Samenvatting

The landscape of medical research is complex and constantly evolving. This complexity becomes especially evident when actors need to balance the ethical and scientific values that protect research participants with considerations of scientific integrity. These two key values, established in international treaties, form the bedrock of all laws, regulations and standards governing medical research and its supervision. While these values are beyond dispute, ensuring them in a complex and dynamic environment remains a challenging task for actors.
This study explores the work done by public and private actors to respond to such dynamics – for example EU harmonization policies, the shifting of research activities to non-academic teaching hospitals, and the complexities of multicentre trials – while continuing to uphold these key values.