David Magnus

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.

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.

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.

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.

Approaching science by considering the epistemological virtues which scientists see as constitutive of good science, and the way these virtues trade-off against one another, makes it possible to capture action that may be lost by approaches which focus on either the theoretical or institutional level. Following Wimsatt (1984) I use the notion of heuristics and biases to help explore a case study from the history of biology. Early in the 20th century, mutation theorists and natural historians fought over the role that isolation plays in evolution. This debate was principally about whether replication was the central scientific virtue (and hence the ultimate goal of science to replace non-experimental evidence with experimental evidence) or whether consilience of inductions was the central virtue (and hence, as many kinds of evidence as possible should be pursued).

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.

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.

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.