Criteria to review and approve proposals:
Risks to subjects are minimized:
- By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
- whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
Risks to subjects are reasonable:
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB will not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
Selection of subjects is equitable:
- In making this assessment the IRB will take into account the purposes of the research and the setting in which the research will be conducted and will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, persons who have mental disabilities, or persons who are economically or educationally disadvantaged.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR §46.116.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR §46.117.
Data collection safeguards:
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, persons with mental disabilities, or persons who are economically or educationally disadvantaged, additional safeguards have been included in the study to protect the rights and welfare of these subjects, in accordance with 45 CFR §46, Subparts B, C, and D.