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Equitable selection of participants (representation of minorities and women in research)

Robert Hood

08/22/2008 01:50 pm

Researcher Help: Equitable selection of participants (representation of minorities and women in research)

Equitable Selection of Participants

Sample Answers and Examples

General Considerations Health disparities among racial and ethnic groups have been identified in conditions such as diabetes, cardiovascular disease, HIV/ AIDS, and cancer. The generalizability of such research takes on increased significance in diseases with known disparities. The ethical principle of justice requires the burdens and benefits of research on various populations be fair. In 1993, the United States Congress passed Public Law 103-43 mandating that all NIH funded clinical trials have “appropriate representation” of minority and women subjects. Florida’s state funded biomedical research programs have also adopted similar requirements.
  • Woman and minorities must be included in all clinical studies
  • Women and minorities must be included in all Phase III clinical studies, and the trials must be designed to allow valid analysis. Phase III clinical studies must include analysis to detect whether there are significant differences among groups
  • Cost is not an allowable reason for not including minorities
  • Investigators must include minority and gender recruitment in subject selection and rationale
  • Investigators must justify any exclusions
  • Investigators must include recruitment and outreach plans for equitable minority and gender recruitment
  • Minority recruitment for non-clinical behavioral research, though not federally mandated, is nevertheless an ethical requirement of justice. Social and behavioral research in which DOH is engaged also needs to include information about minority recruitment.
DOH IRB applications ask investigators to estimate minority recruitment and estimate recruitment by gender at initial and continuing review so the IRB can determine whether research meets the regulatory requirement that there be equitable subject selection. Failure to include this information will cause applications to be returned prior to review.
Required Determinations by the IRB A regulatory criterion for IRB approval is that selection of participants is equitable. Selection of participants is not equitable unless the study includes adequate minority representation, particularly when research concerns conditions where there are known health disparities, unless the investigator can justify any exclusions.
Accreditation Element Element II.5.A: The Research Review Unit has and follows written policies and procedures to evaluate the equitable selection of participants from various populations and sub-populations, when applicable, and considers whether inclusion and exclusion criteria impose fair and equitable burdens and benefits.
Regulations 45 CFR §46.111(a)(3), 21 CFR §56.111(a)(3), OHRP Guidance on Written Institutional Review Board (IRB) Procedures
Guidance
References

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