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It is not the case that Enrolling a research candidate in a trial remains legitimate even when the candidate fails to comprehend disclosed information despite repeated efforts.
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Reasons For
2 perspectives
Reason for 1 of 2
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1.
Valid consent requires actual understanding, not merely the opportunity for understanding, as Faden and Beauchamp argue in 'A History and Theory of Informed Consent' (1986).
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2.
Enrollment without comprehension treats the candidate as a means to research ends, violating Kantian respect for persons as rational autonomous agents.
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3.
Procedural compliance with disclosure cannot substitute for the substantive condition of competent understanding that grounds the moral legitimacy of consent itself.
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Reason for 2 of 2
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1.
Paul Appelbaum's competency standard requires that candidates demonstrably manipulate disclosed information to reach a reasoned decision, not merely receive it.
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2.
When comprehension fails despite repeated efforts, investigators have epistemic evidence that the candidate lacks decision-making capacity, triggering surrogate consent obligations rather than enrollment authorization.
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Reasons Against
1 perspective
Reason against
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1.
Investigators fulfill their obligations by giving candidates the opportunity to issue autonomous authorization.
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2.
Investigators avoid potential fraud by providing disclosure.
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3.
Investigators treat candidates fairly by offering the opportunity for informed consent.
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