An Overview of NIH Policy

NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research

Policy Summary:

• Women and Minority groups must be included in NIH-funded clinical research studies
• Women and Minority groups must be included in Phase III clinical trials & the trial must be designed to document valid analysis
• The NIH supports appropriate outreach programs to recruit and retain women and minority groups in clinical trials

Pre Phase III Considerations:

"Did prior studies indicate significant differences between subgroups?
- Have a plan to conduct valid analyses to distinguish the significant differences between genders and/or racial/ethnic subgroups."

"Did prior studies not support significant differences between subgroups?
- Representation as subject selection standard is not required; however, inclusion and analyses is encouraged."

"Finally, if the prior studies neither supported nor negated significant differences in intervention effects between subgroups, the researcher should have a plan on how to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups."

Policy definitions:

Human Subjects: "A living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or if identifiable private information is being used"

Valid Analysis: "A valid analysis is an unbiased assessment. In order to do a valid analysis the researcher must have a diverse participation population"

Significant Difference: "Significant difference is of clinical or public health importance, based on substantial scientific data"

Resources:

1. https://grants1.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

2. https://grants.nih.gov/grants/funding/women_min/women_min.htm