The guidance on this page details some common topics and scenarios related to sharing results with participants and any other relevant people.
This is a new legal requirement from 28 April 2026.
This guidance is for sponsors of clinical trials of investigational medicinal products (CTIMPs).
It should be reviewed along with our informing participants information which gives guidance on how to effectively communicate study results to participants in a manner compliant with information governance requirements.
This guidance covers:
- collecting and storing identifiable data of participants for the purpose of sharing a summary of results
- collecting and storing identifiable data of non-participants for the purpose of sharing a summary of results
- holding identifiable data for extended periods of time when a deferral is in place
- responsibility for storing identifiable data and sharing summary results
- including sponsor contact details in the information material for participants to check availability of summary results
- contacting participants and relevant people for the purpose of keeping contact details up to date
- when a participant does not want to receive a summary of the trial results, but another relevant person does
- planning for participants who could potentially lose capacity or die before they can be provided a summary of results
- responsibility of a sponsor where a participant unexpectedly dies or loses capacity after taking part in a trial
- providing a summary of results to people who claim to be a relevant person connected to a trial participant
- choosing to direct participants or relevant people to the summary of results in a public registry or the HRA research summaries page
Collecting and storing identifiable data of participants for the purpose of sharing a summary of results
It’s acceptable for sponsors to collect and store identifiable data for this purpose providing they have consent from the participant to do this. As part of the consent process it should be made clear to the participant what data is being collected, for what purpose and how it will be handled (including when it will be deleted).
Sponsors would need to make sure that the data collection is proportionate and justified, and that only the minimum identifiable data needed is collected.
The data would need to also be stored, processed and deleted in a manner that complies with information governance requirements, including UK General Data Protection Regulation (GDPR), the Data Protection Act 2018, the common law duty of confidentiality, and the Caldicott Principles.
Collecting and storing identifiable data of non-participants for the purpose of sharing a summary of results
Sponsors can collect and store personal data of relevant people who are not themselves participants for the purpose of sharing results. To do this, the sponsor will need consent from the relevant person with it being made clear to them what data will be collected, how it will be used and for how long it will be kept (including when it will be deleted).
If a relevant person is offered the opportunity to receive the summary of results but does not wish to receive them, the sponsor should not collect the person’s identifiable data. Sponsors may, however, need to retain proportionate evidence that the offer was made and declined, in order to demonstrate compliance.
As with participant identifiable data, the identifiable data of relevant people must be handled in a way that is compliant with all information governance requirements.
Holding identifiable data for extended periods of time when a deferral is in place
Sponsors can lawfully hold identifiable data securely for as long as they require it for the purpose they communicated when it was collected. This is provided that participants, or other relevant people, have had it clearly explained to them what identifiable data of theirs will be collected, why it is being collected, how it will be retained and deleted. A simple method for consent withdrawal should always be freely available, and if consent is withdrawn, the identifiable details should be deleted.
Sponsors are required to make sure they handle identifiable data in compliance with information governance expectations (for example UK GDPR, common law duty of confidentiality, Caldicott Principles). This includes ensuring safe storage of the data, periodically reviewing the data they hold and retaining and deleting it in line with what was communicated to the individuals when the data was collected or if consent is withdrawn.
Responsibility for storing identifiable data and sharing summary results
Typically, a sponsor will be expected to be responsible, however this may vary depending on the trial, trial location and sponsor. There are some circumstances where the trial location team could take responsibility for sharing results and storing identifiers. This is most relevant when this would be less intrusive than sponsors retaining additional data on individuals, as trial locations often already lawfully hold identifiers for care or regulatory purposes.
Regardless, for all trials it should be clear which organisation will take on this responsibility, making sure roles are clearly defined, legal bases are in place, and robust information governance arrangements are maintained.
Including sponsor contact details in the information material for participants to check availability of summary results
It would be acceptable to include this in a participant information sheet as a supplementary route to help participant and relevant people access the results once they’re available. However, sponsors will still be expected to provide the results directly to participants and relevant people that have previously accepted the offer to receive them.
