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Two kinds of rule regulating human subjects research

Alan Wertheimer argues that before we promulgate some rule regarding the conduct of research on human subjects we ethically ought to consider the consequences of the rule being followed. This ethical requirement has an exception, though, Wertheimer maintains: it doesn't apply to rules that are...

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Autor principal: Sachs, Benjamin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034368/
https://www.ncbi.nlm.nih.gov/pubmed/27774203
http://dx.doi.org/10.1093/jlb/lsv018
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description Alan Wertheimer argues that before we promulgate some rule regarding the conduct of research on human subjects we ethically ought to consider the consequences of the rule being followed. This ethical requirement has an exception, though, Wertheimer maintains: it doesn't apply to rules that are not motivated by considerations of outcome. I agree that there is an exception to be made to Wertheimer's proposed ethical requirement, but not Wertheimer's exception. The important distinction is not that between rules motivated by considerations of outcome and rules motivated otherwise, but between rules designed to enforce ethics and rules not so designed. Before we promulgate the latter kind of rule, we are ethically required to consider the consequences of doing so. This is not so for the former kind of rule. My exception, unlike Wertheimer's, yields the conclusion that we should promulgate, regardless of the consequences of doing so, a rule requiring that the potential benefit to the subject of participation in a study outweigh the risks. This rule is motivated by considerations of outcome, so it would land on the wrong side of Wertheimer's divide. But it's also designed to enforce ethics, so it lands on the correct side of my divide.
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spelling pubmed-50343682016-10-21 Two kinds of rule regulating human subjects research Sachs, Benjamin J Law Biosci Peer Commentary Alan Wertheimer argues that before we promulgate some rule regarding the conduct of research on human subjects we ethically ought to consider the consequences of the rule being followed. This ethical requirement has an exception, though, Wertheimer maintains: it doesn't apply to rules that are not motivated by considerations of outcome. I agree that there is an exception to be made to Wertheimer's proposed ethical requirement, but not Wertheimer's exception. The important distinction is not that between rules motivated by considerations of outcome and rules motivated otherwise, but between rules designed to enforce ethics and rules not so designed. Before we promulgate the latter kind of rule, we are ethically required to consider the consequences of doing so. This is not so for the former kind of rule. My exception, unlike Wertheimer's, yields the conclusion that we should promulgate, regardless of the consequences of doing so, a rule requiring that the potential benefit to the subject of participation in a study outweigh the risks. This rule is motivated by considerations of outcome, so it would land on the wrong side of Wertheimer's divide. But it's also designed to enforce ethics, so it lands on the correct side of my divide. Oxford University Press 2015-05-17 /pmc/articles/PMC5034368/ /pubmed/27774203 http://dx.doi.org/10.1093/jlb/lsv018 Text en © The Author 2015. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Peer Commentary
Sachs, Benjamin
Two kinds of rule regulating human subjects research
title Two kinds of rule regulating human subjects research
title_full Two kinds of rule regulating human subjects research
title_fullStr Two kinds of rule regulating human subjects research
title_full_unstemmed Two kinds of rule regulating human subjects research
title_short Two kinds of rule regulating human subjects research
title_sort two kinds of rule regulating human subjects research
topic Peer Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034368/
https://www.ncbi.nlm.nih.gov/pubmed/27774203
http://dx.doi.org/10.1093/jlb/lsv018
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