Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure.

BACKGROUND: Genomic and biosocial research data about individuals is rapidly proliferating, bringing the potential for novel opportunities for data integration and use. The scale, pace and novelty of these applications raise a number of urgent sociotechnical, ethical and legal questions, including optimal methods of data storage, management and access. Although the open science movement advocates unfettered access to research data, many of the UK's longitudinal cohort studies operate systems of managed data access, in which access is governed by legal and ethical agreements between stewards of research datasets and researchers wishing to make use of them. Amongst other things, these agreements aim to respect the reasonable expectations of the research participants who provided data and samples, as expressed in the consent process. Arguably, responsible data management and governance of data and sample use are foundational to the consent process in longitudinal studies and are an important source of trustworthiness in the eyes of those who contribute data to genomic and biosocial research. METHODS: This paper presents an ethnographic case study exploring the foundational principles of a governance infrastructure for Managing Ethico-social, Technical and Administrative issues in Data ACcess (METADAC), which are operationalised through a committee known as the METADAC Access Committee. METADAC governs access to phenotype, genotype and 'omic' data and samples from five UK longitudinal studies. FINDINGS: Using the example of METADAC, we argue that three key structural features are foundational for practising responsible data sharing: independence and transparency; interdisciplinarity; and participant-centric decision-making. We observe that the international research community is proactively working towards optimising the use of research data, integrating/linking these data with routine data generated by health and social care services and other administrative data services to improve the analysis, interpretation and utility of these data. The governance of these new complex data assemblages will require a range of expertise from across a number of domains and disciplines, including that of study participants. Human-mediated decision-making bodies will be central to ensuring achievable, reasoned and responsible decisions about the use of these data; the METADAC model described in this paper provides an example of how this could be realised.

'I just keep thinking I haven't got it because I'm not yellow': a qualitative study of the factors that influence the uptake of Hepatitis C testing by prisoners.

BACKGROUND: Hepatitis C viral (HCV) infection is a significant public health problem. In the UK, an estimated 200,000 individuals have active HCV infection, most of whom are injecting drug users (IDUs). Many IDUs spend time within the prison system therefore screening for HCV infection in this setting is important. However, uptake of testing within prisons is very low. METHODS: Qualitative interview study. 30 interviews with 25 male and 5 female prisoners with a history of injecting drug use. RESULTS: Personal and institutional barriers to uptake of testing for HCV were identified. Personal barriers included: prisoners' fears and lack of knowledge about HCV, low motivation for testing, lack of awareness about the testing procedure, and concerns about confidentiality and stigma. Institutional barriers included: the prisons' applications procedure for testing, inadequate pre- and post-test discussion, lack of pro-active approaches to offering testing, and lack of continuity of care on discharge and transfer. CONCLUSION: This study highlights potential areas of development in the management of HCV in prisons. Further research is needed to evaluate care pathways for HCV in the prison setting and to develop and assess interventions to improve the uptake of testing for HCV by prisoners.

Managing to manage healthcare resources in the English NHS? What can health economics teach? What can health economics learn?

OBJECTIVES: To provide a 'thick description' of how decision-makers understand and manage healthcare prioritisation decisions, and to explore the potential for using economic frameworks in the context of the NHS in England. METHODS: Interviews were conducted with 22 key decision-makers from six Primary Care Trusts (PCTs) in northern England. A constant comparative approach was used to identify broad themes and sub-themes. RESULTS: Six broad themes emerged from the analysis. In summary, decision-makers recognised the concepts of resources scarcity, competing claims, and the need for choices and trade-offs to be made. Decision-makers even went on to identify a common set of principles that ought to guide commissioning decisions. However, the process of commissioning was dominated by political, historical and clinical methods of commissioning which, failed to recognise these concepts in practice, and departed from the principles. As a result, the commissioning process was viewed as not being systematic or transparent and, therefore, seen as underperforming. CONCLUSIONS: Health economists need to acknowledge the importance of contextual factors and the realities of priority setting. Our research suggests that the emphasis should be on integrating principles of economics into a management process rather than expecting decision-makers to apply the output of ever more seemingly 'technically sound' health economic methods which cannot reflect the dominating and driving complexities of the commissioning process.