Data Trusts for Health Research
Emperor’s new clothes or model for increased participation in birth cohort studies? - Dr Jessica Bell, University of Warwick, explores using data trusts for health research.
Data trusts are an emerging and varied concept, and their operation will differ according to context. Commonly though, data trusts are proposed as a mechanism of data stewardship and a model of data governance with the potential to empower individuals and communities by authorising others (broadly referred to as ‘data intermediaries’) to act on their behalf.
The 2020s may be the next era for seminal advances in longitudinal population studies and birth cohort studies, with new technology creating opportunities for data collection and access at an unprecedented scale. A data trust is one possible approach for data governance to capitalise on this new era, but the concept raises as many questions as answers at this early stage.
With funding from the Data Trusts Initiative, The Born in Scotland Data Trust aims to explore how data trusts might operate in the health research context, specifically in birth cohorts and longitudinal studies that aim to engage participants over their lifetime. Birth cohort studies and longitudinal population studies are a particularly interesting example for exploration because they often involve multiple, related participants; recruiting pregnant women and offering the possibility for children born into the study to become research participants themselves.
Governance considerations
A complex ethical and legal landscape for health research applies to longitudinal studies and birth cohort studies, and typically consent will govern the collection and storage of data and tissue samples from participants over decades. In this paradigm, the mother will consent on behalf of the child to be involved in the research study. In view of the long-term and potentially multi-generational commitment to involvement in health research, some of the goals of data trusts such as empowerment over uses of data and data rights, may offer promise for increasing involvement and engagement of parents and children in birth cohort studies and may help enable access to richer data for improved health outcomes in the future.
In collaboration with CI Professor Rebecca Reynolds at the University of Edinburgh, we will develop a pilot data trust as a governance model for the “Born in Scotland in the 2020s” birth cohort study (hereafter, ‘BIS’). BIS is a pilot study funded by the Medical Research Council to test the feasibility of establishing a large-scale ‘virtual’ pregnancy and birth cohort. Most BIS data will be ‘standard’ administrative, health care records and biological sample data, but the vision is to capture much broader data about participants allowing investigations into the impact of novel environmental exposures on pregnancy. The project will also follow the development of children born into the BIS study. The ambition is that the future cohort will include 100,000 participants and be representative of pregnant women living in Scotland.
Designing a data trust for birth cohort studies
We aim to co-design the data trust with BIS participants, who will be invited to draft the terms of the governing trust instrument to increase understanding of data rights and involvement in decision-making about data. As we are developing the trust model at the pilot stage of the BIS project, this offers a unique chance to try to develop a truly ‘bottom-up’ approach. We aim to recruit data ‘trustees’ from a range of backgrounds pertinent to BIS including research participants and research midwives (who are often involved in the process of recruiting participants).
Representation
Crucially, for this to be possible even in theory, significant public and participant involvement is necessary to build an understanding of data trusts amongst potential participants. Through our engagement activities, we seek to understand the perspectives of women involved in BIS around their participation in health research governance and the desirability of trust models, to start a dialogue and test feasibility for adoption in future research studies.
Working with CI Ann Hagell at the Association for Young People’s Health, we will also explore whether data trusts can help support young people to be more involved in the next generation of birth cohort studies. There is a need for modernised and creative approaches to children’s involvement in birth cohort studies, to increase engagement with young people who are typically underrepresented in public and participant involvement activities and research governance design and whose involvement can significantly enrich research and future health. We will explore the ways in which a data trust can be used to govern children’s data and data rights. Through a series of youth engagement exercises, we hope to hear from young people about their views on involvement and uses of data for health research.
A core component of the project will be examining the alignment (or non-alignment) across health research frameworks and data trust models. In an earlier phase of this project, PI Dr Jessica Bell, University of Warwick, and Professor Melissa Wake (‘GenV’, Murdoch Children’s Research Institute) hosted a bi-national, multi-stakeholder workshop, bringing together 30 participants from multi-disciplinary backgrounds including academics from legal, ethical, governance, medical and information technology backgrounds, representatives of youth advisory groups, stakeholders from different longitudinal cohort studies, and health research regulatory authorities.
Possible benefits identified included increased participation in data governance and engagement with participant concerns over time. Members of a youth advisory group expressed enthusiasm for increased participation and empowerment in birth cohort studies; as well as trustees representing their interests independently from family members and the research team and keeping them informed about the research and data rights. Other advantages included accountable decision-making about data use in the best interests of participants; potentially protecting against conflicts of interests, particularly where research involves commercial partnerships.
Concerns were however expressed around the complexity of the existing landscape, and questions were raised about the added value of data trusts in this context. Communicating the complexity of a data trust to different participants will be challenging and meaningful development of bottom-up data trusts will require clear and constructive co-design. Our workshop emphasised that to meaningfully evaluate the promise of data trusts for increasing participation in health research and the added value to existing models, there is a pressing need for pilot studies and worked up examples to cut through the hype and test the feasibility of data trusts in different contexts in the real world. To ensure we don’t simply reinvent the wheel, there are also valuable lessons to be learned from the experiences of large-scale research projects like UK Biobank Ltd, whose day to data decision-makers are themselves ‘trustees’ in law.
With the UK government explicitly referring to data intermediaries in their response to the ‘Data: a new direction’ consultation, it is clear that data intermediaries are set to be part of the UK data landscape. Through the BIS Data Trust, we look forward to exploring how data trusts, as an example of data intermediaries, might operate within the health research framework to better understand the challenges and opportunities for data trusts for health research in the future.