In October 2025, we brought together an advisory group to help develop a set of principles that will guide the ethical use of simplified arrangements for seeking and recording informed consent in low-intervention clinical trials.
These principles are designed to make sure that consent processes remain respectful, clear, and proportionate, while reducing unnecessary steps and duplication for participants and researchers.
This work forms part of the implementation of the amended clinical trials regulations, which come into force on 28 April 2026.
The advisory group is made up of 12 members and includes public contributors, researchers, clinicians, legal experts, and ethics committee members, ensuring that the guidance reflects both lived experience and professional expertise. Read more about the members and their experience.
In this blog, Kirsty Edwards and Joanne Lloyd, co-facilitators of the group, share an update on their work so far and what the next couple of months will look like.
Broadening the group’s focus
During our first meeting as an advisory group we discussed key elements of what makes for best practice when seeking and evidencing informed consent. We considered elements such as autonomy, privacy, accessibility and the role of public involvement. It was clear from group members that the standards being discussed could apply to all types of research not just low intervention clinical trials.
With this in mind, and in recognition of the important opportunity to draw on the group’s expertise, the scope of our work has been widened to include updating guidance on applying a proportionate approach to the process of seeking consent.
The principles developed for the update of the proportionate guidance will be adapted for the new guidance we’re creating on simplified arrangements for informed consent in low intervention clinical trials.
As a group, we’ve had some really interesting discussions, and a clear message from members is that in updating this guidance we can emphasise that the consent process should be an opportunity to establish clear communication with potential participants. This is key to maintaining and building trust in research.
Drafting the principles
Following our first meeting we agreed to workshop some ideas about what the principles could look like, including several key elements to the consent process.
We talked of the need for respect of autonomy and how seeking consent should go beyond a tick-box exercise to reflect the importance of taking part in health and social care research.
The need to ensure dignity and privacy, while making clear the benefits and risks of participation was discussed. Clarity in the consent conversation, with a need to consider framing, timing, environment and delivery as some considerations, was also highlighted.
Practical components of proportionate approaches have included discussions on the use of e-consent to evidence consent and the best ways of constructing and delivering information. This might include a combination of different options, written, audio, pictorial, easy read or video formats.
Accessibility, and how to support more meaningful approaches, has been a major focus of the group’s deliberations. Enhancing access to research opportunities should be driven by the needs of the individual and the nature of the study. Importantly, taking proportionate approaches to informed consent does not mean limiting access - when applied well, it should broaden opportunities and promote equity for potential participants.
As part of our deliberations, there has been a desire to provide sponsors and researchers with the confidence to use these proportionate approaches with the legal representatives of people who cannot provide their own consent, making sure that those individuals and groups are not unintentionally excluded from research and the potential benefits that low intervention trials can provide.
Next steps
The advisory group met for the fourth and final time in February. We’re now taking some time to reflect on the constructive conversations we’ve had and we’ll continue to develop the principles with further feedback from advisory group members and our review network.
We’re planning to publish the updated guidance on applying a proportionate approach to the process of seeking consent and separate new guidance for simplified arrangements for seeking and evidencing informed consent in low intervention clinical trials in April.
As co-facilitators, it’s been our privilege to be part of this group and to listen to such varied and valuable perspectives, while taking part in considered discussions that are helping to shape the new principles.
Joanne Lloyd, Public Contributor and FacilitatorAs a public contributor and facilitator, it’s been incredibly valuable to be part of shaping these principles from the ground up. Consent is not just a regulatory requirement, it’s about ensuring people feel respected, informed, and able to make decisions that are right for them. Our discussions have focused on what consent looks like in real life, especially when people may be unwell, vulnerable, or unsure. It’s been encouraging to see how lived experience has directly influenced the final guidance.
Kirsty Edwards, Policy Manager, HRAThis advisory group has brought together a unique mix of expertise, including public contributors, clinicians, researchers, and legal specialists. Their insight has been essential in helping us develop principles that are both ethically robust and practical to apply. The aim is to support consent processes that protect participants while enabling important research to take place more efficiently.