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/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/gender, race, and ethnicity information.

Guidance for Principal Investigators

Reporting Inclusion Enrollment Data