NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE THE LIST OF CATEGORIES HAS BEEN REVISED AND CAN BE FOUND AT http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm.
Number 98-01 Human Subject Protections
November 26, 1997
Subject: Expedited Review of Certain Research by Institutional Review Boards
Dear Colleague:
This letter informs Institutional Officials and Institutional Review Board (IRB) Chairs of a proposal to revise the list of research activities which may be reviewed through expedited review procedures. That list, which dates from 1981, is an adjunct to the federal regulations for protection of human subjects.
Notice of the proposed revision appeared in the Federal Register, November 10, 1997, 62FR60607-60611. The Office for Protection from Research Risks (OPRR) and the Food and Drug Administration (FDA) have joined to make an identical proposal.
OPRR strongly encourages you to submit written comments in response to the proposed new list. The creative insights and suggestions of IRB members, researchers, and other interested individuals will help to produce a workable product. In order to allow a generous amount of time for public comment, OPRR and FDA have designated a 4-month comment period, which ends on March 10, 1998. Comments need not be sent to both OPRR and FDA. OPRR and FDA view this effort at revising the list as a significant opportunity to bring the list up-to-date and to incorporate the research community and public at large in this important task.
Please feel free to contact OPRR if you have any questions.
Sincerely,
| /s/ | /s/ | /s/ |
|---|---|---|
|
Gary B. Ellis, Ph.D. Director Office for Protection from Research Risks |
Michele Russell-Einhorn, J.D. Director Regulatory Affairs |
J. Thomas Puglisi, Ph.D. Director Human Subject Protections |