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)

It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value requirement are predicated on (...) what I call the “transactional model of stakeholder obligations”. I go on to problematize this framework, and to introduce an alternative framework for conceptualizing ethical obligations within clinical research. In defending this framework, which I call the “basic structure model of stakeholder obligations”, I also demonstrate how it provides a stronger grounding for the social value requirement that is not vulnerable to critiques grounded in the transactional model. (shrink)

The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.

How do we judge whether an action is morally right or wrong? If an action is wrong, what reason does that give us not to do it? Why should we give such reasons priority over our other concerns and values? In this book, T. M. Scanlon offers new answers to these questions, as they apply to the central part of morality that concerns what we owe to each other. According to his contractualist view, thinking about right and wrong is thinking (...) about what we do in terms that could be justified to others and that they could not reasonably reject. He shows how the special authority of conclusions about right and wrong arises from the value of being related to others in this way, and he shows how familiar moral ideas such as fairness and responsibility can be understood through their role in this process of mutual justification and criticism. Scanlon bases his contractualism on a broader account of reasons, value, and individual well-being that challenges standard views about these crucial notions. He argues that desires do not provide us with reasons, that states of affairs are not the primary bearers of value, and that well-being is not as important for rational decision-making as it is commonly held to be. Scanlon is a pluralist about both moral and non-moral values. He argues that, taking this plurality of values into account, contractualism allows for most of the variability in moral requirements that relativists have claimed, while still accounting for the full force of our judgments of right and wrong. (shrink)

The question of how to handle incidental findings has sparked a heated debate among neuroimaging researchers and medical ethicists, a debate whose urgency stems largely from the recent explosion in the number of imaging studies being conducted and in the sheer volume of scans being acquired. Perhaps the point of greatest controversy within this debate is whether the magnetic resonance imaging scans of all research participants should be reviewed in an active search for pathology and, moreover, whether this search should (...) be performed by a radiologist. Resistance to routine readings performed by radiologists, as opposed to selective review of those scans on which investigators have spotted a possible IF, has been fueled in part by the obvious and enormous cost — financial and logistical — of engaging radiologists to read massive numbers of scans. This cost would be especially burdensome, even prohibitive, to investigators who are not affiliated with a medical center, because of their limited access to radiologists and other medical expertise. (shrink)

Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates. In keeping with the dynamics of the relationship between researcher and subject, they have limited but substantive fiduciary obligations.

Human subject research involving brain imaging is likely to reveal signifcant incidental fndings of abnormal brain morphology. Because of this fact and because of the fduciary relationship between researcher and subject, board-certi-fed or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental fndings may be revealed and what (...) consequences will follow. In the event such fndings are revealed, qualifed physicians should explain to the subject the signifcance of the fndings and the alternatives available. (shrink)

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...) this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

In 1972, the young philosopher Peter Singer published "Famine, Affluence and Morality," which rapidly became one of the most widely discussed essays in applied ethics. Through this article, Singer presents his view that we have the same moral obligations to those far away as we do to those close to us. He argued that choosing not to send life-saving money to starving people on the other side of the earth is the moral equivalent of neglecting to save drowning children because (...) we prefer not to muddy our shoes. If we can help, we must--and any excuse is hypocrisy. Singer's extreme stand on our moral obligations to others became a powerful call to arms and continues to challenge people's attitudes towards extreme poverty. Today, it remains a central touchstone for those who argue we should all help others more than we do. As Bill and Melinda Gates observe in their foreword, in the age of today's global philanthropy, Singer's essay is as relevant now as it ever was. This attractively packaged, concise edition collects the original article, two of Singer's more recent popular writings on our obligations to others around the world, and a new introduction by Singer that discusses his current thinking. (shrink)

As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of (...) incidental findings in imaging research. We conducted an interview study with a purposive sample of researchers at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium. Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

As I write this, in November 1971, people are dying in East Bengal from lack of food, shelter, and medical caxc. The suffering and death that are occurring there now axe not inevitable, 1101; unavoidable in any fatalistic sense of the term. Constant poverty, a cyclone, and a civil war have turned at least nine million people into destitute refugees; nevertheless, it is not beyond Lhe capacity of the richer nations to give enough assistance to reduce any further suffering to (...) very small proportions. The decisions arid actions of human beings can prevent this kind of suffering. Unfortunately, human beings have not made the necessary decisions. At the individual level, people have, with very few exceptions, not responded to the situation in any signihczmt way. Generally speaking, people have not given large sums to relief funds; they have not written t0 their parliamentaxy representatives demanding increased government assistance; they have not demonstrated in the streets, held symbolic fasts, or done anything else directed toward providing thc refugees with the means to satisfy their essential needs. At thc government level, no govcrmmcnt has given the sort of massive aid that would enable the refugees to survive fm: more than a few days. Britain, for instance, has given rather more than most countries. It has, to date, given £14,750,000. For comparative purposes, B1~itain’s share of thc nonreccverabla development costs of the Anglo-French Concorde project is already in excess of £275,000,000, and on present estimates will reach £440,000,¤00. The implication is that the British government values a supersonic transport more than thirty times as.. (shrink)