Abstract
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.
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Notes
- 1.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance), O.J. 4.5.2016 L 119/1.
- 2.
GDPR, Recital 39, which refers to Articles 13 and 14 of that regulation, states that ‘natural persons should be made aware of risks, rules, safeguards and rights in relation to the processing of personal data and how to exercise their rights in relation to such processing’.
- 3.
Guideline on consent under Regulation 2016/679, Article 29 Working Party published 28 November 2017, WP259, p. 21. https://ec.europa.eu/newsroom/article29/item-detail.cfm?item_id=623051.
- 4.
Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak, adopted by the European Data Protection Board on 21 April 2020. https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_guidelines_202003_healthdatascientificresearchcovid19_en.pdf.
- 5.
CJUE 14.02.2019 C-345/17 (Buivids), recital 64.
- 6.
Guideline on consent under Regulation 2016/679, Article 29 Working Party published 28 November 2017, WP259. p. 21. https://ec.europa.eu/newsroom/article29/item-detail.cfm?item_id=623051.
- 7.
Ibid.
- 8.
Ibid.
References
EDPB (2019) Opinion 3/2019 concerning the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b)). Adopted on 23 January 2019. https://edpb.europa.eu/sites/default/files/files/file1/edpb_opinionctrq_a_final_en.pdf
European Commission-DG Health and Food Safety (2019) Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation. https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf
Guideline on consent under Regulation 2016/679, Article 29 Working Party published 28 November 2017, WP259. https://ec.europa.eu/newsroom/article29/item-detail.cfm?item_id=623051
Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak, adopted by the European Data protection Board on 21 April 2020. https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_guidelines_202003_healthdatascientificresearchcovid19_en.pdf
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Colcelli, V. (2023). Consent Withdrawal. In: Colcelli, V., Cippitani, R., Brochhausen-Delius, C., Arnold, R. (eds) GDPR Requirements for Biobanking Activities Across Europe. Springer, Cham. https://doi.org/10.1007/978-3-031-42944-6_15
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