Re: IRB Problem Sally Eckert-Tilotta 05 Mar 2001 10:25 EST

I agree with Jon, and I would add another consideration.  Since the student had graduated, he or she was able to get through the dissertation process without documenting IRB approval.  You should extend  your education process to your graduate dean.

At our institution, it is one more checkoff box for graduate students.
Sometimes it catches students after they have done (or at least started) their study, but most of the time it catches students soon enough that we can get them in front of the IRB.

Sally Eckert-Tilotta, Ph.D., Interim Director
Office of Research & Program Development
University of North Dakota
PO Box 7134
Grand Forks, ND  58202
Tel:  701-777-2049
Fax:  701-777-2504
Email:  xxxxxx@mail.und.nodak.edu

>>> Jon Hart <xxxxxx@MAIL.ROCKEFELLER.EDU> 03/05/01 09:10AM >>>
Obviously, you can't retroactively approve a protocol.  This may have
repercussions to the student if he/she wishes to publish the dissertation.  As
far as damage control, only your IRB knows what kind of project it was and if
the subjects need to be informed, if that is even possible.

To avoid this happening again, I would have your IRB Chair, Dean of Research or
some other person with clout speak to the advisor and to the student's
dissertation committee -- the student should have been advised that the project
needed IRB review, and I believe it should have been the advisor's
responsibility.  Presumably, the advisor had been in on this from the beginning
and subsequently worked through several drafts of the document.  It seems
strange that it took this long to discover it needed review.  It looks like you
have some education issues to address.

At 04:37 PM 3/2/01 -0600, you wrote:

>
> I'd like some feedback on how you would handle the following situation:
>
> We received a request for a human subjects review for a dissertation. The IRB
> did not approve the protocol. When we tried to contact the student we found
> out from the advisor that the student graduated last semester and has left
> the campus. The request was submitted after the project had been completed.
>
> What responsibility does our IRB have?
>
> Sue
>
>
>
>
> ************************************************************
> Sue Keehn, Associate Director
> Office of Research and Sponsored Programs
> University of Arkansas at Little Rock
> (P) 501-569-8474
> (F) 501-371-7614

Jon Hart, Director, Sponsored Programs Administration
The Rockefeller University
1230 York Ave.-Box 82, NY, NY 10021-6399
tel:  (212) 327-8054; fax:  (212) 327-8400

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