Data privacy and data sharing within the regulatory framework governing human, health-related research in Switzerland

Abstract

Since entering into force in 2014, the Human Research Act (HRA) and its ordinances have provided the regulatory framework in Switzerland for accessing health-related personal data and biological material for the purposes of research related to human diseases and to the structure and functioning of the human body. This legislation aims to protect participants’ privacy. At the same time, the scientific community wants to generate knowledge. Aside from the HRA, data privacy in Switzerland is more widely covered by the Federal Act on Data Protection (FADP) and in some cases by the EU’s General Data Protection Regulation (GDPR). When preparing and conducting a clinical study, researchers have to comply with a number of requirements and guidelines in order to respect the rights of patients (i.e. data privacy) and fulfil their duties to the scientific community (i.e. data sharing). This article discusses how these statutory requirements apply to specific clinical study documents, processes, and tools.