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/
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