At VCU we will execute clinical trial agreements without completion of IRB
approval, because we have
a)  a clause requiring IRB approval before comencing patient/subject
contact, and
b)  an internal regulation, which is well supported by institutional
socialization and folk myth, preventing commencing  patient/subject contact
on ANY human-related project prior to IRB approval.

Chuck

At 07:56 AM 2/9/99 -0600, you wrote:
>This happened recently with a Department of Education award and we did not
>activate the award until our principal investigator had IRB approval.
>Also, we sometimes receive contracts for clinical trials with industry
>sponsors before the IRB has approved the protocol and it is our policy not
>to execute those contracts prior to the IRB approval.
>
>Tom Wilson
>
>
>
>
>
>
>At 01:58 PM 2/8/99 -0600, you wrote:
>>What do you do if an NIH agency fails to address human subject issues,
>>proceeds to send you an official award notice with no restrictions at all,
>>then you discover the project needs IRB approval only after the award comes
>>in?
>>
>>Do you:
>>
>>1) Call the agency and tell them what you discovered
>>2) Make your own restrictions
>>3) 1 Only
>>4) 2 Only
>>5) Both 1 and 2
>>6) None of the above. Our institution ________________(fill in blank).
>>
>>(This is not a quiz. We just want to know what you do at your institution.)
>>
>>Thanks,
>>Tim
>>
>>_______________________________________
>>Tim Atkinson
>>Director, Research Support Services
>>Arkansas Children's Hospital Research Institute
>>1120 Marshall Street
>>Little Rock, Arkansas 72202-3591
>>Phone: 501-320-3581
>>Fax: 501-320-3547
>>E-mail: xxxxxx@exchange.uams.edu
>>http://achri.ach.uams.edu/
>>_______________________________________
>>
>>
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>>
>Thomas E. Wilson
>Director, Sponsored Programs
>Baylor College of Medicine
>phone: 713-798-6970
>fax:   713-798-6990
>email: xxxxxx@bcm.tmc.edu
>
>
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Herbert B. Chermside, CRA
Director, Sponsored Programs Administration
Virginia Commonwealth University
PO BOX 980568
Richmond, VA  23298-0568
Express Delivery Only:
 Sanger Hall, Rm. 1-073
 11th & Marshall Streets
 Richmond, VA  23219
Voice:  804-828-6772
Fax     804-828-2521
OFFICE e-mail   xxxxxx@VCU.EDU
Personal e-mail xxxxxx@vcu.edu
http://views.vcu.edu/views/ospa/

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