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OHRP Guidance – IRBs for AIDS Studies

DECEMBER 26, 1984

OPRR REPORTS

GUIDANCE FOR INSTITUTIONAL REVIEW BOARDS FOR AIDS STUDIES

This document is intended to provide guidance concerning studies involving acquired immune deficiency syndrome (AIDS) which are subject to the Department of Health and Human Services (HHS) Regulations for the Protection of Human Subjects, 45 CFR 46. Subpart A of these regulations contains general provisions which apply to all research covered by the regulations. Subparts B, C and D, require additional protections for fetuses, pregnant women, prisoners and children. These additional protections must be observed whenever applicable.

Additionally, the Food and Drug Administration (FDA) regulations, 21 CFR 50 and 56, pertaining to informed consent and Institutional Review Boards (IRBs) and 21 CFR 312 regulations pertaining to new drugs for investigational use, must be observed whenever AIDS studies are subject to FDA jurisdiction. Insofar as the FDA regulations pertain to the membership requirements and functions of IRBs, FDA and HHS regulations are essentially congruent.

Because of the special sensitivity of AIDS research, IRBs are cautioned to exercise particular care in observing all applicable regulatory provisions. IRBs have a responsibility to see that risks to subjects are minimized consistent with sound research design. Whenever appropriate, procedures already being performed on subjects for diagnostic or treatment purposes should be used. IRBs should determine that risks to subjects are reasonable in relation to benefits and the importance of the knowledge that may reasonably be expected to result. The IRBs have primary responsibility for making certain that the informed consent process is properly designed for each research project and that accurate and complete information is provided to subjects.

For regulatory purposes [HHS at 45 CFR 46.102(f)] a human subject means a living individual, about whom an investigator conducting research obtains
(1) data through intervention or interaction with the investigator, or

(2) identifiable private information.

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