David E. Winickoff

From consent to institutions: Designing adaptive governance for genomic biobanks

Biobanks are increasingly hailed as powerful tools to advance health research. The social and ethical challenges associated with the implementation and operation of biobanks are equally well-documented. One of the proposed solutions to these challenges involves trading off a reduction in the specificity of informed consent protocols with an increased emphasis on governance. However, little work has gone into formulating what such governance might look like. In this paper, we suggest four general principles that should inform biobank governance and illustrate the enactment of these principles in a proposed governance model for a particular population-scale biobank, the British Columbia (BC) Generations Project. We begin by outlining four principles that we see as necessary for informing sustainable and effective governance of biobanks: (1) recognition of research participants and publics as a collective body, (2) trustworthiness, (3) adaptive management, and (4) fit between the nature of a particular biobank and the specific structural elements of governance adopted. Using the BC Generations Project as a case study, we then offer as a working model for further discussion the outlines of a proposed governance structure enacting these principles. Ultimately, our goal is to design an adaptive governance approach that can protect participant interests as well as promote effective translational health sciences.

A Collaboratively-Derived Science-Policy Research Agenda

The need for policy makers to understand science and for scientists to understand policy processes is widely recognised. However, the science-policy relationship is sometimes difficult and occasionally dysfunctional; it is also increasingly visible, because it must deal with contentious issues, or itself becomes a matter of public controversy, or both. We suggest that identifying key unanswered questions on the relationship between science and policy will catalyse and focus research in this field. To identify these questions, a collaborative procedure was employed with 52 participants selected to cover a wide range of experience in both science and policy, including people from government, non-governmental organisations, academia and industry. These participants consulted with colleagues and submitted 239 questions. An initial round of voting was followed by a workshop in which 40 of the most important questions were identified by further discussion and voting. The resulting list includes questions about the effectiveness of science-based decision-making structures; the nature and legitimacy of expertise; the consequences of changes such as increasing transparency; choices among different sources of evidence; the implications of new means of characterising and representing uncertainties; and ways in which policy and political processes affect what counts as authoritative evidence. We expect this exercise to identify important theoretical questions and to help improve the mutual understanding and effectiveness of those working at the interface of science and policy.

Gene Patenting—The Supreme Court Finally Speaks

In June 2013, the U.S. Supreme Court unanimously ruled that the patents on BRCA1 and BRCA2 held by Myriad were not valid because human genes are products of nature and therefore not patentable. The authors discuss the implications of this long-awaited decision.

The Stem Cell Research Environment: A Patchwork of Patchworks

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a ‘patchwork of patchworks’. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

Science and Power in Global Food Regulation: The Rise of the Codex Alimentarius

The emergence of the global administrative sector and its new forms of knowledge production, expert rationality, and standardization, remains an understudied topic in science studies. Using a coproductionist theoretical framework, we argue tha the mutual construction of epistemic and legal authority across international organizations has been critical for constituting and stabilizing a global regime for the regulation of food safety. The authors demonstrate how this process has also given rise to an authoritative framework for risk analysis touted as ‘‘scientifically rigorous’’ but embodying particular value choices regarding health, environment, and the dispensation of regulatory power. Finally, the authors trace how enrollment of the Codex Alimentarius in World Trade Law has heightened institutional dilemmas around legitimacy and credibility in science advice at the global level. Taken together, the case illustrates the importance of attending to the iterative construction of law and science in the constitution of new global administrative regimes.

Partnership in U.K. Biobank: A Third Way for Genomic Property?

A property analysis of the U.K. Biobank reveals a new imagination of the genomic biobank as a national common-pool resource. U.K. Biobanks treatment of property and governance exhibit both strengths and weaknesses that may be instructive to genome project planners around the world.

Access to Stem Cells and Data: Persons, Property Rights, and Scientific Progress

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Towards a Social Contract for Genomics: Property and the Public in The 'Biotrust' Model

Large-scale genetics cohort studies that link genotypic and phenotypic information hold special promise for clinical medicine, but they demand long-term investment and enduring trust from human research participants. Currently, there are a handful of large-scale studies that aim to succeed where others have failed, seeking to generate significant private-sector investment while preserving long-term interest and trust of studied communities. With project planners looking for new modes of managing such complex collective endeavors, the idea of using a charitable trust structure for genomic biobanks has received increasing scholarly and policy attention. This article clarifies how thorny questions around property rights, the right to withdraw from research, access to materials, and funding might be handled within such a charitable trust structure to help produce a viable participatory framework for genomics.

Genome and Nation: Iceland's Health Sector Database and its Legacy

North Atlantic between the continents of Europe, America, and the Arctic. Although it may seem an unlikely place for innovation of global significance, the small island nation of Iceland has assumed near iconic status in one field in particular: genomics. Aided by recent advances in genetic technologies and by a bold entrepreneurial vision, Iceland’s genomic innovations have helped transform medical and genealogical information into a new type of global commodity. Furthermore, these innovations—or more precisely, the controversies they have spawned—have helped precipitate the development of global norms governing the relationship between citizens, medical information, markets, and the state. Iceland’s public–private partnership has become a common reference point for other major population genomics initiatives—such as those in Sweden, the United Kingdom, Canada and the United States—but there is often an intriguing gap between what it stands for and what it has become. A November 2005 perspective piece in the New England Journal of Medicine is a good example of how in many accounts of Iceland, important details get lost. In this article, the authors argue that generating the next round of genetic discoveries will require a large number of “health information altruists” to supply health and DNA data and DNA. And they cite the Icelandic government’s ability to construct a “national genomic databank,” in collaboration with deCODE Genetics Inc., as an example of the public’s altruism. This sort of statement is not uncommon in articles written about Iceland, but one problem remains: the country’s Health Sector Database, an international symbol of the new state-led genomics and the biotechnological frontier, was never built. Ten years ago, Kari Stefansson, an Icelandic neurologist turned biotech entrepreneur, co-founded deCODE Genetics and began operating in the suburbs of Iceland’s capital. Eight years ago, Iceland passed the Health Sector Database (HSD) Act, which authorized the construction of the national database. Today, although deCODE continues to announce discoveries, the controversial idea to allow the David E. Winickoff

Precaution and governance of emerging technologies

Precaution can be consistent with support of science Precautionary approaches to governance of emerging technology call for constraints on the use of technology whose outcomes include potential harms and are characterized by high levels of complexity and uncertainty. Although articulated in a variety of ways, proponents of precaution often argue that its essential feature is to require more evaluation of a technology before it is put to use, which increases the burden of proof that its overall effect is likely to be beneficial. Critics argue that precaution reflects irrational fears of unproven risks—“risk panics” (1)—and would paralyze development and use of beneficial new technologies (1, 2). Advocates give credence to this view when they suggest that precaution leads necessarily to moratoria (3). Progress in the debate over precaution is possible if we can reject the common assumption that precaution can be explained by a simple high-level principle and accept instead that what it requires must be worked out in particular contexts. The 2016 report from the U.S. National Academies of Science, Engineering, and Medicine (NASEM) on gene drive research (4) illustrates this position. The report shows both that precaution cannot be rejected out of hand as scaremongering and that meaningful precaution can be consistent with support for science.