METADAC

Lead Research Organisation: Newcastle University
Department Name: Geography Politics and Sociology

Abstract

Some of the most important advances in our understanding of health and society are based on research studies that have been collecting information (or data) from ordinary people over many years. These studies are called longitudinal studies. The UK has a unique history of supporting longitudinal studies, with some starting as long ago as the 1930s. Longitudinal studies collect data about how people live, their health, well-being, education, as well as their social and physical environments. Some also collect biological samples (e.g. blood or urine) which can be processed to obtain data about inherited characteristics (genetics). For example, these studies have shown us that smoking in pregnancy leads to poorer health in babies and that inherited characteristics can affect health conditions such as diabetes and high blood pressure.

Researchers from the UK and around the world can use these data and samples from longitudinal studies to answer important questions about human health and wellbeing. Some of these data collections contain information that is sensitive, especially when different types of data or samples are combined. For this reason access to the data and samples for research is restricted. Only qualified researchers working for recognised research institutions can use these data or samples. Independent committees exist to safeguard the people who contributed the data. The METADAC project runs such an independent committee to approve applications from researchers to access data and samples from UK longitudinal studies. METADAC designs the rules for making sure that access to data and samples for research is safe and secure based on the best practice and policies from around the world. METADAC also ensures that the process of applying for access is fair and transparent. METADAC includes experts in science, ethics, law and clinical practice who have an understanding of the complexities of sharing data and samples for research. METADAC also includes people who provide data and samples for longitudinal studies (the study participants) in developing rules about access and in granting permission for researchers to access data and samples.

METADAC has already successfully completed three years of development - 2015 to 2018. In its second phase (2018 to 2020) METADAC will continue to provide safe and fair access for research which combines different types of data and uses samples. METADAC will strengthen and promote its systems so that more researchers can use data and samples from longitudinal studies to advance knowledge about health and society. As part of its commitment to safe use of data and samples, METADAC will also work closely with other organisations who are charged with keeping the data and samples from UK longitudinal studies safe and secure.

Planned Impact

Impact Summary
At present, there is strong strategic investment in ensuring not only the optimisation of research data use, but also of routine data generated by health and social care services and other administrative data services. The international research community is proactively working towards creating a world in which all such sources of data can, where beneficial, be integrated, linked and jointly interpreted; this potential has been demonstrated in the UK in projects such as The Farr Institute, the Administrative Data research Network, Connected Health Cities, the pan-London Health Information Exchange, and Medical Research Council's Health Data Research UK initiative. The aims of such initiatives and the enhanced data utility they provide are three-fold: (1) to better use data to directly inform front-line clinical care and public health; (2) to enhance the evidence base for health and social care planning and strategic development and formally evaluate key initiatives in these domains; and (3) to enhance the quality and scope of research in health science, bioscience and the social sciences.

In this context there are many beneficiaries of the data and samples made available through the METADAC:

Who will benefit from this funding and how?

Bio- and social science academics who access data and samples through application to METADAC are immediate beneficiaries of this funding. An audit (February 2018) of the disciplines making use of the resource include: Biosocial studies, Biostatistics, Chemistry, Clinical epidemiology, Clinical Science, Communication Studies, Computing, Econometrics, Economics, Education, Employment and work studies, Environmental Studies, Epidemiology, Epigenetics, Genetics, Health Sciences, Immunology, Informatics, Law, Linguistics, Management/Business, medical genetics, Molecular Biology, molecular genetics, Neuroscience, Nutrition, Omics research, Oncology, Paediatrics, Pharmacy, Political science, Psychiatry, Psychology, Public health, Social Science, Social work, Sociology.

