IRB-02: Behavioral/NonMedical Institutional Review Board |
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Inclusion of Women and
Minorities in Study Populations
In the IRB02's analysis of the balance between the risks and benefits within a protocol, an evaluation of the quality of the research is a key factor. In order for research to have the optimal societal benefit, it must sample a population representing the population at large so that the findings are valuable as generalizable to the population at large.
NIH has specific recommends concerning the proper representation of women and minorities in research studies:
- Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them.
- If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided.
- Composition of study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice.
- Gender and racial/ethnic issues should be addressed when developing a research protocol and sample size appropriate for the scientific objectives of the study.
- Protocols must employ a study design with gender and/or minority representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research.
- It is not a requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately, however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation you should include an evaluation of these gender and minority group differences in the proposed study.
- If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research because of the health of the subjects, or other reasons, or if they are the only study population available, or if there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified.
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