Covid-19, Free Exercise, and the Changing Constitution.

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.

Looking Back at Withdrawal of Life-Support Law and Policy to See What Lies Ahead for Medical Aid-in-Dying.

Current efforts to legalize medical aid-in-dying in this country follow a half century of remarkable legal developments regarding when, how, and on whose terms to intervene to prevent death and extend life in critically and terminally ill patients. The starting point-which I call the first stage along the path-was the creation in the two decades following World War II of powerful means of keeping very ill, and typically unconscious, patients alive. The second stage began in the late 1960s as physicians (and then others in society) began to grapple with the consequences of maintaining such patients on life-support indefinitely. Over five decades, judicial decisions, followed by implementing statutes and regulations, transformed legal rights and medical practices. Are the current developments-which center on legalizing medical aid-in-dying-a third stage along the same path, or do the striking differences between the issues raised about life-sustaining treatment and euthanasia suggest that they are separate? What lessons might those proceeding along the aid-in-dying path take from the development of the other path, and if the two paths are still distinct today, might they merge in the future?

Henry Knowles Beecher, Jay Katz, and the Transformation of Research with Human Beings.

The modern history of experimentation with human beings is notable for its ethical lacunae, when even the clearest directives fail to prevent violations of subjects' rights and welfare. One such lacuna occurred during the 25 years between 1947, when the Nuremberg Code was articulated in the judgment passed on the men who had performed medical experiments in the Nazi concentration camps, and 1972, when the revelation of the 40-year-long Tuskegee Syphilis Study shocked the public and pushed Congress to adopt legislation that eventually transformed the governance of human subjects research. The work that Henry Beecher and Jay Katz did on the ethics of human experimentation beginning in 1964-which was mutually supportive but also divergent in its premises and prescriptions-played a prominent role in the policy-making processes. Beecher, whose detailed disclosure of the ethical lapses of leading researchers in his renowned 1966 New England Journal of Medicine article initiated the policy reform process, proved less influential in shaping those reforms than Katz. Ultimately, Beecher was one of the last and best exemplars of "medical ethics," while Katz-in his service on the Tuskegee Syphilis Study Ad Hoc Advisory Panel and in his testimony before, and work with, the Senate Health subcommittee-was an early practitioner of bioethics, a field in which the rules are not all written and applied by the medical profession but arise through a messier process involving outsiders and formal regulatory decisions.

Stimulating and Enhancing Partnerships Between Transplant Professionals and Law Enforcement: Recommendations.

To help combat trafficking in human beings for organ removal (THBOR), transplant professionals need to do more than carry out careful, multidisciplinary screening of potential living donors; they also need to communicate and collaborate with law enforcement professionals. This will involve transplant professionals educating investigators and prosecutors about transplant practices and in turn learning about THBOR and how it is prosecuted. Cases of illegal organ transplantation need to be detected at different levels. First, the victims of the crime itself need to be identified, especially when they present themselves for screening. Physicians have a collective responsibility to prevent exploitation of people, including THBOR victims. The second level involves the more difficult matter of making reports that involve transplant tourists who have returned home after receipt of an organ and need follow-up care. Besides counseling patients prospectively about the legal as well as medical risks in receiving a vended organ in a foreign transplant center, physicians treating such patients could have an obligation to report what has happened, if the government has established a mechanism that either allows reporting THBOR that does not include the identity of the patient or that treats patients as victims provided they cooperate in investigation and prosecution of the persons responsible for obtaining or implanting the organs. The third level of cooperation involves transplant professionals who participate in THBOR. Professional societies need to undertake programs to make physicians and nurses aware that their responsibility to protect their professions' reputation includes identifying members of their professions who depart from professional ethics. Doing so allows the local professional societies and state boards to discipline such violators. All 3 of these functions would be facilitated by the creation by an international body such as World Health Organization of a registry of patients who travel internationally to receive a legitimate organ transplant.

Statement of the Declaration of Istanbul Custodian Group Regarding Payments to Families of Deceased Organ Donors.

Governmental and private programs that pay next of kin who give permission for the removal of their deceased relative's organs for transplantation exist in a number of countries. Such payments, which may be given to the relatives or paid directly for funeral expenses or hospital bills unrelated to being a donor, aim to increase the rate of donation. The Declaration of Istanbul Custodian Group-in alignment with the World Health Organization Guiding Principles and the Council of Europe Convention Against Trafficking in Human Organs-has adopted a new policy statement opposing such practices. Payment programs are unwise because they produce a lower rate of donations than in countries with voluntary, unpaid programs; associate deceased donation with being poor and marginal in society; undermine public trust in the determination of death; and raise doubts about fair allocation of organs. Most important, allowing families to receive money for donation from a deceased person, who is at no risk of harm, will make it impossible to sustain prohibitions on paying living donors, who are at risk. Payment programs are also unethical. Tying coverage for funeral expenses or healthcare costs to a family allowing organs to be procured is exploitative, not "charitable." Using payment to overcome reluctance to donate based on cultural or religious beliefs especially offends principles of liberty and dignity. Finally, while it is appropriate to make donation "financially neutral"-by reimbursing the added medical costs of evaluating and maintaining a patient as a potential donor-such reimbursement may never be conditioned on a family agreeing to donate.

Ethical norms and the international governance of genetic databases and biobanks: findings from an international study.

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.

Imagining a new world: using internationalism to overcome the 10/90 gap in bioethics.

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.

International perspectives on the ethics and regulation of human cell and tissue transplantation.

The transplantation of human cells and tissues has become a global enterprise for both life-saving and life-enhancing purposes. Yet current practices raise numerous ethical and policy issues relating to informed consent for donation, profit-making, and quality and safety in the procurement, processing, distribution, and international circulation of human cells and tissues. This paper reports on recent developments in the international debate surrounding these issues, and in particular on the attention cell and tissue transplantation has received in WHO's ongoing process of updating its 1991 Guiding principles on human organ transplantation. Several of the organizers of an international working group of stakeholders from a wide range of backgrounds that convened in Zurich in July 2006 summarize the areas of normative agreement and disagreement, and identify open questions regarding facts and fundamental concepts of potential normative significance. These issues must be addressed through development of common medical, scientific, legal and ethical requirements for human cell and tissue transplantation on a global basis. While guidance must accommodate the distinct ethical issues raised by activities involving human cells and tissues, consistency with normative frameworks for organ transplantation remains a prime objective.