17 December 2013
New legislation on research involving humans comes into force
• Ordinance on Clinical Trials in Human Research
• Ordinance on Human Research with the Exception of Clinical Trials
• Ordinance on Organisational Aspects of the Human Research Act
The HRA regulates research involving humans (in particular clinical trials), research on human cadavers, embryos and foetuses, and research involving biological material and health-related personal data. All of these research projects must be authorised by an ethics committee. Clinical trials also need to be registered. The overall aim of the new act is to simplify certain processes: it standardises authorisation and registration procedures and reduces the administrative burden for research projects involving low risk for the participants.
The new legislation aims to protect the dignity, privacy and health of human subjects of research. The law also aims to create appropriate conditions for research involving humans, help to improve the quality of this research and foster greater transparency in this area.
Further information on the law and the main changes it involves can be found on the website of the Coordination office for research involving humans (kofam).
Federal Council plans to boost biomedical research and technology
The Federal Council intends to create an optimum environment for biomedical research and technology and continue to support this field. In a comprehensive masterplan it sets out which strategies are to be pursued, which measures have already been taken and those being planned (The Federal Council).