We're having problems dealing with the logistics of obtaining IRB approval for projects which are potentially funded by sponsors who want IRB approval when the proposal submitted.  In other words:  no pending allowed.

Our institution has elected to follow federal guidelines pertaining to IRB issues whether a project is federally funded or not.  So the IRB should be reviewing a copy of the proposal along with the protocol submitted to the IRB.

However, the PI rarely has a final (and sometimes not even a draft) proposal ready at the time s/he submits for IRB approval, especially when full-board review is required (our IRB meets monthly).  They submit a draft proposal and review is performed using that.

They submit their proposal (minutes before the deadline), and we get a final copy of the proposal.

Now, what happens?  Do you trust that the PI hasn't made any changes between drafts and just file the copy with the IRB file?  Do you send the final draft to the IRB for their approval?  Do YOU (SRO) check one draft with the other and see if there are changes?

I recognize that the PI could prevent this from happening, but ...well, I won't go there.

I'd appreciate any info on how institutions deal with this.

Sally Eckert-Tilotta, Ph.D., Associate 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

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