Franci,
I cannot say enough good things about the NIH publication.  At EVMS, we
utilize federal regs for ALL protocols.  Our IRB likes to be very thorough
in its review of protocols and enjoys having federal regs to back up their
decisions.  The new version of the Guidebook is alot more comprehensive
than the last version....a bit more clear about grey areas.  As Administrator
for our IRB I have found it valuable.  Our IRB chooses to err on being strict
in their review vs. lenient.

Rebecca Bacon
Eastern Virginia Medical School
xxxxxx@PICARD.EVMS.EDU