Why has autonomy been a leading idea in philosophical writing on bioethics, and why has trust been marginal? In this important book, Onora O'Neill suggests that the conceptions of individual autonomy so widely relied on in bioethics are philosophically and ethically inadequate, and that they undermine rather than support relations of trust. She shows how Kant's non-individualistic view of autonomy provides a stronger basis for an approach to medicine, science and biotechnology, and does not marginalize untrustworthiness, while also explaining why (...) trustworthy individuals and institutions are often undeservingly mistrusted. Her arguments are illustrated with issues raised by practices such as the use of genetic information by the police or insurers, research using human tissues, uses of new reproductive technologies, and media practices for reporting on medicine, science and technology. Autonomy and Trust in Bioethics will appeal to a wide range of readers in ethics, bioethics and related disciplines. (shrink)

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)

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. (shrink)

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. (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)

This book follows hard upon Korsgaard's The Sources of Normativity. Both present the author's influential version of a Kantian theory of normative ethics and metaethics. Whereas The Sources of Normativity was a systematic investigation of "normativity" written as a single unit, the present volume is a collection of previously published papers, some of them already well known and much discussed, dating between 1983 and 1993. By the nature of the case, one might expect less thematic unity in this book than (...) in the other one, but the present book is a deeper and more wide ranging presentation of the author's views. Korsgaard's historical focus in The Sources of Normativity is less on Kant and more on the British moralists. Creating the Kingdom of Ends deals quite explicitly with the interpretation of Kant's moral philosophy. The papers in this book contain, in my judgment, the heart of Korsgaard's work: a variety of fresh and illuminating insights into Kant's moral theory and its relation to contemporary ethical theory which have helped to reshape the image of Kant's ethics and to refocus the issues dealt with in current moral philosophy. Or to make claims less grand but of more immediate relevance to this review, there is no question that some of the papers in this book have helped to reshape both the present writer's image of Kant's ethics and his conception of the way questions of ethical theory should be addressed. I hope below to say something both about where I think Korsgaard has gotten these matters right, and where I find her position either unclear or dubious. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

Ethical guidelines commonly state that research subjects should have a right to withdraw consent to participate. According to the guidelines we have studied, this right applies also to research on biological samples. However, research conducted on human subjects themselves differs in important respects from research on biological samples. It is therefore not obvious that the same rights should be granted research participants in the two cases. This paper investigates arguments for and against granting a right to withdraw consent to research (...) on biobank samples. We conclude that (1) there are no explicit arguments for such a right in the guidelines we have studied, (2) the arguments against such a right are inconclusive, (3) considerations of autonomy, privacy, personal integrity, and trust in medical research provide sufficient reasons for granting a right to withdraw consent to research on biobank samples, (4) in certain cases, research participants should be allowed to waive this right. (shrink)

Patients participating in the shared benefits of publicly funded health care enjoy the benefits of treatments tested on previous patients. Future patients similarly depend on treatments tested on present patients. Since properly designed research assumes that the treatments being studied are—so far as is known at the outset—equivalent in therapeutic value, no one is clinically disadvantaged merely by taking part in research, provided the research involves administering active treatments to all participants. This paper argues that, because no other practical or (...) moral considerations count decisively against so doing, we could and should oblige patients to agree to receive indicated treatment within the terms of any concurrent research protocols. This ensures their treatment will benefit not only themselves but also future patients through contributing to new knowledge. By analogy with the paying of income tax, patients should not be allowed to “veto” their social responsibility to take part in clinical research. (shrink)

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ‘right’ of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw.This does not imply (...) that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self‐defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ‘push’ participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ‘screen out’ people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on‐going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. (shrink)

Consent forms given to potential subjects in research protocols typically contain a sentence like this: “You have a right to withdraw from this study at any time without penalty.” If you have ever served on an institutional review board or a research ethics committee, you have no doubt read such a sentence often. Moreover, codes of ethics governing medical research endorse such a right. For example, paragraph 24 of the Declaration of Helsinki says, “The subject should be informed of the (...) right… to withdraw consent to participate at any time without reprisal.” Similarly, section C of the Belmont Report says that subjects must be informed that they have the right “to withdraw at any time from the research.” And in section 46.116 of the Common Rule, it says that one of the elements of informed consent must include a statement that “the subject may discontinue participation at any time without penalty or loss of benefit to which the subject is otherwise entitled.”. (shrink)

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.

Most codes of research ethics and the practice of Institutional Review Boards (IRBs) allow human subjects to withdraw from research at any time. Consent forms invariably make a statement to this effect. So understood, a subject's right to withdraw from research is inalienable; she cannot, through her consent, surrender this right. Recently critics have argued that in selected circumstances the right to withdraw from research is alienable; subjects have the moral authority, through their consent, to obligate themselves not to withdraw. (...) Two kinds of cases have been cited to support this. In one case, there will be great benefits lost if subjects are permitted to withdraw before the completion of the protocol. In the other case, there will be harm to third parties if subjects withdraw from the experiment. In this paper, I defend the inalienability of the right to withdraw from research. I argue, first, that securing the desired benefits and avoiding the feared harms can be achieved without allowing waiver. Second, I show that permitting waiver in these cases does not guarantee that the ends sought will be achieved. And third, I articulate positive reasons for conceiving subjects' right to withdraw from research as inalienable. (shrink)

This paper considers the ethical issues raised by biobanking of material from children who are not mature enough to give ethically valid consent. The first part considers consent requirements for entry of such materials in the biobank, whereas the second part looks at the issues that arise when a competent child later wants to withdraw previously sored materials, and at the issues that arise when there is informational entanglement between information about a parent and information about a child. The paper (...) argues for three main conclusions:That it is in most cases acceptable for parents to give proxy consent to entry of material from their children ino biobanks, even though this is not strictly speaking in the best interest of the child;that a right to withdraw from the biobank is more important when material has been entered with proxy consent; andthat disputes about the withdrawal of entangled information, i.e. information that is both about a parent and a child, should be resolved in favour of the child. (shrink)