Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent (...) telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. Results The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. Conclusions The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000332022. (shrink)
This manuscript describes a pilot study in ethics education employing a problem-based learning approach to the study of novel, complex, ethically fraught, unavoidably public, and unavoidably divisive policy problems, called “fractious problems,” in bioscience and biotechnology. Diverse graduate and professional students from four US institutions and disciplines spanning science, engineering, humanities, social science, law, and medicine analyzed fractious problems employing “navigational skills” tailored to the distinctive features of these problems. The students presented their results to policymakers, stakeholders, experts, and members (...) of the public. This approach may provide a model for educating future bioscientists and bioengineers so that they can meaningfully contribute to the social understanding and resolution of challenging policy problems generated by their work. (shrink)
This paper explores the specific questions raised for social epistemology encountered in code and software. It does so because these technologies increasingly make up an important part of our urban environment, and stretch across all aspects of our lives. The paper introduces and explores the way in which code and software become the conditions of possibility for human knowledge, crucially becoming computational epistemes, which we share with non-human but crucially knowledge-producing actors. As such, we need to take account of this (...) new computational world and think about how we live today in a highly mediated code-based world. Nonetheless, here I want to understand software epistemes as a broad concept related to the knowledge generated by both human and non-human actors. The aim is to explore changes that are made possible by the installation of code/software via computational devices, streams, clouds or networks. This is what Mitcham calls a ?new ecology of artifice?. By exploring two case studies, the paper attempts to materialise the practice of software epistemologies through a detailed analysis. This analysis is then drawn together with a notion of compactants to explore how studying tracking software and streams is a useful means of uncovering the agency of software and code for producing these new knowledges. (shrink)
Research ethics education in the biosciences has not historically been a priority for research universities despite the fact that funding agencies, government regulators, and the parties involved in the research enterprise agree that it ought to be. The confluence of a number of factors, including scrutiny and regulation due to increased public awareness of the impact of basic research on society, increased public and private funding, increased diversity and collaboration among researchers, the impressive success and speed of research advances, and (...) high-profile cases of misconduct, have made it necessary to reexamine how the bioscience research community at all levels provides ethics education to its own. We discuss the need to and reasons for making ethics integral to the education of bioscientists, approaches to achieving this goal, challenges this goal presents, and responses to those challenges. (shrink)
This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at the intersection of abortion law (...) and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency. (shrink)
Genetic engineering: past and present as prelude to the future -- Utilitarianism and engineering to maximize welfare -- Deontology: engineering at the edges of disease, disability, difference, and death -- Virtue ethics and engineering for the virtues -- Genetic engineering, fractious problems, and a navigational approach to policymaking.
We show that quantum interference can be interpreted in terms of a phase invariant quantity, not unlike the Berry’s phase. Under this interpretation, closed loops in time become fundamental quantum entities, and all quantum states become periodic. Decoherence is then seen to occur naturally as a consequence. This formalism, although counterintuitive, provides another useful way of assigning meaning to quantum probabilities and quasi-probabilities.
This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)
Lecture given Wednesday 27 October 1993 at a Physics - Computer Science Colloquium at the University of New Mexico. The lecture was videotaped; this is an edited transcript. It also incorporates remarks made at the Limits to Scientific Knowledge meeting held at the Santa Fe Institute 24-26 May 1994.