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Genetic data protection: Privacy and ethical issues related to the collection, storage, and use of genetic data for medical and research purposes

June 2024

The debate on “Genetic data protection: Privacy and ethical issues related to the collection, storage, and use of genetic data for medical and research purposes“, organized by Juridice.ro in June 2024, focused on the issue of consent in genetic research – differences and similarities between GDPR data processing consent and informed patient consent in CTR (Clinical Trials Regulation).

Adela Nuță offered an insightful radiography of the main points addressed during the discussions:

  1. Scope of genetic data processing for researches purposes from both GDPR and CTR perspective. It was outlined the distinction between the purposes of the applicable legislations for the processing of genetic data. Although these purposes may overlap in many cases, the processing of patient data under CTR aims to meet the essential ethical requirements of research projects involving human subjects, while GDPR legislation aims to ensure the right to privacy and the protection of personal data.
  2. Principles of consent from both legislative perspective. It was outlined that although both regulations emphasize the importance of informed consent, according to GDPR provisions, data subjects must be clearly informed about the purpose of data processing, the identity of the data controller, and their rights. In contrast, CTR legislation requires that participants in clinical trials must be fully informed about the purpose of the study, the methods used, and the potential risks and benefits.

Additionally, the conditions for the withdrawal of consent, as well as the consequences of such withdrawal from the perspective of the objectives of clinical studies, were detailed.

  1. Another subject addressed the imperative of informing clinical trial participants, right from the initial consent stage, about all potential future and subsequent purposes for which their genetic data might be processed, as well as the circumstances under which exceptions to this rule may apply.
  2. The debate also encompassed the applicability of other legal grounds that would permit genetic data controllers to process these data apart from the consent obtained from clinical trial participants. Such legal grounds include the controllers’ legitimate interest in such processing or a public interest. This aspect requires controllers to perform comprehensive evaluations of the conditions under which such interests might take precedence over the fundamental rights and freedoms of the study subjects.
  3. To note that a key conclusion of the debate was that, from ethical and data protection perspectives, data controllers must ensure transparency for study subjects and safeguard all their rights when processing such sensitive data. It is also imperative that the legislative framework is continuously adapted to meet these requirements.

The video registration of the debate is available (in Romanian and for subscribers) HERE.

More details about BACIU PARTNERS Data Privacy and Personal Data Processing practice are available HERE.


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