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Consent to discuss participation in research: a pilot study
  1. Sophie Walker1,
  2. Jennifer Potts2,
  3. Lola Martos2,
  4. Alvaro Barrera1,2,
  5. Mark Hancock2,
  6. Stuart Bell2,
  7. John Geddes1,2,
  8. Andrea Cipriani1,2,
  9. Catherine Henshall2,3
  1. 1 Department of Psychiatry, University of Oxford, Oxford, UK
  2. 2 Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK, Oxford, UK
  3. 3 Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK
  1. Correspondence to Dr Catherine Henshall, Faculty of Health and Life Sciences, Oxford Brookes University Faculty of Health and Life Sciences, Oxford OX3 0FL, UK; chenshall{at}


Background Equitable 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.

Objective We 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.

Methods Four 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.

Findings Of 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.

Conclusions There 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 implications Alternative strategies to the opt-in approach, such as transparent opt out approaches, warrant consideration to maximise access to research within routine clinical care.

  • adult psychiatry

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  • Contributors All authors have made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; have been involved in drafting the manuscript or revising it critically for important intellectual content; and have given final approval of the version to be published. Each author takes public responsibility for the content of the manuscript and has agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding This study was funded by the National Institute for Health Research (NIHR) Oxford Health Biomedical Research Centre (BRC-1215-20005).

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR, UK National Health Service, or the UK Department of Health and Social Care.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethics approval Ethical approvals were not required for this study as it was deemed to be a Service Evaluation project by the participating NHS Trust.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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