Carl H. Coleman

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

The contribution of ethics to public health

While ethics in health care dates back at least to the times of Hippocrates, Sun Si Miao,1 and Ibn Sina (Avicenna),2 the field of “bioethics” did not emerge until after World War Two. The birth of bioethics was stimulated by a confluence of factors. First, the Nazis’ medical experiments on concentration camp prisoners heightened concerns about the vulnerability of human subjects in medical research. Second, rapid advances in medicine, including reproductive health, organ transplantation and genetics, raised questions about the purpose and limits of medical technology. Third, post-war civil rights movements led to growing attention to the power imbalances between physicians and patients and the corresponding need to empower patients to control their own health-care decisions. In recent years, there have been efforts to broaden the scope of ethical analysis in health care to focus more directly on public-health issues.3 In contrast to the traditional emphasis of bioethicists on the physician–patient relationship, public-health ethics focuses on the design and implementation of measures to monitor and improve the health of populations. In addition, public-health ethics looks beyond health care to consider the structural conditions that promote or inhibit the development of healthy societies. From a global perspective, key issues in public health ethics include the following: Disparities in health status, access to health care and to the benefits of medical research – For example, questions about resource allocation depend in part on value judgments about the relative importance of small improvements in quality of life for a large portion of the population as compared with a life-saving intervention that would benefit only a few people. Responding to the threat of infectious diseases – Efforts to contain the spread of infectious diseases raise difficult questions about the appropriateness of restricting individual choices to safeguard other people’s welfare. Examples include the use of isolation and quarantine for tuberculosis and pandemic influenza. International cooperation in health monitoring and surveillance – The implementation of the International Health Regulations4 reflects the commitment of countries to collective action in the face of public-health emergencies. Defining the scope of countries’ obligations to act collectively, and determining how those obligations should be enforced, will inevitably raise difficult ethical dilemmas. Exploitation of individuals in low-income countries – Current practices in medical research, for example, may expose participants to significant risks without a benefit for themselves or their communities. Defining and enforcing foreign research sponsors’ obligations to local participants is therefore a critical ethical issue. In the area of organ transplantation, the growing practice of “transplant tourism” exposes individuals living in poverty to significant health risks while also raising broader questions about the commodification of the human body. Health Promotion – The growing public-health threats of noncommunicable diseases, including those caused in part by unhealthy behaviours such as smoking, poor diet or lack of exercise, have raised the question of the extent to which public-health authorities should interfere with personal choices on health. Participation, transparency, and accountability – As an ethical matter, the process by which decisions are made is as important as the outcome of the decisions. In the area of medical research, much attention has been devoted in recent years to strengthening systems for informed consent and community oversight. Once such systems are in place, the next step will be to develop mechanisms for evaluating their effectiveness. Since it was founded 60 years ago, ethics has been at the heart of WHO’s mission to protect and promote the global community’s health. Activities in ethics have been undertaken by many programmes and departments, as well as WHO’s regional offices. For example, in 1994, the Regional Office for the Americas (AMRO/PAHO) created a regional programme on bioethics5,6 In 2002, WHO’s Director-General Dr Gro Harlem Brundtland created an Ethics and Health Initiative, which has since served as a focal point for the ethics activities throughout the organization. Examples include the publication of Guidance on ethics and equitable access to HIV treatment and care (jointly with UNAIDS)7 and of Ethical considerations in developing a public health response to pandemic influenza.8 WHO also contributes to regional capacity-strengthening efforts in ethics, in close collaboration with Member States. For example, the project Networking for Ethics on Biomedical Research in Africa (NEBRA) sought to strengthen African countries’ capacity to engage in effective ethical review processes.9 Articulating ethical and evidence-based policy options is one of WHO’s six core functions.10 WHO’s 60th anniversary and the 30th anniversary of Alma-Ata provide a particular opportunity to reflect on ethical values and dilemmas arising in the field of public health. ■

Potential penalties for health care professionals who refuse to work during a pandemic.

