[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]]
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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.
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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 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document announced in this notice finalizes the draft guidance that was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the draft guidance document from 12 individuals and organizations, and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
[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 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]
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