Office for Human Research Protections (OHRP)

Request for Comments on Categories of Research That May Be Reviewed By the Institutional Review Board (IRB) Through an Expedited Review Procedure

Background:

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364). On that date, the Office for Protection from Research Risks (OPRR), now OHRP, and the Food and Drug Administration (FDA) simultaneously published identical lists of categories of research activities involving human subjects which may be reviewed by the IRB through an expedited review procedure. It has come to OHRP's attention that there has been confusion in the research community about expedited review category 5. OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes.

In addition, OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 (63 FR 60364) to determine if other changes are needed.

As part of its charge to provide expert advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects, the Secretary's Advisory Committee on Human Research Protections (SACHRP), through its Subcommittee on Subpart A, considered whether the current expedited review categories should be modified. On March 14, 2007, SACHRP submitted recommendations regarding expedited review to the Secretary, and on June 18, 2007, the Secretary sent a letter to the SACHRP chairperson, stating that HHS would give serious consideration to these recommendations. In regard to the current expedited review categories, SACHRP recommended that expedited review category 7 should be revised. Therefore, in addition to requesting comments on the entire expedited review list that was published in the Federal Register on November 9, 1998 (63 FR 60364), OHRP is also specifically requesting comments on SACHRP’s recommended revision of expedited review category 7.

As required under 21 CFR 56.110(a), FDA also will publish in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure. FDA intends to issue the list concurrently with OHRP’s issuance of its final notice, and in compliance with 21 CFR 10.115 (good guidance practice regulations). This approach maintains FDA’s practice of moving in tandem on this issue with OHRP.

Submit written or electronic comments by December 26, 2007. Written comments may be sent to EXPEDITED REVIEW, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to expeditedreviewohrp@hhs.gov, or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://archive.hhs.gov/ohrp/documents/20071026.htm.

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