Last year the HRA and MHRA released a joint statement setting out the ethical and legal requirements for using electronic consent (eConsent) in research.
Dr Harriet Teare is part of a team that developed an eConsent system that puts patients at the heart of decision making, with a dynamic element that allows a unique flexibility to the consent process. Harriet has blogged about Dynamic Consent to explain how it works and why eConsent is becoming more commonplace.
Dynamic Consent allows patients to have more control over
their involvement in research and opens up a partnership between the
participant and the research team. This supports the patient journey, beyond
the first consent conversation, with ongoing touchpoints that don’t limit the
consent process to a one-off form.
Importantly, Dynamic Consent can still start with a face-to-face conversation between a healthcare professional and the research participant. It uses a secure electronic portal that only participants and trial staff can access, so users can be confident that their data is safe. The online form explains each consent request in simple language. Videos, diagrams and animations allow the user to tailor the information they need to make informed choices. It also gives participants the flexibility to change their mind.
Patients often get approached to join a research study after they have just had a diagnosis or undergone surgery when their primary focus is on recovery. Being able to go back to their consent form at a later date, once they’ve had more time to think, can make a huge difference.
Sometimes a patient is 90 per cent happy with the consent requests, but there is one aspect they feel uncomfortable with. With traditional consent methods, this might mean the patient withdraws from the entire study, whereas with Dynamic Consent it is possible to agree to some parts but not others. If consent is changed or withdrawn at any point, a member of the trial team is notified and can support the decision-making process, helping the participant to feel more engaged.
Sometimes studies run for many years and over that time people can change their views on how their data or tissue is used in research. Dynamic Consent also allows participants to receive updates on how their data or samples are being used. The flexibility of the programme helps researchers by making re-consenting easier if complex studies need new approvals.
We’ve been really pleased that patients have jumped on the opportunity to have more engagement and interaction with the research they are involved in. We now want to understand more about how this type of interactive eConsent affects the patient experience. We are working with research teams across the globe to collect real-world data on how Dynamic Consent performs against more traditional, paper-based consent forms.
In the beginning researchers and regulators struggled with the concept. They were worried it might be difficult and expensive and there were concerns about it creating risks to the research. I’ve seen a shift over the last six years since I started working on the project, as researchers have started to realise the opportunities of this type of technology. The HRA and MHRA joint statement will help projects like Dynamic Consent to make a real impact.
Dr. Harriet Teare is Deputy Directorfor the Centre for Health, Law and Emerging Technologies (HeLEX) and researcher of Healthcare and Policy at the University of Oxford.
Dynamic Consent and RUDY: a case study
Rare UK Disease Study (RUDY) captures the patient experience of musculoskeletal diseases by gathering information about quality of life and disease specific experiences recorded by patients using a website portal.
RUDY integrated a dynamic consent tool into their existing online platform, giving patients the option to tailor their involvement and decide who could access their data.
The patients on the study responded well to Dynamic Consent, reporting that they found it less overwhelming and that it helped them to feel like trusted partners in the research.
Ethics approval for the study was very straightforward as participant involvement in the study was evident.