Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Digital contact tracing, in combination with widespread testing, has been a focal point for many plans to “reopen” economies while containing the spread of Covid‐19. Most digital contact tracing projects in the United States and Europe have prioritized privacy protections in the form of local storage of data on smartphones and the deidentification of information. However, in the prioritization of privacy in this narrow form, there is not sufficient attention given to weighing ethical trade‐offs within the context of a public (...) health pandemic or to the need to evaluate safety and effectiveness of software‐based technology applied to public health. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Discussion of the “dead donor rule” is challenging because it implicates views about a wide range of issues, including whether and when patients are appropriately declared dead, the validity of the doctrine of double effect, and the moral difference between or equivalence of active euthanasia and withdrawal of life‐sustaining treatment. The DDR will be defined here as the prohibition against removal of organs necessary for the life of the patient—that is, the prohibition of intentionally ending the life of a patient (...) through organ removal. At a minimum, it is difficult not to see the DDR as grounded in a set of laws, norms, values, and practices that are firmly entrenched and have a great deal of philosophical, religious, and legal support. Obviously, the primary argument against the DDR is that it is highly desirable that we continue to procure organs for transplantation, combined with the belief that those from whom we often and possibly typically procure organs are not “really” dead. If donors are not really dead, then we are left with a dilemma: either we abandon organ procurement, or we abandon the DDR. Such a move should be taken only if the way we currently delineate the dead (those from whom it is acceptable to remove organs) cannot be maintained or defended. I will suggest that this is not the case. (shrink)

Volume 20, Issue 9, September 2020, Page 1-3.

According to the mainstream conception of research involving human participants, researchers have been trained scientists acting within institutions and have been the individuals doing the studying, while participants, who are nonscientist members of the public, have been the individuals being studied. The relationship between the public and scientists is evolving, however, giving rise to several new concepts, including crowdsourcing and citizen science. In addition, the practice of gamification has been applied to research protocols. The role of gamified, crowdsourced citizen scientist (...) is new in the domain of scientific research and does not fit into the existing taxonomy of researchers and participants. We delineate and explicate this role and show that, while traditional roles are governed by well‐established norms and regulations, individuals engaged in gamified, crowdsourced citizen science—gamers—fall through the cracks of research protections and regulations. We consider the issues this raises, including exploitation and the absence of responsibility and accountability. Finally, we offer suggestions for how the current lack of appropriate norms may be rectified. (shrink)

:Empirical work has shown that patients and physicians have markedly divergent understandings of treatability statements in the context of serious illness. Patients often understand treatability statements as conveying good news for prognosis and quality of life. In contrast, physicians often do not intend treatability statements to convey improvement in prognosis or quality of life, but merely that a treatment is available. Similarly, patients often understand treatability statements as conveying encouragement to hope and pursue further treatment, though this may not be (...) intended by physicians. This radical divergence in understandings may lead to severe miscommunication. This paper seeks to better understand this divergence through linguistic theory—in particular, H.P. Grice’s notion of conversational implicature. This theoretical approach reveals three levels of meaning of treatability statements: the literal meaning, the physician’s intended meaning, and the patient’s received meaning. The divergence between the physician’s intended meaning and the patient’s received meaning can be understood to arise from the lack of shared experience between physicians and patients, and the differing assumptions that each party makes about conversations. This divergence in meaning raises new and largely unidentified challenges to informed consent and shared decision making in the context of serious illness, which indicates a need for further empirical research in this area. (shrink)

There are many kinds of clinical trials. The regulatory framework within which most drug development takes place appears to be the one that is to be applied to the development of novel stem cell-based clinical trials. In the standard drug development model, appropriate pre-clinical research is conducted, and investigators or research sponsors submit an investigational new drug application to the Food and Drug Administration.If approved, typical clinical trials start with Phase I, which is usually a trial to determine the maximum (...) tolerable dose of a drug. Phase I trials are often referred to as “safety studies” because the primary goal of Phase I research is to determine if an intervention is safe. (shrink)

In their target article, Millum and Bromwich situate their article against a backdrop of well-documented empirical research demonstrating that many participants have variable and often poor...

