From 28 April 2026 any participants in clinical trials of investigational medicinal products (CTIMPs) and/or other relevant people must be offered a summary of the trial's results in a way that can be understood by members of the public.
The summary of the trial results must be provided to participants and/or any other relevant people within 12 months of the end of the trial. The only exception will be if sponsors have a deferral or waiver.
The summary results should describe the trial's results as a whole, not the participant’s individual results.
If a sponsor is designing a CTIMP that will be submitted from 28 April 2026, they’ll need to consider how they'll offer to share results with trial participants and, where applicable, other relevant people.
Applications for ethics approval will need to include detailed information about how the results will be offered. The participant information material should also be clear that this will happen and how.
Where any participants lack sufficient mental capacity at the time results are shared, then a summary of results must be offered to other relevant people, for example:
- a parent, someone with parental responsibility for, or a legal representative of the participant where the participant is under 16 years of age (this should normally be the person who provided consent on behalf of the child to participate)
- the legal representative who provided consent on behalf of an adult lacking capacity
- in cases where the participant was a child at the time of recruitment but reaches the age of 16 by the time the summary results are to be provided, both the participant and the person who originally provided consent for their involvement
- in cases where the participant has lost the capacity to provide consent after the start of the trial or has died, someone who’s engaged in caring for the participant or is interested in the participant's welfare, for example, their legal representative (if there is one) or their next of kin
Which trials this requirement applies to
This legal requirement does not apply to CTIMPs submitted for clinical trial authorisation and an ethics committee opinion before 28 April 2026. However, as a matter of good practice, we expect findings to be communicated to participants unless there is a good reason not to.
All CTIMPs submitted from 28 April 2026 must comply with this requirement, unless a deferral or waiver is agreed for the trial.
When to share results with participants and other relevant people
Unless a deferral or waiver is agreed, trial results are expected to be shared with participants and other relevant people within 12 months after the end of the trial. The results shared with participants must be in a way that can be understood by members of the public.
How to offer participants trial results
When designing a trial, sponsors should consider how they'll offer to share the summary results with participants and any other relevant people after the trial has ended.
The sponsor should design their trial so their approach for offering and sharing a summary of results complies not only with the new clinical trials regulations, but also with information governance requirements (including those set out by UK General Data Protection Regulation legislation and in common law).
Based on feedback, we've produced additional guidance to cover some topics commonly raised.
In some cases, participants could require the information to be provided in a more accessible manner (for example if a trial’s participants were adults lacking capacity or children). We encourage sponsors to consider who is taking part in the trial when producing the results they will share with participants.
For further guidance on why it’s important to communicate findings, and resources on how to do this effectively and in a manner compliant with information governance requirements, read our guidance on informing participants.
For further guidance on what’s considered best practice in terms of writing trial results, read our guidance on writing a plain language (lay) summary.
We’ll be reviewing our published guidance in the coming months and updating it, if necessary, to make sure it still reflects current good practice when the new regulations come into force.
Sharing results when a trial terminates early
If a trial terminates early and it has recruited participants in the UK, the sponsor is encouraged to provide some form of summary results to the participant. This should communicate the results that were obtained for the study and the rationale behind the study being terminated early.
Informing us that results have been provided to participants
When sponsors submit a final report for a CTIMP, they’ll be able to confirm that either the results have been shared with participants who wanted to receive them, or what arrangements are in place to do so.
Requesting a deferral or waiver for this requirement
In some circumstances, a sponsor can request a deferral or a waiver. For further information, please see our guidance on the deferrals and waiver process for the transparency requirements in the new regulations.
If the trial is a Phase 1 CTIMP only involving healthy volunteers, it will automatically be given a deferral for the transparency requirements for 30 months after the end of the trial.