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Re: IRB question -Reply Marsha Green 15 Jan 1997 18:49 EST

 Thought the entire discussion group might like to see this answer from
 one of the participants on the IRB discussion group.

 Marsha Green
 UNLV

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Subject: Re: IRB question -Reply
Author:  xxxxxx@its.mcw.edu at SMTP-UNS
Date:    1/15/97 3:57 PM

Bob:
Our IRB recently agreed to review a private company's protocol under which
our faculty will be doing work, but the company's president is listed as
the PI on the grant.  We signed the company's SPA as the reviewing IRB
because our faculty were interested in collaborating with the company and
we thought it might be a good arrangement.  We are a state institution,
subject to various constitutional provisions, with sovereign immunity
except where waived.  I believe a contractual provision making clear that
the parties are independent contractors, but requiring the company to
comply with IRB requirements, and an indemnification provision should
resolve potential liability issues.  Of course, under the scenario I
describe, the university is obviously not engaging in "unrelated
(to government) business."

I can't share any war stories on the arrangement, as it hasn't even been
finalized yet.

Cynthia Stofberg
Assistant University Counsel
University of New Mexico
Scholes Hall, Rm. 152
Albuquerque, NM  87131-0056
Phone:  (505) 277-5035
FAX:    (505) 277-4154
Email:  xxxxxx@unm.edu