The IAB Presidential Address was delivered by Alexander Capron to the internationally gathered audience at the Closing Ceremony of the 8th World Congress of Bioethics, Beijing on 9th August 2006.

This article highlights major results of a study into the ethical norms and rules governing biobanks. After describing the methodology, the findings regarding four topics are presented: (1) the ownership of human biological samples held in biobanks; (2) the regulation of researchers’ use of samples obtained from biobanks; (3) what constitutes “collective consent” to genetic research, and when it is needed; and (4) benefit sharing and remuneration of research participants. The paper then summarizes key lessons to be drawn from the (...) findings and concludes by reflecting on the importance of such empirical research to inform future governance norms and practices. (shrink)

Physician aid in dying is a broader topic than euthanasia in that the latter usually refers to active euthanasia, while physician assistance also encompasses the issue of assisted suicide. Volumes could be and have been written on physician-assisted death. But my purpose here is to address a specific aspect of the topic: the policy implications with regard to proposed legislation on physician-aided death.Although the title's reference to physician assistance suggests a focus on the role of the professional, what people often (...) take to be most important and at the heart of the topic is the issue of the patient's rights, usually seen as being manifested in four different ways. First is the right to a dignified death, as free from pain and suffering as possible. In crossing national boundaries and preceding the organization of the professions and the creation of societies, this right is viewed as one that ought to be recognized. (shrink)

People do not choose to suffer from catastrophic illnesses, but considerable human choice is involved in the ways in which the participants in the process treat and conduct research on these diseases. Catastrophic Diseases draws a powerful and humane portrait of the patients who suffer from these illnesses as well as of the physician-investigators who treat them, and describes the major pressures, conflicts, and decisions which confront all of them. By integrating a discussion of "facts" and "values," the authors highlight (...) the forces which affect new developments in medicine—such as kidney and heart transplants—and the controversial issues they generate. Katz and Capron explore these issues through the use of dual conceptual perspectives. Their study first examines and evaluates the authority which should be vested in each of the chief participants in the catastrophic disease process—the physician-investigator, the patient-subject and his relatives, the professionals, and the state. Challenging questions are raised concerning medical education, informed consent, and professional responsibility. The authors next explore how the roles and capacities of the participants vary not only according to the basic issues they face but also according to the point in decision-making at which these issues arise. The process of investigating and treating catastrophic diseases, the authors believe, can thus usefully be divided into three decision-making stages—the formulation of policy, the administration of research and therapy, and the review of the decisions and their consequences. In conclusion, Katz and Capron demonstrate the need for a variety of individuals and groups with diverse values to be involved in decision-making in a manner which will not unnecessarily impede the scientific investigation of these diseases. (shrink)

A few years ago a battered infant was admitted to a California hospital. After a period of observation and testing, the physicians concluded that the infant had been beaten so badly that his brain was almost completely destroyed, leaving him permanently unconscious. The hospital had just adopted a policy specifying that life-sustaining treatment for permanent unconsciousness was futile and, therefore, not indicated. According to this policy, after suitable subspecialty consultations and deliberations, including efforts to gain parental agreement and documentation of (...) unanimous ethics committee support, the patient's physician had the authority to discontinue life-sustaining treatment. The infant's physician wished to do this. The mother, however, who was the prime battery suspect, insisted that the baby be kept alive. (shrink)

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

At every moment, somewhere in the world, a group of men and women are sitting around a table deliberating about an ethical issue posed by medicine and research, whether as a research ethics committee; a hospital or clinical ethics committee; a stem‐cell review committee; a gene transfer research committee; a biobank ethics committee; an ethics advisory committee for a medical or nursing association or nongovernmental organization; a state, provincial, national, or intergovernmental bioethics committee; or an ad hoc panel examining a (...) particular development or case. However, the last national committee in the United States, the Presidential Commission for the Study of Bioethical Issues, held its final meeting at the end of August 2016 and closed its doors. Should we regret its departure? I believe that the United States would benefit from having another national bioethics advisory body, but I do not think that the commission should simply have continued under a new president in the same form. Instead, looking at the experience of that commission and its six predecessors—who they were, how they worked, the functions they served, and the problems they experienced—we can derive some useful ideas for anyone planning to build the next commission. (shrink)

Mea culpa. In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects research adopt “as a common core” the HHS regulations, “while permitting additions needed by any department or agency that are not inconsistent with these core provisions.” The commission believed—rightly, I still think—that having uniformity would ease (...) administration, reduce regulatory burdens, simplify oversight, and make research more efficient. Yet our naïve expectation the task could be accomplished in 180 days meant that we failed to anticipate that if it took much longer—namely, the 10 years that passed before the Common Rule was issued—federal officials would thereafter be reluctant to change the regulations and that when they tried to do so twenty years later, with the issuance of the ANPRM in 2011, they would propose comprehensive revisions. I argue that was the wrong conclusion to draw from the difficulties in issuing the first Common Rule, and that the process of producing the new “final rule” on January 19, 2017—during which many of the proposed changes were either dumped or promulgated without being adequately vetted—reinforces the conclusion that a more incremental process, with ongoing involvement of the public through an advisory body like the President's Commission, would be a much better way to proceed. (shrink)

Proposals to use organs from anencephalic infants to meet the growing need for transplantable ogans are well‐meaning but misguided. It would be unwise to amend the Uniform Determination of Death Act to classify anencephalics as “dead.” They are in the same situation as other patients (such as the permanently comatose). Likewise, amending the Anatomical Gin Act to permit organs to be removed from anencephalics would be unjust would set a bad precedent and would likely reduce overall success in this field.

The Covid‐19 pandemic has brought bioethics back to five topics—justice, autonomy, expert authority, religion, and judicial decisions—that were central during its formative period but has cast a new light on each, while also tangling public health policy in the current, rather radical, reshaping of the role of organized religion in society.