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)

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)

In the article “A Conceptual Model for the Translation of Bioethics Research and Scholarship,” Debra Mathews and her colleagues want to apply to bioethics various translational concepts developed for biomedical research. According to experts in translational science, this would mean evaluating not only the extent to which research produces the “changes in thinking, practice, and policy” that interest Mathews et al. but also the appropriateness of bioethics training and the level of competency of people working in the field. Their proposal (...) thus raises two sets of questions. The first, which the authors recognize must be the starting point for their argument, is, what precisely is the field in question? The second is whether the tools of translational science provide the right means of measuring the achievements of bioethics. (shrink)

Does the practice of questioning the decision-making capacity of patients who disagree with recommended medical interventions amount to paternalism on the part of physicians who would not have raised questions about competence had these patients accepted the recommendation? Brudney and Siegler provide a nuanced argument why the practice can be both pragmatically and ethically justifiable, particularly if physicians follow a “decision tree” that they recommend for cases where disagreements occur. Nonetheless, the history of this subject shows that bioethicists have long (...) been worried that the “outcome approach” (challenging patient’s capacity because of substantive disagreements with their choices) undermines respect for autonomy, and the more refined version from Brudney and Siegler still creates some further concerns about the resulting inadequacies in communication and comprehension in the physician-patient relationship. (shrink)

Five decades ago, Henry Knowles Beecher, a renowned professor of research anesthesiology, sought to solve a problem created by modern medicine. The solution proposed by Beecher and his colleagues on the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proved very influential.1 Indeed, other contemporaneous medical developments magnified its significance yet also made the solution it offered somewhat problematic. As we mark this fiftieth anniversary, at a time when concerns about the conceptual model (...) on which its recommendations rested are being voiced by critics from medicine as well as philosophy, it is worthwhile to view the committee's report in relation to the problem that prompted its existence as well as the one to which it was quickly applied. (shrink)

Public health law courses typically focus a good deal of attention on two related topics: the duty of government agencies to control the spread of communicable diseases and their use of the police power to do so. While governments sometimes take forceful actions in responding to disease outbreaks, they can also act to prevent their occurrence. Indeed, one of the great triumphs of public health in the 20th century was the development of vaccines and their widespread use, which seemed on (...) course to relegate many formerly crippling or deadly diseases to the history books. Particular success occurred with vaccinations against childhood diseases such as polio, smallpox, and measles, outbreaks of which once routinely closed schoolrooms, playgrounds, and community swimming pools. By the last quarter of the century, completion of an elaborate schedule of immunizations was not merely the standard in pediatric practice but an official requirement for school enrollment. As a result, the range of communicable diseases that had once terrified parents had become threats to be feared only in memory. (shrink)

Biomedical and behavioral research is a complex, multidisciplinary, and highly varied enterprise with but a single goal: to produce and disseminate knowledge about the causes, effects, prevention, diagnosis, and treatment of human illnesses and impairments. Success requires public trust in the process. When that trust has been shaken (or worse), the response has been to establish offices to exercise oversight of the various actors and to require them to adhere to regulations that specify, with various levels of detail, what they (...) may or may not do.The two regulatory frameworks examined in this report by Barbara Bierer and Mark Barnes began separately, provoked by different scandals and abuses of public trust. (shrink)