1. 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.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance to the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research as distinguished from risks and benefits 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.
3. Selection of subjects is equitable. In making this assessment the IRB takes into account the purposes of the research and the setting in which the research will be conducted. The IRB will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally or physically disabled persons or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
5. Informed consent will be appropriately documented.
6. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. There are adequate provisions to protect the privacy of subjects and to protect the data from unauthorized disclosure.
8. The protocol meets all standards established by the federal government, including those pertaining to special populations such as minors, pregnant women, and prisoners, and meets University guidelines.
9. In reviewing proposals, the IRB will consider, in accordance with the Final Rule, research protocol when procedures included in a proposal are deemed to be inconsistent with sound research design. If a proposal appears to be so flawed that no valid conclusions can be reached, then the IRB may consider rejection of the proposal based on a poor risk/benefit ratio for the potential subjects and the academic institution.
10. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, minors, or persons who are economically or educationally disadvantaged, etc., the IRB will ensure that appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.
