Re: compliance position James R. Brett 31 Jul 2002 11:20 EST
I think Ann Womack has nailed it. Separation of IRB/IACUC from SRO is very much dependent on the level of effort at the institution. Clearly, the person who is interested to do the job of supporting the bids for external funding with blinders to the involvement of human or animal subjects is inherently compromised vis-a-vis the rigorous examination of research protocols. While this may not manifest itself as deliberate promotion in disregard of protection issues, it may easily happen that issues are overlooked or that the pressure of time may become a factor weighing in favor of SRO activities and against IRB/IACUC activities. But, I think this is probably germane to the research intensive and research extensive domains and highly dependent on the number and magnitude of potential conflicts of commitment. For institutions like mine (and Ann's) where the vast majority of human and animal subjects research is funded from within the institution, where very few funded projects are encountered in IRB/IACUC, the necessity for isolation of the IRB/IACUC functions from the SRO diminishes rapidly. The loss of coordination and authority is usually greater than the loss of real or apparent independence of judgment. Moreover, the SRO is not in most institutions just a hustler of grants and contracts. The personnel in these offices have many functions which put them into the position of reading, interpreting, and applying a formidable array of regulations and guidelines. These "regulatory" functions are, perhaps, not of the same "gravity" as issues encountered by IRB/IACUC, but they are serious issues with the potential for making or breaking careers and institutional reputations. I would suggest, therefore, that SRO personnel be given presumptive credit for integrity across the range of these duties. In fact, the most egregious cases exposed to date, the negative and distorting influences have emanated not from individuals within SRO or within IRB/IACUC, but from others who have much stronger influence on the institutional ethos. Jim Anne Womack wrote: > Larry Wexler makes an excellent point in saying the position > should have some distance between it and the SRO (although it's > not always possible---it isn't here, for instance). > For instance I was very surprised a few years ago to learn that > most of the animal- and human-subject research projects > performed on our campus are never connected to proposals to > funding agencies at all. I learned that our office only sees a > fraction of that activity by way of proposals. > > ====================================================================== > 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") > ====================================================================== -- James R. Brett, Ph.D., Director, Office of University Research California State University, Long Beach 562-985-5314 562-985-8665 fax http://www.csulb.edu/~research/ ====================================================================== 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") ======================================================================