Consent and Retrospective Data Collection

Author(s)

Katarzyna Barud, Tima Otu Anwana, Marie-Catherine Wagner, Michael Cepic, Emily Johnson, Max Königseder

Abstract

The secondary use of health data offers great potential for health research. Technological developments, for instance the progress in the field of artificial intelligence, have improved the reusability of datasets. However, the GDPR and ethical guidelines regularly restrict the reuse of personal data when the data subject has not given their informed or explicit consent. In retrospective studies, where researchers use personal data and sensitive data from previous medical examinations, the retrospective collection of the patient's consent can be challenging. This chapter will focus on the potential legal and practical hurdles associated with obtaining consent from the data subject for a new processing purpose. In addition, it will present the ethical considerations associated with consent and retrospective data collection in health and medical research. This chapter will discuss several Horizon 2020 funded research projects in the areas of health and medical research. These research projects will be used as practical examples to demonstrate the issues faced with consent as a legal basis in retrospective research.

Organisation(s)

Department of Innovation and Digitalisation in Law

Pages

99-125

No. of pages

27

DOI

https://doi.org/10.1007/978-981-99-6540-3_7

Publication date

12-2023

Peer reviewed

Yes

Austrian Fields of Science 2012

505003 European law, 505002 Data protection, 505010 Medical law

Keywords

ASJC Scopus subject areas

Law, Management of Technology and Innovation

Portal url

https://ucrisportal.univie.ac.at/en/publications/consent-and-retrospective-data-collection(bfe00137-131d-4fb7-8f72-8dd7a4292bc6).html