Informed consent as a prerequisite for the (re-)use of research data [German]

Publication details

Abstract
Informed consent is an essential prerequisite for the processing of personal data for research purposes. Both the new European General Data Protection Regulation and the ethical guidelines of various specialist disciplines provide detailed requirements in this regard. However, these have not always been reflected in the design of declarations of consent for participation in scientific studies. This article takes a closer look at the requirements of the European General Data Protection Regulation (GDPR) 2 with regard to information obligations for the design of consent forms. A distinction is made between direct data collection and the use of existing scientific data for secondary use.
data for secondary use and the possible exceptions provided for science by the GDPR and the adapted German law in the Data Protection Adaptation Act (DSAnpUG-EU3) are also worked out. In addition, the requirements of ethical guidelines from various disciplines are systematically presented and compared with the requirements of European data protection law. The possibilities and limits of “broad consent” in terms of data protection law and ethics as well as the consequences for the design of consent in research projects and the resulting challenges are discussed in more detail.

Keywords
DS-GVO, Datenschutz, Ethikleitlinien, Ethikkommissionen informierte Einwilligung, Informationspflicht, Löschung, Forschungsdaten