Contacting participants and relevant people for the purpose of keeping contact details up to date
UK GDPR legislation requires that data controllers (sponsors in this case) make sure their data is accurate and up to date for the purpose it was collected. However, sponsors should also be aware that the common law duty of confidentiality and the Caldicott Principles require sponsors to avoid unnecessary intrusion into individuals' private information by limiting use of confidential data to what is reasonably expected.
For these reasons, sponsors should take a proportionate approach when they design their trials. Sponsors should consider whether there is a justifiable need for them to actively contact individuals to confirm the details they hold are accurate, or whether an alternative, less intrusive approach could be taken. An example of a less intrusive approach could include collecting contact details during the initial consent but providing the sponsor’s contact details in the information materials if the participant or relevant person needs to update their details.
When a participant does not want to receive a summary of the trial results, but another relevant person does
Summary trial results should not contain any participant’s identifiable information. This means that a sponsor providing a relevant person with the summary results should make sure that no personal and confidential information about the participant is being disclosed to the relevant person. Therefore, from an information governance perspective the sponsor could still provide the summary of trial results to a relevant person in this scenario.
However, this scenario can create difficulties from an ethical perspective, for example if a participant declines the offer and also expresses a desire for no other relevant people to receive the results. Typically, the wishes of the participant would need to be respected and take priority in this case. In these cases the Research Ethics Committee reviewing the application would comment on any concerns regarding the planned approach to be taken by the sponsor.
Planning for participants who could potentially lose capacity or die before they can be provided a summary of results
Sponsors should carefully consider their planned participant population, the duration of the trial and how long they may seek a deferral for when designing a study. If there is reason to believe that a participant may lose capacity or die within the timeframe, sponsors should consider if they should approach and collect the identifiable data of any relevant people when designing the trial. This will mean that even if a participant does lose capacity or die the sponsor will still be able to provide the summary of results.
As part of the informed consent process, the participant should be asked whether there is anyone (for example a next of kin) they would like to be given the option to receive a copy of the summary of results should anything happen to them. Sponsors should also plan for how they could contact this person, explain what data they will be collecting, collect and store their data (if they consent) in a way that complies with information governance requirements.
Responsibility of a sponsor where a participant unexpectedly dies or loses capacity after taking part in a trial
If participants in a trial are likely to die or lose capacity before the summary results will be available, the sponsor should consider how they could identify and approach relevant people to offer to share the results with them as part of the trial design.
If there is no reason to believe that participants will die or lose capacity before the summary of results would be available, however this unexpectedly happens, the sponsor would not be expected to identify and approach relevant people.
Where a sponsor is contacted by an individual claiming to have known a participant in one of their trials (with the details of the trial being provided) and they request the summary of results, the sponsor should provide them if they’re available. However, the sponsor should not confirm whether a specific individual was a participant in a trial or not, as doing so could result in personal and confidential information of the participant (for example a medical diagnosis) being shared with the enquirer inappropriately.
Providing a summary of results to people who claim to be a relevant person connected to a trial participant
If someone contacts the sponsor to ask for the summary results of a specific study, and these are available, the sponsor should provide them or direct them to where they’re available. As summary results should not contain participants’ identifiable data, there will be no information governance issues with providing this to someone who requests it.
However, if an individual contacts the sponsor and asks for the results of a trial they claim someone they know participated in, the sponsor should proceed with caution.
In this scenario the sponsor should not confirm whether an individual took part in a trial (as doing so could break confidentiality, for example by unintentionally confirming the person has a specific medical condition). Instead, the sponsor should explain they cannot confirm who took part in a trial but offer to provide summary results, if they’re available, for any specific trial the individual can identify.
Choosing to direct participants or relevant people to the summary of results in a public registry or the HRA research summaries page
Sponsors may choose to do this if they wish. However, directing participants only to the scientific summary published in the registry does not meet the legislative requirement for a summary of the results ‘written in a manner that is understandable to laypersons’ to be offered to participants and other relevant people.