Your Questions on Human Subjects Research, Answered

January 10, 2023

If you’re conducting research with human subjects, you might have questions about HHS regulations and NIH policies and how you can prepare proposals and inclusion plans. HHS and NIH experts address many of these questions, along with resources, guidance, and case studies in a 2-part webinar series focused on Human Subjects Research Policies, Clinical Trials, and Inclusion.

Human Subjects Research: Policies, Clinical Trials, & Inclusion on December 6-7

October 31, 2022

Are you working with human subjects in your research and wondering about how HHS regulations and NIH policies apply, how to prepare a research proposal, or how to develop inclusion plans? Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and more at the Human Subjects Research: Policies, Clinical Trials, & Inclusion event on December 6 and 7, 2022.

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.