Alan Wertheimer

(1942 - 2015)

The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects. It is therefore surprising that there has been little justification for that right in the literature. We argue that the right to withdraw should protect research participants from information imbalance, inability to hedge, inherent uncertainty, and untoward bodily invasion, and it serves to bolster public trust in the research enterprise. Although this argument is not radical, it provides a useful way to determine how the right should be applied in various cases.

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive

This article considers the principles that underlie the claim that some contracts are unconscionable and that such contracts should not be enforceable. It argues that it is much more difficult to explain unconscionability than is often supposed, particularly in cases where the contract is mutually advantageous or Pareto superior. Among other things, the article considers whether unconscionability is a defect in process or result, whether the gains in an unconscionable contract are disproportionate, whether there is a strong link between the use of standard forms and unconscionability, and whether the principle of inequality of bargaining power can account for unconscionability. After rejecting several standard explanations of unconscionability, I consider several alternative ways in which it might be explained.

The intentional punishment of the innocent is ordinarily claimed to be a special problem for utilitarian theories of punishment. The unintentional punishment of the innocent is a problem for any theory of punishment which holds that the guilty should be punished. This paper examines the criteria that are relevant to a determination of the appropriate probability of punishment mistakes for a society, and argues that this is the kind of moral problem for which utilitarian judgments, as opposed to considerations of justice, are most appropriate. To illustrate some of the trade-offs involved, the paper employs some hypothetical data.

What I call ‘the standard view’ claims that IRBs should not regard financial payment as a benefit to subjects for the purpose of risk/benefit assessment. Although the standard view is universally accepted, there is little defense of that view in the canonical documents of research ethics or the scholarly literature. This paper claims that insofar as IRBs should be concerned with the interests and autonomy of research subjects, they should reject the standard view and adopt ‘the incorporation view.’ The incorporation view is more consistent with the underlying soft-paternalist justification for risk-benefit assessment and demonstrates respect for the autonomy of prospective subjects. Adoption of the standard view precludes protocols that advance the interests of subjects, investigators, and society. After considering several objections to the argument, I consider several arguments for the standard view that do not appeal to the interests and autonomy of research subjects

It is widely assumed that it is ethical to conduct research with human subjects only if the research has social value. There are two standard arguments for this view. The allocation argument claims that public funds should not be devoted to research that lacks social value. The exploitation avoidance argument claims that subjects are exploited if research has no social value. The primary purpose of this article is to argue that these arguments do not succeed. The allocation argument has little relevance to commercial research. Social value is not necessary to avoid exploitation if subjects benefit from participation. Although the standard arguments for a social value requirement do not succeed, that view might be justified in a different way. It might be justified by appeal to the importance of social trust or the integrity of physician investigators. It is possible but doubtful that these arguments succeed

When does a woman give valid consent to sexual relations? When does her consent render it morally or legally permissible for a man to have sexual relations with her? Why is sexual consent generally regarded as an issue about female consent? And what is the moral significance of consent? These are some of the questions discussed in this important book, which will appeal to a wide readership in philosophy, law, and the social sciences. Alan Wertheimer develops a theory of consent to sexual relations that applies to both law and morality in the light of the psychology of sexual relations, the psychology of perpetrators, and the psychology of the victims. He considers a wide variety of difficult cases such as coercion, fraud, retardation, and intoxication. We can all agree that 'no' means 'no'. This book suggests that the difficult question is whether 'yes' means 'yes'.

Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research