Nancy King

In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that “the line between research and treatment is not always clear to clinicians. Controversy exists regarding whether certain medical procedures should be categorized as research.”This problem currently plagues gene transfer research. A few months prior to the GAO report, an ad hoc committee appointed by National Institutes of Health Director Harold Varmus expressed similar concerns in its assessment of NIH investment in research on gene therapy.

The Covid‐19 pandemic has concentrated bioethics attention on the “lifeboat ethics” of rationing and fair allocation of scarce medical resources, such as testing, intensive care unit beds, and ventilators. This focus drives ethics resources away from persistent and systemic problems—in particular, the structural injustices that give rise to health disparities affecting disadvantaged communities of color. Bioethics, long allied with academic medicine and highly attentive to individual decision‐making, has largely neglected its responsibility to address these difficult “upstream” issues. It is time to broaden our teaching, research, and practice to match the breadth of the field in order to help address these significant societal inequities and unmet health needs.

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

The intrusive state has long viewed women as fetal containers. The Dobbs decision goes further, essentially causing women to vanish when fetuses are abstracted from their relationships to pregnant persons. The ways in which women are first controlled and then made invisible are clearly connected with the move from obedience to omission that has historically affected black Americans. When personal decisionmaking and participation in democracy are regarded as threats, those threatened restrict decisional freedom and political power, deepening structural injustices relating to sex, race, and poverty. Fear of Dobbs has health effects on conditions unrelated to pregnancy and connects with erasures of human value that are not health-related. We reaffirm solidarity as a countering influence. Taking account of the richly relational context in which issues like abortion and political representation arise should lead to better, more meaningful policies, making so many people impossible to unsee.

ABSTRACT:Bioethics needs to expand its vision. We must examine and interrogate the social and structural barriers that help traditionally privileged communities maintain minoritized groups as inherently inferior "others." Justice requires the field to look beyond the walls of hospitals, clinics, and medical academia to address and ameliorate the structural injustices that give rise to health disparities long before differential access to health services becomes an issue for underserved patients. Doing so means engaging in challenging multidisciplinary collaborations in order to understand the sociohistorical complexities of health and illness, appreciate the factors that contribute to shaming and blaming those "others" who are not "us," and work to lessen the discomfort with uncertainty that impedes equity. All of this necessary work takes bioethics well beyond the well-trodden pathways of our usual scholarship and practice. But we simply have to reach higher to do health justice.

Bioethics needs an expanded moral vision. It is now time for bioethics to take full account of the problems of health disparities and structural injustice that are made newly urgent by the COVID-19 pandemic and the effects of climate change. Nancy M. P. King, Gail E. Henderson, and Larry R. Churchill make the case for a more social understanding and application of justice, a deeper humility in assessing expertise in bioethics consulting, a broader and more relevant research agenda, and greater appreciation of the profound health implications of global warming.

“Regenerative medicine” describes a set of innovative approaches to the treatment of illness, injury, and disability, focusing on the growth, replacement, and repair of cells, organs, and tissues specific to the health needs of particular individuals. The extraordinary breadth of application of this approach is clear from an enumeration of just a few areas of regenerative medicine research, such as stem cells, including embryonic stem cells, pluripotent stem cells produced by genetic reprogramming, and multipotent stem cells from non-embryonic tissues; techniques for stimulating endogenous cell growth and repair for the kidney and pancreas in diabetes, or for digits and limbs injured as a result of trauma; and the growth of replacement tissues and organs, for example, blood vessels, hollow organs like the bladder, and even solid organs like the heart. This enormous diversity of applications, all currently in various stages of research and development, stems from a multidisciplinary research orientation incorporating genetics, informatics, basic research into the structure, mechanics, and development of different tissues, and creative production techniques. Despite its enormous promise, however, at this time regenerative medicine’s many applications constitute a very early step along the road to effective treatments. Most of the attention to ethical issues in regenerative medicine has been consumed by debate about the use of human embryonic stem cells in research, specifically, the destruction of embryos in order to create cell lines, disputes over the role of federal funding for research with human embryonic stem cells, and concerns about the safety, scientific purity, and adequacy of consent for the research use of human embryonic stem cell lines. Like other novel biotechnologies, however, regenerative medicine raises a number of additional critical research ethics issues that are not new, but that have not yet been adequately addressed. Instead, as is common in new science, familiar and longstanding questions appear in the fresh context of regenerative medicine research and renew old debates. Advances in regenerative medicine therefore provide a much-needed opportunity to reexamine important issues in human subjects research. Moreover, because regenerative medicine has taken a thoroughgoing translational perspective, seeking to anticipate and plan for the issues (scientific, policy, and practical) that are likely to arise along the full research trajectory from bench to bedside to clinical product, it presents a model system for comprehensively identifying and addressing issues and needs in ethics and policy as they arise in translational research involving this developing science. This article discusses some of the novel technologies within regenerative medicine. The article then examines the range of ethical issues raised by each novel regenerative medicine technology, including but not limited to: the ethics of research design; issues to consider in first-in-humans regenerative medicine research; and informed consent and the therapeutic misconception. The article further considers whether regenerative medicine helps to blur any distinction that may exist between medical treatment and enhancement, possibly creating more ethical issues to address in the long term. The article concludes by advising scholars and policymakers in bioethics to take the opportunity offered by regenerative medicine to move research ethics and policy forward by examining these issues anew through the lens of this groundbreaking medical science.

ABSTRACT:Good science fiction can be a successful vehicle for portraying justice. Science fiction can stimulate moral imagination in much the same way as the most effective justice theories, connecting the world in which we live with a range of alternative futures deliberately and creatively made plausible. A selective examination of classic and recent science fiction stories and novels provides contextual framing for considering questions of climate justice, virtuous personal action in the face of structural injustice, and the problem of what justice means when some people are regarded as “other.” By connecting compelling images of individual responsibility with the complex challenges posed by striving for social justice, science fiction can also help render justice work appealing and achievable—an essential step that is reinforced in closing by a brief set of maxims.

_Bioethics, Public Moral Argument, and Social Responsibility_ explores the role of democratically oriented argument in promoting public understanding and discussion of the benefits and burdens of biotechnological progress. The contributors examine moral and policy controversies surrounding biomedical technologies and their place in American society, beginning with an examination of discourse and moral authority in democracy, and addressing a set of issues that include: dignity in health care; the social responsibilities of scientists, journalists, and scholars; and the language of genetics and moral responsibility.