Transition Plans for Reporting Sex/Gender, Race, and Ethnicity Information in Non-Competing Type 5 Progress Reports

Notice Number: NOT-OD-14-085

Key Dates
Release Date: April 30, 2014

Related Announcements
NOT-OD-15-078
NOT-OD-15-005
NOT-OD-13-092
NOT-OD-14-086
NOT-OD-14-064

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this NIH Guide Notice is to notify grantees of changes related to reporting sex/gender, race, and ethnicity information when conducting NIH-defined clinical research. On October 16, 2014, the NIH will transition to a new module within the eRA Commons (known as the Inclusion Management System, or IMS) used for reporting sex/gender, race, and ethnicity information as required by the NIH Policy on the Inclusion of Women and Minorities in Clinical Research (see NOT-OD-14-086). The previous system (known as the Population Tracking System) will be retired this summer.

The NIH is also transitioning to an updated format for reporting sex/gender, race, and ethnicity information. As noted in NOT-OD-13-092, the NIH has modified the format used to report sex/gender, race, and ethnicity information of individuals enrolled in clinical research studies. Applicants submitting competing applications have been using the updated formats starting with receipt dates on or after September 25, 2013.

It is now time to transition to the modified format for Type 5 non-competing progress report submissions using the PHS 2590 or the RPPR (Research Performance Progress Report) as we prepare to deploy the Inclusion Management System.

Transition timeline for new inclusion enrollment reporting format

Awards with start dates BEFORE October 1, 2014 must use the previous inclusion enrollment reporting format.

  • When submitting a progress report before July 18, continue to use the link in the RPPR that brings you to the current Pop Tacking system.
  • When submitting a progress report after July 18, the link will take you to a PDF of the previous inclusion report format that you will attach to section G.4.b of the RPPR.
  • If using the PHS2590, use the PDF version of the previous inclusion enrollment reporting format.

Awards with start dates AFTER October 1, 2014 must use the updated inclusion enrollment format.

  • When submitting a progress report between July 18, 2014 and October 16, 2014 grantees will be directed to upload a PDF of the updated inclusion enrollment reporting format in section G.4.b of the RPPR rather than access a link to a structured data form.
  • Once the Inclusion Management System is available on October 17, 2014, grantees submitting non-competing Type 5 progress reports using the RPPR will have access to a link to the Inclusion Management System in Section G.4.b of the RPPR that will allow reporting of the inclusion enrollment data using the updated reporting format.
  • If using the PHS2590, use the PDF version of the updated inclusion enrollment reporting format.

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: https://grants.nih.gov/grants/funding/women_min/women_min.htm.

Inquiries

Please direct all inquiries to:

Meredith Temple-O'Connor, Ph.D.
NIH Inclusion Policy Officer
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-7124
Email: inclusion@od.nih.gov