How do the Guidelines impact on Institutional Review Boards (IRBs)?
IRBs have long had as part of their responsibilities the examination of ethical issues and the determination of equitable selection of subjects in accordance with the regulations for protection of human subjects (45 CFR 46.111(a)(3)). The inclusion of both men and women and of minorities in research (intramural and extramural) is important, both to ensure that they receive an appropriate share of the benefits of research and that they do not bear a disproportionate burden. To the extent that participation in research offers direct benefits to the participants, under-representation of men, women, or minorities denies them the opportunity to receive this benefit. Moreover, for the purpose of generalizing research results, investigators must include the widest possible range of population groups.
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- What categories of research involving children can an Institutional Review Board approve?
- When does human stem cell research need to be reviewed by the Institutional Review Board?
