National Bioethics Advisory Commission Research Articles

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Advance Directives and Research Advance Directives

Advance Directives and Research Advance Directives

Challenges Working with Presidential Bioethics Commissions

Presidential commissions come and go by design, and it is reasonable to wonder about the impact of their recommendations. I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments (from 1994 to 1995) and as senior consultant to the National Bioethics Advisory Commission (from 1999 to 2000) for its report on multinational research. I continue to reflect on and look for the impact of both these commissions. ACHRE's charter included the review of experiments with ionizing radiation sponsored or conducted by the United States government since the 1940s. The committee was also charged with investigating specific intentional releases of radiation into the environment. ACHRE had a somewhat unique difficulty built into its work: the need to make retrospective ethical judgments. With the National Bioethics Advisory Commission, my main role as senior consultant consisted of writing chapters of the report on multinational research for the commissioners' approval. A more important concern for me as a hired consultant was how to maintain intellectual and moral integrity. Unlike when writing scholarly papers, where I can express my own views, when I was drafting text for a presidential commission, the commissioners' views took precedence over my own when we disagreed. I wondered, how much could I comply with the commissioners' positions without compromising my own integrity?

Reflections on the National Bioethics Advisory Commission and Models of Public Bioethics

The National Bioethics Advisory Commission, of which I was a member, was established by a 1995 executive order that identified its "first priority" as "the protection of the rights and welfare of human research subjects." Not surprisingly, then, most of NBAC's work focused on research involving human subjects or participants. A second priority concerned "issues in the management and use of genetics information, including but not limited to, human gene patenting." NBAC's charter (in contrast to the executive order) listed this charge as "part B" of the "first priority." Nonetheless, NBAC never fully developed it. In addition to responding to requests and recommendations from the National Science and Technology Council, NBAC could accept suggestions from Congress and the public for bioethical issues it should consider, and it could also identify other issues to consider and set priorities among them. From its first meeting on October 4, 1996, until its charter expired on October 3, 2001, NBAC produced six reports, with 120 recommendations. In this essay, I make a few observations about principles and moral reasoning in NBAC's deliberations and about NBAC's attention to religious beliefs in the context of two bioethical controversies, provide a rough evaluation of NBAC's impact, and consider three possible models for future public bioethics directed at federal public policy.

Ripples: What to Expect When You Serve on a Bioethics Commission.

Cloning was the issue that put the National Bioethics Advisory Commission on the map, but the first clue that NBAC would address cloning was a terse fax from the White House to each of us who served on the Commission. The fax noted that with the birth of the sheep named Dolly, mammalian cloning was now a reality, and it tasked NBAC with providing advice on the ethics of human cloning and how the nation should respond to it. We were given ninety days to report our findings. That's a very tight deadline for a report written by a committee, but we met it, and along the way, I learned important lessons. My goal in this essay is to share what I learned at the ramparts of what I will call, with apologies to George Lucas, the Cloning Wars and through NBAC's work on five additional reports.

Risk assessment in clinical trials: it don't mean an ethical thing if it ain't got that probability ring!

Since clinical trials are conducted in a context of inherent uncertainty, the assessment of risk is central to their scientific design and ethical conduct. Substantial evidence points to a pervasive misunderstanding of the concept of risk within the clinical research community that results in risk assessment being one of the least satisfactory parts of trial protocols. At its core, the problem rests with the fact that medicine, unlike the social sciences, economics, and philosophy which now pursue their respective scientific methodologies grounded in a probabilistic paradigm, remains wedded to a deterministic paradigm. However, it is from within the probabilistic rather than the deterministic paradigm that justification for conducting clinical research is to be found. Since prospectively their outcomes, including benefit and harm, are unknowable, clinical trials take place under conditions of uncertainty. In recognizing this, the Belmont Report (Belmont) [1] called for the assessment of risk involved in participating in clinical trials with three goals in mind. The first, for clinical researchers, is to determine whether the research design poses minimal risk of harm to participants. The second goal, for prospective participants, is to help them to decide whether to participate in the trial. The third goal, for institutional review boards (IRB’s), is to enable members to determine whether the risk of harm relative to the likelihood of benefit favors benefit over harm for trial participants. By way of confirmation, the National Bioethics Advisory Commission (NBAC) declared that “risk is a central organizing principle, a filter through which protocols must pass” [2] if scientific validity, patient participation, and IRB approval are to be considered reasonable. But given the centrality of risk assessment to scientific validity, a patient’s informed consent to participation and IRB approval, why in a 2002 study would up to two-thirds of respondents find that trial protocols provide insufficient information regarding the likelihood of both risks and benefits [3]? Why is it that so few protocols pass through the NBAC filter and in the way envisaged by Belmont? Closer reading of Belmont also reveals that risk assessment requires a specific understanding of the concept of risk which: refers to a possibility that harm may occur. However, when expressions such as ‘small risk’ or ‘high risk’ are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing harm and the severity (magnitude) of the envisioned harm [1, pg7]. (Cont.)

