Maintaining consent
Researchers may consider using dynamic or continuous consent to confirm that participants are still willing to take part in some or all aspects of the research. Participants should be made aware that they can withdraw their consent to participate in research at any point during a trial without prejudice.
The addition of privacy notices to trial websites or portals is an option researchers can use to display detailed information about how data are protected and used in research. The Information Commissioner’s Office provides guidance for generating privacy notices. Privacy notices can be updated when necessary, keeping participants informed of any changes to how their information is used. Such notices satisfy two basic goals of the Data Protection Act 2018 – that researchers are transparent about how information is being used and that participants are clearly informed about its usage. Participants should be made aware of how to access privacy notices, such as providing a weblink in the participant information sheet.
Where consent is the lawful basis for processing participant data, withdrawing consent to trial participation may preclude further processing of health systems data unless a provision is made for participants withdrawing trial participation to allow ongoing data collection. For this reason, researchers should carefully consider whether having consent to process these data is sufficient to meet the needs of the trial.
Participants have the right to object to processing of their personal data under Article 21 of UK GDPR. Researchers must inform participants of this right to object. However, this right is not absolute when processing is necessary to carry out a task in the public interest (see Article 21(6) UK GDPR). Where a participant objects to the processing of their data, researchers may be able to continue processing if they can demonstrate a compelling reason for doing so. Researchers should seek advice from their Information Governance Officer or the Information Commissioner’s Office (ICO).
Consent materials should include details of any data processing that will occur beyond participation in the trial. Researchers should also consider the validity of consent for adults who lose or regain capacity (or those with fluctuating capacity) during a trial. England and Wales, Scotland, and Northern Ireland follow different legislation regarding adults lacking capacity and as such, local guidance should be consulted in the first instance.