Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)
The language of “participant-driven research,” “crowdsourcing” and “citizen science” is increasingly being used to encourage the public to become involved in research ventures as both subjects and scientists. Originally, these labels were invoked by volunteer research efforts propelled by amateurs outside of traditional research institutions and aimed at appealing to those looking for more “democratic,” “patient-centric,” or “lay” alternatives to the professional science establishment. As mainstream translational biomedical research requires increasingly larger participant pools, however, corporate, academic and governmental research programs (...) are embracing this populist rhetoric to encourage wider public participation. We examine the ethical and social implications of this recruitment strategy. We begin by surveying examples of “citizen science” outside of biomedicine, as paradigmatic of the aspirations this democratizing rhetoric was originally meant to embody. Next, we discuss the ways these aspirations become articulated in the biomedical context, with a view to drawing out the multiple and potentially conflicting meanings of “public engagement” when citizens are also the subjects of the science. We then illustrate two uses of public engagement rhetoric to gain public support for national biomedical research efforts: its post-hoc use in the “care.data” project of the National Health Service in England, and its proactive uses in the “Precision Medicine Initiative” of the United States White House. These examples will serve as the basis for a normative analysis, discussing the potential ethical and social ramifications of this rhetoric. We pay particular attention to the implications of government strategies that cultivate the idea that members of the public have a civic duty to participate in government-sponsored research initiatives. We argue that such initiatives should draw from policy frameworks that support normative analysis of the role of citizenry. And, we conclude it is imperative to make visible and clear the full spectrum of meanings of “citizen science,” the contexts in which it is used, and its demands with respect to participation, engagement, and governance. (shrink)
Since the late 1980s, the human genetics and genomics research community has been promising to usher in a “new paradigm for health care”—one that uses molecular profiling to identify human genetic variants implicated in multifactorial health risks. After the completion of the Human Genome Project in 2003, a wide range of stakeholders became committed to this “paradigm shift,” creating a confluence of investment, advocacy, and enthusiasm that bears all the marks of a “scientific/intellectual social movement” within biomedicine. Proponents of this (...) movement usually offer four ways in which their approach to medical diagnosis and health care improves upon current practices, arguing that it is more “personalized,” “predictive,” “preventive,” and “participatory” than the medical status quo. Initially, it was personalization that seemed to best sum up the movement's appeal. By 2012, however, powerful opinion leaders were abandoning “personalized medicine” in favor of a new label: “precision medicine.” The new label received a decisive seal of approval when, in January 2015, President Obama unveiled plans for a national “precision medicine initiative” to promote the development and use of genomic tools in health care. (shrink)
Federal law often avoids setting minimum standards for women’s health and reproductive rights issues, leaving legislative and regulatory gaps for the states to fill as they see fit. This has mixed results. It can lead to state innovation that improves state-level health outcomes, informs federal health reform, and provides data on best practices for other states. On the other hand, some states may use the absence of a federal floor to impose draconian policies that pose risks to women’s and maternal (...) health. Health reforms at the federal level must trod carefully to enable state innovation, while imposing foundational safeguards for promoting women’s health nationwide. (shrink)
Lee emphasizes the need to better understand the moral relationship between researchers and participants connoted by precision medicine, with the framework of “the gift” offering bioethics a...
Oocyte donation raises conflicts of interest and commitment for physicians but little attention has been paid to how to reduce these conflicts in practice. Yet the growing popularity of assisted reproduction has increased the stakes of maintaining an adequate oocyte supply and minimizing conflicts. A growing body of professional guidelines, legal challenges to professional self-regulation, and empirical research on the practice of oocyte donation all call for renewed attention to the issue. As empirical findings better inform existing conflicts and their (...) potential harms, we can better attempt to reduce these conflicts. To that end, the article first describes the nature of conflicts in oocyte donation and relevant regulations and professional guidelines. We then describe studies on conflicts at four phases of oocyte donation: recruitment, screening, stimulation, and post-stimulation monitoring. Next we consider three models for conflict reduction in medicine generally: improved professional self-regulation, outright restriction like Stark anti-referral laws, or the use of conflict mediators, like in living organ donation. We ultimately conclude that improved professional self-regulation is a reasonable starting place for oocyte donation. (shrink)
Bioethics and feminist scholarship has explored various justice implications of nonmedical sex selection and family balancing. However, prospective users’ viewpoints have been absent from the debate over the socially acceptable bounds of nonmedical sex selection. This qualitative study provides a set of empirically grounded perspectives on the moral values that underpin prospective users’ conceptualizations of justice in the context of a family balancing program in the United States. The results indicate that couples pursuing family balancing understand justice primarily in individualist (...) and familial terms rather than in terms of social justice for women and girls or for children resulting from sex selection. Study participants indicated that an individual’s desire for gender balance in their family is ethically complex and may not be inherently sexist, immoral, or socially consequential, particularly given the social context in which they live. Our findings suggest that the social conditions that contribute to prospective users’ desires for gender balance in their families may direct them away from recognizing or engaging broader social justice concerns relating to sexism and stratified reproduction. (shrink)
