Suchergebnisse

ObjectivesUK longitudinal population studies have complex governance structures and participant safeguards. As a new Trusted Research Environment (TRE) for >20 longitudinal studies, the UK Longitudinal Linkage Collaboration (UK LLC) must ensure effective public/participant input to make central design and operational decisions whilst retaining participant trust and acceptability.
ApproachThe UK LLC's governance model is based on the principle that participant trust lies with their study; not supporting infrastructure providers. Therefore, the UK LLC takes responsibility for system governance and data sharing agreements whilst studies retain control over participant data and its uses. Our public/participant model reflects this. We have established centralised groups to advise on data access applications and on UK LLC communications. Simultaneously we work with study managers to gain insight from their involvement work and also commission UK LLC specific activities. Including participants as well as the public helps elicit a range of input and views.
ResultsWe have integrated public/participant input across the UK LLC by recruiting: a public panel to review applications; an advisory panel to contribute to our methodological development; and public/participant advisors to sit on the UK LLC Strategic Advisory Committee. We also work with studies' involvement managers to draw insights from, and coordinate new, study-level involvement.
This has informed the development of data application frameworks and brings a public viewpoint to decisions regarding linkage of functionally anonymous participant NHS records for research. The involvement of study participant groups has shaped the design of data flows into the TRE (e.g., where some studies do not permit the flow of address data for geospatial research) and has helped set a 'social contract' regarding acceptable UK LLC data use.
ConclusionWorking with public/participant representatives directly, and in partnership with study managers, we have developed safeguards and integrated a public/participant voice into key UK LLC activities. Our ongoing aim is to develop a sustainable new-way-of-working for record linkage in longitudinal research which is acceptable to participants and the public.

IntroductionDigital footprint records -- the tracks and traces amassed by individuals as a result of their interactions with the internet, digital devices and services -- can provide ecologically valid data on individual behaviours. These could enhance longitudinal population study databanks; but few UK longitudinal studies are attempting this. When using novel sources of data, study managers must engage with participants in order to develop ethical data processing frameworks that facilitate data sharing whilst safeguarding participant interests.
ObjectivesThis paper aims to summarise the participant involvement approach used by the ALSPAC birth cohort study to inform the development of a framework for using linked participant digital footprint data, and provide an exemplar for other data linkage infrastructures.
MethodsThe paper synthesises five qualitative forms of inquiry. Thematic analysis was used to code transcripts for common themes in relation to conditions associated with the acceptability of sharing digital footprint data for longitudinal research.
ResultsWe identified six themes: participant understanding; sensitivity of location data; concerns for third parties; clarity on data granularity; mechanisms of data sharing and consent; and trustworthiness of the organisation. For cohort members to consider the sharing of digital footprint data acceptable, they require information about the value, validity and risks; control over sharing elements of the data they consider sensitive; appropriate mechanisms to authorise or object to their records being used; and trust in the organisation.
ConclusionRealising the potential for using digital footprint records within longitudinal research will be subject to ensuring that this use of personal data is acceptable; and that rigorously controlled population data science benefiting the public good is distinguishable from the misuse and lack of personal control of similar data within other settings. Participant co-development informs the ethical-governance framework for these novel linkages in a manner which is acceptable and does not undermine the role of the trusted data custodian.

