An Overview of NIH Policy
NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research
- 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."
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"