Research ethics education in the biosciences has not historically been a priority for research universities despite the fact that funding agencies, government regulators, and the parties involved in the research enterprise agree that it ought to be. The confluence of a number of factors, including scrutiny and regulation due to increased public awareness of the impact of basic research on society, increased public and private funding, increased diversity and collaboration among researchers, the impressive success and speed of research advances, and (...) high-profile cases of misconduct, have made it necessary to reexamine how the bioscience research community at all levels provides ethics education to its own. We discuss the need to and reasons for making ethics integral to the education of bioscientists, approaches to achieving this goal, challenges this goal presents, and responses to those challenges. (shrink)

This manuscript describes a pilot study in ethics education employing a problem-based learning approach to the study of novel, complex, ethically fraught, unavoidably public, and unavoidably divisive policy problems, called “fractious problems,” in bioscience and biotechnology. Diverse graduate and professional students from four US institutions and disciplines spanning science, engineering, humanities, social science, law, and medicine analyzed fractious problems employing “navigational skills” tailored to the distinctive features of these problems. The students presented their results to policymakers, stakeholders, experts, and members (...) of the public. This approach may provide a model for educating future bioscientists and bioengineers so that they can meaningfully contribute to the social understanding and resolution of challenging policy problems generated by their work. (shrink)

Human genetic engineering may soon be possible. The gathering debate about this prospect already threatens to become mired in irresolvable disagreement. After surveying the scientific and technological developments that have brought us to this pass, _The Ethics of Genetic Engineering_ focuses on the ethical and policy debate, noting the deep divide that separates proponents and opponents. The book locates the source of this divide in differing framing assumptions: reductionist pluralist on one side, holist communitarian on the other. The book argues (...) that we must bridge this divide, drawing on the resources from both encampments, if we are to understand and cope with the distinctive problems posed by genetic engineering. These problems, termed "fractious problems," are novel, complex, ethically fraught, unavoidably of public concern, and unavoidably divisive. Berry examines three prominent ethical and political theories – utilitarianism, Kantianism, and virtue ethics – to consider their competency in bridging the divide and addressing these fractious problems. The book concludes that virtue ethics can best guide parental decision making and that a new policymaking approach sketched here, a "navigational approach," can best guide policymaking. These approaches enable us to gain a rich understanding of the problems posed and to craft resolutions adequate to their challenges. (shrink)

This study analyzes 435 oocyte donor recruitment advertisements to assess whether entities recruiting donors of oocytes to be used for in vitro fertilization (IVF) procedures include a disclosure of risks associated with the donation process in their advertisements. Such disclosure is required by the self-regulatory guidelines of the American Society for Reproductive Medicine (ASRM) and by law in California for advertisements placed in the state. We find very low rates of risk disclosure across entity types and regulatory regimes, although risk (...) disclosure is more common in advertisements placed by entities subject to ASRM's self-regulatory guidelines. Advertisements placed in California are more likely to include risk disclosure, but disclosure rates are still quite low. California-based entities advertising outside the state are more likely to include risk disclosure than non-California entities, suggesting that California's law may have a modest “halo effect.” Our results suggest that there is a significant ethical and policy problem with the status quo in light of the known and unknown risks of oocyte donation and the importance of risk disclosure to informed consent in the context of oocyte donation. (shrink)

This essay describes an interdisciplinary educational experiment in health law. The experiment was funded by the National Science Foundation, received Institutional Review Board approvals, incorporated inter-disciplinary faculty and graduate students from several universities in Atlanta, and employed problem-based learning. After discussing my motivation to undertake this experimental approach to teaching health law, I explain how the course was developed and structured and how we are assessing its results. I also offer some reflections on why other health law teachers might be (...) motivated to incorporate some features of our experimental approach into their own classes, and some thoughts on how they might do so based on lessons learned.I undertook this experiment to test in an educational setting an approach to problem solving that I have developed for addressing certain kinds of seemingly intractable policy problems. I call this a “navigational approach” to “fractious problems.”. (shrink)