Viewpoint: Interests, rights and standards of care in the context of globalized medicine

Viewpoint: Interests, rights and standards of care in the context of globalized medicine

Self-contained Bioethics and the Politics of Legal Prohibition

Law and bioethics have traditionally expressed an elective affinity. Bioethics has often spoken “in the language of the law,” or at least in a pidgin that the law can easily understand, and bioethicists have conceptualized their principles and arguments in ways that make them amenable to legal translation. However, there has always been a tradition of bioethical reflection, what I describe as “self-contained bioethics,” that is deeply suspicious of its own readability to legal forms of interpretation; a tradition for which proximity to the law and a consideration of the actual circumstances of legal action compromises the purity of ethical inquiry. The article examines the work of President Bush's Council on Bioethics on human cloning as an example of this type of bioethical inquiry. In its 2002 report “ Human Cloning and Human Dignity: An Ethical Inquiry” the Council professed to keep specific legal and policy options at arm's length to better explore the ethical significance of the issues at stake without being “skewed” by considerations of practical expediency. The article compares the form of bioethical advice produced by the Council with the opinion on human cloning that its predecessor, the National Bioethics Advisory Commission (NBAC), issued in 1997. In NBAC's report the discussion of the paths of legal action was thoroughly and explicitly integrated into the moral analysis. Ultimately, the President's Council resorted to the law, understood as an instrument of absolute prohibition, to translate its purified moral argument into social reality in the form of a ban or a moratorium. Yet, by not using legal considerations to focus and refine its bioethical inquiry, and instead resorting to the law merely as a tool of proscription, the Council guarantees that its advice remains as controversial in the short term as ineffective in the long run.

RESEARCH VULNERABILITY: AN ILLUSTRATIVE CASE STUDY FROM THE SOUTH AFRICAN MINING INDUSTRY

The concept of 'vulnerability' is well established within the realm of research ethics and most ethical guidelines include a section on 'vulnerable populations'. However, the term 'vulnerability', used within a human research context, has received a lot of negative publicity recently and has been described as being simultaneously 'too broad' and 'too narrow'. The aim of the paper is to explore the concept of research vulnerability by using a detailed case study - that of mineworkers in post-apartheid South Africa. In particular, the usefulness of Kipnis's taxonomy of research vulnerability will be examined. In recent years the volume of clinical research on human subjects in South Africa has increased significantly. The HIV and TB pandemics have contributed to this increase. These epidemics have impacted negatively on the mining industry; and mining companies have become increasingly interested in research initiatives that address these problems. This case study explores the potential research vulnerability of mineworkers in the context of the South African mining industry and examines measures that can reduce this vulnerability.

Consent and anonymization in research involving biobanks: differing terms and norms present serious barriers to an international framework.

Biological samples—such as tissues, blood and cells—are an increasingly important tool for research into human diseases and their genetic and physiological causes. To ease their storage and access, many of these samples are now stored in biobanks. The number of human biological samples in such collections amounted to several hundred million in 1999 in the USA alone—about one sample per US citizen (Eiseman, 2000; Azarow et al , 2003)—and is increasing rapidly. Three‐quarters of the clinical trials that drug companies submit to the US Food and Drug Administration (Rockville, MD, USA) for approval now include a provision for sampling and storing human tissue for future genetic analysis (Abbott, 2003). At the same time, there is a boom of population biobanks, as more and more countries establish new sample collections (Kaiser, 2002). Among the best known are: the Icelandic Health Sector Database; the Estonian Genome Project; the UK Biobank; the CARTaGENE Project in Quebec, Canada; the Banco Nacional de ADN in Spain; the International HapMap Project; and several US biobanks, such as the National Children's Study, the Marshfield Clinic's Personalized Medicine Research Project and the National Health and Nutrition Examinations Surveys. ![][1] This boom of biobanks has spawned a ‘boomlet’ of regulations and guidelines, which has created controversies, particularly about the importance and definition of informed consent. The consent of participants is usually required before biobank samples can be used in research, but the nature of this consent, and how it is obtained, vary widely. Many European guidelines take the view that general consent is acceptable to use samples for future, as yet unspecified, research projects; US and Canadian policy follows a more rigorous standard of consent. Until 2004, both Europe and the USA considered coded and linked anonymized samples—in which a code links the sample to its donor—as identifiable and therefore … [1]: /embed/graphic-1.gif

