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The regulatory framework that governs research involving human subjects in the United States was developed based on the ethical principles described in the Belmont Report. The principle of respect for persons demands that research consider an individual’s right to determine whether or not to participate in research. In the regulations, respect for persons is manifested in the informed consent requirements. However, the regulations do not provide clear direction for institutional review boards (IRBs) when presented with research that involves adult subjects who lack the capacity to give their informed consent. The regulations merely require that researchers obtain the legally effective informed consent of the subject or the subject’s legally authorized representative. To assist IRBs with their assessment of such research, we propose a framework for assessing the appropriateness of inclusion of such subjects through the application of a framework that takes into account the level of risk presented by the proposed research as well as the expected benefits that individual subjects are likely to accrue through their participation in the research. This framework takes into account the principle of respect for persons as well as the principles of beneficence and justice.

Adults Lacking Capacity to Give Consent: When Is It Acceptable to Include Them in Research?