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Human Subjects

Role of the IRB

The role of the IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research. To accomplish this purpose, IRBs follow a federally-mandated process to review research protocols and related materials (e.g., informed consent documents and investigator brochures), ensuring that research meets eight criteria for approval.

The criteria for approval (45 CFR 46.111) are as follows:

  1. Risks to subjects are minimized:
    (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
    (ii) 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 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. 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, such as children, prisoners, pregnant women, mentally 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, in accordance with, and to the extent required by [regulations].
  5. Informed consent will be appropriately documented, in accordance with, and to the extent required by [regulations].
  6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  8. When some or all of the subjects 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 subjects.

The Board reviews all studies using the criteria above. If the Board determines that one or more of the criteria are not met, or if the Board feels that it cannot determine whether a criterion is met, the submission will be tabled or disapproved.

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