Two kinds of rule regulating human subjects research
Abstract
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.
Citation
Sachs , B A 2015 , ' Two kinds of rule regulating human subjects research ' , Journal of Law and the Biosciences , vol. 2 , no. 2 , pp. 431-437 . https://doi.org/10.1093/jlb/lsv018
Publication
Journal of Law and the Biosciences
Status
Peer reviewed
ISSN
2053-9711Type
Journal article
Rights
Copyright 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. 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
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