The Role of Informed Consent in Biobanks after the General Data Protection Regulation

Abstract

This Thesis evaluates the role of informed consent in biobank research and the impact of the General Data Protection Regulation (GDPR) for the informed consent procedure when providing biological and related data to biobanks. Aim of the research is to assess especially two derogations which offer relief for the demand of obtaining an informed consent from a sample donor; Recital 33 which allows the use of a broad consent in the field of scientific research, and the research exemption provided in the Article 9(2)(j), which allows re-purposing personal data for scientific purposes without asking a consent from the person whom the data originates from. The applicability and relevance of those provisions will be examined from the perspective of biobank sample donor’s right to privacy and right to data protection.

This Thesis suggests the derogations provided in the GDPR will modify the meaning of informed consent in the field of biomedical research. The main findings are that the GDPR did not improve the data autonomy of individuals who participate in biobank research. Instead, the derogations provided are made in favor of the researcher: the aim of the GDPR was to empower individuals control over their data processing, but it seems that scientific research is an acceptable reason to exclude decisional power form individuals.