Duties of IRBs

IRBs are required to review and have the authority to approve, require modifications in, or disapprove all research activities covered by the regulations (17). They must require that information given to subjects as part of informed consent is in accordance with the general requirements for informed consent that are set out in the regulations. Additionally, they may require that other information be given to subjects when they judge that such information would further protect the rights and welfare of the subjects (18).

IRBs must require documentation of informed consent in all studies except those specified in the regulations in which documentation may be waived (19). Clinical drug trials are not among the classes of studies in which documentation of informed consent may be waived.

IRBs must provide written notification to investigators and institutions of their decisions to approve, require modifications in, or disapprove proposed research activities (20). Decisions to disapprove proposed research proposal must be accompanied by a statement of reasons for the decision and provide the investigator an opportunity to respond in person or in writing (21).

IRBs must conduct continuing reviews of research they approve at least once each year. More frequent reviews may be required if the risk of a particular research project so warrants (22). IRBs have the authority to suspend or terminate approval of research that is not being conducted in accordance with their requirements or that has been associated with unexpected serious harm to subjects. Such action must be accompanied by a statement of reasons for it and be communicated to the investigator, appropriate institutional officials, and the Secretary of HHS (23).

The regulations require that IRBs must follow the written procedures that are set out in the assurances they have filed with HHS (24), review proposed research at convened meetings at which a majority of IRB members are present, vote approval by a majority of members present at the meeting (25), and be responsible for reporting to the appropriate institutional officials and the Secretary of HHS ''any serious or continuing noncompliance by investigators with the requirements and determination of the IRB'' (26).

Institutions that are cooperating in multiinstitutional studies, such as clinical drug trials, must each review and approve the proposed studies. Such institu tions may, however, use joint review, rely on the review of another qualified IRB, or utilize similar arrangements to avoid duplication of efforts (27).

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