Academics working in the field of Ethical, Legal and Social Implications (ELSI) research benefit from interaction with, contribution to and learning from governance developments undertaken in METADAC, either directly as members of the committee or as part of the international community of scholars of which Prof Murtagh is a part. As Co-lead of the Regulatory and Ethics Working Group of the Global Alliance for Genomics and Health, member of the ELSI 2.0 Steering Committee, member of the International Association of Bioethics, International Sociological Association Prof Murtagh promotes use and understanding of the METADAC. Likewise Prof Burton, Blell and members of the METADAC committee promote METADAC through their networks.

Longitudinal studies, whose data and sample applications are managed by METADAC, benefit directly by having access to an independent governance infrastructure which administer, develops and undertakes data and sample access management and policy. There is a major benefit in ensuring that those leading longitudinal studies can concentrate primarily on the science and technology that relates to that rather than the work associated with governing access to the data and samples produced by those studies leaving this instead to an independent interdisciplinary group of specialists who can pull together all of the requisite knowledge and understanding to address governance in this rapidly evolving field and respond to new challenges as they arise.

That longitudinal studies benefit through the mutual learning from other studies has been demonstrated in the pilot. With outreach to other longitudinal studies and the user community this shared and collaborative learning will grow.

Citizens benefit from the outcomes and impact of the research conducted on the basis of applications for data and samples to METADAC.

Publications

10 25 50
 
Description Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure
Abstract
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.
Keywords: Data ethics, Data governance, Data access, Data Access Committee (DAC), Governance,
Participant involvement, Ethnography, Qualitative research, Interdisciplinarity
Exploitation Route The methods and approaches of METADAC may be used by other data access governance infrastructures.
Sectors Digital/Communication/Information Technologies (including Software),Healthcare,Government, Democracy and Justice

 
Description ALSPAC (Various grants including 2010 Strategic Renewal funded by MRC and WT) 
Organisation University of Bristol
Department Avon Longitudinal Study of Parents and Children (ALSPAC)
Country United Kingdom 
Sector Academic/University 
PI Contribution ALSPAC and 1958BC have worked together (and in collaboration with BioSHaRE-eu) in the joint development of DataSHIELD, and in continuing to explore the extension of ESPRESSO (the power calculator developed for designing UK Biobank) to enable construction of simulated study data that applicants can work with before making a definitive application for real data. This will help applicants to refine their applications to enhance efficiency, and will avoid misunderstandings where a research group is literally unable to do what they thought they could do when they applied.
Collaborator Contribution Paul Burton has just moved to University of Bristol where he has taken on a central role in the ALSPAC project. Precisely how extensive this role will be, and the extent to which the funders (MRC and WT) would like us to move towards a seamless joint management structure for 1958BC and ALSPAC is currently a focus of active discussion between the two projects and the funders. Joint work on enhancing data access infrastructures for both 1958BC and ALSPAC (Burton, Davey-Smith, Ring).
Impact ESPRESSO work is ongoing. In addition, both 58READIE and ALSPAC are working together to develop an online application system which can be used by both cohorts in order to streamline the application and awards process. New ESPRESSO paper (in collaboration with UK Biobank) recently submitted, Opal/DataSHaPER/DataSHIELD paper describing true federated analysis is on the point of being accepted.
Start Year 2010
 
Description BBMRI-LPC 
Organisation UK Biobank
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Staff associated with the 58READIE project at the University of Leicester are managing the UK arm of the study, managing the submission of applications to the 1958 Birth Cohort and the UK Biobank that qualify under the BBMRI-LPC access criteria (more than one EU nation with no applicant from the nation hosting the specified biobanks). Qualifying access applications that also pass the standard review procedures (of 1958 Birth Cohort or UKBB) will be entitled to a subsidy under BBMRI-LPC.
Collaborator Contribution BBMRI-LPC (Biobanking and Biomolecular Resources Research Infrastructure - Large Prospective Cohorts) is an EU Research Infrastructure Project that aims to improve access and standardize procedures, smoothing access to samples and/or data and allowing integrated research across different cohorts by independent European investigators. In coordination with BBMRI, the proposal will develop a large prospective cohort management structure for a connection, integration and access provision project BBMRI-LPC. BBMRI-LPC is using 1958BC as one of its two major UK data access sites.
Impact Staff on the 58READIE project continue to provide advice and information about the cohort to enable BBMRI-LPC to update their cohort catalogues and meet their required work package deliverables.
Start Year 2012
 
