In financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. (...) Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research. (shrink)

Pressure is mounting to hold researchers and research institutions accountable for the protection of human subjects. When subjects or their family members believe they have been injured, they are increasingly willing to file lawsuits. Recent cases indicate that institutional review boards and their members may be pulled more and more into the legal fray.On September 17, 1999, 18-year-old Jesse Gelsinger died while participating in research conducted by the University of Pennsylvania's Institute for Gene Therapy. Gelsinger was involved in a Phase (...) I clinical trial testing a new approach to treatment of ornithine transcarbamylase deficiency, a rare metabolic disorder. Although infants affected by the severe form of OTC die shortly after birth, Gelsinger suffered from a relatively mild form. It appears undisputed that the cause of Gelsinger's death was not the disorder itself, but multiple organ system failure triggered by the virus used to carry new genetic material into his system. (shrink)

This article focuses on two possible missions for a national bioethics commission. The first is handling differences of worldview, political orientation, and discipline. Recent work in political philosophy emphasizes regard for the dignity of difference manifested in "conversation" that seeks understanding rather than agreement. The President's Council on Bioethics gets a mixed review in this area. The second is experimenting with prophetic bioethics. "Prophetic bioethics" is a term coined by Daniel Callahan to describe an alternative to compromise-seeking "regulatory bioethics." It (...) involves a critique of modern medicine. In the contemporary context, the areas of biotechnology and access to health care cry out for prophetic attention. The Council has addressed biotechnology; unfortunately, that experience suggests that the kind of prophecy that it practices poses risks to conversation. With regard to access issues, the article proposes an effort that unites themes of human dignity, solidarity, and limits in support of reform, while highlighting, rather than papering over, differences. (shrink)