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Received in OIRA 09/30/2024
0925-0770 202103-0925-002
DoD Usage of Inclusion Enrollment Report Form
The DOD was directed by the United States Senate Appropriations Subcommittee on Defense to develop a plan to ensure the appropriate representation of women and minorities in its extramural research in Congressional report 115-290, page 213, which accompanied H.R. 6157, the Department of Defense Appropriations Act of 2019. The report stated that the Congressionally Directed Medical Research Programs (CDMRP) shall work in coordination with the National Institutes of Health (NIH) to develop a plan that provides for: "(1) representation of women and minorities in each clinical trial, as well as the data on specific challenges researchers face in seeking to include women and minorities in their studies; (2) examination of biological variables, including the appropriate analysis of differential outcomes by sex, in clinical research; (3) practice of making clinical findings, subgroup analyses, and data publicly available, as appropriate and applicable; and (4) requirements (including, but not limited to, programmatic controls) and updated guidelines to ensure the appropriate representation of women in clinical research." The resulting CDMRP policy on the Inclusion of Women and Minorities as Subjects in Clinical Research requires submission of the Inclusion Enrollment Report (IER) form by researchers at the time of proposal submission and annually for funded investigators so that CDMRP may track anticipated and actual enrollment of participants by sex/gender, race, and ethnicity. The data will be used to ensure appropriate representation of women and minorities in clinical research and to monitor the efficacy and impact of the CDMRP policy.
Nicholas Schuff 757 817-7203 [email protected]

IC Title Status Responses Hours Dollars Document Type Form No. Form Name

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,100 0 0 2,100 0 0
Annual Time Burden (Hours) 2,100 0 0 2,100 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Miscellaneous Actions
This is a new Request for Common Form with a new associated burden.