European Commission Directorate-General For Health And Food Safety: Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation
Processing of personal data in the context of emergency clinical trials (Article 35 of the CTR)
Once the strict conditions of Article 35 of the CTR are fulfilled, a subject can be enrolled in a clinical trial in the situation of emergency, exceptionally without any prior informed consent. Following an intervention, the informed consent should be sought from a subject or his or her legal representative as soon as possible in order to maintain the subject in the clinical trial. In case a subject/legal representative does not confirm his/her consent, the participation of the subject cannot be continued.
As the prior informed consent of the subject is only an additional safeguard and not the legal basis for the processing from a data protection perspective, the legal basis for the processing of personal data in the context of emergency clinical trials remains the public interest pursued in Article 6(1) (e) of the GDPR or the legitimate interest pursued in Article 6(1) (f) of the GDPR. In addition, the initial processing, necessary to provide a person with a treatment and to record its outcomes, in the absence of consent in the meaning of Article 28 of the Clinical Trial Regulation, can also be justified on a ground of vital interests of the data subject (Article 35 of the CTR in conjunction with Article 6(1) (d) and Article 9(2) (c) of the GDPR).
In light of Article 35(3) of the CTR in case participation in a trial will not be confirmed by the ex-post informed consent given by that person or his/her legal representative, that person or legal representative should be informed of the right to object to use the data gathered initially. If the person confirms its participation in a trial, data can be further processed for the purpose of that trial.
If a data subject dies before the consent could be confirmed/refused, the processing of that data is no longer covered by the GDPR and the conditions for processing may be determined by national law.
Download all questions and answers in the Florence Beginner’s Guide to GDPR for Clinical Trials.
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This information was sourced from the European Commission Directorate-General For Health And Food Safety: Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation.
