Journal Article


Informing National Health Service patients about participation in clinical research: A comparison of opt-in and opt-out approaches across the United Kingdom

Abstract

Objective: Recruitment to clinical research in the NHS remains challenging. One barrier is accessing patients to discuss research participation. Two general approaches are used in the UK 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 NHS patients are given opportunities to discuss research participation. Method: This sequential mixed methods study comprised three phases: (1) an Appreciative Inquiry across UK Trusts, and (2) online surveys and (3) focus groups with NHS staff and patients at a representative mental health Trust. Results: The study was conducted between June and October 2019. Out of seven NHS 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, whilst the involvement of research-active clinicians and established patient-clinician relationships were cited as important to ‘opt-in’ success. Phase 2 and 3 were conducted at a different Trust (Oxford Health NHS Foundation Trust, OHNHSFT) 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.

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Authors

Henshall, Catherine
Potts, Jennifer
Walker, Sophie
Hancock, Mark
Underwood, Mark
Broughton, Nick
Ede, Roger
Kernot, Catherine
O’Neill, Lorcan
Geddes, John R.
Cipriani, Andrea

Oxford Brookes departments

Oxford School of Nursing and Midwifery

Dates

Year of publication: 2020
Date of RADAR deposit: 2020-10-14


Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License


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