Re: research compliance officers & IRB membership status Barbara Lodico 24 Oct 2001 16:37 EST
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 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================