Guidance on Institutional Review Board Continuing Review of Research, 74734-74735 [2010-30198]
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74734
Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Guidance on Institutional Review
Board Approval of Research With
Conditions
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office for Human Research
Protections.
ACTION: Notice.
AGENCY:
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
https://www.hhs.gov/ohrp/policy/
conditionalapproval2010.html or https://
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draft guidance that was made available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comments on the draft guidance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.
SUMMARY:
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 selfaddressed 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
jlentini on DSKJ8SOYB1PROD with NOTICES
DATES:
VerDate Mar<15>2010
20:11 Nov 30, 2010
Jkt 223001
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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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 https://
www.hhs.gov/ohrp/policy/
conditionalapproval2010.html or https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Guidance on Institutional Review
Board Continuing Review of Research
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.
AGENCY:
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
https://www.hhs.gov/ohrp/policy/
continuingreview2010.html or https://
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
SUMMARY:
E:\FR\FM\01DEN1.SGM
01DEN1
Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Notices
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.
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 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:
DATES:
jlentini on DSKJ8SOYB1PROD with NOTICES
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;
VerDate Mar<15>2010
20:11 Nov 30, 2010
Jkt 223001
(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.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
74735
II. Electronic Access
The guidance document is available
on OHRP’s Web site at https://
www.hhs.gov/ohrp/policy/
continuingreview2010.html or https://
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]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Food Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Food Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 30 and 31, 2011, from
8:30 a.m. to 4:30 p.m.
Location: The Hilton Hotel, Silver
Spring, 8727 Colesville Rd., Silver
Spring, MD 20910, 301–589–5200.
Contact Person: Carolyn Jeletic,
Center for Food Safety and Applied
Nutrition (HFS–024), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–1913 or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014510564. Please call the
Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 75, Number 230 (Wednesday, December 1, 2010)]
[Notices]
[Pages 74734-74735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30198]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.hhs.gov/ohrp/policy/continuingreview2010.html or https://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
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 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 https://www.hhs.gov/ohrp/policy/continuingreview2010.html or https://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]
BILLING CODE 4150-36-P
