Re: Just In Time and IRB/IACUC
Walker,Celia 17 Sep 1998 11:24 EST
Victoria couldn't have said it better. Couple that with a) federal
regulations govern the regulatory approval process for all of our protocols
-- these can't be neglected or locally altered when a contracting entity of
one federal government wishes it. b) The review process takes time (both
for the committee to convene, as well as for the necessary changes to be
made), and even the minimum amount of time in which it would be feasible to
review a protocol may be longer than the JIT process would feasibly have
available. Example: early on, JIT would give the institutions something
like a week to get the final paperwork in after notification of intent to
award. Neither our IRB nor IACUC routinely could respond that quickly to
review a protocol; nor could researchers prepare a protocol to submit to
the committees that quickly. Our committees also anticipate significant
increased pressure to approve protocols "because the sponsor says it is ok
by virtue of the award."
Celia S. Walker
Director, Regulatory Compliance
Colorado State University
Ft. Collins, CO 80523-2046
Voice: 970-491-1563 FAX: 970-491-2293
xxxxxx@research.colostate.edu