In this article I will argue first that if ignorance poses a problem for valid consent in medical contexts then framing effects do too, and second that the problem posed by framing effects can be solved by eliminating those effects. My position is thus a mean between two mistaken extremes. At one mistaken extreme, framing effects are so trivial that they never impinge on the moral force of consent. This is as mistaken as thinking that ignorance is so trivial that (...) it never impinges on the moral force of consent. At the other mistaken extreme, framing effects are so serious that their existence shows that consent has no independent moral force. This is as mistaken as the idea that ignorance is so serious that its existence shows that consent has no independent moral force. I will argue that, instead of endorsing either of these mistaken extreme views, we should instead endorse a moderate view according to which framing effects sometimes pose a serious challenge for the validity of consent, just as ignorance does, but one which we can solve by eliminating the effect, just as we can solve the problem of ignorance by eliminating it. (shrink)

The U.S. Code of Federal Regulations governing federally funded research on human subjects assumes that harmful research is sometimes morally justifiable because the beneficiaries of that research share a particular vulnerability with its subjects. In this article, I argue against this assumption, which occurs in every subpart of the Code of Federal Regulations that deals with specific vulnerable populations . I argue that shared vulnerability is no exception to the general principle that harming one person in order to benefit another (...) is no more justifiable if the two people have traits in common. Further, shared vulnerability is not a reasonable proxy for any morally relevant desideratum of research, in particular the desire to benefit the worst off, the desire to avoid exploitation, and the desire to use vulnerable populations in research only when necessary. (shrink)

Subsequent consent can be morally efficacious. First, it licenses nostalgia and dismissiveness no more than its prior cousin does. Second, it's coherent because linked to the mental state of not minding. Third, it's just as vulnerable to bilking as prior consent is, as is clear once we distinguish between basing moral assessments on expectations versus on actual outcomes. Fourth, mind control is illegitimate because it short circuits the subject's will, not because its consent is subsequent. Finally, our intuitions about rape (...) show that dissent sometimes outweighs consent in matters of sex, not that subsequent consent is always inefficacious. (shrink)

In this paper I argue, against the current consensus, that the right to withdraw from research is sometimes alienable. In other words, research subjects are sometimes morally permitted to waive their right to withdraw. The argument proceeds in three major steps. In the first step, I argue that rights typically should be presumed alienable, both because that is not illegitimately coercive and because the general paternalistic motivation for keeping them inalienable is untenable. In the second step of the argument, I (...) consider three special characteristics of the right to withdraw, first that its waiver might be exploitative, second that research involves intimate bodily access, and third that it is irreversible. I argue that none of these characteristics justify an inalienable right to withdraw. In the third step, I examine four considerations often taken to justify various other allegedly inalienable rights: concerns about treating yourself merely as a means as might be the case in suicide, concerns about revoking all your future freedoms in slavery contracts, the resolution of coordination problems, and public interest. I argue that the motivations involved in these four types of situations do not apply to the right to withdraw from research. (shrink)

So long as a ban is enforceable, large private athletic institutions—such as Major League Baseball and the National Collegiate Athletic Association—should not allow their athletes to take performance-enhancing drugs. The argument I present is game-theoretic: though each athlete prefers unilateral permission to dope over a universal ban, he also prefers a universal ban over universal permission to dope. That is because, while doping improves absolute measures of performance, it does not improve relative performance if many athletes dope. Large private athletic (...) institutions should honour their athletes' preferences and should not enact any policy that gives only some athletes but not others permission to dope. Thus, they should ban doping. My paper examines and defends this game-theoretic argument. After explaining the argument, I compare it to other arguments for the same conclusion. I then discuss whether the game-theoretic argument counterintuitively fails to justify banning some forms of doping, and whether it counterintuitively justifies banning things other than doping. After arguing that a doping ban on game-theoretic grounds is neither wrongly paternalistic or nor wrongfully coercive, I end by discussing some limitations of the argument. (shrink)

In this paper, I will examine a puzzling discrepancy between the way clinicians are allowed to treat their patients and the way researchers are allowed to treat their subjects: in certain cases, researchers are legally required to disclose quite a bit more information when obtaining consent from prospective subjects than clinicians are when obtaining consent from prospective patients. I will argue that the proper resolution of this puzzling discrepancy must appeal to a pragmatic criterion of disclosure for informed consent: that (...) what needs to be disclosed in order for consent to be valid depends on what the patient/subject needs to know in order to make a decision. I will then use this pragmatic criterion of disclosure to argue that when obtaining consent researchers should be permitted to omit the same information clinicians are, given certain qualifications. I will also examine how this puzzle forces us to confront some perhaps surprising truths about valid consent. My broader aim in this paper is to examine, not so much the puzzle itself, but rather what this particular puzzle can teach us about more theoretical issues surrounding informed consent. (shrink)

Futility is easily defined as uselessness. The mistaken appearance that it cannot be defined is explained by difficulties applying it to particular cases. This latter problem is a major goal of clinical training and cannot be solved in a pithy statement.

The Code of Federal Regulations permits harmful research on children who have not agreed to participate, but I will argue that it should be no more permissive of harmful research on such children than of harmful research on adults who have not agreed to participate. Of course, the Code permits harmful research on adults. Such research is not morally problematic, however, because adults must agree to participate. And, of course, the Code also permits beneficial research on children without needing their (...) explicit agreement. This sort of research is also not problematic, this time because paternalism towards children may be justifiable. The moral problem at the center of this paper arises from the combination of two potential properties of pediatric research, first that it might be harmful and second that its subjects might not agree to participate. In Section 2 of this article I explain how the Code permits harmful research on non-agreeing children. Section 3 contains my argument that we should no more permit harmful research on non-agreeing children than on non-agreeing adults. In Section 4, I argue that my thesis does not presuppose that pediatric assent has the same moral force that adult consent does. In Section 5, I argue that the distinction between non-voluntary and involuntary research is irrelevant to my thesis. In Section 6, I rebut an objection based on the power of parental permission. In Section 7 I suggest how the Code of Federal Regulations might be changed. (shrink)

ABSTRACT The 2006 Institute of Medicine (IOM) report, ‘Ethical Considerations for Research Involving Prisoners’, recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category‐based to a risk‐benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk‐benefit constraints on prisoner research must be justified in a different way from those on pediatric research. In this paper I argue that additional risk‐benefit (...) constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category‐based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non‐prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk‐benefit constraints may seem to address – coercion, undue inducements, exploitation, and protection from harm – are in fact not solved by adding further risk‐benefit constraints on prisoner research. (shrink)

In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research – (...) cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. (shrink)