Reminder About Inclusion of Participants in Clinical Research

NIH continues to follow all laws (e.g., 42 USC 289a-2) and existing NIH policies that help NIH ensure clinical research includes the appropriate participant demographics to make certain the scientific question under study is addressed in a robust and generalizable manner. Applicants proposing clinical research studies must continue to provide plans including the relevant groups in Section 2 of the PHS Human Subjects and Clinical Trials Information Form.

When developing inclusion plans, applicants should follow the appropriate form instructions found on the How to Apply – Application Guide page.

For more information about NIH inclusion policies, check out the Inclusion Policies for Human Subjects page.

Questions? [email protected]
Categories: Top Stories

Related News

What Study Information Should Be Included on a ClinicalTrials.gov Entry?

A ClinicalTrials.gov study record is intended to summarize key information from a study’s protocol and the study’s findings. The study sponsor or investigator is responsible for ensuring that their studies follow all applicable laws and regulations and for submitting complete, accurate, and up-to-date information about their study.

You Ask, We Answer

FY25 Enrollment Data from NIH-Supported Clinical Research Now Available

As part of NIH’s continued efforts to increase the transparency of the NIH research portfolio, data on the sex, race, ethnicity, and age of participants in fiscal year (FY) 2025 NIH-supported clinical research are now available. 

New Resources

For technical issues E-mail OER Webmaster