Journal of Law, Medicine and Ethics 32 (2):338-348 (2004)

Alex Rajczi
Claremont McKenna College
An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us to know more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits.
Keywords medical research  informed consent  risk-benefit ratio
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DOI 10.1111/j.1748-720X.2004.tb00480.x
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References found in this work BETA

On Liberty.John Stuart Mill - 1859 - Broadview Press.
Cost-Value Analysis in Health Care: Making Sense Out of QALYs.Erik Nord - 2001 - Philosophical Quarterly 51 (202):132-133.

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Citations of this work BETA

A Framework for Risk-Benefit Evaluations in Biomedical Research.Wendler Annette Rid David - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
Limits to Research Risks.F. G. Miller & S. Joffe - 2009 - Journal of Medical Ethics 35 (7):445-449.

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