Catherine Heeney

Data sharing in genomics — re-shaping scientific practice

Funding bodies have recently introduced a requirement that data sharing must be a consideration of all funding applications in genomics. As with all new developments this condition has had an impact on scientific practice, particularly in the area of publishing and in the conduct of research. We discuss the challenges that must be addressed if the full benefits of data sharing, as envisaged by funders, are to be realized.

Assessing the privacy risks of data sharing in genomics.

The protection of identity of participants in medical research has traditionally been guaranteed by the maintenance of the confidentiality of health information through mechanisms such as only releasing data in an aggregated form or after identifying variables have been removed. This protection of privacy is regarded as a fundamental principle of research ethics, through which the support of research participants and the public is maintained. Whilst this traditional model was adopted for genetics and genomics research, and was generally considered broadly fit for purpose, we argue that this approach is increasingly untenable in genomics. Privacy risk assessments need to have regard to the whole data environment, not merely the quality of the dataset to be released in isolation. As sources of data proliferate, issues of privacy protection are increasingly problematic in relation to the release of genomic data. However, we conclude that, by paying careful attention to potential pitfalls, scientific funders and researchers can take an important part in attempts to safeguard the public and ensure the continuation of potentially important scientific research.

Breaching the Contract? Privacy and the UK Census

Along with informed consent, anonymization is an accepted method of protecting the interests of research participants, while allowing data collected for official statistical purposes to be reused by other agencies within and outside government. The Decennial Census, carried out in a number of countries, including the United Kingdom, is a major event in the production of research data and provides an important resource for a variety of organizations. This article combines ethical evaluation, a review of relevant law and guidance, and analysis of 30 qualitative interviews (carried out during the period of the 2001 UK Census), in order to explore the adequacy of the current framework for the protection of informational privacy in relation to census data. Taking account of Nissenbaums concept of “contextual integrity,” Vedders concept of “categorical privacy,” and Sens call to heed of the importance of “actual behavior,” it will be argued that the current “contractarian” view of the relationship between an individual participant and the organization carrying out the Census does not engage sufficiently with actual uses of data. As a result, people have expectations of privacy that are not matched by practice and that the current normative—including the governance—framework cannot capture.

Planning for translational research in genomics.

Translation of research findings into clinical practice is an important aspect of medical progress. Even for the early stages of genomics, research aiming to deepen understandings of underlying mechanisms of disease, questions about the ways in which such research ultimately can be useful in medical treatment and public health are of key importance. Whilst some research data may not apparently lend themselves to immediate clinical benefit, being aware of the issues surrounding translation at an early stage can enhance the delivery of the research to the clinic if a medical application is later found. When simple steps are taken during initial project planning, the pathways towards the translation of genomic research findings can be managed to optimize long-term benefits to health. This piece discusses the key areas of collaboration agreements, distribution of revenues and recruitment and sample collection that are increasingly important to successful translational research in genomics.

An “Ethical Moment” in Data Sharing

This study draws on interviews with forty-nine members of a biomedical research community in the UK that is involved in negotiating data sharing and access. During an interview, an interviewee used the words “ethical moment” to describe a confrontation between collaborators in relation to data sharing. In this article, I use this as a lens for thinking about relations between “the conceptual and the empirical” in a way that allows both analyst and actor to challenge the status quo and consider other ethical possibilities. Drawing on actor network theory (ANT), I approach “the empirical” using the concepts of controversy and ontological uncertainty as methodological tools to tackle the problem of ethics. I suggest that these concepts also provide a bridge for understanding the ontological structure of the virtual and the actual, as described in Deleuze’s Difference and Repetition. While other science and technology studies scholars have sought to draw on Deleuze, this article addresses the integration of ethics and empirical research. It arises as a critical reaction to existing treatments of this problem as found in empirical ethics, especially in the sociology of bioethics, and indirectly in ANT texts.

Balancing the local and the universal in maintaining ethical access to a genomics biobank

BackgroundIssues of balancing data accessibility with ethical considerations and governance of a genomics research biobank, Generation Scotland, are explored within the evolving policy landscape of the past ten years. During this time data sharing and open data access have become increasingly important topics in biomedical research. Decisions around data access are influenced by local arrangements for governance and practices such as linkage to health records, and the global through policies for biobanking and the sharing of data with large-scale biomedical research data resources and consortia.MethodsWe use a literature review of policy relevant documents which apply to the conduct of biobanks in two areas: support for open access and the protection of data subjects and researchers managing a bioresource. We present examples of decision making within a biobank based upon observations of the Generation Scotland Access Committee. We reflect upon how the drive towards open access raises ethical dilemmas for established biorepositories containing data and samples from human subjects.ResultsDespite much discussion in science policy literature about standardisation, the contextual aspects of biobanking are often overlooked. Using our engagement with GS we demonstrate the importance of local arrangements in the creation of a responsive ethical approach to biorepository governance. We argue that governance decisions regarding access to the biobank are intertwined with considerations about maintenance and viability at the local level. We show that in addition to the focus upon ever more universal and standardised practices, the local expertise gained in the management of such repositories must be supported.ConclusionsA commitment to open access in genomics research has found almost universal backing in science and health policy circles, but repositories of data and samples from human subjects may have to operate under managed access, to protect privacy, align with participant consent and ensure that the resource can be managed in a sustainable way. Data access committees need to be reflexive and flexible, to cope with changing technology and opportunities and threats from the wider data sharing environment. To understand these interactions also involves nurturing what is particular about the biobank in its local context.

The path forward for DNA data.

The possibility that individuals may be identifiable in pools of DNA data appears to have come as a surprise to researchers and funding bodies (News of the Week, “Whole-genome data not anonymous, challenging assumptions,” J. Couzin, 5 September, p. [1278][1]) ([1][2]). But these concerns could