Risk-based regulation of biomedical research

The Swiss Academy of Medical Sciences (Käthe-Zingg-Schwichtenberg-Fonds for research projects in medical ethics) decided to support a small exploratory project on risk-based approaches to regulating biomedical research.

Project summary: The ethical acceptability of biomedical research critically depends on protecting participants from excessive risk. Research regulations and guidelines are designed to ensure that this requirement is met. Due to fundamental changes in the research landscape, investigators and research ethics committee members are increasingly dissatisfied with existing regulatory requirements. Many call for a “risk-based” system of research oversight that matches various safeguards for participants – including independent ethical review and safety monitoring – to the level of risk posed by the research. However, it remains unclear what such a system would or should look like. The proposed project aims to provide a preliminary overview and critical analysis of the existing approaches to risk-based research oversight.