Institute of Health & Society

METADAC

METADAC: Managing Ethico-social, Technical & Administrative issues in Data Access

What?

Members of the D2K (Data to Knowledge) Research Group based in IHS are centrally involved in the METADAC project. This infrastructural project is led by Prof Madeleine Murtagh (PEALS Centre, Faculty of Humanities and Social Sciences [HaSS]) and Prof Paul Burton is a co-investigator. Paul Burton and Madeleine Murtagh co-lead D2K.

How?

The METADAC project (Managing Ethico-social, Technical and Administrative issues in Data ACcess) resources a national multi-agency (ESRC, MRC and Wellcome Trust) data access committee (chaired by Madeleine Murtagh) which covers several of the UK’s major cohort studies (1958BC, 1970BC, Millennium BC, ELSA, Understanding Society).

METADAC develops, implements and maintains the administrative and technical activities and policies needed to realise an access mechanism that is able to deal with the specialist governance and technical issues that arise in jointly managing the complex – and often bio-technically or informatically state-of-the-art - biomedical/social data and/or biosamples that are collected by these cohorts and must be rendered safely accessible to third-party users.

METADAC is also intended to provide a scalable mechanism to incorporate additional cohorts in the future. Given this contextual backdrop, METADAC’s primary purpose is to ensure scientifically optimal but well governed access to, and use of, the scientific resources under its governance.

Crucially, METADAC is committed to a streamlined, proportionate and responsive form of governance – and the technology to implement it - which maintains full regard to the consents and expectations of the study participants that are the original source of the research materials held by each study.

Why?

In a world where rapid technological progress and an ageing population place ever increasing demands on medical and social care, one of our most potent weapons is the translation into societal benefit of scientific resources embodied in longitudinal cohorts studies and biobanks.

Although it is easy to appeal to the simple idea of using these resources wisely, the reality is more challenging. Internationally, this is a major strategic issue for most large-scale data/sample generating biomedical and social studies as well as for their funders, who wish to see an optimal use of and return from their investments. The apparently simple administrative task of granting access to data and biosamples is often far from straightforward because of potential – or actual – conflicts of interest between study participants, data generators, data users, funders, ethico-legal experts, specialist lobby groups and policy developers.

For publicly funded studies these are all legitimate stakeholders, with different opportunities to express their perspectives. Appropriately balancing these views is a complex process involving understanding of the underlying science as well as the relevant ethical, legal, social and technical issues. Effectively managing extensive and complex data and biosamples requires active and innovative governance and technical oversight of access to data and biosamples.

In 2015, our funders wondered whether the specialist issues underpinning these aims and the constant need to evolve new policies and approaches to address novel challenges as they arise might most effectively and efficiently be addressed by a national DAC covering multiple studies. This led to the experimental funding of METADAC which we would claim has performed well against all relevant metrics. However, it is the view of the funders that actually matters, and the project is currently being reviewed for renewal by all three funders (with ESRC as lead agency) and a decision will emerge later in 2018.