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dc.contributor.authorCipriani, Andrea
dc.contributor.authorHenshall, Catherine
dc.contributor.authorPotts, Jennifer
dc.contributor.authorHancock, Mark
dc.contributor.authorUnderwood, Mark
dc.contributor.authorBroughton, Nick
dc.contributor.authorEde, Roger
dc.contributor.authorKernot, Catherine
dc.contributor.authorO'Neill, Lorcan
dc.contributor.authorGeddes, John R
dc.identifier.citationCatherine Henshall1,2, Jennifer Potts2, Sophie Walker3, Mark Hancock2, Mark Underwood2, Nick Broughton2, Roger Ede2, Catherine Kernot2, Lorcan O’Neill2, John R Geddes2,3 and Andrea Cipriani. Informing National Health Service patients about participation in clinical research: A comparison of opt-in and opt-out approaches across the United Kingdom. Australian & New Zealand Journal of Psychiatry 21st November 2020 1–9en
dc.description article is distributed under the terms of the Creative Commons Attribution 4.0 License ( which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (
dc.description.abstractObjective: 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.en
dc.description.sponsorshipSupported by the NIHRen
dc.subjectRecruitment (Research)en
dc.subjectPatient Participationen
dc.titleInforming National Health Service patients about participation in clinical research: A comparison of opt-in and opt-out approaches across the United Kingdomen

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