Genomics and High-Consequence Infectious Diseases: A Scoping Review of Emerging Science and Potential Ethical Issues.

Host genomic research on high-consequence infectious diseases is a growing area, but the ethical, legal, and social implications of such findings related to potential applications of the research have not yet been identified. While there is a robust ethical debate about the ethical, legal, and social implications of research during an emergency, there has been less consideration of issues facing research conducted outside of the scope of emergency response. Addressing the implications of research at an early stage (anticipatory ethics) helps define the issue space, facilitates preparedness, and promotes ethically and socially responsible practices. To lay the groundwork for more comprehensive anticipatory ethics work, this article provides a preliminary assessment of the state of the field with a scoping review of host genomic research on a subset of high-consequence infectious diseases of relevance to high-level isolation units, focusing on its ethically relevant features and identifying several ethical, legal, and social implications raised by the literature. We discuss the challenges of genomic studies of low-frequency, high-risk events and applications of the science, including identifying targets to guide the development of new therapeutics, improving vaccine development, finding biomarkers to predict disease outcome, and guiding decisions about repurposing existing drugs and genetic screening. Some ethical, legal, and social implications identified in the literature included the rise of systems biology and paradigm shifts in medical countermeasure development; controversies over repurposing of existing drugs; genetic privacy and discrimination; and benefit-sharing and global inequity as part of the broader ecosystem surrounding high-level isolation units. Future anticipatory ethics work should forecast the science and its applications; identify a more comprehensive list of ethical, legal, and social implications; and facilitate evaluation by multiple stakeholders to inform the integration of ethical concerns into high-level isolation unit policy and practice.

The medicalization of obesity, bariatric surgery, and population health.

This article examines how the medicalization of obesity validates the use of bariatric surgery to treat obesity in the United States and how expansions in access to bariatric surgery normalize surgical procedures as disease treatment and prevention tools. Building on this discussion, the article poses two questions for population health regarding health technology: (1) to what extent does bariatric surgery treat obesity in the United States while diverting attention away from the ultimate drivers of the epidemic and (2) to what extent does bariatric surgery improve outcomes for some groups in the US population while simultaneously generating disparities? We conduct a brief, historical analysis of the American Medical Association's decision to reclassify obesity as a disease through internal documents, peer-reviewed expert reports, and major media coverage. We use medicalization theory to show how this decision by the American Medical Association channels increased focus on obesity into the realm of medical intervention, particularly bariatric surgery, and use this evidence to review research trends on bariatric surgery. We propose research questions that investigate the population health dimensions of bariatric surgery in the United States and note key areas of future research. Our objective is to generate a discourse that considers bariatric surgery beyond the medical realm to better understand how technological interventions might work collectively with population-level obesity prevention efforts and how, in turn, population health approaches may improve bariatric surgery outcomes.

"When Does It Stop Being Peanut Butter?": FDA Food Standards of Identity, Ruth Desmond, and the Shifting Politics of Consumer Activism, 1960s-1970s.

This article uses a historical controversy over the U.S. Food and Drug Administration's standard of identity for peanut butter as a site for investigating three topics of high importance for historians of technology, consumption, and food activism: how new industrial food-processing technologies have become regulatory problems; how government, industry, and consumer actors negotiate standards development; and how laypeople try to shape technological artifacts in spaces dominated by experts. It examines the trajectory of consumer activist Ruth Desmond, co-founder of the organization the Federation of Homemakers. By following Desmond's evolving strategies, the article shows how the broader currents of the 1960s-70s consumer movement played out in a particular case. Initially Desmond used a traditional style that heavily emphasized her gendered identity, working within a grassroots organization to promote legislative and regulatory reforms. Later, she moved to a more modern advocacy approach, using adversarial legal methods to fight for consumer protections.

"What is the FDA Going to Think?": Negotiating Values through Reflective and Strategic Category Work in Microbiome Science.

The US National Institute of Health's Human Microbiome Project aims to use genomic techniques to understand the microbial communities that live on the human body. The emergent field of microbiome science brought together diverse disciplinary perspectives and technologies, thus facilitating the negotiation of differing values. Here, we describe how values are conceptualized and negotiated within microbiome research. Analyzing discussions from a series of interdisciplinary workshops conducted with microbiome researchers, we argue that negotiations of epistemic, social, and institutional values were inextricable from the reflective and strategic category work (i.e., the work of anticipating and strategizing around divergent sets of institutional categories) that defined and organized the microbiome as an object of study and a potential future site of biomedical intervention. Negotiating the divergence or tension between emerging scientific and regulatory classifications also activated "values levers" and opened up reflective discussions of how classifications embody values and how these values might differ across domains. These data suggest that scholars at the intersections of science and technology studies, ethics, and policy could leverage such openings to identify and intervene in the ways that ethical/regulatory and scientific/technical practices are coproduced within unfolding research.

Barriers to Considering Ethical and Societal Implications of Research: Perceptions of Life Scientists.

BACKGROUND: As part of an empirical study investigating how life scientists think about ethical and societal implications of their work, and about life science research in general, we sought to elucidate barriers that scientists might face in considering such implications. METHOD: Between 2005 and 2007, we conducted a study consisting of phone interviews, focus groups, and a national survey of life scientists at biomedical research institutions. The study population included graduate students, postdoctoral fellows, faculty, clinical instructors, and research staff. We analyzed data through qualitative and quantitative methods. RESULTS: In analyzing the data, we found that life scientists do, in fact, face barriers to considering ethical and societal implications of research. We categorized these barriers as falling into four broad domains: (1) lack of awareness of ethical and societal implications; (2) lack of relevance of such concerns to their specific research; (3) self-confidence in their ability to resolve such concerns; and (4) aspects of the daily practice of science itself. CONCLUSIONS: Life science researchers experience elements inherent in their training and in the conduct of science as barriers to thinking about ethical and societal implications related to their work. These findings suggest areas in which research ethics educators, bioethicists, and the scientific community can focus their efforts to improve social and ethical accountability in research.

Biomedical scientists' perceptions of ethical and social implications: is there a role for research ethics consultation?

BACKGROUND: Research ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical research. A number of these programs are modelled after clinical ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science researchers' perceived need for and utility of research ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with researchers from Stanford University and a mailed survey in December 2006 to 7 research universities in the U.S. FINDINGS: A total of 16 researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of researchers surveyed (51%) reported that they would find a research ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects research (20% vs 10%; chi(2) p<0.001). CONCLUSION: Our findings indicate that biomedical researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.