Beth

we did much the same thing and have had much the same situation from USDE.
I have no idea what is going on and when I tried to call and talk a bit I
had didficulty making connections!

Our project was reviewed and approved by the IRB and I, too, thought that
providing the information (yes, and date) was what we needed to do.

I think this regulation is in shakedown period and we are getting the fallout!

Mary

At 04:19 PM 11/6/98 -0600, Beth Seaton sent a message saying:
*         We recently submitted two applications to USDE using the new
*         424 forms which cover human subjects review as item #11
*         on the form.  I checked the "yes" box indicating that human
*         subjects were part of the research and I entered the
*         exemption number in the exemption box.
*
*         I received an e-mail message back from USDE stating that
*         because I entered a date in the date box, my response was
*         confusing (I see now that the date only should be used
*         if the project undergoes expedited or full review).  I had to
*         resubmit the entire form, eliminating the review date (even
*         though we do review exempt research) AND send a cover letter
*         "providing sufficient information to allow a determination
*         that the designated exemptions are appropriate."
*
*         I was really taken aback by this last request.  The original
*         application material stated to "provide sufficient
*         information in the APPLICATION (which, to me, meant the
*         proposal) to allow a determination that the designated
*         exemptions are appropriate."
*
*         Does anyone know why USDE wants to get in the business of
*         second guessing the local IRB?  Has anyone else had a similar
*         experience?
*
*         Beth Seaton
*         Director, Sponsored Projects
*         Western Illinois University
*         xxxxxx@ccmail.wiu.edu
*
*
Mary H. Watson, Ph.D.           xxxxxx@valdosta.edu
Director, Grants and Contracts  Phone: (912)333-7837
Valdosta State University       FAX:  (912)245-3853
Regional Continuing Education
Center, Room 215
900 N. Patterson Street
Valdosta, GA  31698