National Bioethics Advisory Commission Research Articles

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).

At Law: Research Oversight and Adults with Cognitive Impairment

Biomedical research at times involves adults who are unable to make decisions independently Studies of dementia, psychiatric illnesses, developmental disabilities, and other conditions may involve individuals whose disorders or medications impair their ability to understand the facts necessary to make informed choices about participation. Two types of undesirable errors can occur when researchers recruit participants from groups that include individuals whose decisionmaking abilities are in question. One type of error occurs when investigators enroll incapable adults without the informed and voluntary consent of a responsible surrogate decisionmaker. The other occurs when capable individuals are prevented from making their own choices about study participation. In each case, there is a violation of the Belmont Report's respect-for-persons principle. In the first case, persons are inadequately protected from harm, and in the second, individuals able to exercise autonomy are blocked from doing so. (1) These ethical concerns are widely recognized. Indeed, one of the early U.S. research scandals involved the administration of cancer cells to elderly patients with mentally debilitating conditions in the absence of either the subjects' or their surrogates' informed consent. More recently, during the 1990s, investigators conducting a federally funded schizophrenia study failed to provide adequate information about research risks to subjects and their families. These incidents alerted health professionals and the public to problems that can arise when subject populations include adults who may lack decision-making capacity. (2) At the same time, the federal regulations governing human research devote little attention to the distinct concerns that arise when the decisionmaking capacity of adult subjects is in question. According to the Federal Policy for the Protection of Human Subjects, (3) also known as the Common Rule, individuals incapable of issuing valid informed consent may be enrolled in research with the informed consent of a legally authorized Other Common Rule provisions classify mentally disabled adults as a vulnerable category of For the most part, however, the federal regulations give investigators and Institutional Review Boards (IRBs) the responsibility to determine what measures are needed to respect and protect subjects. The rule fails to address several important matters, such as standards for decisionmaking capacity, assent and dissent by incapable adults, and qualifications of an incapable subject's representative. In 1998, the National Bioethics Advisory Commission (NBAC) examined these matters in its Report and Recommendations on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. (4) The NBAC proposed new federal regulations and made recommendations to others with research oversight duties. State legislators were one target of the NBAC recommendations. To date, the federal government has failed to respond to the NBAC'S proposals for regulatory action. The NBAC recommendations have triggered action at the state level, however. In 2002, legislatures in California and Virginia passed laws specifying which persons could act as research representatives on behalf of adults lacking decisionmaking capacity. (5) Although some states already have laws relevant to surrogate decisionmaking in research, the California and Virginia provisions are more detailed than most. As such, they offer guidance to other states seeking to fill gaps in the federal oversight system. California's new law both identifies and establishes an order of priority for potential research surrogates. Previously designated research agents have the highest priority; followed by legal conservators or guardians, spouses, domestic partners, adult children, custodial parents, adult siblings, and adult grandchildren. In the absence of these family members, the closest relative of those available may fill the research surrogate position. …

Ethical and legal standards for research in prisons.

Biobehavioral research, especially that which is conducted with prisoners, has become much more closely regulated in the last 30 years. State and federal law, as well as professional standards, regulate the conduct of many types of research; in the case of prisoners, this regulation is even more stringent. However, currently no mandatory, uniform, national regulatory or oversight process exists, and many privately funded research endeavors are operating in a regulatory void. In response to this, the National Bioethics Advisory Commission has argued for the creation of a single, national, independent regulatory body to oversee all human participant research, regardless of funding source. As ethicolegal research standards evolve alongside advances in science and technology, an appreciation of the history of prisoner research and an awareness of current standards is critical to conducting ethical prison research.

Stem Cell Research: Why Medicine Should Reject Human Cloning

Stem Cell Research: Why Medicine Should Reject Human Cloning

Addiction, neuroscience and ethics

Neuroscience models have much to offer the field of addiction, but they will be self-defeating if they lead to severe restrictions on the type of neuroscience research that can conducted in future. A major challenge for the addiction field is to integrate the insights that neuroscience research has provided on drug use and addiction with those provided about drug use and addiction by clinical, epidemiological, sociological and economic research. The challenge is (1) to develop theories of addiction that take seriously the neurobiological bases for drug effects and addictive phenomena; (2) without depicting addicts as automatons whose behaviour is under the control of the drugs acting on the receptors sites in their brains; and (3) while recognizing the opportunities for individual decision, interpersonal influence and social policy to affect the drug use and the behaviour of drug-dependent people.

Donating spare embryos for embryonic stem-cell research

Donating spare embryos for embryonic stem-cell research

Clinical research in developing countries: recent moral arguments.

