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.

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).

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.

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.