Modifications to NIH’s Planned and Cumulative Inclusion Enrollment Forms

Notice Number: NOT-OD-13-092

Key Dates
Release Date: July 26, 2013

Related Announcements
NOT-OD-13-091

Issued by
National Institutes of Health (NIH)

Purpose

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.

Key changes:

  1. The Planned Enrollment Report will now include the "More than one race" category.  The "More than one race" category will be used for reporting the planned number of individuals who you believe will identify with more than one racial category.   Currently, this category has only been available when reporting actual cumulative enrollment. 
  2. The layout of both the Planned Enrollment Report and the Cumulative Inclusion Enrollment Report has been modified to reduce confusion about racial and ethnic information being distinct concepts.
  3. The modified Planned Enrollment Report and Cumulative Inclusion Enrollment Report are structured data forms.  As such, they will replace the need to attach enrollment tables as pdf files on electronically submitted competing grant applications.

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.

Inquiries

Please direct all inquiries to:

Grants Information
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-0714
Email: GrantsInfo@nih.gov
Web: http://grants.nih.gov/grants/oer.htm


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