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.
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.
Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles.
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