Ethics guidelines for research with the recently dead.

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

International stem cell tourism and the need for effective regulation. Part II: Developing sound oversight measures and effective patient support.

Part I of this article, published in the March 2010 issue of the Kennedy Institute of Ethics Journal, traces and addresses the provision of unproven stem cell treatments in Russia and India, examines the concept of innovative treatment, and concludes that stronger regulations are needed to protect the health and informed choices of patients. The current paper, Part II, proposes that the regulatory frameworks for the development of safe and efficacious treatments in effect in the United States and the United Kingdom provide examples of strong oversight measures from which countries seeking to obtain international credibility for their biotechnological competence could draw when developing regulations for stem cell treatments. Major sources of information available to persons who consider receiving such unproven treatments are explored in order to understand and address their concerns. The paper concludes with proposed measures to inform those considering the pursuit of unproven stem cell treatments abroad more accurately about their efficacy and safety and provide them with improved medical and social support in their home countries.

International stem cell tourism and the need for effective regulation. Part I: Stem cell tourism in Russia and India: clinical research, innovative treatment, or unproven hype?

Persons with serious and disabling medical conditions have traveled abroad in search of stem cell treatments in recent years. However, weak or nonexistent oversight systems in some countries provide insufficient patient protections against unproven stem cell treatments, raising concerns about exposure to harm and exploitation. The present article, the first of two, describes and analyzes stem cell tourism in Russia and India and addresses several scientific/medical, ethical, and policy issues raised by the provision of unproven stem cell-based treatments within them. The distinction between treatment based on proven clinical research and "innovative treatment" is addressed and the authors conclude that the innovations at issue constitute neither. Regulatory measures need to be developed or strengthened in accord with internationally accepted standards in such countries to protect those seeking stem cell treatments.

Ethical issues regarding fertility preservation in adolescents and children.

Certain forms of treatment for cancer in children and adolescents may significantly affect their fertility. Oncologists and specialists in reproductive medicine are attempting to use various methods of fertility preservation to address this problem. However, major medical/biological issues must be resolved before many of these methods can be considered accepted medical treatments. In addition, ethical considerations that such treatments bring to the fore, including those relevant to assent by children and the provision of experimental treatment to children, must be taken into account. This article addresses the current and future medical and ethical status of the development of fertility-preserving treatment for adolescents and children who are to receive cancer treatment.

Promises and perils of public deliberation: contrasting two national bioethics commissions on embryonic stem cell research.

National bioethics commissions have struggled to develop ethically warranted methods for conducting their deliberations. The National Bioethics Advisory Commission in its report on stem cell research adopted an approach to public deliberation indebted to Rawls in that it sought common ground consistent with shared values and beliefs at the foundation of a well-ordered democracy. In contrast, although the research cloning and stem cell reports of the President's Council on Bioethics reveal that it broached two different methods of public deliberation--balancing goods and following an overarching moral principle--it adopted neither. Thereupon its primer mover, Leon Kass, influenced particularly by the approach of Leo Strauss, sought to develop a method of public deliberation guided by tradition and practical wisdom. When this failed, the Council fell back on a method that took account of shared fundamental values of a free democracy--a method remarkable akin to that employed by the National Bioethics Advisory Commission. Respect for diverse reasonable conceptions of the good in a democratic polity requires national bioethics commissions to seek and incorporate that which is valuable in opposing positions.

Developing human-nonhuman chimeras in human stem cell research: ethical issues and boundaries.

The transplantation of adult human neural stem cells into prenatal non-humans offers an avenue for studying human neural cell development without direct use of human embryos. However, such experiments raise significant ethical concerns about mixing human and nonhuman materials in ways that could result in the development of human-nonhuman chimeras. This paper examines four arguments against such research, the moral taboo, species integrity, "unnaturalness," and human dignity arguments, and finds the last plausible. It argues that the transfer of human brain or retinal stem cells to nonhuman embryos would not result in the development of human-nonhuman chimeras that denigrate human dignity, provided such stem cells are dissociated. The article provides guidelines that set ethical boundaries for conducting such research that are consonant with the requirements of human dignity.

The ethics of human reproductive cloning: when world views collide.

Two camps in bioethics with seemingly opposing world views have staked out conflicting positions regarding the ethics of human reproductive cloning. These camps do not appear to share common concepts or ways of reasoning through which to exchange views and come to a meeting of minds about uses of this technology. Yet analysis of their respective approaches to several issues surrounding reproductive cloning, such as where the ethical limits of individual reproductive choice lie, whether the use of this technology would violate human dignity, whether it would create risks to the resulting fetuses and children that would make its use intolerable, and whether it would challenge certain core social values, reveals that they are not wholly opposed to one another. Indeed, it displays that they hold certain beliefs, values, and concerns in common. Moreover, it indicates that the different world views that they each presuppose, while flawed in certain respects, do not collide in every respect, but can be reconciled in significant ways that provide fertile ground for agreement about several issues related to human reproductive cloning.

