There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the ‘therapeutic misconception’, but has ignored the ‘completion misconception’. This article argues that, other things being equal, (...) prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult. (shrink)
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. (shrink)
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. (shrink)
Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...) the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to confuse participating in research with receiving personalized medical care. This .. (shrink)
It is universally accepted that participants in biomedical research have the right to withdraw from participation at any time, except, perhaps, when withdrawal would constitute a threat to their health or the health of others. The right to withdraw is encoded in nearly every document on the requirements for ethical conduct of research on humans, including the U.S. Code of Federal Regulations governing all federally-funded research, the Common Rule (45 CFR 46); the Declaration of Helsinki (WMA 2008); the 2002 research (...) guidelines of the Council for International Organizations of Medical Sciences (CIOMS 2002); and the Belmont Report (National Commission 1979). Presumably, if codification of the right in these .. (shrink)
Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
Gesundheit and colleagues offer dramatic examples of the medical treatment of terrorists but then pose the suggestion that those who engage in terrorism forfeit their right to medical care, and, consequently, that physicians have no obligation to treat them. Their argument presupposes that a physician’s obligation to provide medical care depends on the patients’ right to health care. Therefore, someone who commits heinous and abhorrent acts thereby waives the right to health care and the physicians’ duty to provide health care (...) might consequently be absolved. This view may appeal to physicians who have experienced the complexity and discomfort of treating someone whose morality or even humanity they question, such as a rapist, a serial killer, or a perpetrator of genocide. However we have grounds to believe that the duty of physicians to treat is not based on the moral worth of patients, but rather on the duties that physicians have, and this notion renders any concern about the unacceptability of any person’s behavior irrelevant in determining whether to provide treatment. We will first argue that not all duties are directly derived from rights, and then illustrate how deontological views, along with common views on the role morality of physicians, provide a basis for offering indiscriminate medical care. Second, we will discuss the physician’s role in the context of war, and offer one compelling moral reason on the basis of which warfare norms do indeed obligate physicians to extend their duty to care toward enemies, terrorists included, independently of whatever right they maintain. (shrink)
: Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.
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. (shrink)
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. (shrink)