META-DAC - Managing Ethico-social and Technical issues and Administration of Data Access Committee

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

Abstract

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 publically 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 issues and Administration Data Access Committee) is a multi-agency multi-study data access structure which will service several of the UK's major cohort studies (1958BC, 1970BC, Millennium BC and Understanding Society) and to provide a scalable mechanism to incorporate additional cohorts in the future (eg. ELSA). The META-DAC 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.

Technical Summary

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. Complex decisions about data access are not simply ethical or technical; they go to the heart of the politics of scientific research. 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 issues and Administration Data Access Committee) is a multi-agency multi-study data access structure which will service several of the UK's major cohort studies (1958BC, 1970BC, Millennium BC and Understanding Society) and to provide a scalable mechanism to incorporate additional cohorts in the future (eg. ELSA). The META-DAC 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.

Planned Impact

Not Applicable
 
Description PLS guidance take-up
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
Impact The METADAC guidance for writing in plain language is published at http://www.metadac.ac.uk/files/2017/06/v1.0-Plain-language-guidance-for-METADAC-applications.pdf The Keynote speaker at the Festival of Genomics 2020, Vivienne Parry OBE, referred to the METADAC plain-language-summary guidance in her keynote session, as an excellent source of good practice for researchers. Her role as head of Engagement at Genomics England and the national reach of the genomics festival audience demonstrate take-up of the guidance by the wider research community in the UK and beyond. https://www.genomicsengland.co.uk/
URL https://www.festivalofgenomics.com/
 
Description ESRC invitation only call for the recommissioning of the METADAC.
Amount £374,999 (GBP)
Funding ID ES/S008349/1 
Organisation ESRC Impact Acceleration Account Cambridge 
Sector Academic/University
Country United Kingdom
Start 10/2018 
End 09/2020
 
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-ERIC 
Organisation Biobanking and Biomolecular Resources Research Infrastructure
Country Austria 
Sector Charity/Non Profit 
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 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 non-epistemic 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 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 CLS-data sharing 
Organisation University College London
Department Centre for Longitudinal Studies
Country United Kingdom 
Sector Academic/University 
PI Contribution METADAC develops and provides managed governance and study-design advice to CLS studies that have genetic data or biological samples, i.e. 1958 birth cohort, 1970 birth cohort, and millennium birth cohort. This allows data-sharing for sensitive genetic data and for depletble biological resource.
Collaborator Contribution CLS maintain the data, give technical advice on applications for data sharing, and issue data as well as contributing to future development of METADAC infrastructure.
Impact The outputs are listed as publications for METADAC. They are too numerous to detail here.
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 Academic/University 
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 TwinsUK 
Organisation King's College London
Department Department of Twin Research and Genetic Epidemiology
Country United Kingdom 
Sector Academic/University 
PI Contribution METADAC provides advice on issues of data-sharing that Twins UK is considering; it is also the appeal route for data-sharing decisions.
Collaborator Contribution TwinsUK join METADAC meetings on a 6-weekly basis and face-to-face workshops to continue to jointly assess the current issues in genetic data sharing.
Impact Development of good practice between METADAC and Twins UK
Start Year 2015
 
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
 
Description Cheltenham Science Festival (invited presentation) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Invited speaker at The Times Cheltenham Science Festival, speaking in the evening to nearly 100 attendees with co-speaker Ian Craddock. Talk covered ethics and governance in bioscience and time was reserved in the schedule for a lively question and answer session moderated by a skilled Chair. Members of the public asked questions about Longitudinal (Cohort) studies and about care.data plans for linkage of NHS data for use in health research.
Year(s) Of Engagement Activity 2015
URL http://www.cheltenhamfestivals.com/science/
 
Description EASST meeting - Epistemic and non-epistemic values driving data sharing in practice for data and sample access 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The presentation on the values driving data sharing in practice, and the METADAC model, led to discussion of the drivers of data sharing with the conference attendees, and sharing the METADAC model more widely.
Year(s) Of Engagement Activity 2016
URL http://www.sts2016bcn.org/
 
Description EU biobank week Vienna - the METADAC model. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The METADAC model for data access was presented by Prof Madeleine Murtagh and Dr Stephanie Roberts. The audience were primarily scientists and clinicians involved with or setting up biobanks and there were many questions for further discussion at the end. Questions covered practicalities such as how we achieve the speed of decisions and ethico-legal considerations like how we deal with incidental findings.
Year(s) Of Engagement Activity 2016
URL http://europebiobankweek.eu
 
Description Europe Biobank Week: Challenges for data sharing: old governance meets new technologies 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation on data access challenges and decision-making was given to ~250 atttendees of the Europe biobank week conference. Questions and discussions with audience members followed.
Year(s) Of Engagement Activity 2016
URL https://mail.google.com/mail/u/1/#inbox?compose=15ac8b0b8bc64451
 
Description Inviited seminar, Telethon Kids Institute and Raine Birth Cohort, Australia 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The METADAC model was presented to 10 senior researchers from the Telethon Kids Institute and Raine Birth Cohort Study. Discussion & plans for future activity followed.
Year(s) Of Engagement Activity 2016
 
Description Social and epidemiological issues in big data - data sharing in population sciences 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited presentation on data sharing and big data at the Department of Public Health, Adelaide, Australia. The METADAC model was shared with academics from the Department and plans for future work were made.
Year(s) Of Engagement Activity 2016
 
Description The METADAC model - Invited seminar Melbourne 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Invited seminar to present the METADAC model for data access at the Murdoch Children's Research Institute Melbourne Australia. The audience was senior researchers from the Institute and there was lively discussion following the presentation and great interest in how METADAC is addressing the challenges of data sharing, e.g. incidental findings.
Year(s) Of Engagement Activity 2016