Description BBMRI-LPC 
Organisation UK Biobank
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Staff associated with the 58READIE project at the University of Leicester are managing the UK arm of the study, managing the submission of applications to the 1958 Birth Cohort and the UK Biobank that qualify under the BBMRI-LPC access criteria (more than one EU nation with no applicant from the nation hosting the specified biobanks). Qualifying access applications that also pass the standard review procedures (of 1958 Birth Cohort or UKBB) will be entitled to a subsidy under BBMRI-LPC.
Collaborator Contribution BBMRI-LPC (Biobanking and Biomolecular Resources Research Infrastructure - Large Prospective Cohorts) is an EU Research Infrastructure Project that aims to improve access and standardize procedures, smoothing access to samples and/or data and allowing integrated research across different cohorts by independent European investigators. In coordination with BBMRI, the proposal will develop a large prospective cohort management structure for a connection, integration and access provision project BBMRI-LPC. BBMRI-LPC is using 1958BC as one of its two major UK data access sites.
Impact Staff on the 58READIE project continue to provide advice and information about the cohort to enable BBMRI-LPC to update their cohort catalogues and meet their required work package deliverables.
Start Year 2012
 
Description BBMRI-LPC Consortium 
Organisation Biobanking and Biomolecular Resources Research Infrastructure
Country Austria 
Sector Academic/University 
PI Contribution Research under METADAC is contributing to greater understanding of the human, relational and political barriers to data access across Europe.
Collaborator Contribution BBMRI-LPC has provided access to participants in research aiming to better understand barriers to data access across Europe and in the UK.
Impact Invited presentations Title: Challenges in Europe with regards data sharing Where and when: BBMRI-LPC Final Consortium Meeting, Levi, Kittila, Finland, 8-9 September 2016 Audience: 50 partners/members of the BBMRI-LPC study (EU-FP7 infrastructure) Impact: sharing the METADAC model more widely, influencing European biobank practice in data sharing Conference presentations/dissemination Presenters: Murtagh, MJ & Roberts, SJ. Title: The METADAC model for data and sample access, Where and When: EU BIOBANK WEEK, VIENNA, 16 August, 2016 Audience: 150 delegates Impact: sharing the METADAC model more widely, great interest in how we address the challenges of data sharing, eg. Incidental findings Title: The METADAC model for data and sample access, Where and When: EU BIOBANK WEEK, VIENNA, 16 August, 2016 Audience: 150 delegates Impact: sharing the METADAC model more widely, great interest in how we address the challenges of data sharing, eg. Incidental findings Title: Epistemic and nonepistemic values driving data sharing in practice for data and sample access, Where and When: EASST meeting, 1 September, 2016 Audience: 100 delegates Impact: Discussion of the drivers of data sharing and sharing the METADAC model more widely
Start Year 2012
 