THE SEVERE ACUTE RESPIRATORY SYNDROME (SARS) EPIdemic and the spread of avian influenza have generated renewed interest in health care professionals’ (HCPs’) obligations to work during a pandemic. However, most discussions of this issue have occurred on a relatively abstract level of ethical analysis, with less attention to what should actually happen to HCPs who are unwilling to work. Should HCPs who refuse to work be fired from their jobs? Should they lose their licenses? Should they go to jail? It is a real possibility that some HCPs may refuse to work during a pandemic. Working during pandemics could place HCPs—and, by extension, their families—at significant risk of infection. Protective measures like masks may reduce the risk, but some HCPs were infected during the SARS crisis even after such measures were implemented. Even though most HCPs continued to work during the SARS epidemic despite the risks, survey results indicate that a substantial number of HCPs would be unwilling to work under comparable conditions. This commentary argues that the penalties for refusing to work during a pandemic should be limited to those an HCP would face for refusing to treat patients with contagious infections in nonpandemic situations. This argument is important because some states, such as Maryland and South Carolina, have enacted laws that authorize license revocations, fines, or even imprisonment for HCPs who disobey public health officials’ orders to work during public health emergencies. These penalties would apply even to HCPs whose occupations do not ordinarily encompass clinical responsibilities, or to HCPs who are not currently part of the workforce—for example, physicians or nurses who are taking time off from work to care for their children. These laws seem unjustified.

Guidelines for Physician‐Assisted Suicide: Can the Challenge Be Met?

he question of legalizing physician-assisted suicide (PAS) has become a serious public debate. GrowT ing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS,’ many physicians have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.2 As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients;j a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted.4 Proposals to legalize assisted suicide are also pending in at least a dozen state legislatures.’ More significant, two federal appellate courts recently concluded that absolute prohibitions on assisted suicide violate the constitutional rights of competent, terminally ill patients who wish to hasten death.h If the United States Supreme Court affirms one or both of these decisions, absolute prohibitions against assisted suicide may no longer be enforceable in any state. Even if the Court reverses both decisions, states would remain free to legalize assisted suicide through legislation, referenda, or judicial interpretation of state constitutional guarantees.

Closing the gaps in genetics legislation and policy: a report by the new york state task force on life and the law.

The New York State Task Force on Life and the Law, a state bioethical policy commission, recently completed a project addressing the ethical, legal, and social concerns surrounding the predictive uses of genetic testing. Its report, Genetic Testing and Screening in the Age of Genomic Medicine, makes legislative, public policy, and practice recommendations on a host of issues. As part of this project, the Task Force reviewed the current policy and legislative landscapes related to confidentiality protections for genetic information and the use of genetic information by insurers. It also assessed requirements for informed consent to clinical genetic testing and for the use of clinical samples for genetics research. The Task Force considered gaps and unintended consequences of relevant genetic testing legislation and assessed its flexibility to address new uses of genetic testing, such as pharmacogenetic testing, and new ways of offering tests, such as multiplex testing panels. The Task Force also considered the relevance of the pleiotropic characteristic of genes for issues of informed consent to genetic testing and the confidentiality of genetic information. The Task Forces recommendations, presented here, seek to promote the appropriate uses of clinical genetic testing and research while preventing potential harms.

The “Disparate Impact” Argument Reconsidered: Making Room for Justice in the Assisted Suicide Debate

The partnership that has developed over the years between elected officials, health directors, and attorneys came about through necessity and practicality. This article examines this partnership and some of the conflicts and problems it contains. The article discusses the problems of overlap of authority between public health departments and elected officials. It also emphasizes that existing laws and regulations often provide sufficiently flexible authority, and that such laws and regulations can be exercised in new ways to address current public health problems. The article concludes with a discussion of the challenges faced by public health officials and legislators in forming a partnership to secure necessary financial support and legal authority for public health activities. Language: en

Developing public policy on assisted reproductive technologies: reflections on the work of the new york state task force on life and the law∗ ∗

In April 1998, the New York State Task Force on Life and the Law released a 474-page report examining the clinical, legal, and ethical issues raised by developments in assisted reproductive technologies (ARTs) (1). The Task Force, a nonpartisan advisory commission, was created by executive order in 1985 and is charged with developing public policy on issues arising from medical advances. The 24 Task Force members, who serve without compensation, include leaders in the health care professions, law, and bioethics, as well as patient advocates and representatives of diverse religious communities. Seven of the Task Force’s proposals have been enacted into law in New York State. Task Force recommendations also have been embraced as models for legislation in other states and have been cited in numerous judicial decisions (2–6).

