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An institutional review board (IRB) is
|“||a standing committee composed of scientists, physicians, and others not directly involved with the proposal being reviewed (The IRB's membership and function are defined in the regulations to ensure that it has sufficient expertise and diversity to provide appropriate review. Diversity should include gender, race, culture, and profession. In addition to scientists, the IRB must include at least one person who is not otherwise connected with the institution and at least one non-scientist.). IRBs review proposals for research on humans to make sure that risks to subjects are minimized, that the potential benefits of the research outweigh the risks to subjects, and that the subjects will be respected as persons and not just used as research subjects. Under federal regulations, IRBs are required to ensure that subjects first be fully informed of the risks and benefits of the research and then have an opportunity to consent or decline to participate in the research unless the IRB decides that consent can be waived.||”|
- ↑ Specified in 45 C.F.R. 46.
- ↑ Protecting Data Privacy in Health Services Research, at 4.