Re: Human Subjects Education II Herbert B. Chermside 18 Sep 2000 10:59 EST

On September 14, NIH posted the following information on its "current news
flashes".
http://grants.nih.gov/grants/news.htm
It defines explicitly how universities are to respond to the earlier
requirement for notifying NIH of the education received by each PI and key
person on ethical conduct of human research.

"Current News Flash(es):

 Clarification on Required Education in the Protection of
Human Research
 Participants

 September 14, 2000:
 This is to clarify the June 5, 2000 NIH Guide announcement
on Required Education in the Protection of
 Human Research Participants. The NIH has received a large
number of inquires regarding the recent
 announcement requiring investigators to document their
education in the protection of human subjects. This
 notice is intended to clarify two issues: (1) what
constitutes documentation and (2) when documentation
 should be submitted to the NIH.

 With respect to the type of documentation, the NIH requires
a letter that includes the names of the key
 personnel who are responsible for the design and conduct of
the study; the title of the education program
 completed by each named personnel plus a one sentence
description of the program. This letter must be
 signed by the principal investigator and co-signed by an
institution official.

 The timing of submission of documentation is in keeping with
just-in-time procedures. Thus, the NIH will
 request this letter documenting education before an award is
issued. "

This explicit direction obviates the survey I was running on ways
institutions will handle this reporting requirement.  It also eliminates
any possibility that institutions can come up with a central solution  that
obviates each PI creating a letter.  Why does everyone assume that the PI
can do just one more thing?  Don't they already have enough to do!

Chuck

Herbert B. Chermside, CRA
Director, Sponsored Programs Administration
Virginia Commonwealth University
PO BOX 980568
Richmond, VA  23298-0568
Express Delivery Only:
 Sanger Hall, Rm. 1-073
 11th & Marshall Streets
 Richmond, VA  23219
Voice:  804-828-6772
Fax     804-828-2521
OFFICE e-mail   xxxxxx@VCU.EDU
Personal e-mail xxxxxx@vcu.edu
http://views.vcu.edu/ospa/

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