The following represent the criteria employed by the IRB in reviewing proposals. These are based on the Belmont Report.
- Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not needlessly expose subjects to risk.
- The research plan protects the privacy of subjects and the confidentiality of data.
- Risks to subjects are reasonable in relation to anticipated benefits (if any) to the subjects, and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable. The IRB will take into account the purpose of the research and the setting in which the research will be conducted, and will be especially cognizant of the special problems of research involving vulnerable populations. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have to be included in the study to protect the rights and welfare of these subjects.
- Informed consent will be appropriately documented.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure safety of subjects.