Designing Analyses by Sex or Gender, Race, and Ethnicity in NIH-defined Phase 3 Clinical Trials

March 10, 2022

NIH-defined phase 3 clinical trials are required to conduct and report analyses by sex or gender, race, and ethnicity for each primary outcome. These analyses, referred to as “valid analyses” are unbiased assessments that on average, yield the correct estimate of the difference in outcomes between two groups of participants.

I Am Conducting NIH-funded Research With Humans and Am Obtaining Identifiable Information About the Participants. Is My Research Covered by a Certificate of Confidentiality?

January 27, 2022

Yes, the research activity that you describe is deemed to be issued a Certificate of Confidentiality (CoC), i.e., your research is covered by a CoC. All NIH-funded research activities in which the investigator collects or uses “covered information” is deemed to be issued a Certificate of Confidentiality.

Should I Report the Sex or Gender of Study Participants to NIH?

December 16, 2021

NIH uses sex/gender to indicate that either sex or gender may be reported for inclusion enrollment purposes. The NIH encourages investigators to design their data collection instruments in a way that allows the participants to self-identify their sex or gender in a way that is meaningful within the study’s context. Participants always have the option not to identify with either sex/gender category. If both sex and gender identity are collected, investigators may choose which one to report based on the scientific question(s) that are the focus of the study.