evaluating Research Undergoing 
Continuing Review;
    (2) Process for Conducting Continuing Review;
    (3) Additional Considerations for Continuing Review of Multicenter 
Research Projects;
    (4) When Expedited Review Procedures may be Used by an IRB for 
Continuing Review;
    (5) Determining the Frequency of Continuing Review;
    (6) Determining the Effective Date of Initial IRB Approval and the 
Dates for Continuing Review;
    (7) Lapses in IRB Approval;
    (8) Communicating the IRB's Continuing Review Determination to 
Investigators and the Institution;
    (9) Suspension or Termination of IRB Approval of Research or 
Disapproval of Research at the Time of Continuing Review;
    (10) Identifying the Point When Continuing Review is no Longer 
Necessary; and
    (11) Continuing Review is Not Required for Exempt Human Subjects 
Research Projects.
    The guidance document announced in this notice finalizes the draft 
guidance that was made available for public comment through a notice in 
the Federal Register on November 6, 2009 (74 FR 57487). OHRP received 
comments on the draft guidance document from 18 individuals and 
organizations, and those comments were considered as the guidance was 
finalized. The majority of commenters expressed general support for the 
draft guidance document. The final guidance document is largely 
unchanged from what was proposed in the draft guidance, with only minor 
clarifying edits made in response to many of the comments.
    To enhance human subject protections and reduce regulatory burden, 
OHRP and the Food and Drug Administration (FDA) have been actively 
working to harmonize the agencies' regulatory requirements and guidance 
for human subjects research. The guidance document announced in this 
notice was developed as a part of these efforts. When FDA finalizes its 
related guidance entitled ``Guidance for IRBs, Clinical Investigators, 
and Sponsors: IRB Continuing Review After Clinical Investigation 
Approval,'' which was made available in draft for public comment 
through a notice in the Federal Register on January 13, 2010 (75 FR 
1790), OHRP will update the guidance document announced in this notice 
as needed to harmonize with FDA's final guidance document.

II. Electronic Access

    The guidance document is available on OHRP's Web site at http://www.hhs.gov/ohrp/policy/continuingreview2010.html or http://www.hhs.gov/ohrp/policy/continuingreview2010.pdf.

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.

    Dated: November 24, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2010-30198 Filed 11-30-10; 8:45 am]
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