* Respondent:  College of Charleston (volume approx. $2.5 million)

*Our research program is growing so the # of protocols per month has been
steadily rising.  At current rate, we would do 30-40 per year (many are
exempt).

*I am currently the only professional staff in the office so I do
compliance along with all pre-award and some post-award administration.
FTE devoted to IRB right now is very small (but needs to be increased
because of growing number of protocols).

*We review at proposal stage, but often research is unfunded so the
investigator is ready to begin when he/she submits the protocol for
review.  We would not intentionally wait until award for a funded project.
Seems that is contrary at least to what PHS wants, as they ask for
a review date on the face page of the application.

*If we were a subcontractor, we would do our own IRB review on our part of
the protocol.  If we subcontracted work to another entity, we would expect
the subcontractor's IRB to provide its own review for its portion of the
project, although I suspect our IRB would want to some degree to be
informed about subcontractor activities.  (We haven't had that situation
yet.)

Here's a question that just came up for our institution.  If a P.I.
at another institution just wants to use our students as research subjects,
what level of review should there be at our institution to ensure the
protection of "our own" and who should give the approval--the IRB chair or
some other administrator?  I have one of these on my desk right now and
our IRB is meeting on Monday, so any quick insights would be helpful.

Barbara H. Gray                                       xxxxxx@cofc.edu
Director of Sponsored Programs                        Phone:  (803) 953-5673
University of Charleston, SC                          FAX:    (803) 953-1434
66 George Street
Charleston, SC 29424-0001