[Federal Register Volume 75, Number 230 (Wednesday, December 1, 2010)]
[Notices]
[Page 74734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30201]



[[Page 74734]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Guidance on Institutional Review Board Approval of Research With 
Conditions

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of the Assistant Secretary for Health, Office for 
Human Research Protections.

ACTION: Notice.

-----------------------------------------------------------------------

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 Approval of Research with 
Conditions.'' The guidance document provides OHRP's first formal 
guidance on this topic. The document, which is available on OHRP's Web 
site at http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or 
http://www.hhs.gov/ohrp/policy/conditionalapproval2010.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 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document announced in this notice finalizes the draft guidance that was 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 57486). OHRP received comments on 
the draft guidance document from 12 individuals and organizations, and 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 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 guidance document.
    Submit written comments to Comments on Conditional IRB Approval 
Guidance, Office for Human Research Protections, 1101 Wootton Parkway, 
Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to 
ohrp@hhs.gov 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 Irene.Stith-Coleman@hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    OHRP is announcing the availability of a guidance document entitled 
``Guidance on IRB Approval of Research with Conditions.'' The guidance 
document provides OHRP's first formal guidance on this topic. 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 nine 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) May an IRB approve some components of a proposed research study 
and defer taking action on other components at the time of initial 
review?
    (8) 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?
    (9) What must the IRB records include regarding the documentation 
of conditions of IRB approval of research?
    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 57486). OHRP received 
comments on the draft guidance document from 12 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.

II. Electronic Access

    The guidance document is available on OHRP's Web site at http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or http://www.hhs.gov/ohrp/policy/conditionalapproval2010.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. 2010-30201 Filed 11-30-10; 8:45 am]
BILLING CODE 4150-36-P