The two target articles in this issue draw an important connection between disability bioethics and geriatric bioethics. Dominic JC Wilkinson makes a pragmatic case for using frailty as a fa...

Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might instead be intended to replace it. We are editors of bioethics and humanities journals who have been contemplating the implications of this ongoing transformation. We believe that generative AI may pose a threat to the goals that animate our work but could also be (...) valuable for achieving those goals. In the interests of fostering a wider conversation about how generative AI may be used, we have developed a preliminary set of recommendations for its use in scholarly publishing. We hope that the recommendations and rationales set out here will help the scholarly community navigate toward a deeper understanding of the strengths, limits, and challenges of AI for responsible scholarly work. (shrink)

Recent advancements in large language models (LLMs) have ushered in a transformative phase in artificial intelligence (AI). Unlike conventional AI, LLMs excel in facilitating fluid human–computer d...

The new generative artificial intelligence (AI) tools, and especially the large language models (LLMs) of which ChatGPT is the most prominent example, have the potential to transform many aspects o...

The American Journal of Bioethics, Volume 11, Issue 8, Page 1, August 2011.

Bioethicists are often interested mostly in national standards and institutions, but state governments have historically overseen a wide range of bioethical issues and share responsibility with the federal government for still others. States ought to have an important role. By allowing for multiple outcomes, the American federal system allows a better fit between public opinion and public policies.

Bioethicists are often interested mostly in national standards and institutions, but state governments have historically overseen a wide range of bioethical issues and share responsibility with the federal government for still others. States ought to have an important role. By allowing for multiple outcomes, the American federal system allows a better fit between public opinion and public policies.

Philosophers and historians of science have tended to denigrate the status and usefulness of the practice of natural history. The development of biology in this century is seen as the replacement of an older, descriptive and speculative method with a quantitative, experimental and well-founded science. This account embodies a philosophical view about the nature of science, which deems certain kinds of evidence and certain ways of producing knowledge appropriate. Natural history is seen as inadequate, providing insufficient support for establishing theory. (...) ;I develop a case study which shows this account to be incorrect. The case study concerns the debate over the role of geographical isolation in speciation between 1905 and 1907. After some preliminary historical background to the debate, I present a detailed discussion of the arguments made by naturalist David Starr Jordan . The debate that ensued centered on the kinds of evidence one should use in doing science--fieldwork versus experiments. Thus, this case study offers excellent subject matter for understanding natural history. ;After examining the debate and its participants in some detail, we can see that at the heart of this debate is an epistemological issue over what virtues are central to science. In particular, while natural historians like Jordan were advocating an approach which emphasized the consilience of inductions--and hence a variety of kinds of evidence--a more experimentally oriented group of biologists were advocating the centrality of replication and hence argued that all non-experimental forms of evidence should be abandoned. Contrary to expectations, the naturalists had the better theory. (shrink)

This month’s Target Article by Blumenthal-Barby et al. (2022) offers a defense of the importance of philosophy to bioethics. The authors cite the crucial role of philosophers in the development and...

Biologists often define evolution as a change in allele frequencies. Consideration of the evolution of the pocket mouse will show that it is possible to have evolution without any change in the allele frequencies in a population (through change in the genotype frequencies). The implications of this for genic selectionism are then discussed. Sober and Lewontin (1982) have constructed an example to demonstrate the blindness of genic selectionism in certain cases. Sterelny and Kitcher (1988) offer a defense against these arguments (...) which assumes a conventionalist approach to populations. The example considered here will be shown to offer a more plausible and far-reaching argument against the view that alleles can always be seen as the units of selection. (shrink)

(2013). Can Informed Consent Go Too Far? Balancing Consent and Public Benefit in Research. The American Journal of Bioethics: Vol. 13, No. 4, pp. 1-2. doi: 10.1080/15265161.2013.778645.

Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.