[Federal Register Volume 71, Number 10 (Tuesday, January 17, 2006)]
[Proposed Rules]
[Pages 2493-2494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-357]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 56
[Docket No. 2001N-0322 (formerly 01N-0322)]
Institutional Review Boards: Requiring Sponsors and Investigators
to Inform Institutional Review Boards of Any Prior Institutional Review
Board Reviews; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of an advance notice of proposed rulemaking (ANPRM) entitled
``Institutional Review Boards: Requiring Sponsors and Investigators to
Inform IRBs of Any Prior IRB Reviews'' that published in the Federal
Register of March 6, 2002 (67 FR 10115).
DATES: The ANPRM is withdrawn February 16, 2006.
FOR FURTHER INFORMATION CONTACT: Patricia M. Beers Block, Good Clinical
Practice Program (HF-34), Food and Drug Administration, 5600 Fishers
Lane, rm. 9C24, Rockville, MD 20857, 301-827-3340.
SUPPLEMENTARY INFORMATION: In 1998, the Department of Health and Human
Services, Office of the Inspector General (OIG) issued several reports
on institutional review boards (IRBs). The OIG sought to identify the
challenges facing IRBs and to make recommendations on improving Federal
[[Page 2494]]
oversight of IRBs. One recommendation was that sponsors and clinical
investigators be required to notify IRBs of any prior review (see OIG,
Department of Health and Human Services, ``Institutional Review Boards:
A Time for Reform,'' p. 14, June 1998; http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf). The OIG report stated that the OIG had:
* * * heard of a few situations where sponsors and/or research
investigators who were unhappy with one IRB's reviews switched to
another without the new IRB being aware of the other's prior
involvement. This kind of IRB shopping deprives the new IRB of
information that it should have and that can be important in
protecting human subjects. The ground rules should be changed so
that sponsors and investigators have the clear obligation to inform
an IRB of any prior reviews (footnote omitted). The obligation
should be applied to all those conducting research funded by HHS or
carried out on FDA-regulated products. It will have particular
importance for those sponsors and investigators working with
independent IRBs.
Id.
After reviewing the OIG's recommendation, FDA published an ANPRM on
March 6, 2002 (67 FR 10115) (see http://www.fda.gov/OHRMS/DOCKETS/98fr/030602a.pdf) announcing it was considering whether to amend its IRB
regulations to require sponsors and investigators to inform IRBs about
any prior IRB review decisions. We invited public comments on: (1) The
frequency of IRB shopping and under what circumstances IRB shopping has
occurred; (2) what information about prior IRB review should be
disclosed, where should it be disclosed, and who should disclose it;
and (3) what methods, other than disclosure of prior IRB reviews, might
prove to be valuable for dealing with IRB shopping.
In response to this ANPRM, FDA received 55 comments. The majority
of the comments reported they had little or no first hand knowledge of
instances of IRB shopping, and did not believe IRB shopping presented a
significant problem. Many comments expressed concern about the
logistics of maintaining a system that would enable the exchange of
information among IRBs, especially when studies involved multiple study
sites. There was concern that maintaining such a system would
substantially increase the IRBs' workload and not provide any
additional human subject protection. There was also concern that
waiting for information from other IRBs prior to the review of research
proposals within a particular institution might contribute to delays in
the review of these proposals.
The Office for Human Research Protections (OHRP) also informed FDA
that it considered the OIG's recommendation to require sponsors and
investigators to notify IRBs of any prior IRB review of a research
plan. OHRP concluded that it had no reason to believe that IRB shopping
was occurring with any regularity in the review of HHS conducted or
supported human subjects research.
Based on these reasons, FDA concluded that IRB shopping either does
not occur or does not present a problem to an extent that would warrant
rulemaking at this time.
In a letter dated February 26, 2005, FDA advised the OIG of these
findings and conclusions. FDA is now withdrawing this ANPRM. A
withdrawal does not prevent the agency from taking action in the
future. Should FDA decide to undertake rulemaking sometime in the
future, the agency will provide new opportunities for comment.
Dated: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-357 Filed 1-13-06; 8:45 am]
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