Description BioSHaRE-EU 
Organisation University of Groningen
Country Netherlands 
Sector Academic/University 
PI Contribution BioSHaRE-EU (Stolk R, et al): FP7 Large Scale Integrating Project (P Burton, Scientific Coordinator; M Murtagh, Co-investigator). At present there are two main collaborative sub-projects: the 1958 Birth Cohort was one of the first three cohorts (since extended to none) that have been set up to enable truly federated joint analysis of harmonized data using, Opal, DataSHaPER and DataSHIELD (Burton) for the Healthy Obese Project (one of the scientific core projects of BioSHaRE-EU). This successful world's "first" was first demonstrated at the BioSHaRE-EU annual conference in Paris (November 2012) and this year's annual meeting (Barcelona, November 2013) has seen the first workshop in which researchers (other than those who have developed the systems) were able to start undertaking true federated harmonized data analysis themselves. This work is now ongoing and will generate important outputs both in terms of the development of DataSHIELD and of the science related to the Healthy Obese Project. BioSHaRE-EU is also central to the development of ESPRESSO (Burton - see Current primary project is a proposed extension of ESPRESSO (see collaboration/partnership with ALSPAC, below). Murtagh is developing a program of ethnographic research based on data access and biobanking. This work is funded jointly under 58READIE and BioSHaRE-EU. With their consent, the ACCC (the committee overseeing access to 1958 Birth Cohort data and samples) is being observed and recorded as part of Murtagh's research program, which feeds in directly to the Social Program in BioSHaRE-EU (which Murtagh leads).
Collaborator Contribution BioSHaRE-EU focuses on the development of a harmonized biobanking and data access infrastructure across Europe with the specific aim of realizing scientific projects that require sample sizes too large to be accrued in any other way.
Impact 58READIE has worked in conjunction with BioSHARE-EU on the Healthy Obese Project to produce a DataSHaPER consisting of 96 harmonised variables. Work on an ethnographic study of the operation of the Access Committee for CLS Cohorts has also been performed with an initial report presented to the Committee itself. Two papers are planned to describe the results of this ethnographic study.
Start Year 2010
 
Description CLOSER 
Organisation Economic and Social Research Council
Country United Kingdom 
Sector Public 
PI Contribution 58READIE is working with CLOSER on a number of issues that are of central strategic importance to the development of effective national mechanisms for data access and exploitation. Two current issues being addressed together are the development of a strategy for utilisation of biosamples (unlike data, these represent a finite resource), and development of a framework for feedback of clinically relevant findings. In addition we interface with CLOSER in relation to data harmonization - a formal DataSHaPER for 1958BC on 96 variables has been created for the Healthy Obese Project under BioSHaRE-eu (harmonized with 8 other major European cohorts) and we will work with CLOSER by contributing our experience in this area to the construction of harmonized meta-data standards for 1958BC planned over the next year
Collaborator Contribution The UK is home to the largest and longest-running longitudinal studies in the world. The Cohorts and Longitudinal Studies Enhancement Resource (CLOSER) plasy a vital role in maximising the use, value and impact of these studies both within the UK and abroad. It will focus on nine of the country's leading studies, with participants born as early as 1911 and as recently as 2007. 1958BC is one of the cohorts centrally involved in CLOSER.
Impact Still in initial stages with full impact yet to be determined
Start Year 2012
 
Description CLOSER 
Organisation University College London
Department Centre for Longitudinal Studies
Country United Kingdom 
Sector Academic/University 
PI Contribution 58READIE is working with CLOSER on a number of issues that are of central strategic importance to the development of effective national mechanisms for data access and exploitation. Two current issues being addressed together are the development of a strategy for utilisation of biosamples (unlike data, these represent a finite resource), and development of a framework for feedback of clinically relevant findings. In addition we interface with CLOSER in relation to data harmonization - a formal DataSHaPER for 1958BC on 96 variables has been created for the Healthy Obese Project under BioSHaRE-eu (harmonized with 8 other major European cohorts) and we will work with CLOSER by contributing our experience in this area to the construction of harmonized meta-data standards for 1958BC planned over the next year
Collaborator Contribution The UK is home to the largest and longest-running longitudinal studies in the world. The Cohorts and Longitudinal Studies Enhancement Resource (CLOSER) plasy a vital role in maximising the use, value and impact of these studies both within the UK and abroad. It will focus on nine of the country's leading studies, with participants born as early as 1911 and as recently as 2007. 1958BC is one of the cohorts centrally involved in CLOSER.
Impact Still in initial stages with full impact yet to be determined
Start Year 2012
 
