Data platforms represent a new paradigm for carrying out health research. In the platform model, datasets are pooled for remote access and analysis, so novel insights for developing better stratified and/or personalised medicine approaches can be derived from their integration. If the integration of diverse datasets enables development of more accurate risk indicators, prognostic factors, or better treatments and interventions, this obviates the need for the sharing and reuse of data; and a platform-based approach is an appropriate model for facilitating this. Platform-based approaches thus require new thinking about consent. Here we defend an approach to meeting this challenge within the data platform model, grounded in: the notion of ‘reasonable expectations’ for the reuse of data; Waldron’s account of ‘integrity’ as a heuristic for managing disagreement about the ethical permissibility of the approach; and the element of the social contract that emphasises the importance of public engagement in embedding new norms of research consistent with changing technological realities. While a social contract approach may sound appealing, however, it is incoherent in the context at hand. We defend a way forward guided by that part of the social contract which requires public approval for the proposal and argue that we have moral reasons to endorse a wider presumption of data reuse. However, we show that the relationship in question is not recognisably contractual and that the social contract approach is therefore misleading in this context. We conclude stating four requirements on which the legitimacy of our proposal rests.

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Objective: Recruitment to clinical research in the National Health Service remains challenging. One barrier is accessing patients to discuss research participation. Two general approaches are used in the United Kingdom to facilitate this: an ‘opt-in’ approach (when clinicians communicate research opportunities to patients) and an ‘opt-out’ approach (all patients have the right to be informed of relevant research opportunities). No evidence-based data are available, however, to inform the decision about which approach is preferable. This study aimed to collect information from ‘opt-in’ and ‘opt-out’ Trusts and identify which of the two approaches is optimal for ensuring National Health Service patients are given opportunities to discuss research participation. Method: This sequential mixed methods study comprised three phases: (1) an Appreciative Inquiry across UK Trusts, (2) online surveys and (3) focus groups with National Health Service staff and patients at a representative mental health Trust. Results: The study was conducted between June and October 2019. Out of seven National Health Service Mental Health Trusts contacted (three ‘opt-out’ and four ‘opt-in’), only four took part in phase 1 of the study and three of them were ‘opt-out’ Trusts. Benefits of an ‘opt-out’ approach included greater inclusivity of patients and the removal of research gatekeepers, while the involvement of research-active clinicians and established patient–clinician relationships were cited as important to ‘opt-in’ success. Phases 2 and 3 were conducted at a different Trust (Oxford Health NHS Foundation Trust) which was using an ‘opt-in’ approach. Of 333 staff and member survey responders, 267 (80.2%) favoured moving to an ‘opt-out’ approach (phase 2). Nineteen staff and 16 patients and carers participated in focus groups (phase 3). Concern was raised by staff regarding the lack of time for clinical research, with clinical work taking precedence over research; patients were concerned about a lack of research activity; all considered research to be beneficial and were supportive of a move to ‘opt-out’. Conclusion: Findings suggest that ‘opt-out’ is more beneficial than ‘opt-in’, with the potential to vastly increase patient access to research opportunities and to enable greater equality of information provision for currently marginalised groups. This should ensure that healthcare research is more representative of the entire population, including those with a mental health diagnosis.

BackgroundEquitable access to research studies needs to be increased for all patients. There is debate about which is the best approach to use to discuss participation in research in real-world clinical settings.ObjectiveWe aimed to determine the feasibility of asking all clinical staff within one hospital Trust (an organisation that provides secondary health services within the English and Welsh National Health Service) to use a newly created form on the Trust’s electronic patient records system, as a means of asking patients to consent to discuss participation in research (the opt-in approach). We also aimed to collect feedback from patients and clinicians about their views of the opt-in approach.MethodsFour pilot sites were selected in the Trust: two memory clinics, an adult mental health team and an acute adult ward. Data were collected in three phases: (1) for 6 months, pilot site staff were asked to complete a consent to discuss participation in research form with patients; (2) staff feedback on the form was collected through an online survey; and (3) patient feedback was collected through focus groups.FindingsOf 1779 patients attending services during the pilot period, 197 (11%) had a form completed by staff and 143 (8%) opted-in to finding out about research. Staff cited limited time, low priority and poor user experience of the electronic patient records system as reasons for low uptake of the form. Patients generally approved of the approach but offered suggestions for improvement.ConclusionsThere were mixed results for adopting an opt-in approach; uptake was very low, limiting its value as an effective strategy for improving access to research.Clinical implicationsAlternative strategies to the opt-in approach, such as transparent opt out approaches, warrant consideration to maximise access to research within routine clinical care.

Background: Asylum seekers who are granted leave to remain in the United Kingdom are required to make a rapid transition to housing and welfare benefits. The challenges facing new refugees during this ‘transition period’ can affect their mental health, but this has not been quantified. Aims: To assess the impact of the transition period on new refugees’ mental health in the 12 months after being granted leave to remain in the United Kingdom. Method: A longitudinal survey design was used to measure the mental health of 30 newly recognised refugees at monthly intervals in the first 6 months and again at 1 year after receiving leave to remain in the United Kingdom. There were five outcome measures for symptoms of anxiety, depression, distress, post-traumatic stress disorder (PTSD), post-migration living difficulties (PMLD) and a life events calendar to record key changes in housing and welfare. Results: The results showed that the trajectory of scores across all measures fluctuates, but overall they all improve from baseline to Month 12. Scores for depression and PMLD showed significant improvement at Month 5, and scores for anxiety, depression, distress and PMLD showed significant improvement at Month 12. PTSD scores did not show significant improvement at any month. In months with a high number of stressful life events, participants had worse PMLD and PTSD scores. Conclusion: Overall improvement in mental health could partly be explained by the stability of being granted leave to remain in the United Kingdom, but may also be due to the high level of practical support these participants received. Recommendations are made for those working with clients during the transition period.