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IRBs review research from the vantage point of protecting the rights
and welfare of human research subjects and are required to evaluate proposed research activities using the following criteria:
- The study is consistent with sound scientific principles, ethical
guidelines, and legal requirements.
- Risks to subjects are minimized by using procedures that are consistent with sound research principles and that do not unnecessarily expose subjects to risk.
- Risks to subjects are reasonable relative to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
- The necessary elements of informed consent have been met and documented and additional elements added when appropriate.
- Additional appropriate safeguards have been provided if potentially
vulnerable subjects are to be studied (e.g., children, prisoners, financially
or educationally disadvantaged people).
- Subject selection is equitable, with attention to the inclusion of
minorities and both genders in study populations so that research findings can be applied to all persons at risk for the disease, disorder or condition under study.
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