NOTE: THIS GUIDANCE HAS BEEN REPLACED BY OHRP�S AUGUST 11, 2003 GUIDANCE ENTITLED, "GUIDANCE ON THE USE OF EXPEDITED REVIEW PROCEDURES." CLICK HERE FOR THE AUGUST 11, 2003 GUIDANCE.
| Number 99-01 |
| Human Subject Protections |
January 6, 1999
Subject: Expedited Review of Certain Research by Institutional Review Boards
Dear Colleague:
This letter conveys to Institutional Officials and Institutional Review Board (IRB) Chairs a revised
list of categories of research that may be reviewed by an IRB through an expedited review
procedure. This list is shared by the U.S. Department of Health and Human Services (HHS) and
the Food and Drug Administration (FDA). The Office for Protection from Research Risks
(OPRR) published this list on November 9, 1998 (63 FR 60364).
The 1998 list is effective immediately and supersedes the 1981 list. OPRR policy provides that
only institutions with a Multiple Project Assurance (MPA) or a Cooperative Project Assurance
(CPA) may use expedited review for initial or continuing review of HHS-supported research.
Institutions with MPAs, CPAs, and Single Project Assurances (SPAs) may use expedited review
for minor changes in the research as described in
45 CFR 46.110(b)(2).
The list may be accessed on the Internet by going to the OPRR Human Subjects homepage
/polasur.htm and simply clicking on the item under Regulations that says Research That May Be Reviewed through an Expedited Procedure. A copy
of the November 9, 1998 Federal Register notice and expedited review list is also available via
FAX, by calling 301-594-0464 and requesting document #1031. (For the list alone, request
document #1030.)
Please feel free to contact OPRR if you have any questions.
Sincerely,
National Institutes of Health, 6100 Executive Blvd., Rockville, MD 20892-7507
_____________________________________________________________________________________________
January 5, 1999
Dear Colleague:
This letter conveys to Institutional Officials and Institutional Review Board (IRB)
Chairs the revised list of categories of research that may be reviewed by an IRB
through an expedited review procedure. The Office for Protection from Research
Risks (OPRR) and the Food and Drug Administration (FDA) each published
identical, but separate, revised lists on November 9, 1998 in the Federal Register
(63 FR 60364 and 63 FR 60353). This list is an adjunct to the federal regulations for
the protection of human subjects.
The 1998 list is effective immediately and supersedes the 1981 list. The list of
categories of research that are eligible for expedited review are the same on both the
OPRR and the FDA lists.
Expedited review procedures are described in 45 CFR 46.110 and 21 CFR 56.110.
The IRB Chair, or one or more experienced reviewers designated by the Chair from
among the members of the IRB, reviews the research and may either approve it or
refer it to the full IRB for discussion.
Attached is the 1998 list of research activities for which expedited review procedures
may be available.
Gary B. Ellis, Ph.D.
Director
OPRRMichele Russell-Einhorn, J.D.
Director
Regulatory AffairsJ. Thomas Puglisi, Ph.D.
Director
Human Subject Protections
DEPARTMENT OF HEALTH & HUMAN SERVICES
PUBLIC HEALTH SERVICE
Gary B. Ellis, Ph.D.
Director
Protection from Research RisksStuart L. Nightingale, M.D.
Associate Commissioner
for Health Affairs
Food and Drug Administration