Addressing The Knowledge Gap – Developing CONSULT E-learning On Trials Involving Adults Lacking Capacity To Consent

Historically, trials have focused on the number of participants who take part without paying too much attention to whowas being included – or rather, being excluded. More recently, however, there has been growing attention on ensuring that trials are inclusive of groups who are under-served by research. This has led to funders such as the National Institute of Health and Care Research (NIHR) now making inclusion a condition of funding.

Under-served groups include those who experience lower inclusion in research than would be expected from population estimates, or where there are important differences in how a group responds to or engages with healthcare interventions compared to other groups. Both the NIHR, and more recently the World Health Organisation, have recognised that one such under-served group are people who lack the capacity to give consent for themselves.

Exclusion of people with impaired capacity to consent

People who are unable to provide their own consent are frequently excluded from trials where they are an important part of the clinical population who could benefit from the intervention. This exclusion is due to the particular ethical and legal considerations in studies including adults lacking capacity. With different legal frameworks applying in different parts of the UK and for different types of research, many researchers find trials involving adults with impaired capacity challenging to conduct.

“It feels like an insurmountable black box of horrendousness that I dare not go. It feels very much that if you get this wrong you will be illegal ….. and the ethics police will come for you … so we just try to avoid it” (Researcher, CONSULT-ENABLE Study)

In the CONSULT project which is funded by Health and Care Research Wales and explores the ethical, legal, and methodological challenges encountered in research involving adults with impaired capacity to consent, researchers told us that they would benefit from having better support. That led to us developing the INCLUDE Impaired Capacity to Consent Framework as a tool for researchers to design and conduct trials involving people with impaired capacity to consent, and a website of information and resources. Researchers also told us that they do not always have the knowledge and skills they feel they need and that they would benefit from better training in this area.

“We need better support and guidance, particularly around the correct terminology, who needs to give consent, and how it varies between different countries, to give people more confidence to set up this sort of study” (Researcher, CONSULT-ENABLE Study)

Developing the CONSULT e-learning for researchers

Funded by a UKRI Impact Accelerator Award, the training was developed over four stages, including an initial survey to explore researchers views about the current gaps in training, the main challenges they encountered when designing and conducting these trials in a range of populations and settings, and what they found worked well. It also explored their experiences of public involvement to support these trials. The project was supported by a Lay Advisory Group and a Researcher Advisory Group who helped shape the format of the e-learning and the content which was based on the findings from the CONSULT project.

The training consists of four e-learning modules covering an introduction to the topic, the legal and ethical frameworks that apply, a deeper dive into issues around consent and consultation with a focus on supporting participants’ decision-making, and the methodological issues to consider. Each module contains videos and case studies to illustrate key content and the role of public involvement, with links to more resources throughout and collated at the end.

It is free to access via Moodle registration, and can be completed at the learner’s own pace, taking about half a day in total. On completion of the e-learning there is the option to download a certificate. It is designed to support researchers, alongside using the INCLUDE Impaired Capacity to Consent Framework, to design and conduct trials that are more inclusive of adults with impaired capacity to consent.

Launching the CONSULT e-learning

We launched the training in December at a webinar with 160 registered attendees including researchers, members of the public, research ethics committee members and others. Prof Kerry Hood, Director of UK CRC CTU Network and Dean of Research & Innovation for Biomedical and Life Sciences at Cardiff University, shared reflections on the importance of inclusivity in trials. Vicky Shepherd, who led the project with Martina Svobodova and Nicky Ivins, presented on the background to the project and how it can help researchers and Sian Jones, a member of the Lay Advisory Group, shared her personal reflections. An expert panel then provided insightful responses to questions raised by webinar attendees who shared some of the key challenges they encounter. A recording of the webinar is available, and feedback has shown that both the webinar and the training have made a valuable contribution towards shinning some light into the ‘black box of horrendousness’.

The CONSULT e-learning can be accessed via the CONSULT website, alongside instructions and a link to the launch webinar: https://www.capacityconsentresearch.com/training

We would like to thank the Lay Advisory Group, Researcher Advisory Group, and all those who kindly completed the survey.