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)
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)
: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)
(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.
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)
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). (shrink)
One strategy for defenders of gene patenting is to adopt a constructivist interpretation of genetic testing to avoid the I argue that accepting this view (which seems to be the approach of the U.S. Office of Patents and Trademarks) results in an intolerable dilemma for physicians. They must either infringe patents or fail to act on all the medically relevant information they possess (malpractice).
