Review/Approval of Research

Review of Research:

In conducting the review of research, the IRB shall follow the regulations as stated in 45 CFR 46.109 and the University policy as described herein.

Approval of Research:

• Risks to participants are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
• Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of 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 of therapies participants 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 benefits that fall within the purview of its responsibility.
• Selection of participants 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 and is particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
• Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with 45 CFR 46.116.
• Informed consent will be appropriately documented, in accordance with 45 CFR 46.117.
• The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
• There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.

Further, when some or all of the participants 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 been included in the study to protect the rights and welfare of these participants.