Rebecca Clark writes:

>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.

Good point, almost forgot about that one!  When we first dealt w/ this issue
we were planning to have the PIs provide a written summary of any recent
literature as part of the annual review process, and relate recent info to the
the study.  Now I have to regroup w/ my IRB chair and ExSec and decide
where we're going on that front.  Thnx for reminding me.

Len