During the 1990s, bioethicists raised questions about certain clinical trials conducted in developing countries. These inquiries led to revisions in the Declaration of Helsinki and recommendations from the US National Bioethics Advisory Commission. This article raises doubts about the original questions and subsequent recommendations. It is possible that impractical solutions have been proposed for nonexistent ethical problems.

A Review of Current Events in Human Subjects Protection

Bioethics is a subject that has been gaining increased attention through the last few years. Factors such as globalization of research, genetic medicine, and tragic events in clinical trials have drawn attention to the importance of protecting human participants in medical research. The October 2000 revision of the Declaration of Helsinki and the release of two reports by the National Bioethics Advisory Commission are just a few examples of the recent efforts by policymaking bodies to modernize bioethical standards. This review provides an introduction to several of the groups that are participating in the reshaping of bioethical policy in the United States and around the globe. Although there are multiple bioethical issues currently being debated, three specific topics are discussed: the use of placebo controls in clinical trials, posttrial access to medicines, and financial conflicts of interest.

Community involvement in the ethical review of genetic research: lessons from American Indian and Alaska Native populations.

The National Bioethics Advisory Commission has proposed that regulatory oversight for research with human subjects be extended beyond the protection of individual research participants to include the protection of social groups. To accomplish this, the commission recommends that investigators and ethics review boards a) work directly with community representatives to develop study methods that minimize potential group harms, b) discuss group implications as part of the informed consent process, and c) consider group harms in reporting research results. We examine the utility of these recommendations in the context of research with American Indian and Alaska Native communities. Because much attention has been given to the question of how best to consult with members of these communities in the design and conduct of research, we believe it behooves investigators to consider the lessons to be learned from research involving American Indians and Alaska Natives. After describing several difficulties surrounding the application of the commission's approach to these research contexts, we propose a research agenda to develop best practices for working with local communities in the ethical assessment of epidemiologic and environmental health research.

The Human embryonic stem cell debate: science, ethics, and public policy

Human embryonic stem cells can divide indefinitely and have the potential to develop into many types of tissue. Research on these cells is essential to one of the most intriguing medical frontiers, regenerative medicine. It also raises a host of difficult ethical issues and has sparked great public interest and controversy.This book offers a foundation for thinking about the many issues involved in human embryonic stem cell research. It considers questions about the nature of human life, the limits of intervention into human cells and tissues, and the meaning of our corporeal existence. The fact that stem cells may be derived from living embryos that are destroyed in the process or from aborted fetuses ties the discussion of stem cell research to the ongoing debates on abortion. In addition to these issues, the essays in the book touch on broader questions such as who should approve controversial research and what constitutes human dignity, respect, and justice. The book contains contributions from the Ethics Advisory Board of the Geron Coroporation; excerpts from expert testimony given before the National Bioethics Advisory Commission, which helped shape recent National Institutes of Health policy; and original analytical essays on the implications of this research.

Regulating Research for the Decisionally Impaired: Implications for Mental Health Professionals

Mental health professionals, in fulfilling their different roles, often become involved with research protocols involving decisionally impaired current or prospective human subjects, many of whom are elderly. The opening section of this paper briefly describes the present regulatory environment regarding human subjects research, followed by an overview of the Institutional Review Board (IRB) process. There then ensues an enumeration of some of the general criticisms of the current regulatory scheme that have been enunciated recently. Particular concerns concerning decisionally impaired persons as research subjects are then addressed, referring when applicable to the recommendations made by the National Bioethics Advisory Commission (NBAC) in its 1998 report on this subject and the implications of those recommendations for mental health professionals.

Stem Cell Research: A Target Article Collection Part I - Jordan's Banks, A View from the First Years of Human Embryonic Stem Cell Research

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory Board, and the National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate.

A home for the National Bioethics Advisory Commission electronic archive.

ON 3 OCTOBER 2001, the National Bioethics Advisory Com-mission (NBAC), an 18-member advisory board established by Executive Order 12975 on 3 October 1995 and chartered on 20 October 1999 to make recommendations to the National Science and Technology Council, ceased operation. The National Reference Center for Bioethics Literature was selected to preserve the electronic archive and copies of printed documentation of NBAC's work. Consequently, NBAC's former website is now available in its entirety at: http://bioethics.georgetown.edu/nbac. The print documents have been added to the collection of archival materials at the NRC.

Informed consent for population-based research involving genetics.

