A report by the Nuffield Council on Bioethics, contrary to the Declaration of Helsinki, permits most important research initiatives in developing countries.The Ethics of Research Related to Health Care in Developing Countries by the Nuffield Council on Bioethics makes a number of innovative recommendations that depart from codes such as the Declaration of Helsinki. It recommends that standards of care might be relativised to the standard of that nation. It recommends that very good reasons need to be given for not (...) giving post-trial access to medications but recognises that there may be justifiable instances of this. It is the view of the authors that these and other recommendations of the report are sensible pieces of advice given the complexities of the developing world. (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)

Economic globalization has profound implications for health. The scale of injustice at a global level, reflected in inexorably widening disparities in wealth and health, also has critical implications for health related research – in particular when the opportunities for exploiting research subjects are carefully considered. The challenge of developing universal guidelines for international clinical research is addressed against the background of a polarizing, yet interdependent, world in which all are ultimately threatened by lack of social justice. It is proposed that (...) in such a world there is a need for new ways of thinking about research and its relevance to health at a global level. Responsibility to use knowledge and power wisely requires more radical changes to guidelines for research ethics than are currently under consideration. (shrink)

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.

Despite a high and growing global average income, billions of human beings are still condemned to lifelong severe poverty, with all its attendant evils of low life expectancy, social exclusion, ill health, illiteracy, dependency, and effective enslavement. This problem is solvable, despite its magnitude.

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)

This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...) rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored. (shrink)

This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...) social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)