Implementation of NIH inclusion guidelines: survey of NIH study section members

Area of Science:

• Clinical research policy
• Health equity
• Research ethics

Background:

• National Institutes of Health (NIH) mandates inclusion of women, minorities, and children in clinical research.
• Institutional Review Boards (IRBs), NIH Scientific Review Groups (SRGs), and program staff oversee PI adherence to inclusion guidelines.

Purpose of the Study:

• To survey SRG members regarding their experiences and attitudes toward NIH inclusion guidelines.
• To identify respondent characteristics predicting attitudes towards the inclusion policy.

Main Methods:

• A survey was distributed to 746 SRG members.
• 425 SRG members responded to the survey.
• Univariate and bivariate statistical analyses were performed on the collected data.

Main Results:

• SRG members reported NIH inclusion guidelines increase attention to diversity in clinical research.
• Respondents view gender and race as crucial for assessing study sample diversity.
• SRG members believe current NIH guidelines adequately promote the inclusion of underrepresented groups.
• SRG members perceive Principal Investigators as generally compliant with inclusion guidelines.

Conclusions:

• Respondents' potential bias due to NIH funding is a limitation.
• Future research should examine IRB and NIH program officer perceptions of PI compliance.
• Further studies are needed to assess the broader societal impact of these inclusion policies.