Application and Reporting Process for Inclusion Policy

When applying for NIH clinical research grants, investigators should address plans for inclusion on the basis of sex and gender. Researchers must also report progress on inclusion for any ongoing research or for competing renewal applications and when closing out an award. NIH had implemented a new data system called the Human Subject System (HSS) for reporting sex and gender, race, and ethnicity information.

Guidance for Principal Investigators

Reporting Inclusion Enrollment Data