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date: 13 November 2019

Abstract and Keywords

The preeminence of informed consent in human subjects protections reflects Western democratic societies' ethical and political commitments to secure each citizen against both coercive and paternalistic influences of other people. Society permits adults extensive personal discretion in choices such as where to live, what to eat, how to dress, and whether to be in research. In short, individuals are afforded extensive discretion in choosing what to do and what is in their own best interests. Informed consent to enroll in research is especially important because research necessarily involves procedures such as randomization and blinding that are done to assure that the project will produce generalizable knowledge.

Keywords: randomization, informed consent, personal discretion, cognitive impairment, decision-making ability, proxy role

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