Responding to requests regarding prayer and religious ceremonies by patients near the end of life and their families.

Prayer and religious ceremonies may help patients near the end of life and their relatives find comfort and discover meaning in their lives. In this paper, we analyze how physicians might respond in two situations regarding prayer and religious ceremonies. First, how should physicians respond when such patients or their families ask physicians to pray for them or with them? Physicians' responses to such requests will depend on their own religious and spiritual beliefs, the congruence of their beliefs with those of the patient and family, and their relationship with the patient. Many physicians may be willing to be present and stand silently while the patient prays. Second, how should physicians respond when such patients and families seek to carry out their religious and spiritual practices in the hospital? Religious ceremonies can provide meaning, hope, and solace to patients and families. Institutional guidelines regarding religious ceremonies should allow as much leeway as is compatible with good care both for the patient for whom the ritual is offered and also for other patients within the facility. Physicians should inquire whether there are religious and spiritual practices that patients and families would like to engage in. However, physicians should be cautious about recommending specific ceremonies or pratices. Physicians can respond to requests and respect patients' spiritual needs in ways that may deepen the therapeutic doctor-patient relationship, without compromising their own religious and spiritual beliefs or professional roles.

Wrestling with the future: should we test children for adult-onset genetic conditions?

Genetics professionals have been reluctant to test children for adult-onset conditions because they believe this would create psychosocial harm to children not counterbalanced by significant benefits. An additional concern they express is that such testing would violate the autonomy of these children as adults. Yet weighing the harms and benefits of such testing results in a draw, with no substantial harms proven. Moreover, such testing can enhance, rather than violate the adult autonomy of these children. In deciding whether to proceed with predictive testing of children, parents, mature children, and health care professionals should consider a complex of factors relevant to the particular child. The importance of these factors will vary depending on the condition at issue, the age and stage of development of the child, family dynamics, and the concerns, values, and objectives of the parents and mature child. The final decision whether to test a child for an adult-onset condition should rest with the parents and the mature child.

Public policy and the sale of human organs.

Gill and Sade, in the preceding article in this issue of the Kennedy Institute of Ethics Journal, argue that living individuals should be free from legal constraints against selling their organs. The present commentary responds to several of their claims. It explains why an analogy between kidneys and blood fails; why, as a matter of public policy, we prohibit the sale of human solid organs, yet allow the sale of blood; and why their attack on Kant's putative argument against the sale of human body parts is misplaced. Finally, it rejects the claim that the state is entitled to interfere with the actions of individuals only if such actions would harm others. We draw certain lines grounded in what Rawls has termed "public reason" beyond which we do not give effect to the autonomous self-regarding decisions of individuals. Public resistance to the sale of human body parts, no matter how voluntary or well informed, is grounded in the conviction that such a practice would diminish human dignity and our sense of solidarity. A system of organ donation, in contrast, conveys our respect for persons and honors our common humanity.

Can autonomy and equity coexist in the ICU?

KIE: Cohen reviews two collections of essays on ethical issues in critical care medicine: Ethics and Critical Care Medicine, edited by John C. Moskop and Loretta Kopelman (D. Reidel; 1985), and "Ethical Moments in Critical Care Medicine," a symposium issue of Critical Care Clinics, edited by James P. Orlowski and George A. Kanoti (1986 Jan; 2(7): 189 p.). Some of the topics discussed by the contributors include physician beneficence vs. patient autonomy in critical care decision making; the pressures created by the "rescue ethos" of the critical care setting; the selection of patients for admission to intensive care; the equitable distribution of critical care resources; and the increasing need to factor costs into treatment decisions. E. Cassell, E.D. Pellegrino, J. Katz, D. Walton and N. Donen, J. Moskop, J. Perrin, H.T. Engelhardt, R. Veatch, J. Paris and F. Reardon, S. Youngner, and S. Imbus and B. Zawacki are among the essayists.^ieng

Ethics committees -- 1990 and beyond: the genie out of the bottle?

KIE: The "Ethics committees" column in this issue of the Hasting Center Report features an introduction by Cynthia B. Cohen and four brief commentaries on the roles hospital ethics committees may play in the making of institutional and public health care policy in the 1990s. The implications for ethics committees of the pending federal Patient Self-Determination Act are discussed by John C. Fletcher in "The Patient Self-Determination Act: yes," and by Alexander Morgan Capron in "The Patient Self-Determination Act: not now." The pros and cons of a broader, more public role for ethics committees in reconciling the business and patient care aspects of health care delivery are debated by Cohen in "Ethics committees as corporate and public policy advocates," and by Philip Boyle in "Business ethics in ethics committees?" News items by Thomasine Kushner ("Networks across America") and Todd Sagin ("The Philadelphia story") conclude the column.^ieng