14. How
should women and minorities be included in research?
Research benefits and burdens should be distributed fairly. If an
individual or group is denied access to a clinical trial that might be
beneficial or if some people are singled out to bear the burden of risks
associated with a study, the requirement for fairness is not met. In accordance
with the policies of the National Institutes of Health, the IRB requires
researchers applying for federal funds to give breakdowns of their participant
populations by gender and minority group. Studies with the potential to
address issues relevant to both sexes must recruit both genders, and minority
populations should be included in a study population wherever feasible.
Researchers must justify the exclusion of women or minorities. The IRB
makes exceptions only if there is adequate scientific justification for
exclusion, such as when a disease predominates in one gender.