New report published on simplified arrangements for consent in clinical trials

We’ve published the findings of a survey we ran earlier this year to gather feedback on simplifying arrangements for the consent process in certain clinical trials.

This is part of the work we’re doing to support updated clinical trials regulations coming into force in the United Kingdom on 28 April 2026.

The new regulations will allow sponsors of certain clinical trials to use simplified arrangements for obtaining and evidencing consent.

This provision will only apply to clinical trials that present a lower risk to participants because they meet specific criteria.

Our survey

We ran an online survey from November 2024 to January 2025 to help us get a better understanding of people’s views on simplifying the arrangements for obtaining and evidencing consent.

We asked if people felt it would be acceptable for a doctor to record research participant’s consent in their medical records for eligible trials.

We invited feedback from the public, researchers, research participants, and Research Ethics Committee (REC) members. Almost 1,000 people completed the survey.

The results have provided insights into where simplified arrangements could be valuable to researchers and the public but also highlighted concerns about how this could work in practice.

The results

Our findings showed that 55% of those who completed the survey did not support the proposal.

Members of the public cited concerns about a perceived absence of information about the clinical trial and physical proof that consent had been given.

53% of researchers who completed the survey responded positively to the proposal, however some were concerned that verbal consent could become overly brief and the participant could be less informed as a result.

The results from our survey also showed that researchers appreciated the potential for simplified arrangements to make the process simpler and less intimidating for participants, which could widen participation.

While the response rate for research participants was low, 57% agreed to the proposal, however concerns were again raised about the lack of evidence of consent.

REC members were relatively evenly split, with 46% in favour of the proposal and 42% not in favour. Their feedback included concerns about the risk of abuse and coercion without evidence of consent through a signed participant consent form.

We also identified a number of key considerations shared by respondents as part of the feedback. This included looking at ways to reduce the burden of complex participant information sheets and consent forms, reflecting the legal aspect of informed consent in the process, and reviewing alternative ways to gather evidence of verbal consent.

Next steps

Through the findings of this survey, we've deepened our understanding of the views of those who would be directly impacted by changes to the consent process.

It’s been a very beneficial activity which has also highlighted where there might be opportunities to reduce burden and widen access.

We’re committed to hearing from more of our stakeholders to help us shape our next steps.

As part of this work, we’re now setting up an advisory group made up of a range of people who will have the appropriate expertise, skills, and experience to inform the development of simplified means of seeking consent that maintain people’s trust.

We expect the group to be established by autumn and will share more on their work in the coming months.

“We’re grateful to everyone who shared their views. It’s encouraging to see clear support for more flexible approaches to seeking consent that continue to protect participants.

“I look forward to working with the new advisory group to explore simplified arrangements for seeking and documenting consent that maintain people’s trust.”

Clive Collett, Head of Policy and Engagement at the HRA