Re: IRB Issue Rebecca Clark 21 Mar 1995 17:44 EST

In response to Barbara and Len, I am also dealing with the issue of
annual/continuation review of approved research and the OPRR Notice.  I agree
with Len's solution and don't really see any other way of handling the
review.  Though I may distribute the burden of reviews to subcommittee's of
one, who will then report back to the full Board.

Question:    I run IRB's for three separate hospitals, one of which has a
multiple project assurance with NIH.  The other 2 hospitals run FDA research
and don't have any NIH funding or research.  Here's the question:  the OPRR
Guidebook defines OPRR as the agency responsible for implementing DHHS
regulations 45 CFR 46, the NIH regs.  In light of the OPRR Notice, are you
applying this to FDA research as well as NIH research?  And what is your take
on the statement that the IRB should review a summary of any recent
literature, findings or other relevent information?  This looks like a strong
move into reviewing scientific merit and validity on a yearly basis.  I'd
appreciate your comments.