Tom
 At UMDNJ we have instituted a human subjects protection program which is comprised of a university level staff of 3 with responsibilities for education/training, IRB administration and monitoring/compliance functions.

At our main campuses (3) we have a Director level position and staffing levels based on volume of 7,6, and 2 FTE's.

The Executive Director of the Program at the University level, as well as the Director's of the campus IRB's are voting members of each board.

These individuals have no responsibility what so ever for any grant related function, their sole responsibility is to assure that the human subjects protection program is functioning appropriately.

We have a seperate compliance office for the university and compliance offices at each major campus.  The compliance offices and each of the IRB's work closely together for any compliance issue, but the IRB functions do not report to them.  We communicate regularly and when the IRB conducts a for cause investigations, we keep the univeristy compliance office informed of what we have found.

I hope this helps.

Barbara

Barbara J. LoDico, CIP, B.S.
Executive Director of Human Subjects Protections
University of Medicine & Dentistry of New Jersey
Office of the Vice President for Research
65 Bergen Street, Suite 1414
Newark, NJ 07107-3001
Ph 973-972-1149
Fax 973-972-5320
Beeper: 800-745-6950
xxxxxx@umdnj.edu

>>> xxxxxx@BGNET.BGSU.EDU 10/24/01 02:41PM >>>
Hello all:

I have a questions which I believe has been posted and responded to on the
list before. However, I'm unable to search the archives at HRINET for some
reason or another...

What is the exact status of research compliance officers at your
institutions in relation to the IRB?

In particular,  I'm interested in:

Are they voting members of the IRB?
Are they ex-officio non-voting members?
Are they ex-officio voting members?
...any other combinations you can think of?

I suspect from what I recall seeing in the past, the actual
title/responsibilities may make a difference too--research compliance
officer, coordinator, administrator, etc; and how many full-time/part-time
positions make up the IRB administrative staff.

Here at BGSU we have 1 full-time Director of Compliance working with both
human subjects and animal care and use. This individual is not part of the
Sponsored Research Office.

Thanks in advance for any insight/advice.

Tom

Tom Kornacki
Associate Director
Office of Sponsored Programs and Research
Bowling Green State University
106 University Hall
Bowling Green, Ohio 43403
419-372-2481; 419-372-0304 (fax)
xxxxxx@bgnet.bgsu.edu
http://www.bgsu.edu/offices/spar

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