July 13, 2000

ORCA ALERT # 3: 

FDA IRB Reviews and SOP Manuals

* * See also ORCA Alert # 2 May 19, 2000 * *

The Food and Drug Administration (FDA) has started its intense review of Institutional Review Board (IRB) activities.  So far the emphasis has been on research projects considered to be of high risk for enrolling human subjects.  There is scrutiny of the IRB procedures, processes, Minutes and a general assessment of the knowledge level of IRB members of the pertinent Regulations and how they are to be applied. 

An area of particular emphasis has been the guidance embodied in the IRB Standard Operating Procedure (SOP) manuals.  FDA is particularly critical of places where there is no manual or where the manual is rudimentary, at best, and where the manual’s contents is not well understood by the IRB members and the administrative support staff.

“FDA considers the presence and use of an up-to-date IRB SOP manual is a key criterion in its assessment of an effective IRB.”

It is strongly suggested that a review be conducted to review the adequacy of your IRB SOP manual.  While this office is still in the process of collecting and will be evaluating the adequacy of these IRB SOP manuals, this does not obviate the need for you to immediately evaluate your situation, especially if you are a VAMC with an independent IRB.

This office has a subcommittee to its Training Education and Development (TED) Focus Group that is examining the need for guidance on a suggested Table of Contents for a VA IRB SOP manual.

While there is no generally approved template for IRB SOP manuals, you might consider approaching one or other of the following individuals for assistance:

Dr. Frank Zieve, ASOC R&D, Richmond VAMC:  franklin.zieve@med.va.gov
Dr. Steven Peckman, Associate Director OPRS, UCLA:  speckman@oprs.ucla.edu