D2K, PEALS, Newcastle University

METADAC: Managing Ethico-social, Technical and Administrative issues in Data ACcess

What is METADAC?

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.

 The METADAC (Managing Ethico-social, Technical and Administrative issues in Data ACcess) data access committee is a multi-agency multi-study data access structure which serves several of the UK’s major cohort studies (1958BC, 1970BC, Millennium BC, ELSA, Understanding Society) and provides a scaleable mechanism to incorporate additional cohorts in the future. The METADAC will develop, implement and maintain all administrative and technical activities plus policies needed to realise an access mechanism that is fit for purpose given the complex biomedical/social data and samples in question: its primary aim to optimise the use of the scientific resources under its governance. The METADAC is committed to a streamlined, proportionate and responsive form of governance which maintains full regard to the consents and expectations of the study participants who provided the research materials.

 Complex decisions about data access are not simply ethical or technical; they go to the heart of the politics of scientific research.

Criteria for accessing data and bio-samples

The METADAC data access committee considers the more sensitive access decisions for five longitudinal studies:  ELSA, Understanding Society, and the 1958, 1970 and Millennium Birth Cohorts. Other studies are likely to be added in the future.

New applications must be submitted at least 10 working days in advance of the METADAC meeting. Deadlines are published online at METADAC-meeting-dates. The Technical Review Team will identify the basic technical and scientific questions and highlight any problems, if possible resolving them before the METADAC meets.  The METADAC committee will discuss all applications and decide whether to approve, seek further information, request revisions or to reject the application. Approval may be subject to conditions.

The METADAC will assess whether applications meet the following criteria:-

[All criteria must be met if research proposal is to be approved]

  1. The application has been submitted by bona fide researchers with sufficient experience to carry out the work proposed.
  2. The application meets the criteria on the application form for seniority of the principal applicant.
  3. There is negligible risk that the application will produce information that may allow individual study participants to be identified.
  4. The application does not violate (or potentially violate) any of the consent given by the participants or their guardians.
  5. The application does not violate (or potentially violate) any of the ethical permissions granted to the study* from which data or samples are requested.
  6. The application addresses topics that fall within the acknowledged remit of the study, as understood by participants.
  7. There is no substantive risk that the application might upset or alienate study members or of reducing their willingness to continue as participants.
  8. There is no substantive risk that the application might harm individuals in the study, or the study as a whole.
  9. Includes a good quality plain language summary – following the METADAC guidance.
  10. The application does not require access to a depletable finite resource (whole blood extracted DNA, blood, saliva and urine).
    If the application does require access to samples, then the criteria in the METADAC biosample strategy guidelines have been met. Applications for finite bio-samples are seen as being in competition with other potential research projects**, and the quality of the science is reviewed formally (if necessary using independent external reviewers). The METADAC biosample strategy guidelines contain more detail of the process.

* ‘Study’ refers to one of the longitudinal studies under METADAC governance.
** ‘Project’ refers to projects proposed in data/samples applications to METADAC.

Expert governance and policy implementation forum

The METADAC also provides an expert forum for discussion of new, complex or difficult issues in data governance issues.  In addition to the studies mentioned above, the TwinsUK study has an observer on the METADAC committee and can refer applications to METADAC for discussion should any issues arise that require expert discussion.  The METADAC has a wider responsibility for reviewing and developing the implementation of emerging policies to reflect rapid changes in the scientific, social and ethico-legal underpinning of this important area of bioscience, as well as considering best practice in the practical and administrative aspects of Data Governance.

Download METADAC’s terms of reference (pdf, 121kb)

METADAC is funded jointly by MRC, Wellcome Trust and ESRC.

MRC logoWT co-funded logoESRC logo

Contact the METADAC secretariat