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PubMed2001

The presence and influence of religion in American bioethics.

From the inception of the relatively short history of American bioethics in the mid-to-late 1960s, the place of religion in this field has been complex and controversial. It has also been a subject of more than casual interest and concern to bioethicists, and to an array of medical and non-medical groups in U.S. society for whom the activities and issues in which bioethics is engaged have ongoing import. The questions and the tensions linked to the status and influence of religion in the sphere of bioethics have ramifications that extend beyond bioethics and biomedicine into matters involving the relationship of religion to the institutional structure of American society--most particularly its political, legal foundations, and realm of public affairs--and to its cultural attributes and tradition. It is within this larger perspective that we will consider the association between American bioethics and religion. Our analysis includes two case studies: (1) how, in the early years of bioethics, a pioneering organization in the field dealt with the "redefinition of death" in its discussions and in a major medical journal publication; and (2) the way in which the most recently appointed federal bioethics commission, the National Bioethics Advisory Commission, involved religion in its work on cloning and stem cell research.

Attitude to Death↗
PubMed2005

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.

Advisory Committees↗
PubMedDate not supplied

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices.

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.

Biomedical Research↗
PubMed2004

Ethical review of health research: a perspective from developing country researchers.

BACKGROUND: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs). METHODS: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations. RESULTS: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. CONCLUSION: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.

Academic Medical Centers↗
PubMedDate not supplied

Research involving persons with mental disorders that may affect decisionmaking capacity.

In December 1998, the US National Bioethics Advisory Commission (NBAC) published the above-named report. The committee made twenty-one recommendations, some of which provide a set of requirements that NBAC believes should be satisfied in all research involving persons with mental disorders, while some are optional protections, that may be considered appropriate, depending on the particular circumstances of the research. The full recommendations are reprinted below.

Advisory Committees↗
PubMed2006

Diversity and deliberation: bioethics commissions and moral reasoning.

This article considers the sort of diversity in perspective appropriate for a presidential commission on bioethics, and by implication, high-level governmental commissions on ethics more generally. It takes as its point of comparison the respective reports on human cloning produced by the National Bioethics Advisory Commission, appointed by President Bill Clinton, and George W. Bush's President's Council on Bioethics, under the leadership of its original chair, Leon Kass. I argue that the Clinton Commission Report exemplifies forensic diversity (the type of diversity between contesting parties in a legal case), while the Kass Council Report exemplifies academic diversity (the diversity found in a medieval disputatio). Drawing upon Thomas Aquinas, I argue that the type of diversity most appropriate for such advisory bodies is deliberative diversity, which facilitates the President's process of taking counsel. After considering their respective charges, I suggest that neither the Clinton Commission nor the Kass Council possessed an adequate degree of deliberative diversity for their respective tasks.

Advisory Committees↗
PubMedDate not supplied

Human stem cell research: some controversies in bioethics and public policy.

In the United States, controversy has raged about ethical public policies toward some potential sources of human stem cells for research, particularly human embryos left over from in vitro fertilization (IVF) or created through somatic cell nuclear transfer. This article critically examines the ethical and policy issues, particularly as they have emerged in the reports and recommendations of two presidentially appointed advisory bodies: The National Bioethics Advisory Commission (NBAC) and the President's Council on Bioethics (PCB).

Bioethics↗
PubMed2000

Of clones, stem cells, and children: issues and challenges in human research ethics.

In the past 3 years, five scientific stories captivated the media and public attention: a sheep, Dolly, was cloned in Scotland; two scientific teams in the United States reported that they had isolated human stem cells; Jesse Gelsinger, an 18-year-old patient, died in a gene transfer experiment at the University of Pennsylvania; Vanderbilt University reported that it is providing fetal surgery for meningomyelocele; and researchers announced that a herd of previously cloned cows appears to be genetically younger than had been expected. These reports illustrate important issues in the ongoing discussion about research on children; indeed some of them challenge the breadth of the definition of research on children. This article, originally presented at an International Symposium sponsored by UNESCO on Bioethics and the Rights of the Child, describes how the National Bioethics Advisory Commission (NBAC) addressed two of these subjects-cloning and stem cell research-and identifies five challenges that science and society must address in the face of such emerging research technologies.

Animals↗
PubMedDate not supplied

Ethics, politics, and human embryo stem cell research.

Three reports on ethical aspects of research involving human embryonic stem cells were issued in the final months of 1999. Two were from governmental agencies or commissions: the National Institutes of Health and the National Bioethics Advisory Commission. The third report was issued by the American Association for the Advancement of Science and the Institute for Civil Society. All three reports endorse the use of federal funds for embryonic stem cell research, but other differences distinguish these reports. This article describes the differences and provides an ethical analysis of the main arguments.

Embryo, Mammalian↗
PubMed1997

Inside the Beltway again: a sheep of a different feather.

The appearance of a sheep named Dolly, the first clone of an adult mammal, dramatically affected the agenda, pace of work, and visibility of the National Bioethics Advisory Commission. The Commission's approach to its task and some of the issues it considered in responding to President Clinton's request for review and recommendations within 90 days are described.

Advisory Committees↗
PubMed1999

Challenges to human subject protections in US medical research.

United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.

Advisory Committees↗
PubMedDate not supplied

Unmanaged care: the need to regulate new reproductive technologies in the United States.