This essay describes an interdisciplinary educational experiment in health law. The experiment was funded by the National Science Foundation, received Institutional Review Board approvals, incorporated inter-disciplinary faculty and graduate students from several universities in Atlanta, and employed problem-based learning. After discussing my motivation to undertake this experimental approach to teaching health law, I explain how the course was developed and structured and how we are assessing its results. I also offer some reflections on why other health law teachers might be (...) motivated to incorporate some features of our experimental approach into their own classes, and some thoughts on how they might do so based on lessons learned.I undertook this experiment to test in an educational setting an approach to problem solving that I have developed for addressing certain kinds of seemingly intractable policy problems. I call this a “navigational approach” to “fractious problems.”. (shrink)

In vitro fertilization using donated oocytes has proven to be an effective treatment option for many prospective parents struggling with infertility, and the usage of donated oocytes in assisted reproduction has increased markedly since the technique was first successfully used in 1984. Data published by the Centers for Disease Control and Prevention on the use of assisted reproductive technologies in the United States indicate that approximately 12% of all ART cycles in the country now use donated oocytes. The increased use (...) of oocyte donation in the United States has prompted discussion regarding risks associated with the process and how best to ensure the safety of oocyte donors.Physical risks associated with oocyte donation include bleeding, infection, ovarian hyperstimulation syndrome and a potential, although unconfirmed, increased risk of developing various forms of cancer, such as uterine, colon, breast, ovarian, and endometrial cancers. (shrink)

This essay describes an interdisciplinary educational experiment in health law. The experiment was funded by the National Science Foundation, received Institutional Review Board approvals, incorporated inter-disciplinary faculty and graduate students from several universities in Atlanta, and employed problem-based learning. After discussing my motivation to undertake this experimental approach to teaching health law, I explain how the course was developed and structured and how we are assessing its results. I also offer some reflections on why other health law teachers might be (...) motivated to incorporate some features of our experimental approach into their own classes, and some thoughts on how they might do so based on lessons learned.I undertook this experiment to test in an educational setting an approach to problem solving that I have developed for addressing certain kinds of seemingly intractable policy problems. I call this a “navigational approach” to “fractious problems.”. (shrink)

We believe that the professional responsibility of bioscience and biotechnology professionals includes a social responsibility to contribute to the resolution of ethically fraught policy problems generated by their work. It follows that educators have a professional responsibility to prepare future professionals to discharge this responsibility. This essay discusses two pilot projects in ethics pedagogy focused on particularly challenging policy problems, which we call “fractious problems”. The projects aimed to advance future professionals’ acquisition of “fractious problem navigational” skills, a set of (...) skills designed to enable broad and deep understanding of fractious problems and the design of good policy resolutions for them. A secondary objective was to enhance future professionals’ motivation to apply these skills to help their communities resolve these problems. The projects employed “problem based learning” courses to advance these learning objectives. A new assessment instrument, “Skills for Science/Engineering Ethics Test”, was designed and administered to measure the success of the courses in doing so. This essay first discusses the rationale for the pilot projects, and then describes the design of the pilot courses and presents the results of our assessment using SkillSET in the first pilot project and the revised SkillSET 2.0 in the second pilot project. The essay concludes with discussion of observations and results. (shrink)

This essay discusses four challenges posed to a global bioethics by articles on: divergent national policies on compensation of egg donors for IVF, efforts to advance the development of international guidelines for the management of neonates on the edge of viability, bioethics training workshops in Uganda, a bioethicist’s reflection on a visit to Pakistan. The article then discusses several approaches to developing a global bioethics and how these approaches might meet the four challenges. The essay concludes with discussion of the (...) author’s development of a navigational approach to policymaking for fractious bioethical policy problems and how this compares to other approaches to developing a global bioethics. (shrink)

This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)

This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at the intersection of abortion law (...) and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency. (shrink)