Bridging the gap between gene discovery and our ability to use genetic information to benefit health requires population-based knowledge about the contribution of common gene variants and gene-environment interactions to the risk of disease. The risks and benefits associated with population-based research involving genetics, especially lower-penetrance gene variants, can differ in nature from those associated with family-based research. In response to the urgent need for appropriate guidelines, the Centers for Disease Control and Prevention formed a multidisciplinary group to develop an informed consent approach for integrating genetic variation into population-based research. The group used expert opinion and federal regulations, the National Bioethics Advisory Commission's report on research involving human biological materials, existing consent forms, and literature on informed consent to create suggested language for informed consent documents and a supplemental brochure. This language reflects the premise that the probability and magnitude of harm, as well as possible personal benefits, are directly related to the meaning of the results for the health of the participant and that appropriate disclosures and processes for obtaining consent should be based on an assessment at the outset of the likelihood that the results will generate information that could lead directly to an evidence-based intervention. This informed consent approach is proposed to promote discussion about how best to enable potential participants to make informed decisions about population-based research involving genetics and to suggest issues for consideration by research sponsors, institutional review boards, and investigators.

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.

Pharmacogenetics and pharmacoepidemiology.

This paper seeks to stimulate consideration of the short- and long-term possibilities raised by research into pharmacogenetics and pharmacoepidemiology, to identify potential tissue databanks linked to population data, and to summarize our ethical responsibilities. Short term, we might identify selected disorders or risk factors, such as for drug-associated serious events, and might find selected target populations. Long term, we might incorporate genomics techniques into population data and map genetic risk factors for diseases and drug responses. Tissue specimens that might be linked to clinical data lie in certain data resources: clinical trials, ad hoc cohorts, case registries, and cross-sectional and longitudinal population samples. Specific areas must be addressed in research using human tissue and genetic material, including the ethical threat to privacy. We must avoid misuse of genetic information by breaching confidentiality and putting at risk specific genetically identifiable groups. The National Bioethics Advisory Commission recently addressed the issue of serum and tissue data banks in a published report summarized in this paper. Social, methodologic, and ethical issues relate to any protocol using serum and tissue, and indicate a need for broad educational efforts. We must set guidelines as pharmacogenetics research becomes a dimension of pharmacoepidemiology.

Ethical issues in the design and conduct of clinical trials in developing countries.

There has been considerable controversy about the ethics of clinical trials that are sponsored or conducted by groups in industrialized countries but carried out in developing countries.1–8 The National Bioethics Advisory Commission, of which we serve as chairman and executive director, respectively, has recently addressed these and related issues.9 International collaborative research covers a broad spectrum of methods, topics, and research strategies. In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. In particular, we focus on phase 3 and other drug trials that, if successful, can lead to the use . . .

National Bioethics Advisory Commission Report: Ethical and Policy Issues in International Research

National Bioethics Advisory Commission Report: Ethical and Policy Issues in International Research

Ethical challenges at the beginning of the millennium.

In the mid-1980s, the Centers for Disease Control and Prevention (CDC) recognized the need to study genetic risk factors for common diseases such as diabetes and heart disease. To take advantage of a rare opportunity to obtain a nationally representative, population-based sample to study genetic risk factors, the CDC collected and stored DNA as part of the Third National Health and Nutrition Examination Survey (NHANES III). At the time, the methods for studying these risk factors in large epidemiologic studies were not available. However, in the midst of planning for NHANES III, a revolution was occurring in the field of genetics. The resulting changes would provide a means to realize the goal of explaining why some people are more susceptible than others to risks such as elevated cholesterol or exposure to carcinogens. During this period, ethicists were increasingly asking questions about the safety and risks for participants in genetic research. Was genetic research different from other research? Were new rules for obtaining informed consent for genetic research needed, or should our methods of obtaining informed consent be equally rigorous for all research? When collection of the NHANES III DNA bank was complete in 1994, the CDC and the National Institutes of Health (NIH) held a workshop to address these questions. The published recommendations of this workshop stimulated a national debate that resulted in a significant change in the way genetic epidemiologic research is done in the United States including not only stored biologic specimens but data collected for one purpose but used for another. In 1999, the National Bioethics Advisory Commission (NBAC) published recommendations for the ethical use of human biological materials. The recommendations of the NBAC and policies and practices of the CDC about informed consent for research on stored tissue samples will serve as models for future epidemiologic research. The problems that were recognized in the national debate that ensued and the solutions that followed will affect the way we gain access to biological specimens and data in the 21st century. Published in 2001 by John Wiley & Sons, Ltd.

Draft report by National Bioethics Advisory Commission raises new questions

Draft report by National Bioethics Advisory Commission raises new questions