IV. Criteria for approval of research
In order to approve research covered by this policy, the IRB shall conduct a risk benefit analysis that all of the following requirements are satisfied:
(1) Risks to subjects are minimized, by employing procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk.
(2) 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 should 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 should 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.
(3) When appropriate, the research plan includes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(4) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations.
(5) Informed consent is sought from each prospective subject or the subject's legally authorized representative and appropriately documented, in accordance with the requirements described in the Informed Consent section of this policy.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When some or all of the subjects are likely to be members of vulnerable populations, additional safeguards are included in the study to protect the rights and welfare of these subjects.