No component of IRB functioning attracts more attention or engenders more controversy than the concept of informed consent. For most IRBs, review and revision of the consent form submitted by the investigator constitutes the committee’s major interaction with the project. Although the properly functioning IRB must review project design, the criteria for subject selection, the risk/benefit ratio, and similar components of the proposal, most IRBs will reject totally only a small percentage of projects that come up for consideration, and the majority of submitted proposals will eventually be approved, usually subject to some modification of the consent form as submitted by the investigator. Many research proposals originate outside the institution where they will actually be conducted (e.g., clinical trials of new drugs or new procedures sponsored by pharmaceutical firms, or multiinstitutional cooperative therapeutic trials). In most such cases, the research design has usually been constructed with sufficient expertise such that a local IRB is unlikely to find serious shortcomings with the overall proposal; it is generally the consent form and its applicability to the local patient population that requires action by the IRB.
KeywordsConsent Form Final Regulation Research Office Human Subject Research Oral Consent
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