Notice Number: NOT-OD-13-092
Release Date: July 26, 2013
National Institutes of Health (NIH)
The purpose of this Guide Notice is to announce that NIH has modified the forms used to provide information regarding planned enrollment and actual cumulative enrollment of individuals involved in clinical research studies on the basis of sex/gender, race, and ethnicity. Using a simplified layout, the modified forms will allow NIH to collect inclusion data in a structured format for competing and, eventually, non-competing applications.
The policies for the inclusion of women and minorities in clinical research and the required collection of participants' sex/gender, race, and ethnicity have not been modified.
Timeline: The modified reporting forms will be phased in starting with competing applications submitted electronically following the timeline of NIH’s use of the updated electronic application (Forms C). Paper competing applications using the PHS 398 (rev. 06/2012) will be required to use the modified forms.
Non-competing continuation applications will continue to use the current forms for inclusion data provided in the PHS 2590 or RPPR until further notice.
Additional Resources: Additional guidance regarding these changes as well as other topics related to the inclusion of women and minorities in clinical research can be found at: http://grants.nih.gov/grants/funding/women_min/women_min.htm.
Please direct all inquiries to:
Office of Extramural Research
National Institutes of Health
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health®
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