In a recent article in this journal, we argued that living organ donation from a parent to a child should be described as a beneficent rather than an altruistic act. Emotional relationships can generate an obligation of beneficence to help those with whom we have these relationships. This may involve an obligation for a parent to donate an organ to a child, even though it entails some risk to the parent. The parent's donation is not altruistic because altruistic acts are (...) not obligatory but optional, and they are motivated solely or primarily by other-regarding concerns. In contrast, donor parents' other-regarding concerns are inseparable from their own self-regarding concerns. An individual who donates to a stranger is acting altruistically. She may choose to help others to whom she is not emotionally related for a variety of reasons—sympathy, compassion, generosity, or a desire to give something back to humanity. But she does not have an obligation to do so. Although she may benefit as a consequence of donating, this is not her reason for donating. Instead, her action is motivated by a concern for the recipient's own sake. This is what makes the donation altruistic, and it can be justified without any expectation of benefit to the donor. However, although the potential competent donor decides whether the donation is in her best interests, physicians have the right to refuse to perform a transplant if the risks to the donor are too great or the potential benefits to the recipient are too small. (shrink)

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges (...) emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Most recent thinking about thevulnerability of research subjects uses a``subpopulation'' focus. So conceived, theproblem is to work out special standards forprisoners, pregnant women, the mentally ill,children, and similar groups. In contrast, an``analytical'' approach would identifycharacteristics that are criteria forvulnerability. Using these criteria, one couldsupport a judgment that certain individuals arevulnerable and identify needed accommodationsif they are to serve as research subjects.Seven such characteristics can be evident inchildren: they commonly lack the capacity tomake mature decisions; they are subject to theauthority of (...) others; they (and their parents)may be deferential in ways that can maskunderlying dissent; their rights and interestsmay be socially undervalued; they may haveacute medical conditions requiring immediatedecisions not consistent with informed consent;they may have serious medical conditions thatcannot be effectively treated; and they (andtheir parents) may lack important sociallydistributed goods. Each of thesevulnerabilities can call for special care inthe design and implementation of researchprotocols. (shrink)

Death of a normal volunteer highlights problems with research review and protection of subjectsHealthy volunteer dies in asthma studyOn July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the study.1 (...) Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment.Ellen Roche was a 24 year old technician from the Johns Hopkins Asthma and Allergy Centre who volunteered to take part in a study designed to provoke a mild asthma attack in order to help doctors discover the reflex that protects the lungs of healthy people against asthma attacks. After inhaling hexamethonium, a medication used for treating high blood pressure in the 1950s and 60s, Ms Roche became ill. She developed a cough and her condition worsened over the next week until she was put on a ventilator. With her lung tissue breaking down, blood pressure falling and her kidneys beginning to fail, nothing could be done to save her.2 She died on June 2, about a month after entering the study.The Office for Human Research Protections investigated the circumstances of Ms Roche's death and accused the Hopkins Institutional Review Board of failing to take proper precautions. It also evaluated the human subject protection system at Hopkins. The OHRP found that prior to approving the study, Hopkins researcher …. (shrink)

This article summarizes some of the results of the BIOMED II project “Basic Ethical Principles in European Bioethics and Biolaw” connected to a research project of the Danish Research Councils “Bioethics and Law”. The BIOMED project was based on cooperation between 22 partners in most EU countries. The aim of the project was to identify the ethical principles of respect for autonomy, dignity, integrity and vulnerability as four important ideas or values for a European bioethics and biolaw. The research concluded (...) that the basic ethical principles cannot be understood as universal everlasting ideas or transcendental truths but they rather function reflective guidelines and important values in European culture. The method of the research was conceptual, philosophical analysis of the cultural background of the four values or normative ideas that people use and find important in their existence. Moreover, this was combined with analysis of empirical legal material and policy documents. Also, a number of qualitative interviews with relevant experts were carried out. Another important result of the BIOMED project was the partner's Policy Proposals to the European Commission, the Barcelona Declaration, unique as a philosophical and political agreement between experts in bioethics and biolaw from many different countries. The Policy Proposals are reprinted here at the end of the article. (shrink)

Book reviewed in this article: Protecting The Vulnerable: A Reanalysis of Our Social Responsibilities. By Robert E. Goodin. Chicago: University of Chicago Press.

This paper examines the ethical difficulties of organ donation from living donors and the problem of causing harm to patients or research subjects at their request. Graham Greene explored morally similar questions in his novella, The Tenth Man.

Imagine you are walking down a city street. It is windy and raining. Amidst the bustle you see a young woman. She sits under a railway bridge, hardly protected from the rain and holds a woolen hat containing a small number of coins. You can see that she trembles from the cold. Or imagine seeing an old woman walking in the street at dusk, clutching her bag with one hand and a walking stick with the other. A group of male (...) youths walk behind her without overtaking, drunk and in the mood for mischief. It doesn't need an academic to say what vulnerability is. We can all see it, much more often than we care to. (shrink)

Spurred by a severe shortage of cadaveric organs, there has been a marked growth in living organ donation over the past several years. This has stimulated renewed interest in the ethics of this practice. The major concern has always been the possibility that a physician may seriously harm one person while trying to improve the well-being of another. As Carl Elliott points out, this puts the donor's physician in a difficult predicament: when evaluating a person who volunteers to donate an (...) organ, “a doctor is in the position of deciding not simply whether a subject's choice is reasonable … but whether he [the doctor] is morally justified in helping the subject accomplish it.”1 This question has become even more difficult since the introduction of living donor operations that are more risky than living kidney donation and the suggestion that volunteers at added risk may sometimes be acceptable.2 So, how can we decide when the risk is too much? (shrink)