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Health Law and Policy Commons

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Maurer School of Law: Indiana University

2008

Decisionally Incapacitated Human Subjects

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Full-Text Articles in Health Law and Policy

Research With Decisionally Incapacitated Human Subjects: An Argument For A Systemic Approach To Risk-Benefit Assessment, Carl H. Coleman Jul 2008

Research With Decisionally Incapacitated Human Subjects: An Argument For A Systemic Approach To Risk-Benefit Assessment, Carl H. Coleman

Indiana Law Journal

The amount of medical research with persons who lack decision-making capacity is rapidly increasing, but in most states it takes place without clear legal authority. In addition to creating significant liability risks for researchers and persons who provide consent on behalf of incapacitated subjects, the lack of explicit legal standards means that few, if any, safeguards exist to protect incapacitated persons' rights and welfare. Previous efforts to close the gap between clinical reality and legal requirements have failed in part because they have not provided a coherent or persuasive ethical justification for permitting this research. This Article seeks to fill ...