Raymond,
If these folks are volunteering to teach and you depend heavily on them
for the success of the academic program, I don't think I'd risk creating
ill will and possibly losing those services, which would cost a lot to
replace, for the very nominal fee that you could collect for an IRB
review. I think, if your IRB does the reviews for them, there is some
liability, but in the event of a problem, the lawyers would have to
prove your IRB's or institution's negligence in the review and
oversight. If your IRB determines that it is willing to provide the
review and oversight for these "outside" studies, you could use a
modified version of OHRP's "Unaffiliated Investigator Agreement" with
the physicians. To reduce your liabililty exposure, you might also want
to set up some additional professional development offerings for them
and perhaps institute a robust audit program so that you are assured
that the studies are occurring in those private offices in the manner in
which they were approved. One of the reasons an IRB must have a
community member is to ensure that local values and concerns are
considered during the reviews. I would think that your local IRB could
do that much better than a commercial IRB in some other city or state.
If your institution and IRB don't want to take on the responsibility for
these "private" studies, then be sure that these physicians aren't using
recruiting materials that might suggest that their studies are in anyway
sponsored or approved by your institution. (This would be very difficult
to monitor, so you may want to cover it in the teaching agreement or
complimentary faculty appointment.) Finally, perhaps there is a way to
turn this into an opportunity for some of your med students to work with
these physicians and learn a little about research and research ethics.
Good luck!
Barbara

Dr. Raymond Papka wrote:

> Colleagues: Our institution is a community-based medical school that
> utilizes a large number of voluntary physicians to teach medical
> students. Many of these physicians are given a “complimentary” faculty
> appointment (e.g. clinical assistant professor of urology). Lately, we
> have had a number of requests for our institutional IRB to review
> proposed human studies for these phyicians to do studies in their
> private practice. I think we should charge a fee for this as it turns
> out to be a significant amount of work. Also, I am presuming that
> having done this, the institution assumes some liability. I would
> appreciate learning from others 1) if they encounter similar requests,
> 2) how do you handle these requests, and 3) am I correct in assuming
> the institution has some liability for the study subjects if some goes
> wrong? Thanks in advance for your input. REP
>
> Raymond E. Papka, Ph.D.
>
> Professor and Chairman, Department of Neurobiology
>
> Interim Associate Dean for Research
>
> Northeastern Ohio Universities College of Medicine (NEOUCOM)
>
> 4209 State Rt. 44, PO Box 95
>
> Rootstown, OH 44272
>
> phone: 330-325-6636
>
> fax: 330-325-5916
>
> email: xxxxxx@neoucom.edu <mailto:xxxxxx@neoucom.edu>
>
> http://www.neoucom.edu/audience/about/departments/neurobiology
>
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--
Barbara H. Gray
Director of Sponsored Research
Desert Research Institute
2215 Raggio Parkway
Reno, Nevada  89512-1095
Telephone:	775-673-7381
Fax:		775-673-7459
E-mail:	xxxxxx@dri.edu
www.dri.edu

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