Data protection in clinical trials: Key issues from a legal perspective

Abstract

Human research is one of the most regulated academic domains. A main focus of regulations is the protection of trial participants’ physical integrity and personal data. In Switzerland, the federal Human Research Act (HRA) and its related ordinances are primarily relevant. These research regulations contain provisions on how research data are to be managed in order to protect participants’ data privacy. When cantonal universities conduct clinical trials, they must also comply with their cantonal data protection laws. Standards set by the EU and international organisations also have a major impact on human research. Despite the increased protection of personal data, there is some room for improvement. This article reviews the legal basis for data privacy in Switzerland as it relates to research participants’ data and takes a closer look at a few key issues from the perspective of study participants.