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Capacity, Vulnerability, and Informed Consent for Research

Published online by Cambridge University Press:  01 January 2021

Michelle Biros
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Abstract

This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 46 , Issue 1: The Future of Informed Consent in Research & Translational Medicine: A Century of Law, Ethics & Innovation , Spring 2018 , pp. 72 - 78
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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