I would add that the biggest problem I have seen with individual
investigators' research is lack of staff to provide adequate recordkeeping.
You may want to look into what kind of support they have.

Jon Hart, M.P.A., C.I.P.
Senior Director
Office of Sponsored Programs Administration
Human Subjects Protections Program
The Rockefeller University
email:  xxxxxx@mail.rockefeller.edu
Tel:  (212) 327-8054; fax:  (212) 327-8400

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of
Robert Bienkowski
Sent: Tuesday, April 11, 2006 1:48 PM
To: xxxxxx@HRINET.ORG
Subject: Re: [RESADM-L] IRB approvals for adjunct faculty

If the voluntary faculty members are conducting industry-sponsored trials
(eg, drug or device studies) then the IRB can bill the sponsor (and they
will pay!). If the docs are conducting original research, then that's great
and I would suggest you not charge them because it increases the academic
standing of your adjunct faculty.

Either way, the IRB will have to actually check out the doctors' offices to
make sure that they adequate facilities for resuscitation, storing research
data, respecting participants' privacy, etc. Also, their staffs will have to
have appropriate training in conduct of research, applicable regs, and human
research protections.

Bob

--
Robert S Bienkowski, PhD
xxxxxx@att.net

 -------------- Original message ----------------------
From: "Dr. Raymond Papka" <xxxxxx@NEOUCOM.EDU>
> 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
>
> http://www.neoucom.edu/audience/about/departments/neurobiology
>
>
>
>
>
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>
>
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