External Researchers Recruiting Subjects on Campus Barbara Gray 29 Oct 2001 15:09 EST
RESADM Colleagues, I'm looking for some guidance on how to handle requests from researchers outside our institution wanting to advertise for research subjects on our campus. Currently, we require these "external" researchers to request permission and submit for our review the original application sent to the jurisdictional IRB, any modification or continuation requests, copies of the IRB approvals, and a copy of the informed consent form. Our IRB does the same kind of review (exemption, expedited, or convened) that the jurisdictional IRB did. We, however, do not "approve" protocols or attempt to take jurisdiction over the research; we just give or deny permission to recruit study participants on our campus (through posting of flyers; announcements in classes or on the email system; advertisements in the student newspaper; or a booth at the student center). We are now realizing that we may have given the camel an inch too much. We initially adopted the practice in the name of collegiality because the state's major medical university is six blocks up the street and most requests were for non-invasive research. We are now beginning to see riskier protocols from the medical university plus a real proliferation of requests from researchers not associated with any university. Most troubling are the requests from private physicians and research centers in the community who are involved in multi-center clinical trials. Most of their studies involve non-FDA approved drugs or drugs that have not been approved by the FDA for the specific purpose proposed in the research. One study even proposed administering a relatively new medication approved for glaucoma treatment (and known to cause permanent pigmentation changes in some individuals) to healthy individuals (including our students) to determine the drug's safety!!! Most offer payments to volunteers which might be considered coercive to cash-strapped college students. Although these studies have been reviewed by for-profit IRBs in other states, there is no indication of that the values and character of our particular community--and especially our campus-- were considered. In some cases, the external reviewers don't have copies of the original IRB application or cannot get them for us because they contain proprietary information. (So far, we have denied permission when the investigator can't supply all the required documentation.) In addition to student safety and institutional liability concerns, we are being overwhelmed administratively. At our last IRB meeting, we had almost as many "external" request reviews on the agenda as our own studies. And we are concerned that our social/behavioral IRB really doesn't have the expertise to understand these clinical studies. Needless to say, we are rethinking our policy about allowing external researchers to recruit on our campus and have started generating options (which thus far include no external recruitment allowed at all; no non-university researchers allowed to recruit; no recruitment for drug or other invasive studies; requiring agreement that the researcher's institution/organization will indemnify and hold harmless our college in the event of injury and/or pay all legal costs if we are sued as a result of injury; or a combination of these options.) Here's the information I need, especially from non-medical institutions: 1. Do you allow external researchers to recruit subjects on your campus? 2. If you do, do you have specific policies and procedures that they must follow? 3. (and) Do you in any way restrict the types of studies for which they can recruit on your campus? 4. If you were in our shoes, what would you do? Thanks! Barbara -- ================================================================== Barbara H. Gray, Director Office of Research & Grants Administration College of Charleston 66 George Street Charleston, SC 29424 Campus Location: 407-G Bell Bldg. Office: 843.953.5673 Desk: 843.953.5885 Fax: 843.953.6577 e-mail: xxxxxx@cofc.edu URL: http://www.orga.cofc.edu/ ================================================================== ====================================================================== 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") ======================================================================