Subject Selection is Equitable — the third criterion for approval

The next installment in our review of the criteria for IRB approval of research

The third approval criterion reads, “Seletion of subjects is equitable.” This criterion is rooted in the Belmont Report’s principle of justice. Who ought to receive the benefits of research, and who should bear its burdens? In considering this criterion, IRB reviewers should take into account the research’s purpose and the setting in which it will be conducted, as well as the proposed recruitment methods used. Some populations, such as children, prisoners, or people who are cognitively impaired, may merit extra protections. Is a population being targeted for inclusion only because it is readily available or easily manipulable? Are any groups being unfairly excluded from research from which they might benefit? ¬†The inclusion/exclusion criteria, any listed justifications for including or excluding certain groups, and the proposed recruitment processes are among the¬†elements to be weighed when determining whether subject selection is equitable.