DIVERSITY AND DELIBERATION.

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.

INFORMED CONSENT AND COLLABORATIVE RESEARCH: PERSPECTIVES FROM THE DEVELOPING WORLD

Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.

Field Notes

Field Notes Thomas H. Murray, President Four board members depart. Have you heard the one about the doctor, the lawyer, the politician, and the guy with the Yale mascot? Probably not, I'm guessing. It helps to know something about the history of The Hastings Center. Until the Center's new bylaws were adopted in 1998, being elected to its board of directors could be a life sentence. The Center's current bylaws limit the service of its directors to eight years since the clock began ticking in 1998. We are about to lose the first set of directors to term limits, and what a loss it is. Let me start with Chris Getman. Chris is an investment manager, a wonderfully warm friend, and keeper of the Yale bulldog, whom I met when Chris brought him here one day several years ago. The quintessential Yalie, even to the point of being awarded the Yale Medal, the university's highest honor to an alumnus, Chris is such a lovely person that it's hard to imagine even a Harvard grad could dislike him. We'll miss him. The politician is Richard Lamm, former Governor of Colorado and an inspiration for the debate over setting limits for health care. Long before I met him, I was suspicious of the relatively crude position on age-based rationing attributed to him. When I read his actual speech, I found it provocative to be sure, but much more nuanced and thoughtful than his would-be critics acknowledged. Dick has a talent for seeing complex problems clearly and a passion for trying to solve them, without concern for the caricatures he knows will follow. Since then, he's been as thoughtful and loyal a friend as he is courageous and original a thinker. Joe Iseman is the lawyer, and he's an extraordinarily accomplished one. Somehow, with a stellar career at a top New York law firm (since 1941!), which has to be one of the most competitive environments humankind has created, Joe remains as kind and generous a person as I've ever met. The Center has been graced by his wise counsel, as I have by his warm friendship. He admitted that the party to celebrate his ninetieth birthday comes right on the heels of his last board meeting this June. He's earned a pardon. Now we come to the doctor. One of the earliest, most prominent, and most eloquent voices in the field, Eric Cassell has been linked to the Center almost since its founding. In 1971, he joined its Task Force on Dying. (Obviously, they licked that problem.) His recent book, Doctoring, joins his others, such as The Healer's Art and The Nature of Suffering, in the canon of seminal works in ethics and the humanities. Eric and I came to know each other well through our work on the National Bioethics Advisory Commission. Witnessing his sparkling insights and wry humor up close is a failsafe recipe for admiration and friendship. It is impossible in this brief space to list all the accomplishments of these four retiring members of our board, or to acknowledge adequately the Center's debt to them. But I can't resist saying something personal. Thanks to these four splendid persons, I've come to understand better the nature of suffering, the value of a wise counselor, the great importance of engagement in public life and public policy, and, of course, what it's like to live with Handsome Dan, the Yale bulldog. Copyright © 2006 The Hastings Center

The US National Bioethics Advisory Commission as a boundary organization

Public bioethics advisory bodies have been a staple of US public policy for addressing public biotechnology- related controversies, in spite of the limited impact these bodies have had on policy-making. These advisory bodies serve an important tacit function as boundary organizations that stabilize the border between science and politics, preserving the autonomy of science from incursion by other societal stakeholders. In this paper the boundary work of the US National Bioethics Advisory Commission is examined at the border of science and ethics, in its deliberations on embryonic stem cell research. The coupling of scientific and ethical uncertainty, and that of research productivity and integrity assurance in the Commission's deliberations is described. It is argued that the Commission's boundary work reinforced the authority of science and marginalized conflicting civic-sector concerns. Copyright , Beech Tree Publishing.

A summary of important documents in the field of research ethics.

