Phil,
When this notice came out, we wondered whether our current method was
in compliance.  Currently, I am the Chairman's designee.  At the annual
review of all active protocols, I pull each file and review it in light of
all changes, adverse events, internal policy changes etc..  The consent
must be updated to reflect any policy changes before it is approved for
another year.  Once the file has been reviewed, necessary revisions/updates
are noted in the file.  This information is forwarded tot he Chairman for
concurrence.  Once the Chairman signs for the revisions (or the status quo)
a letter is sent to the investigator outlining  the review findings.  Approval
is not given until all items are addressed.  This "system" was devised about
four years ago.  We have had a string of Chairmen whose amin responsibilities
lie in the clinical arena.  Out of necessity, I stepped in and initiated
a more thorough process.  It seemed logical to me.  Our IRB is pretty active.
We review about 23 new protocols per month and have over 700 active protocols.
This task is quite a job for me but has proven benefical.  It's just another
hat I wear in the life of a research administrator....

Becca Bacon
Eastern Virginia Medical School
xxxxxx@picard.evms.edu

P.S.  I'll go into this further if you have more questions.