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IRB matter Celia Walker 24 Mar 1995 14:27 EST

Could someone(s) with vast amounts of human research and OPRR experience
addresss the matter of Single Project Assurances and how institutions with
Multiple Project Assurances should use them?  Specifically, if one of our
projects (MPA approved) involves another organization lacking an MPA, where do
SPAs come into play?  How does our institution monitor the status of an SPA?
How long does it take to have an SPA approved by OPRR?  For what projects (HHS
funding?  Common Rule Agencies funding? type of organization?  "sensitivity"
of project?) are SPAs required.  I am familiar with the 45 CFR 46 section
typically cited for SPA matters, but would like some interpretation and
practical advice about when and how SPAs should be used.

I understand from OPRR that this a topic of considerable increased and recent
attention on their part.  General helpful information can be posted to the
list;  information on specific projects and how you dealt with them might be
better sent via e-mail directly to me "off-line."  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