How should ethics be incorporated into public health policy and practice

The ethical obligations of those who work for health are as old as the health professions themselves; indeed, the commitment to place the interests of clients above all else is one of the hallmarks of professionalism. Ethical prescriptions are found in many cultures, such as the oath and associated writings of Hippocrates in ancient Greece and the writings of the medieval Jewish philosopher Maimonides. Though originating with the professions, ethical duties are of concern to society in general, and their violation – as by the doctors who conducted experiments in the Nazi prison camps – can constitute human rights as well as ethical violations. In response to the tremendous expansion of the powers of medicine and biomedical science in the 20th century, the new field of bioethics emerged in the 1960s, first in North America and western Europe and eventually around the world. With contributions not only from moral philosophers but also from physicians, nurses and other health professionals, social and natural scientists and lawyers, bioethics has become a field of major concern. Health professionals, health authorities and the public debate the issues raised by organ and tissue transplantation, unequal access to life-saving medicines, new reproductive technologies and vast increases in the numbers and types of clinical trials. While abundant analysis and official guidelines have been produced on most of the ethical issues in health care and research, until recently the field of public health received relatively little attention among ethicists. Similarly, while ethical questions have always been an implicit part of public health practice, the idea of incorporating a formal process of ethical deliberation into public health policy-making remains relatively new. As the ethics of public health receives greater attention, new paradigms and methods of ethical analysis will have to be developed. In particular, whereas medical ethics has traditionally aimed to protect individual interests in the context of the physician–patient relationship, public health ethics focuses on the design and implementation of measures to monitor and improve the health of broader populations. In addition, public health ethics must look beyond health care per se to consider the structural conditions, and social and economic determinants that promote or inhibit the development of healthy societies. Incorporating ethical analysis into public health raises many challenging questions. For example, what does ethical analysis add to public health beyond legal or public policy analysis? Is the law itself subject to a process of ongoing ethical scrutiny? When ethicists appeal to “values”, who gets to decide which values are worthy of protection or how these values should be prioritized in cases of conflict? How should ethical analysis address the tension between universal principles and culturally specific values, and find common ground among individuals from diverse cultural backgrounds? Such questions have practical implications for how public health policies are designed, implemented and evaluated. For example, when public health authorities make decisions about allocating limited resources, they will implicitly or explicitly determine which principles and values underlie those decisions. Such decisions also vary according to the processes by which they are made and to what extent the public, nongovernmental and international organizations, and national or regional governments participate in these processes. A Bulletin theme issue, to be published in August 2008, will provide a forum for examining these and related issues. The goal of this theme issue is to explore how ethical considerations have been and should be incorporated into decision-making about public health issues. The Bulletin encourages the submission of papers covering practical examples that illustrate how ethical questions have been addressed at the domestic and international levels. For example, how have governments or professional associations used ethical analysis to evaluate health-care workers’ obligations during influenza pandemics? What does ethics have to say about the use of financial incentives to increase the supply of organs for transplantation? In general, we seek to publish specific examples of structures and processes that have been used for ethical deliberation, combined with a candid examination of these options’ advantages and drawbacks. Contributions from authors from developing countries are particularly welcome. It is hoped that the papers in this issue will help national policy-makers reflect on the need to consider ethics in formulating and implementing health policies, while also providing best practices that can be adapted to specific national contexts. The issue will provide a forum for units at WHO headquarters and regional offices that have engaged in ethical analysis of their programmes to share their work. Finally, the empirical basis of the papers will provide much-needed data about global efforts to address ethical issues and the impact these efforts are having on the health of populations. The deadline for submissions is 11 January 2008. All submissions will go through the Bulletin’s peer review process. ■

Is there a constitutional right to preconception sex selection

(2001). Is There a Constitutional Right to Preconception Sex Selection? The American Journal of Bioethics: Vol. 1, No. 1, pp. 27-28.

Stemming the Tide: Assisted Suicide and the Constitution

n November 8,1994, Oregon became the first state in the nation to legalize assisted suicide. Passage 0 of Proposition 16 was a milestone in the campaign to make assisted suicide a legal option. The culmination of years of effort, the Oregon vote followed on the heels of failed referenda in California and Washington, and other unsuccessful attempts to enact state laws guaranteeing the right to suicide assistance. Indeed, in 1993, four states passed laws strengthening or clarifying their ban against assisted suicide.’ No doubt, Proposition 16 is likely to renew the effort to legalize assisted suicide at the state level. The battle over assisted suicide is also unfolding in the courts. Litigation challengmg Proposition 16 on the grounds that it violates the equal protection clause is ongoing in Oregon.2 More significantly, three cases, two in federal courts and one in Michigan state court, have been brought to establish assisted suicide as a constitutionally protected right. These three cases have yielded important rulings that foreshadow the ultimate resolution of this issue by the United States Supreme Court. The federal lawsuit challenging Washington State’s law barring assisted suicide as unconstitutional, Compassion in Dying v. State of Washington, resulted first in a much-publicized district court ruling striking down the law.3 O n March 9, 1995, the United States Court of Appeals for the Ninth Circuit overturned that decision, holding that a right to assisted suicide is not protected by the United States Con~titution.~ In a similar lawsuit challenging New York‘s laws prohibiting assisted suicide, Quill v. Koppell, the district court upheld the statutes, dismissing the lawsuit after a preliminary hearings The Michigan Supreme Court decision was a consoli-