Consent Withdrawal: What Is the Procedure If Consent Will Later Be Withdrawn

To answer the question about the consequences of withdrawing consent, it is necessary to recognise that consent in the context of the Clinical Trials Regulation should not be confused with consent as a legal basis for the processing of personal data under the GDPR. As a consequence, in the context of clinical trials the data subject’s consent is limited to processing related exclusively to the research activities. Without prejudice to the GDPR, the withdrawal of informed consent does not affect the activities already carried out and the use of data obtained based on informed consent before the withdrawal. In the case of withdrawal of consent by the data subject, all research activities carried out with the clinical trial data relating to that person must cease. Withdrawal of consent does not affect processing that is based on particular legal grounds, and special safeguards are put in place in the case of the processing of health data for research purposes.