Characterizing human embryonic stem cells: biological and social markers of identity.

Human embryonic stem cells are elusive, recalcitrant entities that resist characterization and standardization. Without agreements about what the cells are and how best to systematize cell culture and testing, data cannot be extracted meaningfully, the nascent field will be slow to stabilize, and significantly, there may be safety risks for patients. I discuss efforts to characterize cells definitively and standardize practices across uniquely derived lines, labs, and researchers. I argue that such efforts are made more complicated by layered identities imposed on them by classification conventions, interactions with researchers and laboratory environments, and inheritances from genetic ancestry. The need to understand and possibly capitalize on such distinct, cumulative identities is in tension with the desire to stabilize the field under conditions of political and scientific uncertainty. The article links STS work on standardization with anthropological perspectives on identity and material culture in science.

Accounting for accountable care: Value-based population health management.

Accountable Care Organizations (ACOs) are exemplars of so-called value-based care in the US. In this model, healthcare providers bear the financial risk of their patients' health outcomes: ACOs are rewarded for meeting specific quality and cost-efficiency benchmarks, or penalized if improvements are not demonstrated. While the aim is to make providers more accountable to payers and patients, this is a sea-change in payment and delivery systems, requiring new infrastructures and practices. To manage risk, ACOs employ data-intensive sourcing and big data analytics to identify individuals within their populations and sort them using novel categories, which are then utilized to tailor interventions. The article uses an STS lens to analyze the assemblage involved in the enactment of population health management through practices of data collection, the creation of new metrics and tools for analysis, and novel ways of sorting individuals within populations. The processes and practices of implementing accountability technologies thus produce particular kinds of knowledge and reshape concepts of accountability and care. In the process, account-giving becomes as much a procedural ritual of verification as an accounting for health outcomes.

Cellular therapies for heart disease: unveiling the ethical and public policy challenges.

Cellular therapies have emerged as a potential revolutionary treatment for cardiovascular disease. Promising preclinical results have resulted in a flurry of basic research activity and spawned multiple clinical trials worldwide. However, the optimal cell type and delivery mode have not been determined for target patient populations. Nor have the mechanisms of benefit for the range of cellular interventions been clearly defined. Experiences to date have unveiled a myriad of ethical and public policy challenges which will affect the way researchers and clinicians make decisions for both basic and clinical research. Stem cells derived from embryos are at the forefront of the ethical and political debate, raising issues of which derivation methods are morally and socially permissible to pursue, as much as which are technically feasible. Adult stem cells are less controversial; however, important challenges exist in determining study design, cell processing, delivery mode, and target patient population. Pathways to successful commercialization and hence broad accessibility of cellular therapies for heart disease are only beginning to be explored. Comprehensive, multi-disciplinary and collaborative networks involving basic researchers, clinicians, regulatory officials and policymakers are required to share information, develop research, regulatory and policy standards and enable rational and ethical cell-based treatment approaches.

Claims and disclaimers: whose expertise counts?

Medical anthropologists have long recognized that interactions between state, clinical, scientific and lay participants transform understandings of illness. There are competing claims to knowledge in such interactions, which may be in tension with concepts of jurisdictional authority and assumptions about what constitutes different types of expertise. This paper focuses on the regulatory processes of the Food and Drug Administration in order to examine the social processes involved in negotiating and sustaining domains of knowledge across various boundaries of authority. I use the example of the way roles of commercial interests, patient interest groups and federal oversight agencies in defining and caring for health "problems" appear to be shifting with new modes of circulating information about prescription drugs. What counts as "medical expertise" when decisions about taking pharmaceuticals are moved away from former gatekeepers (physicians and insurance plans) to patients who are reframed as consumers? In this reordering new questions are raised about the location of risk and responsibility, and relations of credibility, authority and expertise.

Concepts of risk in nanomedicine research.

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and procedures that develop, test, and oversee any novel technology. This supports recommendations to coordinate efforts through an interagency Working Group and a Secretary-level Advisory Committee to provide flexibility and sensitivity to emerging issues of concern.

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern.

Science, ethics, and the "problems" of governing nanotechnologies.

Commentators continue to weigh in on whether there are ethical, social, and policy issues unique to nanotechnology, whether new regulatory schemes should be devised, and if so, how. Many of these commentaries fail to take into account the historical and political environment for nanotechnologies. That context affects regulatory and oversight systems as much as any new metrics to measure the effects of nanoscale materials, or organizational changes put in place to facilitate data analysis. What comes to count as a technical or social "problem" says much about the sociotechnical and political-historical networks in which technologies exist. This symposium's case studies provide insight into procedural successes and failures in the regulation of novel products, and ethical or social analyses that have attended to implications of novel, disruptive technologies. Yet what may be needed is a more fundamental consideration of forms of governance that may not just handle individual products or product types more effectively, but may also be flexible enough to respond to radically new technological systems. Nanotechnology presents an opportunity to think in transdisciplinary terms about both scientific and social concerns, rethink "knowns" about risk and how best to ameliorate or manage it, and consider how to incorporate ethical, social, and legal analyses in the conceptualization, planning, and execution of innovations.