In the aftermath of allegations of the misuse of human eggs in the United States, questions are being raised about whether profitable reproductive services should continue to function in a free market under the aegis of physicians or should be regulated. Other countries in which reproductive technologies are employed to a significant degree have developed regulations governing their use, many as a result of recommendations made by inter-disciplinary commissions that solicited public input. Policy makers in the United States have been reluctant to regulate reproductive technologies, however, because their use is politically controversial, they want to whittle down government, some do not consider infertility an illness, and some believe regulation would interfere with the right to reproduce. Yet the unfettered use of reproductive technologies can create such harms as lack of informed consent, providing procedures not medically indicated for financial gain, practice by unqualified personnel, injury to patients and donors, failure to screen donated gametes, and inadequate medical record keeping. Americans place special value on the welfare of children and those who bring them into the world. Such values can outweigh individual procreative liberty when new reproductive technologies are at issue. Although the optimal course would be to establish a regulatory body to govern reproductive technologies, this is not politically feasible now. The newly established National Bioethics Advisory Commission provides a forum in which issues surrounding reproductive technologies should be addressed at this time in the United States.

Advisory Committees↗
PubMed1999

Breaking the stalemate: a prospective regulatory framework for unforseen research uses of human tissue samples and health information.

The legal and ethical issues raised by new research uses of previously collected human tissues and health information are increasingly important to genetics research. This Article discusses and criticizes current positions on such uses, including the recent report of the National Bioethics Advisory Commission, Research Involving Human Biological Materials. It then proposes a new regulatory framework for tissue and information collected in the future that would better protect the interests of the people who provide them. It ends by suggesting a resolution for the problems of previously collected tissue and information.

Advisory Committees↗
PubMed2003

Embryonic stem cell research: one small step for science or one giant leap back for mankind?

At the forefront of modern debate over the ethical use of biotechnology is embryonic stem cell research. In this poignant analysis of its legitimacy, the author examines the history of this research in light of the United States' policy favoring the protection of human beings over scientific progress. Stem cells, which can divide in culture to create specialized cells in the human body, possess significant potential for curing disease, particularly when taken from human embryos. However, as evidenced by the research atrocities committed under the Nazi regime, the benefits of human research do not come without a cost to humanity. Recognizing this, the later trial of these scientists produced the Nuremberg Code, a set of natural law principles guiding future research on humans that continues to influence health policy decisions. Drawing on this background, the author first considers the appropriate legal status for a human embryo. Biologically, the characteristics of a human embryo place it between human tissue and a constitutional person. Judicially, the answer is even less clear. The author analyzes case law in the context of abortion and in vitro fertilization, as well as classifications by the common law, state legislation, and the National Bioethics Advisory Commission, to conclude that a human embryo should be subject to the same legal and ethical restrictions as any other "human subject." Accordingly, the author argues that embryonic stem cell research violates the ethical standards and purposes of the Nuremberg Code and should be banned by federal legislation. Such a prohibition will fulfill the societal policy choice of protecting potential life and vulnerable human subjects.

Abortion, Induced↗
PubMed1999

Who is the parent in cloning?

In July 1996, a sheep named Dolly was born in Scotland. What makes Dolly's birth noteworthy is that she is the result of the first successful cloning attempt using the nucleus of an adult cell. The technique that led to Dolly's birth involved transferring the nucleus of a mammary cell from an adult sheep to the enucleated egg cell of an unrelated sheep with gestation occurring in a third sheep. The possibility of applying this technique to human reproduction raised concerns worldwide with several countries moving for an immediate bans on human cloning. In the United States, President Clinton requested that the National Bioethics Advisory Commission ("NBAC"), a multidisciplinary group composed of scientists, lawyers, educators, theologians, and ethicists study the implications of cloning and issue recommendations. The Commission consulted other scientists, ethicists, theologians, lawyers, and citizens with interests in this advancing technology and concluded that, "at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning." This Article was included in a larger work prepared at the request of, and submitted to the Commission by, law professor Lori B. Andrews. Cloning through nuclear transfer will change the way we create and define families. This Article explores how existing law relating to parentage, surrogacy, egg donation, and artificial insemination may apply in the cloning context to clarify the parent-child relationship established through cloning.

Advisory Committees↗
PubMed2001

Core safeguards for clinical research with adults who are unable to consent.

The National Bioethics Advisory Commission has proposed new safeguards for clinical research with adults who are unable to consent. Three other major U.S. groups have also proposed additional safeguards for this population, and existing Canadian and European guidelines already include such safeguards. While these six guidelines agree on some safeguards, they disagree on others. To allow important research to proceed while protecting adults who are unable to consent, it will be crucial to resolve these differences. This paper uses a side-by-side comparison of these six guidelines to highlight their major points of consensus, analyze their significant differences, and distill six core safeguards.

Adult↗
PubMed1999

Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness.

The field of psychiatry has an opportunity to construct a more refined, perhaps more enduring understanding of the ethical basis of mental illness research. The aim of this paper is to help advance this understanding by 1) tracing the evolution of the emerging ethic for biomedical experimentation, including recent recommendations of the President's National Bioethics Advisory Commission, and 2) reviewing data and concepts related to compelling ethical questions now faced in the study of mental disorders. Empirical findings on informed consent, the ethical safeguards of institutional review and surrogate decision making, and the relationship between scientific and ethical imperatives are outlined. Psychiatric researchers will increasingly be called upon to justify their scientific approaches and to seek ways of safeguarding the well-being of people with mental illness who participate in experiments. Most importantly, psychiatric investigators will need to demonstrate their appreciation and respect for ethical dimensions of investigation with special populations. Further empirical study and greater sophistication with respect to the distinct ethical issues in psychiatric research are needed. Although such measures present many challenges, they should not interfere with progress in neuropsychiatric science so long as researchers in our field seek to guide the process of reflection and implementation.

Bioethics↗