Description CLS, UKHLS and METADAC 
Organisation University of Essex
Department Institute for Social and Economic Research, Essex
Country United Kingdom 
Sector Academic/University 
PI Contribution The METADAC team makes ethical and governance judgments about more sensitive applications involving biomedical data for CLS participants, but also works closely with CLS and UKHLS, influencing their research practice and design to help ensure developing national governance policies can be applied in practice throughout the coming years of the longitudinal studies.
Collaborator Contribution Based on close communication with METADAC, CLS and UKHLS develop and maintain the Data Access Strategies under which METADAC operates. CLS and UKHLS feed back to METADAC any study-specific issues that need to be taken account for good governance, especially issues that influence the development of good practice and 'future-proof' governance decisions.
Impact This is a multidisciplinary collaboration including social science, ethicolegal expertise, genetic and medical science, bioinformatics as well as technician's and study managers expertise in assessing the potential practical impact of developments in good governance of data and human samples.
Start Year 2015
 
Description CLS, UKHLS and METADAC 
Organisation University of London
Department Institute of Education
Country United Kingdom 
Sector Academic/University 
PI Contribution The METADAC team makes ethical and governance judgments about more sensitive applications involving biomedical data for CLS participants, but also works closely with CLS and UKHLS, influencing their research practice and design to help ensure developing national governance policies can be applied in practice throughout the coming years of the longitudinal studies.
Collaborator Contribution Based on close communication with METADAC, CLS and UKHLS develop and maintain the Data Access Strategies under which METADAC operates. CLS and UKHLS feed back to METADAC any study-specific issues that need to be taken account for good governance, especially issues that influence the development of good practice and 'future-proof' governance decisions.
Impact This is a multidisciplinary collaboration including social science, ethicolegal expertise, genetic and medical science, bioinformatics as well as technician's and study managers expertise in assessing the potential practical impact of developments in good governance of data and human samples.
Start Year 2015
 
Description Centre for Longitudinal Studies (CLS) 
Organisation University College London
Department Centre for Longitudinal Studies
Country United Kingdom 
Sector Academic/University 
PI Contribution P Burton sits on the Strategic Advisory Board for the Centre for Longitudinal Studies
Collaborator Contribution The CLS is responsible for running several of Britain's internationally renowned birth cohort studies: the 1958 Birth Cohort; the 1970 Birth Cohort; and the Millennium Cohort Study.
Impact Provision of strategic and scientific advice . Ongoing DataSHIELD and ESPRESSO development - new ESPRESSO paper (in collaboration with UK Biobank) recently submitted, Opal/DataSHaPER/DataSHIELD paper describing true federated analysis is on the point of being accepted.
Start Year 2010
 
Description English Longitudinal Study of Ageing 
Organisation English Longitudinal Study of Ageing (ELSA)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution The METADAC project provides data access governance for genetic data combined with phenotypic data produced within the English Longitudinal Study of Ageing (ELSA) and as part of that role provides advice on enacting data access and data sharing policy in practice.
Collaborator Contribution ELSA contributes to policy in practice development within METADAC and with its partners.
Impact Societal outcomes are produced in the form of new basic knowledge and evidence for genetic understandings of health and to contribute to the development of medical treatment and subsequently to better health in the population.
Start Year 2016
 
Description Understanding Society Data Access Committee Secretariat Support 
Organisation Economic and Social Research Council
Country United Kingdom 
Sector Public 
PI Contribution We provide a model for other major data providers to help them manage and provide access to data and samples in longitudinal studies, particularly in terms of facilitating and enhancing applications for new secondary research
Collaborator Contribution Funding only
Impact The secretariat for the AC3 (Access Committee for CLS Cohorts) which is funded under the 58READIE Grant continues to provide direct support in an advisory capacity to the Understanding Society Data Access Committee Secretariat.
Start Year 2012
 
Description CHIP ME: Citizen health through public private initiatives - Galway 4-5 September 2017 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Particpating in non-traditional research model dialogues with researchers and interested public
Year(s) Of Engagement Activity 2017
URL http://chipme.eu/eng/home.aspx