Today's researchers are obligated to conduct their studies ethically. However, it often seems a daunting task to become familiar with the important ethical codes required to do so. The purpose of this article is to examine the content of those ethical documents most relevant to the biomedical researcher. Documents examined include the Nuremberg Code, the Declaration of Helsinki, Henry Beecher's landmark paper, the Belmont Report, the U.S. Common Rule, the Guideline for Good Clinical Practice, and the National Bioethics Advisory Commission's report on research protections for the mentally ill.

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.

Ethics, Regulation, and Biomedical Research

Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States.

MACQUEEN AND BUEHLER RESPOND

In our article we addressed a number of questions regarding the boundary between human subjects research, as defined by federal regulations, and public health practice, as defined by state and federal public health policy and law. The vast majority of work done by public health agencies is not research, and this boundary is usually clear. For example, a randomized controlled trial to evaluate an experimental tuberculosis therapy is human subjects research, despite the public health mission driving the work, and should be reviewed by an institutional review board (IRB). Conversely, a state mandate that physicians report cases of tuberculosis to public health authorities represents public health practice, despite the potential richness of the resulting data for research, and allows health departments to monitor tuberculosis trends and direct prevention and care services. Mechanisms exist to protect the confidentiality of those reported to public health surveillance systems or receiving public health services. There are, however, areas of practice where oversight may be inadequate or lacking. In contemplating new approaches to ensuring ethical public health practice, oversight by a group familiar with public health law and human rights would be more meaningful than review by an IRB familiar mainly with research ethics and procedures. We share Wedeen’s interest in ethical public health. We made no arguments justifying ends over means, and Wedeen’s assertion that we have taken such a position represents a serious misreading of our article. We explicitly argued for the creation of oversight or guidance mechanisms that are meaningful and appropriate for public health. Our intent was to promote thoughtful discussion and informed action in resolving the challenges faced by public health practitioners and researchers who strive to meet their obligations ethically. The National Bioethics Advisory Commission called for innovative solutions to correct the limitations of current procedures for distinguishing research from practice and for ensuring the ethical conduct of investigations in which the risks primarily involve stigmatization or potential threats to privacy and confidentiality.1 The engagement of community advisory boards by public health agencies is one approach to addressing these concerns,2,3 reflecting parallel interest in such boards for research projects.4 Another approach would be to more clearly inform and engage the public concerning the objectives, methods, and procedures of public health practice, in turn improving the oversight of public health agencies already provided by the political process of governance.5

The Poster Child for the Need for Central Review of Research Protocols: The Children's Oncology Group

Multiple groups, including the National Bioethics Advisory Commission, the American Society of Clinical Oncology (ASCO), the National Coalition of Comprehensive Cancer Centers (Personal communication with Robert B. Catalano, PharmD, Vice President for Regulatory Affairs, Coalition of National Cancer Cooperative Groups), Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group (COG).

Human Research Accreditation Relevant to Anthropology

Anthropology NewsVolume 45, Issue 6 p. 27-27 Human Research Accreditation Relevant to Anthropology Marjorie A Speers, Marjorie A Speers AAHRPP Marjorie Speers is Executive Director of the Association for the Accreditation of Human Research Protection Programs. She served as acting Executive Director of the National Bioethics Advisory Commission, where she oversaw the development of Ethical and Policy Issues in Research Involving Human Participants, a comprehensive report on the oversight system of protection: Previously, Speers was Deputy Associate Director for science at the Centers for Disease Control and Prevention, where she oversaw all domestic and international research. She has also held faculty positions at the University of Texas Medical Branch at Galveston and the University of Connecticut.Search for more papers by this author Marjorie A Speers, Marjorie A Speers AAHRPP Marjorie Speers is Executive Director of the Association for the Accreditation of Human Research Protection Programs. She served as acting Executive Director of the National Bioethics Advisory Commission, where she oversaw the development of Ethical and Policy Issues in Research Involving Human Participants, a comprehensive report on the oversight system of protection: Previously, Speers was Deputy Associate Director for science at the Centers for Disease Control and Prevention, where she oversaw all domestic and international research. She has also held faculty positions at the University of Texas Medical Branch at Galveston and the University of Connecticut.Search for more papers by this author First published: 07 July 2009 https://doi.org/10.1111/an.2004.45.6.27 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume45, Issue6September 2004Pages 27-27 RelatedInformation