Office of Research and Project Administration

The following message is posted on behalf of Patty Bardeen:
*******************************************************

January 24, 2007

TO:             All Grant Administrators and Principal Investigators

FROM:           Patty Bardeen
                Executive Secretary
                Institutional Biosafety Committee

RE:             New Registration Process for Human Subjects Trials

The Institutional Biosafety Committee (IBC) is proud to announce its new registration process for research involving human subjects.  This process has been changed to decrease the Principal Investigator’s time burden and to clarify what types of protocols require IBC approval.

Protocols involving human subjects and the following require approval from the biosafety committee.

1.      Introduction of Recombinant DNA (plasmids) or gene transfer vectors (including virus vectors) into human subjects;

2.      Introduction of genetically engineered micro-organisms into human subjects;

3.      Infectious agents, deliberately introduced into human subjects (including live vaccines if they are experimental in nature and/or not FDA-approved for use in the specific study population)

4.      The analysis of, or experimentation, with sera, blood products, or other human specimens in UR research laboratories or in those UR labs that are NOT accredited with the College of American Pathologists (CAP).

Note: SMH and Highland Clinical Labs are CAP accredited. Therefore, if your clinical study ONLY involves using these labs for specimen analysis or experimentation, then you do NOT have to register with the IBC.

Please note registration is required with the IBC by the National Institutes of Health and by the institution. You can find the new registration instructions and forms on the IBC webpages under “Human Subjects Study that Require IBC Approval ” at <http://www.safety.rochester.edu/ibc/ibchumanmenu.html> .

Thank you for your cooperation.  By registering with the IBC, you will help ensure the University of Rochester is in compliance with applicable biosafety requirements.  If you have any questions regarding IBC registration, you may contact me via e-mail at pbardeen@safety.rochester.edu <mailto:pbardeen@safety.rochester.edu> or via phone at x5-2402.

c.c.    Mary Adams
        Janice Taylor