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Chapter XII - Criteria for Approval of Human Participants Research

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The criteria that must be met for the GA IRB to recommend approval of a human participants’ research study is outlined below. These criteria apply when human research is reviewed by either expedited or convened-Board review procedures:

  • Risks to participants are minimized (a) by using procedures consistent with sound research design that do not unnecessarily expose participants to risk; and (b) 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 should consider 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 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;
  • Selection of participants is equitable. In making this assessment, the IRB should consider 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, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
  • Informed consent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with and to the extent required by 32 CFR 219.116;
  • Informed consent will be appropriately documented, in accordance with and to the extent required by 32 CFR 219.117;
  • When appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants;
  • When appropriate there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.

In addition, when some or all of the participants are likely to be vulnerable to coercion or undue influence, such as military service members, children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, the IRB will consider additional safeguards to protect the rights and welfare of these participants.

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