I thought the following paragraph from this article was interesting:

"In response to mounting concerns about the adequacy of protection of research participants, at a regulatory level, increasing attention is being focused on safety and confidentiality of human subjects participating in research protocols.  Beginning with applications submitted for the January 2001 council round, institutional review board (IRB) approval is no longer required prior to NIH peer review; previous NIH policy had been that IRB approval was required at the time of submission. Compared with the 19.1% of the applications with human subject concerns in the May and October 2002 councils, in the 3 councils preceding January 2001, human subject concerns were noted in 15.5% of the 17249 pre–rule change applications (P<.001). These observations suggest that human subject concerns are not being adequately addressed in the preparation of clinical grant applications, and this problem may have been augmented by rescinding the requirement for IRB approval prior to NIH peer review. In the current analysis, although applications with human subject concerns may have received less favorable priority scores for other reasons, they did not fare as well as clinical applications without these concerns. Reviewers are instructed to take such concerns into account when assigning a priority score. Consequently, human subject concerns raised at the time of review may have contributed to, although do not totally explain, the less favorable review outcomes for clinical applications."
p.842

At 11:30 AM 2/20/2004, you wrote:
>I wanted to alert you to this article of interest.
>JAMA Table of Contents for February 18,  2004; Vol. 291, No. 7
>NIH Peer Review of Grant Applications for Clinical Research
>     Theodore A. Kotchen, Teresa Lindquist, Karl Malik, and Ellie Ehrenfeld
>     JAMA 2004;291 836-843
>     http://jama.ama-assn.org/cgi/content/abstract/291/7/836?etoc
>
>scott
>
>Scott Davis, CRA
>Sponsored Programs Administrator
>
>Office of Research Administration
>University of Oklahoma Health Sciences Center
>Ph: 405.271.2090   Fax: 405.271.8651
>E-mail: xxxxxx@ouhsc.edu
>
>
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