Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Our society's practice of inadequately representing women as subjects of clinical research is unjust, not only because it results in inequalities in the quality and availability of care that have a detrimental impact on women's health, but also because it is linked to women's oppression. Although recent policy changes help to resolve the problems, more must be done. Additional remedies for the injustices of our society's research practices are proposed.

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)

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)

There is significant evidence that the health needs of women and minorities have been neglected by a medical research community whose agendas and protocols tend to focus on more advantaged segments of society. In response, the National Institutes of Health and Food and Drug Administration in the United States have recently issued new policies aimed at increasing the utilization of women in clinical studies. As well, the U.S. Congress passed the NIH Revitalization Act of 1993, which specifically mandates increased inclusion (...) of women and racial and ethnic groups in clinical studies. On the face of it, such gender and race-specific policies would appear to be morally problematic because traditionally ethics opposes the use of sex or race as legitimate criteria for distributions of benefits or burdens in social policies. Hence, these policies pose some significant moral questions. Feminist ethics provides us with a framework for evaluating such policies because of its readiness to recognize that socially and politically significant factors such as sex and race are morally relevant in setting public policy. Of course, feminist ethics does not simply endorse all appeals to sex and race but only the policies in which attention to such factors will contribute to social justice. In this essay, I Identify some of the Important ethical questions that a feminist ethics perspective raises about research policies devised to promote the Inclusion of women in clinical studies. (shrink)