Sally,

 We would pretty much do as you are, except that we put a condition of
approval that any deviation from the IRB application with the draft
submission and final submission must be reviewed and approved prior to study
initiation.

 We also check what goes out to make sure it is the same study- not that we
don't trust anyone.  Once we confirm that it is the same, we update the
approval to include the grant #,  etc. and remove the condition of approval
that was placed on the first notice.

Barbara
Barbara J. LoDico, IRB Administrator
Coordinator, Research and Sponsored Programs
New Jersey Medical School, MSB C-690
185 so. Orange Ave., Newark, NJ 07103

xxxxxx@umdnj.edu
phone (973) 972-3608
fax      (973) 972-3585

-----Original Message-----
From:   Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of
Sally Eckert-Tilotta
Sent:   Friday, January 28, 2000 2:19 PM
To:     xxxxxx@HRINET.ORG
Subject:        IRB and Proposal logistics

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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