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

Lead Research Organisation: University of Bristol
Department Name: Social Medicine

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

Publications

10 25 50
 
Description Biomedical Resources Grant (jointly funded by MRC & Wellcome Trust)
Amount £642,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 08/2015 
End 07/2020
 
Description DOUBLE ENTRY CANNOT FIND OUT HOW TO DELETE
Amount £140,000 (GBP)
Organisation Economic and Social Research Council 
Sector Public
Country United Kingdom
Start 01/2016 
End 07/2017
 
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 World Universities Network Research Development Fund - Workshop on sharing sensitive data
Amount £25,028 (GBP)
Organisation Worldwide Universities Network 
Sector Academic/University
Country Global
Start 08/2016 
End 08/2017
 
Description 58-READIE and METADAC 
Organisation University of Bristol
Department School of Social and Community Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution The METADAC team makes ethical and governance judgments about best practice, influencing and informing the decisions and practice of the 58-READIE team in issuing 1958 birth cohort data and samples for research use.
Collaborator Contribution The 58-READIE team (under grant G1001799) makes practical and technical judgments about data and sample maintenance and issue, taking into account good practice and cost effectiveness, informing and influencing the decisions and practice of the METADAC team in refining approvals for before issue of 1958 birth cohort data and samples for research use.
Impact The outcome is an evolving understanding of the application of governance policies in practice in longitudinal studies. The collaboration includes social science, ethicolegal expertise, genetic and medical science, bioinformatics
Start Year 2015
 
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 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 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 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 Invited Presentation. CLOSER Knowledge Exchange Workshop on Disclosure Control. Flexible disclosure control for microdata using DataSHIELD. London, January 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact As a recipient of funding from CLOSER for a project (led by Andy Boyd) focussing on the sharing/co-analysis of sensitive data I was invited to contribute to this workshop which was pitched at a mathematically more technical audience with greater theoretical and practical experience in working in data integration and the sharing of sensitive information than at most of the venues where I present. As well as describing DataSHIELD and its role as tool to support the sharing/co-analysis of sensitive data, I was also able to provide the workshop with practical issues and challenges arising from my work with the 1958 Birth Cohort under 58READIE (now 58FORWARDS) grant and ALSPAC.

This was particularly useful for me because it enabled me to get more technical feedback than I usually receive. This was useful not only for DataSHIELD development, but also for strategy relating to infrastructural development under the 58FORWARDS grant
Year(s) Of Engagement Activity 2016
URL http://www.closer.ac.uk/event/methods-disclosure-control/
 
Description Membership of Expert Committee to judge large grants submitted by Quebecoise applicants to the Canadian Foundation for Innovation fund (2017) - Montreal 23-24/1/2017 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The Canada Foundation for Innovation (CFI) was created by the Government of Canada in 1997. It aims to build Canada's capacity to undertake world-class research and technology development that benefits all Canadians. Because of major CFI investments in state-of-the-art infrastructure, Canadian universities, colleges, research hospitals and non-profit research institutions are able to attract and retain more top research talent from around the world, facilitate the training of the next generation of Canadian researchers, and to support private-sector innovation and the creation of high-quality jobs that strengthen Canada's position in the global knowledge-based economy.

I was invited to sit as an overseas member on a provincial (Quebecoise) panel aimed at identifying the strongest applications from Quebec that fell under the heading "OMIQUES / OMICS" - primarily genomics and metabolomics. At a subsequent provincial meeting pulling all applications together across all of Quebec the assessments of our panel will determine which applications (under 'omics) will be put forward to the national competition. My panel reviewed a total of 13 applications over two days and I was one of the two lead presenters on 3 of these.

In the 2017 Innovation Fund competition, CFI will invest up to $425 million for large research infrastructure in Canada. For this competition, the CFI had asked institutions to propose transformative infrastructure projects to underpin cutting-edge research. The aim is to support major initiatives that allow institutions and their researchers to build on established capabilities to accelerate current research and technology development or to enhance emerging strategic priority areas.

I was able to bring knowledge and experience derived in no small part from my work with the 1958BC and ALSPAC projects to help consideration of grants which generally had a major epidemiological component and, in particular, the application of high throughput omics work on large scale biomedical/health science infrastructures. In return I learnt a lot - both from the funding mechanism and from the high quality applications about how another nation is organising its strategic development of this field which entails huge amounts of research funding.
Year(s) Of Engagement Activity 2017
URL https://www.innovation.ca/sites/default/files/Funds/2017-if-guidelines-to-complete-a-notice-of-inten...
 
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
 
Description University of Adelaide. Talk on development of DataSHIELD 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Disseminated understanding and knowledge of DataSHIELD within Australia and related this to importance of liberal but secure data sharing from major biomedical studies such as ALSPAC and 1958BC. There was a particular focus on potential for vertical DataSHIELD for record linkage and including plans for implementation on SAIL, as developed under CIPHER, Farr Scotland and ALSPAC
Year(s) Of Engagement Activity 2016
URL http://www.datashield.ac.uk
 
Description World Universities Network Workshop: Data Analysis with Privacy Protection for Epidemiological Research (DAPPER). Bristol, August 2016 - a Satellite workshop of International Population Data Linkage Conference, Swansea, Wales. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I led the workshop and gave two lectures. The workshop focused on the importance and challenges associated with largescale sharing and co-analysis of biomedical/health/social data - particularly data that might be classified as sensitive. This pushed forward international discussion of a number of strategies for taking forward new approaches (including governance) and tools for managing, sharing and co-analysing sensitive data in the biomedical, health and social sciences

The workshop has catalysed a follow-up workshop in the coming year.
Year(s) Of Engagement Activity 2016
URL http://www.wun.ac.uk/wun/research/view/dapper-data-analysis-with-privacy-protection-for-epidemiologi...