In response to U.S. Public Health Service projects promoting attention to disparities in the outcomes of mental health treatments, in July 2001, the American Psychological Association, the National Institute of Mental Health, and the Fordham University Center for Ethics Education convened a group of national leaders in bioethics, multicultural research, and ethnic minority mental health to produce a living document to guide ethical decision making for mental health research involving ethnic minority children and youths. This report summarizes the key recommendations distilled from these discussions.
A decade of empirical work in brain imaging, genomics, and other areas of research has yielded new knowledge about the frequency of incidental findings, investigator responsibility, and risks and benefits of disclosure. Straightforward guidance for handling such findings of possible clinical significance, however, has been elusive. In early work focusing on imaging studies of the brain, we suggested that investigators and institutional review boards must anticipate and articulate plans for handling incidental findings. Here we provide a detailed analysis of different approaches to the problem and evaluate their merits in the context of the goals and setting of the research and the involvement of neurologists, radiologists, and other physicians. Protecting subject welfare and privacy, as well as ensuring scientific integrity, are the highest priorities in making choices about how to handle incidental findings. Forethought and clarity will enable these goals without overburdening research conducted within or outside the medical setting.
This book examines the ethical controversies that have surrounded the design and conduct of international medical research sponsored by industrialized countries or industry, and carried out in developing countries. The chief concern is that research subjects in developing countries may be exploited because sponsors of research employ double standards. One debate focuses on whether the standard of care provided to subjects of medical research in developing countries should be the same as what research subjects receive in North America and Europe. Other concerns are whether the process of obtaining informed consent in developing countries is adequate, and whether prior ethical review of research meets standards that are well established in the industrialized world. Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail.
What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. The type of multinational research likely to raise the most ethical concerns is that in which the investigators or sponsors are from a powerful industrialised country or a giant pharmaceutical company and the research is conducted in a developing country. Second is the situation of women, who are made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. In the face of cultural values and practices, or governmental policies, these women suffer serious consequences for their health and even lives. Examples are provided, and it is suggested that in some cases vulnerable individuals can be harmed but not exploited. On the positive side, recent developments reveal a new awareness of exploitation and efforts to enhance the ability of developing countries to protect themselves and their citizens from exploitation at the hands of powerful sponsors of research. In addition, human rights principles are increasingly being used to monitor the actions (or inaction) of governments regarding women's reproductive rights and vulnerability with respect to HIV/AIDS, and to take remedial actions.
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