Research @non-Affiliated Facilities Rebecca B. Bacon 03 Aug 1995 07:06 EST

Having sites such as these, I feel I can answer your question.  We are
a private, non-profit, community based medical school.  Translates into
many community faculty....and the fact that we do not own a hospital.

Currently, we would not approved research for persons totally non-affiliated
with our institution.  It's a liability issue in addition to bad press in
the event poor research came out of the facility.

We have a MPA.  Additionally, we have a relationship with certain area
hospitals who have agreed that we will serve as their IRB.  Our course our
institution has "appropriate paperwork" in place to verify the arrangement.
OPRR gave us a template and it's called an IAA or Inter-Institutional
Agreement.  Top management at the hospital must sign inaddition to our
Associate Dean for Research, the IRB Chairman and OPRR.  It becomes an
amendment to your MPA.  Basically it states that they are aware of 45 CFR 46
and agree to abide.

Community faculty on the other hand sign a different document.  Since these
individuals perform research within the private practice setting, and
utilize our IRB, we want to make sure they're aware of the regs, their
responsibilities etc.  I should repeat, these individuals are affiliated
with the institution (some type of appointment) not just a private
physician "off the street".  Although I can't recall the exact title of
the agreement, it is something we got from OPRR to use inthis instance.
Copies of this document are not forwarded to OPRR.  It's signed by
the community faculty member and the institution and becomes part of our
official record.

To my knowledge, we do not check on their insurance nor ask for a copy.
These are reputable businesses in which we have fostered relationships
for many years.  Maybe a long, long time ago this transpired but I am not
aware.

We are always amending our MPA because local hospitals do not want to set up
their own IRB.  Obviously an administrative burden inaddition to $$$.  The
process is fairly easy.  If anyone wants further assistance, contact me and
I'll what I can do.  Otherwise call OPRR and they'll send you a diskette
with the templates.

Rebecca Bacon
DIrector, Office of Research
xxxxxx@picard.evms.edu