A new study undertaken by an interdisciplinary team at Oxford Health NHS Foundation Trust and the Oxford Health Biomedical Research Centre, has shown that an ‘opt-out’ approach to research recruitment could benefit both clinical research and patient care.
![Keyboard with words opt and out superimposed onto two of the keys](https://oxfordhealthbrc.nihr.ac.uk/wp-content/uploads/2020/12/shutterstock_454464124.jpg)
The study, conducted in three phases across four UK NHS trusts, used focus groups, an appreciative inquiry and online surveys to compare two approaches to discussing research with patients. These included an ‘opt-in’ approach, where clinicians communicate opportunities to patients, and an ‘opt-out’ approach where all patients have the right to be informed about research opportunities.
The team’s findings showed that ‘opt-out’ has significant advantages for both patients and researchers. Dr Cathy Henshall, Head of Research Delivery at Oxford Health, who led the project says:
“Our focus groups have shown that patients consider research to be important and that they want to be made aware of opportunities to participate in research. Our study demonstrates that the ‘opt-out’ approach is optimal for ensuring NHS patients are made aware of these opportunities and are empowered to decide to what extent they wish to participate. An ‘opt-out’ approach also helps make healthcare research more inclusive and representative, enabling access to information about research to currently marginalised groups.”
Research staff were joined on the project by colleagues from the trust’s senior management and communications teams as well as by Roger Ede, a member of the Patients and Research Group based at the Trust’s Warneford Hospital. Mr Ede says:
“As a patient, it seems to me a natural option to want to participate in research projects that will benefit others in their clinical treatments down the line. Undoubtedly, many more people would be happy to participate in the present, and would want to do so, if the opportunities to contribute to research were more widely advertised and better understood. To move to an ‘opt-out’ model for medical research is logical, and a good outcome. I hope that it will be widely adopted across the health system, and ultimately become normal practice.”
The study, published in the Australian and New Zealand Journal of Psychiatry, also indicated that clinical and research staff support the use of an ‘opt-out’ approach in recruiting research participants. Dr Henshall adds:
“One of the major benefits of the opt-out approach is that it removes the burden of research recruitment from clinical staff. So, although the ongoing engagement and support of clinical teams is critical, their role in the process can focus on advising and supporting patients considering participating in a study.”
Following on from the team’s findings, Oxford Health NHS Foundation Trust will pilot an ‘opt-out’ approach to its own research recruitment in 2021. In addition to showing the benefits of ‘opt-out’ the study has also highlighted some of the challenges in implementing this approach. Obtaining the support of senior management and information governance leads early in the project is critical as is developing strong and consistent communications to support the implementation.
Dr Nick Broughton, CEO of Oxford Health NHS foundation trust comments:
“Research is a priority for Oxford Health and the Trust is committed to using the most inclusive recruitment practices to ensure that all our patients have the opportunity to make informed choices about their participation. I welcome this research as an important step towards transforming practice in clinical research recruitment both at Oxford Health and across the NHS.”
The research was funded by the NIHR Oxford Health Biomedical Research Centre. The full paper is available on open access and can be found here https://journals.sagepub.com/doi/10.1177/0004867420973261.