NIH has issued NOT-OD-18-014, which amends NOT-OD-02-001. The purpose of this Notice is to inform the research community that NIH is amending its NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research to include a requirement that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analyses by sex/gender, race, and/or ethnicity are submitted to Clinicaltrials.gov. All other aspects of the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research remain unchanged.
