The Role of the Institutional Review Board

Abstract

The purpose of the Institutional Review Board (IRB), protection of the rights and welfare of human research subjects, is outlined. The written consent form must inform the subjects that determination of safety and efficacy is the purpose of the study. The FDA has not found it necessary to disqualify IRBs, since compliance is achieved by lesser actions, such as temporary suspension of authority to review FDA regulated studies. The FDA does not prohibit preparation of portions of informed consent forms by the sponsor if objectivity and accuracy are scrupulously maintained. Deliberately misleading study subjects could render the consent invalid. The accuracy of written translations of consent forms must be assured by the IRB. Advertising to prospective study subjects should be regarded as the initiation of the informed consent process, and held to the same constraints. Payment for participation in the study must be reviewed by the IRB to assure lack of undue influence. The function of the IRB should be limited to protection of the human subjects of the research.