[I'm not sure how many of us on RESADM-L deal with human/animal/biosafety
regulatory issues, so if this isn't your area, would you mind passing the
query on to your institution's person who does deal in ACUC and IRB issues.]

1)  A faculty member challenges the practice of reviewing human subjects
protocols as proposals, not later, as awards. 45 CFR 46.103(f) states that
proposal or applications must be reviewed, no funds can be expended until
appropriate approvals have been obtained, etc., but he cites "common
practice."  He maintains that the U of IL (U-C), U of Arkansas, U of MN, and U
of Vermont, to his knowledge, review at the award stage, not proposal stage.
He also cited Dept of Ed's inattention to IRB approvals, but Dept of Ed has
assured me they know they haven't been enforcing regulatory things like they
should, and they intend to pay more attention to that.

2) Same faculty member thinks that second or third-tier sub-contractors on
federal awards should not have to do their own IRB reviews if the prime has
its IRB approval.  We examine each case, and only rarely accept another IRB
approval in lieu of our own.

I would be interested in knowing (respond to the list or me directly -- I'll
tally and post to the list)
 institution name
 approximate number of human research (IRB) protocols reviewed annually
 professional FTEs (positions) devoted to administering IRB matters
(yes, I'm also looking at staffing loads)
 review as proposals or later (if later, when?)
 if later, could you send me your Assurance or procedures describing
how you handle it?
 how do you deal with IRB approvals for subcontracts you issue or when
you are a subcontractor yourself?

Thanks for your help.
................................................................
Celia S. Walker, Director
Office of Regulatory Compliance
608 University Services Center
Colorado State University
Ft. Collins, CO  80523
TEL:303/491-1563         FAX:303/491-1958
INTERNET:xxxxxx@vines.colostate.edu