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:

1) Fire the Director, Office of Sponsored Research - he was supposed to
catch the problem when reviewing the proposal ;=(

2) It has never happened here! :=)

3) If it DID happen here we would not accept the award until human subjects
requirements were met. These include informing NIH that (approval)? has
been issued).

The REAL problem arises if the problem goes undetected until work with
human subjects has begun. In that case one would suspend the work until the
IRB could act on it. I think we would inform the program officer of the
problem and send him the result of the IRB's deliberation. One would have
to decide if it were an instance of "continuing noncompliance" if I recall
the terminology correctly - if so one would be obligated to inform OPRR.

Charlie

>(This is not a quiz. We just want to know what you do at your institution.)
>
>Thanks,
>Tim
>

>

 ****************************************************
 * Charles E. Graham, PhD., DSc.
 *
 * xxxxxx@lsu.edu
 * (alias to xxxxxx@unix1.sncc.lsu.edu [faster])
 *
 * Director, Office of Sponsored Research/OSR
 * Interim Chair, Institutional Review Board
 * 117 David Boyd Hall, Louisiana State University
 * Baton Rouge, LA 70803
 *
 * 225-388-8692    FAX: 225-388-6792
 *** NOTE NEW AREA CODE!!!***
 * OSR Server: http://www.osr.lsu.edu/

 *****************************************************

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