Background: Residing in greener areas is increasingly linked to beneficial health outcomes, but little is known about its effect on respiratory health. Objective: We examined associations between residential greenness and nearby green spaces with lung function up to 24 years in the UK Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort. Methods: Lung function was measured by spirometry at eight, 15 and 24 years of age. Greenness levels within circular buffers (100-1000 m) around the birth, eight-, 15- and 24-year home addresses were calculated using the satellite-derived Normalized Difference Vegetation Index and averaged (lifetime greenness). The presence and proportion of green spaces (urban green spaces, forests and agricultural land) within a 300 m buffer was determined. First, associations between repeated greenness and green space variables and repeated lung function parameters were assessed using generalized estimation equations (N = 7094, 47.9% male). Second, associations between lifetime average greenness and lifetime average proportion of green spaces with lung function at 24-years were assessed using linear regression models (N = 1763, 39.6% male). All models were adjusted for individual and environmental covariates. Results: Using repeated greenspace and lung function data at eight, 15 and 24 years, greenness in a 100 m buffer was associated with higher FEV1 and FVC (11.4 ml [2.6, 20.3] and 12.2 ml [1.8, 22.7], respectively, per interquartile range increase), as was the presence of urban green spaces in a 300 m buffer (20.3 ml [-0.1, 40.7] and 23.1 ml [-0.3, 46.5] for FEV1 and FVC, respectively). These associations were independent of air pollution, urbanicity and socio-economic status. Lifetime average greenness within a 100 m buffer and proportion of agricultural land within a 300 m buffer were associated with better lung function at 24 years but adjusting for asthma attenuated these associations. Discussion: This study provides suggestive evidence that children whose homes are in more vegetated places or are in close proximity of green spaces have better lung function up to 24 years of age. ; The present analyses are part of the Ageing Lungs in European Cohorts (ALEC) study (www.alecstudy.org), which has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 633212. Célina Roda is the recipient of a European Respiratory Society Fellowship [RESPIRE3-201703-00127], under H2020 - Marie Skłodowska-Curie actions COFUND]. The funding sources were not involved in the study design, in the collection, analysis and interpretation of data, the writing of the report and in the decision to submit the article for publication.

IntroductionTrusted Research Environments (TREs) are secure computing environments that provide access to data for approved researchers to use in studies that can save and improve lives. TREs rely on Data Access Agreements (DAAs) to bind researchers and their organisations to the terms and conditions of accessing the infrastructure and data use. However, DAAs can be overly lengthy, complex, and can contain outdated terms from historical data sharing agreements for physical exchange of data. This is often cited as a cause of significant delays to legal review and research projects starting.
ObjectivesThe aim was to develop a standardised DAA optimised for data science in TREs across the UK and framed around the `Five Safes framework' for trustworthy data use. The DAA is underpinned by principles of data access in TREs, the development of which is described in this paper.
MethodsThe Pan-UK Data Governance Steering Group of the UK Health Data Research Alliance led the development of a core set of data access principles. This was informed by a benchmarking exercise of DAAs used by established TREs and consultation with public members and stakeholders.
ResultsWe have defined a core set of principles for TRE data access that can be mapped to a common set of DAA terms for UK-based TREs. Flexibility will be ensured by including terms specific to TREs or specific data/data owners in customisable annexes. Public views obtained through public involvement and engagement (PIE) activities are also reported.
ConclusionsThese principles provide the foundation for a standardised UK TRE DAA template, designed to support the growing ecosystem of TREs. By providing a familiar structure and terms, this template aims to build trust among data owners and the UK public and to provide clarity to researchers on their obligations to protect the data. Widespread adoption is intended to accelerate health data research by enabling faster approval of projects, ultimately enabling more timely and effective research.

ObjectivesWe created a panel with members of the public and longitudinal study participants who review our data access requests. This panel forms an integral part of our data access application process, giving the public a say who can access the data for research.
MethodsWe advertised our lay member vacancies using social media, newsletters, word of mouth and the internet. We appointed six people to the public panel. Our panel includes study participants, NHS service users, parents, carers, and people with experience of disability, neurodiversity, and long-term health conditions.
The Panel Terms of Reference were created with help from stakeholders and study teams involved in longitudinal studies that involve the public in data access applications. This ensured that the purpose of the panel was clear. The panel reviews lay summaries and makes sure that researchers have adequate public involvement in their project.
ResultsPanel members have reviewed 28 applications. Researchers present their research at an online meeting with the panel then answer questions from the panel members. We publish meeting minutes on our website for transparency.
A 6-month review was overwhelmingly positive - all panel members indicated they felt valued. They felt able to challenge and question researchers as part of the data access application process. This provides a level of public scrutiny to our work.
"I feel there's a real value in the panel. You get a real sense that this has got such potential to make a contribution." (panel member)
We are further developing the Panel Terms of Reference with panel members. We will consider additional areas of responsibility, for example, public benefit review.
ConclusionWe regularly review how to improve public involvement in our work. The panel has proven its value during our application process. Therefore we are exploring with the panel a new approach to assess the public benefit of applications and what is meant by 'public benefit research'.