On February 2nd, the European Data Protection Board published a series of responses related to inquiries prepared by the European Commission (justice and consumer section). These consultations are aimed at the EDPB solving questions about the protection of personal data used in clinical research.
European Data Protection Board
The document is divided into six different sections that are developed in various paragraphs and contain answers to questions ranging from ethical issues, informed consent to anonymization processes, and the collection and processing of personal data obtained in medical research.
Regarding informed consent and data processing, special focus is placed on its legal basis and on the distinction between informed consent and the legal basis of consent required under the standards of the General Data Protection Regulation, both terms being, complementary to such protection; and the need to have a special consent from the patient when there is no other way out than to resort to the treatment that the research is developing, to improve the quality of life of the subject.
The same happens when data controllers conduct clinical trials in different State Members of the EU, and it is necessary to homogenize the legal basis of all of them -when conducting the project- to comply with the GDPR standards and their own localisms.
An interesting topic that the document tries to elucidate, although it will be left to a later consultation, is the possibility of extending the consent of the owner of the data – the subject of the trial – extracted in one trial, for other trials of the same nature.
Related questions about the Data Protection document
Regarding obtaining broad consent in terms of clinical trials, the EDPB refers in a certain way to recital 33 of the GDPR, in order to minimize the requirements of specific consent when the purpose of the data processing cannot be determined at an initial stage of harvest.
Finally, the document refers to relative issues such as:
1) The use of the information obtained directly from the owner of the data for other purposes than those originally reported and if necessary and in which cases -and how-, must comply with the requirement of transparency.
2) The application of processes of pseudonymization and anonymization of personal data in clinical trials.
3) The processing of specific categories of data and their treatment on a large scale during clinical trials.
For further information or professional advice regarding clinical trials, legal requirements, compliance, and data protection, you can contact our Moeller’s Legal Department Members in charge of this area through our Relationship Managers Vivien Racy and/or Vivianne Cardoso, following this link.