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