Release Date: October 2, 2014
National Institutes of Health (NIH))
The purpose of this NIH Guide Notice is to notify NIH applicants and grantees about using the new Inclusion Management System (IMS) for reporting sex/gender, race, and ethnicity information as required by the NIH Policy on the Inclusion of Women and Minorities in Clinical Research. The existing system was retired for grantee use in non-competing progress reports in July 2014. The new Inclusion Management System will be released October 17, 2014, and will take advantage of the structured inclusion data being collected on competing applications to pre-populate inclusion data records and allow grantees to directly manage their inclusion data in the system throughout the awarded project period.
Key Changes for October 17, 2014, and beyond:
(1) Inclusion enrollment report forms received with competing application submissions will automatically populate the IMS.
(2) NIH grantees completing their RPPR (Research Progress Performance Report) will be prompted in Item G.4.b to access and update inclusion records directly in IMS.
(3) Grantees will be able to access their inclusion enrollment data through the IMS, found through the eRA Commons Status page, and can review or update their inclusion data as needed.
(4) NIH will migrate ongoing enrollment information from the previous data system to the IMS. Because the report format has been adjusted, grantees will be prompted to update Cumulative Inclusion Enrollment data in the IMS format at the time of the RPPR. They are encouraged to update Planned Enrollment data as well.
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:
Meredith Temple-O'Connor, Ph.D.
NIH Inclusion Policy Officer
Office of Extramural Research
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