Terry, it's written right in our assurance  (OPRR version) that exemptions
will be reviewed in this office to determine if in fact they qualify for
that status.
CJ

xxxxxx@ASU.edu
Coordinator of Regulatory Affairs
Box 878206
Arizona State University
Tempe, AZ  85287-8206
Phone: (602) 965-6788
FAX:   (602) 965-7772

 ----------
From: RESADM-L
To: Carol Jablonski
Subject: IRB and UG class projects
Date: Thursday, October 05, 1995 9:34AM

 There are 2 unrelated points I would like to address.  The first
relates to types of review.  Even though I suspect most understand that
"exempt" is NOT a type of review by the IRB, I believe it is often confused
in that way.  "Exempt" means "exempt from Federal regulations concerning
use of humans in research"; therefore, the IRB has no direct role in
evaluating those projects.  The real issue is what process or who makes the
final determination of whether or not the proposed project is exempt.  This
is a decision that should not be left solely to the PI.  The recommendation
of the PI in this regard should be reviewed by an independent person(s) for
final determination.  If this decision becomes a function of the IRB as a
whole, then I propose that the system is too beaurocratic and excessive.
However, I do believe it is a good idea that records are maintained to
verify that the proposed project was disclosed and determined to be exempt
from regulations.

 Second, our IRB does review student projects.  Experience suggested
that students wanted to do something "significant" which often was equated
with "sensitive".  Therefore surveys or other student projects regula
the review process, students (and more importantly faculty) learned what is
appropriate and guided students accordingly, thus reducing issues the IRB
seems now to need to deal with while still maintaining the class projects
as good educational experiences.

Terry A. May, Ph.D.                       Voice:    520-523-6788
 Director of Research Administration     FAX:      520-523-1075
 Office of Grant & Contract Services     INTERNET: xxxxxx@nauvax.ucc.nau.edu
 100 Babbitt Admin. Ctr., Box 4130
 Northern Arizona University
  Flagstaff, AZ  86011-4130