Matt,

Stick to your guns!  An IRB that does not meet to review what exempters and
expediters have been doing or to discuss important current  issues in human
subject research is doing a disservice to the subjects involved.

At the College of Charleston (with about 8-10 IRB actions per month), we have
nine regularly scheduled meetings each year (we take May, Dec, and July
off--unless there is a protocol that requires convened review, in which case we
will call a special meeting).

The IRB has given me the authority to exempt protocols, but I always report on
them at the next IRB meeting (brief description of the purpose and methodology
and the exemption criterion met).  Members are free to ask questions about the
protocols, and they sometimes do.

We use (monthly) rotating two-member expediting teams.  They report on their
reviews in the same manner at the next IRB meeting.  This is in accordance with
45 CFR 46.110(c) which says "Each IRB which uses an expedited review procedures
shall adopt a method for keeping all members advised of research proposals
which have been approved under the procedure."  We implement this requirement
locally through the regular reporting at a meeting that is not more than two
months away.  At that time, if a member at that meeting raises questions about
the expedited review and the majority see a problem, we will immediately
suspend the expedited approval and resolve the issue to the board's
satisfaction with the investigator.  If your IRB doesn't meet regularly and
frequently, how long might a protocol that some members think has problems go
on before the problems are addressed?  An what is the impact of that on the
subjects?

(As an aside:  Recently, some of our members expressed the thought that perhaps
all members who are interested should have the opportunity to review the
protocol and provide input to the expediting team.  Since we have recently gone
to posting the protocols to a secure website for member review (thus saving
some trees and time), we now let all members know when the expedited protocols
are there for viewing.  The are told who the review team members are and are
given a certain amount of time to provide their comments directly to team
members.)

Our agendas also include reporting on protocol modifications, continuing
reviews, and receipt of final reports since the last meeting.  Sometimes we
also get requests from other institutions to recruit subjects from our campus.
The Board of Trustees has delegated the responsibility for review and approval
of these subject recruitment to the IRB, so those projects are also reported on
if they were exempted or expedited and voted on if they require convened
review.  We also have many other topics on the agenda--we seem to always be
improving our application forms, and we stay on top of the hot topics.
Sometimes we run out of time for these often spirited discussions.

The frequent face-to-face meetings are imperative to IRB member training.  The
discussions and exchange of ideas help them learn the regs and, maybe more
importantly, the local policies and procedures for implementation of those
regs.  If they don't have the advantage of this learning experience, I don't
see how we could ask them to be expediters.  Also, I question whether you are
in keeping with, if not the letter, then the spirit of the law if if you do not
have this kind of frequent face-to-face dialogue.

If you have members who don't want to meet on a regular basis, then perhaps
they should resign and make room for people with more interest and devotion.

Good luck!

BG
==================================================================
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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