UCONN Health Center has done this in the past, but only for private
physicians who happen to hold a faculty appointment in the School of
Medicine, where the research will be conducted in their private offices.  We
have insisted on the right to audit their records, and have them comply with
IRB R&Rs, and indemnify us.

Len Paplauskas
Asst. VP for Research
UCONN HC
 ----------
From: Research Administration Discuss
To: Multiple recipients of list RES
Subject: Re[2]: IRB question -Reply
Date: Wednesday, January 15, 1997 2:42PM

 We haven't got that far in the process yet and I'm sure all those
 questions will come up...we haven't received the protocol as yet so
 will review the situation and be ready for it!  The question just
 barely came up a couple weeks ago.  Judging from some of the responses
 that have come back on this subject from the IRB discussion group,
 it's a lot more complicated underneath than what it first appears.

 Marsha Green
 UNLV
 xxxxxx@

______________________________ Reply Separator
_________________________________
Subject: Re: IRB question -Reply
Author:  Research Administration Discussion Group
<xxxxxx@health.state.ny.us> at SMTP-UNS
Date:    1/15/97 2:39 PM

Interesting response, but can you tell me whether or not your institution
has considered the "responsibility" aspect of this action?  Will UNLV be
responsible for what happens or be forced to be involved at this other
institution/company should a legal circumstances arise?

Mary Ann Jurgus
Loyola University at the Medical Center
Maywood, Il. 60153
fax: 708-216-5881
Phone: 708-216-4288
e-mail: xxxxxx@wpo.it.luc.edu

>>> Research Administration Discussion Group
<xxxxxx@health.state.ny.us> 1/14/97  6:20 pm >>>
 Gayle,

 I'm going to pass this request on to the IRB Discussion Group
 (xxxxxx@its.mcw.edu) so you may get some answers on this
subject
 there.  We just received a similar request to do a protocol review by
 someone outside UNLV but haven't received the paperwork from
them yet.
 This person was also advised to "link up" with a nearby university.
 As far as I know, our IRB has never reviewed an "outside" protocol.
 It's new ground for us too.  We're going to treat it like all other
 UNLV protocols reviewed under OPRR regulations.

 Marsha Green
 Sponsored Programs Coordinator
 IRB Secretary
 UNLV
 xxxxxx@ccmail.nevada.edu

______________________________ Reply Separator
_________________________________
Subject: IRB question
Author:  Research Administration Discussion Group
<xxxxxx@health.state.ny.us> at SMTP-UNS
Date:    1/14/97 2:39 PM

The Univ. of Maine's Protection of Human Subjects
Board was contacted by a non-profit organization
in the State of Maine with a request for assistance.
This non-profit organization recently received a
grant from the CDC, but the grant evidently has a
research component involving the use of human
subjects.  At this point, the only information I
know is that the topic is "partner violence," and
includes the use of focus groups and questionnaires.

This organization does not have an IRB, and OPRR
suggested that they link up with a local university
to get a review and approval by a human subject's
board.

I called OPRR and asked what the University's
responsibilities/limitations were when conducting
a review for someone outside the University.  I
was told we would assume the same responsibilities
and liabilities as if the project were being
conducted by a member of our university.

Does anyone have any advice?  Has anyone undertaken such
a review?  If so, did you enter into a formal agreement
about issues of responsibility and liability? What
monitoring of the project did you do?

Thanks for any help; I'd love to talk with anyone with
experience in this area.

Gayle Anderson
Assistant to the IRB
University of Maine
(xxxxxx@maine.maine.edu)
207/581-1498