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Switch to: References
Citations of:
Women and health research: ethical and legal issues of including women in clinical studies
Washington, D.C.: National Academy Press (1994)
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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 (...) |
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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 (...) |
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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. |
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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 (...) |
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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... |
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Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access (...) |
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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 (...) |
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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 (...) |
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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 (...) |
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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 (...) |
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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 (...) |
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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 (...) |
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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 (...) |
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