Re: Re[2]: IRB question -Reply Paplauskas,Leonard 16 Jan 1997 07:55 EST
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