But the slope is a slippery one. The IRB is a peer reivew body and most of them are employed by the same organization as the PI. Isn't such a situation rich with opportunities for conflict of intrest, even if we place the IRB function under an institutional exec who's neutral (or even suspicious of) research involving human subjects? The guidelines were set up to give local control and local responsibility for protection of human subjects, and that requires a degree of trust in the integrity and competence of local people. We could avoid conflicts of interest by means of a system of central IRBs unconnected to our institutions--but many of us are troubled by the idea that an IRB at a remote site can judge whether subjects somewhere else are adequately protected. -----Original Message----- From: Hastings, Kari L [mailto:xxxxxx@PARTNERS.ORG] Sent: Friday, January 28, 2000 2:40 PM To: xxxxxx@HRINET.ORG Subject: Re: IRB and Clinical Trials You are perfectly right Chuck. For those of you who subscribe to the Washington FAX, this issue was addressed today with Mark Yessian from the HHS Office of the IG coming down on the side of separation in order to avoid even the appearance of conflict of interest. He commented that this was a point of contention in the Duke case. Unfortunately small institutions have a difficult time doing just that. Kari Hastings ---------- From: Herbert B. Chermside [SMTP:xxxxxx@VCU.EDU] Sent: Friday, January 28, 2000 2:06 PM To: xxxxxx@HRINET.ORG Subject: Re: IRB and Clinical Trials OPRR seriously questions that an institutional officer whose job can be seen to be an attempt to increase the amount of research the institution does, especially human research, can avoid a conflict with the responsibility of protecting all of the interests of human subjects. In more than one case OPRR has formally or informally required that these responsibilities be separated. Some might question that this is a real conflict, and others might question the assumption that a professional cannot manage both responsibilities without conflict, but the wise view is probably that the mere appearance of a possible conflict (particularly when that appearance is in a regulator's eye), is sufficient to cause the institution to give strong consideration to institutionalizing a separation of these responsibilities. The concept of Conflicts of Interests is not limited to individuals; institutions may have conflicts, or may create them by their internal organization. Chuck At 09:48 AM 1/25/00 -0600, you wrote: >Good morning! > >My question is related to the conduct and business of clinical trials and the management of IRB's. I had an investigator ask an intriguing question and want to hear from you all. This investigator has made reference to conflict of interest and ethics. I would appreciate any and all responses whether to this listserv or directly to me. > >Question: In a centralized research administration office, do you think there is a conflict of interest or any ethical problems if the person responsible for the management of the IRB also be involved in the pursuit of clinical trial business? > >Thank you. > > >Thane J. Peterson >Director of Research >Iowa Health System >1215 Pleasant, Suite 305 >Des Moines, Iowa 50309 > >515-241-5725 >515-241-4185 FAX > >WWW.IHSDESMOINES.ORG > > >====================================================================== > 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") >====================================================================== > Herbert B. Chermside, CRA Director, Sponsored Programs Administration Virginia Commonwealth University PO BOX 980568 Richmond, VA 23298-0568 Express Delivery Only: Sanger Hall, Rm. 1-073 11th & Marshall Streets Richmond, VA 23219 Voice: 804-828-6772 Fax 804-828-2521 OFFICE e-mail xxxxxx@VCU.EDU Personal e-mail xxxxxx@vcu.edu http://views.vcu.edu/ospa/ ====================================================================== 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") ====================================================================== ====================================================================== 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") ======================================================================
