Human Subjects Research at Non-university Facilities Christina K. HANSEN 02 Aug 1995 14:56 EST

 What parameters does your institution place on the conduct of human
 subjects research at non-owned facilities?

 I realize that the type of research may affect the decision.  For
 example, survey research in shopping malls or private homes may be
 acceptable, while surgical procedures at non-affiliated community
 hospitals would receive more scrutiny.

 Specifically, I am interested in how your institution would handle a
 pharmaceutical company-sponsored drug trial involving Alzheimers
 patients where the research is to be done in private hospitals/care
 facilities and also by private physicians in their offices.  None of
 these sites has either a Multiple or a Single Project Assurance.

 Would your institution's IRB assume review responsibility for these
 other sites?  Would your institution require the sites to assume
 liability for their actions related to the research protocol, and do
 you routinely verify that the institutions have the insurance to do
 so?  What type(s) of agreements would your institution require in
 place of/addition to any subcontract agreement?

 Christina Hansen, Director
 Office of Research Administration
 University of California, Irvine
     xxxxxx@UCI.EDU