Inclusion Policy and Procedures

Inclusion Policy Documents

Document Title

Description

Link

Original Posting Date

Guide Notice:  Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research

This notice amends the NIH policy on the inclusion of women and minorities as subjects in clinical research.
This Notice informs the research community of a requirement that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analyses by sex/gender, race, and/or ethnicity are submitted to Clinicaltrials.gov.

Website

11/28/2017

Full Policy: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – Amended

This notice updates the NIH policy on the inclusion of women and minorities as subjects in clinical research.
It supersedes the 1994 Federal Register notice and the August 2000 notice in the NIH Guide to Grants and Contracts.

Website

10/09/2001

Guide Notice: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
(NOT-OD-02-001)

The October 2001 policy provides a consolidated, concise, and clear document of the updates and changes to the NIH policies.

Website

10/09/2001

Guidance on Reporting Race and Ethnicity: NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research
(NOT-OD-01-053)

This document provides additional guidance and instruction for using the revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity found in the PHS 398 (rev. 5/01) and PHS 2590 (rev.5/01) instructions and forms.

Website

08/08/2001

 


NIH-defined Phase III Clinical Trials: Special Considerations