How to Design Consent for Health Data Research? An Analysis of Arguments of Solidarity

How to Design Consent for Health Data Research? An Analysis of Arguments of Solidarity
Original Article
Svenja Wiertz
Public Health Ethics, 12 December 2023
Excerpt
…Informed consent has been set down as a core ethical requirement for medical research in the Declaration of Helsinki and the Nuremberg Code but was traditionally understood to apply to research with direct involvement of patients. As research without direct involvement of patients—based solely on collected data or biospecimen—becomes more relevant and prevalent, another set of normative requirements, also operating under the name of consent, comes into play: Gefenas et al. have employed the terms of ‘interventional consent’ and ‘informational consent’ to mark this difference. Informational consent, governed in the European Union today mainly under the General Data Protection Regulation (GDPR) sets the legal standards for processing personal data…