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

Abstract

BackgroundGenomic 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.MethodsThis 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.FindingsUsing 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.

The reported impact of public involvement in biobanks: A scoping review

“…There is a growing literature on the role of public involvement in the ethical, legal and policy implications of biobanking. [10][11][12][13][14][15] In 2019, Nunn et al 6 conducted a global review of involvement in genomic research, finding that only one third of studies involved the public and concluding that more involvement would have intrinsic value for future studies. Yet, as Nunn et al note, there are few published accounts of the impact that public involvement has had on the governance, design and conduct of biobanks, 16 or on the public who are involved.…”

“…Biobanks invited public input into varied aspects of the organization. Most commonly, the public had a role in governance (18), and in working with researchers to determine models of consent and the design of consent forms (14). Thirteen biobanks involved the public in discussion of promotional measures and recruitment strategies.…”

Data Access Committees

“…Some suggest that DACs should be independent of the institution to avoid any conflicts of interest. Indeed many independent DACs exist for this reason such as the MalariaGEN and Managing Ethico-social Technical and Administrative DACs [33,34]. To motivate data sharing, we must recognise that sharing data might reveal sensitive information not only about data subjects but also about researchers, healthcare providers and/or their institutions which might cause harm or embarrasment [35].…”

Involving research participants in a pan-European research initiative: the EPAD participant panel experience

“…It has been suggested that the experience and expertise of participants directly affected by research activities as well as the wider public and patient community, can "contribute knowledge and ethical perspectives highly relevant to research decisions" [22] that can improve the success of the research project. Participant perspectives are thus being incorporated throughout the research process, ranging from decisions about data access [23] to the establishment of 'participant panels' in a range of longitudinal or large-scale studies, including the ALSPAC study [24], the UK's 100,000 Genomes project [25] and the US AllofUs precision medicine initiative [26]. However, there has been little discussion of how such participant, patient and public involvement, or PPPI (3PI) can work, or what difference it can make.…”