Protecting and respecting the vulnerable: existing regulations or further protections?
Theoretical Medicine and Bioethics 34 (1):17-28 (2013)
Abstract
Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in researchDOI
10.1007/s11017-013-9242-8
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Citations of this work
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Response to Open Peer Commentaries: On Social Harms, Big Tech, and Institutional Accountability.James A. Anderson, Melissa D. McCradden & Elizabeth A. Stephenson - 2022 - American Journal of Bioethics 22 (10):6-8.
References found in this work
The limitations of "vulnerability" as a protection for human research participants.Carol Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler & Jeremy Sugarman - 2004 - American Journal of Bioethics 4 (3):44 – 49.
Facing up to paternalism in research ethics.Franklin G. Miller & Alan Wertheimer - 2007 - Hastings Center Report 37 (3):24-34.
Undue Inducement: Nonsense on Stilts?Ezekiel J. Emanuel - 2005 - American Journal of Bioethics 5 (5):9-13.
The influence of risk and monetary payment on the research participation decision making process.J. P. Bentley - 2004 - Journal of Medical Ethics 30 (3):293-298.