[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]



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.


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DATES: The ANPRM is withdrawn February 16, 2006.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.
    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]