Despite the attempts to promote the inclusion of pregnant women into clinical research, this group is still widely excluded. An analysis of the “vulnerability of pregnant women” that questions deeply internalized stereotypes is necessary for finding the right balance in the protection of pregnant women as research participants. Criticism of the traditional account of vulnerability will lead to an alternative that focuses on situations rather than groups and on the obligations of responsible parties. The paper adds to the current general (...) discussion of vulnerability and at the same time addresses the specific problem of drug treatment during pregnancy. (shrink)

In this commentary on Eva Feder Kittay's Love's Labor: Essays on Women, Equality, and Dependency, I focus on Kittay's dependency theory. I apply this theory to an analysis of women's inadequate access to high-quality, cost-effective healthcare. I conclude that while quandaries remain unresolved, including getting men to do their share of dependency work, Kittay's book is an important and original contribution to feminist healthcare ethics and the development of a normative feminist ethic of care.

Die Medikamentenversorgung während der Schwangerschaft stellt für die zu behandelnden Frauen und die behandelnden Ärzte gleichermaßen ein Problem dar. Eine „evidence based“ Therapie wirft allerdings die schwierigen Fragen auf, ob und inwiefern Arzneimittelforschung an schwangeren Frauen gerechtfertigt sein könnte und, wenn ja, unter welchen Bedingungen. In meinem Beitrag stelle ich die aktuelle Situation hinsichtlich Forschung und Therapie während der Schwangerschaft dar. Es folgt eine Darstellung von Ergebnissen aus Gesprächen, die mit schwangeren und frisch entbundenen Frauen geführt wurden. Abschließend werden die (...) Kernkonflikte der Debatte diskutiert, und es wird aufgezeigt, dass Arzneimittelforschung an schwangeren Frauen dringend geboten ist. Nur in einer geringen Anzahl von Studientypen ergeben sich tatsächlich problematische Fragen, zu deren Lösung verschiedene Argumentationslinien aufgezeigt werden. (shrink)

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by (...) trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (shrink)

Living organ donation has developed into an important therapeutic option in transplantation medicine. However, there are some medico-ethical problems that come along with the increasing reliance on this organ source. One of these concerns is based on the observation that many more women than men function as living organ donors. Whereas discrimination and differential access have been extensively discussed in the context of cadaveric transplantation and other areas of health care, the issue of gender imbalance in living organ donation has (...) received less attention. This paper presents relevant data from the Eurotransplant and UNOS transplantation systems and discusses possible explanations for the documented gender discrepancies. The conclusion calls for are view of existing practice guidelines in order to secure effective protection of particularly vulnerable potential donors and an equitable donor-recipient-ratio in living organ donation. (shrink)

Rosamond Rhodes (2005) has provided much food for thought in her interesting and provocative article. Probably the most controversial point is her proposal that participation in a research project...

Closed Loop medical devices such as Closed Loop Deep Brain Stimulation and Brain Computer Interface are some of the emerging neurotechnologies. New generations of implantable brain–computer interfaces have recently gained success in human clinical trials. These implants detect specific neuronal patterns and provide the subject with information to respond to these patterns. Further, Closed Loop brain devices give control to the subject so that he can respond and decide on a therapeutic goal. Although the implants have improved subjects’ quality of (...) life, their use has raised varied ethical concerns. The aim of this study is to provide an overview of the ethical implications specific to the therapeutic goals of closed loop brain implants. The authors analyze the related work qualitatively and quantitatively so as to help readers in understanding the various ethical implications of closed loop brain implants. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to compensate (...) and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound. (shrink)

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public’s health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to (...) be expanded in two ways to reflect a ‘public health notion of post-market effectiveness’, which incorporates normative public health considerations: effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize a vaccine’s effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense. (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)

As a consequence of recent changes, health research policies in the United States mandate the inclusion of women and members of racial and ethnic minority groups as experimental subjects in biomedical research. This article analyzes debates that underlie these policies and that concern the medical management of bodies, groups, identities and differences. Much of the uncertainty surrounding these new policies reflects the fact that researchers, physicians, policy makers and health advocates have adopted competing, and often murky, understandings of the nature (...) of sex, gender, racial and ethnic differences, and of the relation of the biological to the social in the manifestation of bodily illness. (shrink)