Ethical Issues in Genetics and Infectious Diseases Research: An Interdisciplinary Expert Review.

Purpose: Research in genetics and infectious diseases (ID) presents novel configurations of ethical, legal, and social issues (ELSIs) related to the intersection of genetics with public health regulations and the control of transmissible diseases. Such research includes work both in pathogen genetics and on the ways that human genetics affect responses to ID. This paper identifies and systematizes the unique issues at this intersection, based on an interdisciplinary expert review.

Genomics in Patient Care and Workforce Decisions in High-Level Isolation Units: A Survey of Healthcare Workers.

The impact of host genomics on an individual's susceptibility, immune response, and risk of severe outcomes for a given infectious pathogen is increasingly recognized. As we uncover the links between host genomics and infectious disease, a number of ethical, legal, and social issues need to be considered when using that information in clinical practice or workforce decisions. We conducted a survey of the clinical staff at 10 federally funded Regional Ebola and Other Special Pathogen Treatment Centers to understand their views regarding the ethical, legal, and social issues related to host genomics and the administrative and clinical functions of high-level isolation units.

The Ethics of Precision Rationing: Human Genetics and the Need for Debate on Stratifying Access to Medication.

Rising prices for new, transformative therapies are challenging health systems around the world, leading many payers and providers to begin rationing access to treatments, even in the countries that have been most resistant to doing so. This is the case for direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV). However, little attention has been paid to the increasing role that human genetics might play in rationing decisions.

Genomics and Infectious Diseases: Expert Perspectives on Public Health Considerations regarding Actionability and Privacy.

There is growing evidence that human genetics plays a significant role in shaping human responses to infectious diseases. For instance, individuals' genetic susceptibility or resistance to infectious disease is likely to affect disease transmission. Yet little attention has been paid to the ethical, legal, and social implications of research in genomics and infectious disease, despite the unique ethical issues that arise in this arena.

What If the Influenza Vaccine Did Not Offer Such Variable Protection?

Background: The protection that an influenza vaccine offers can vary significantly from person to person due to differences in immune systems, body types, and other factors. The question, then, is what is the value of efforts to reduce this variability such as making vaccines more personalized and tailored to individuals.

Methods: We developed a compartment model of the United States to simulate different influenza seasons and the impact of reducing the variability in responses to the influenza vaccine across the population.

Personal Genetic Information about HIV: Research Participants' Views of Ethical, Social, and Behavioral Implications.

Background: Personal genetic information (PGI) about HIV is produced in research and entering the clinic and direct-to-consumer market, but little consideration has been given to ethical and social issues, public perspectives, and potential behavioral implications.

Objectives: This research queried the views of research participants at risk for or infected with HIV, exploring their perspectives on HIV-related PGI and its ethical, social, and behavioral implications.

Methods: We used focus groups to collect rich information about participants' perspectives on the ethical, social, and behavioral implications of PGI about HIV and host genetic research.

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.

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.

"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.

"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.

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.

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.

Strangers at the benchside: research ethics consultation.

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.