Applications & procedure
Human research projects are categorised according to the statutory requirements. The category determines which authorisation procedure a project must undergo and which official conditions must be fulfilled.
The categorisation system for human research projects in Switzerland is regulated in detail. Thus the regulation clearly distinguishes between different kinds of research and includes special provisions for specific project types.
The criteria for classification are mapped out in detail, ranging from the risks for participants to the type of prevention and treatment procedures and to the authorisation status of medical devices and medicinal products.
The research project category is pivotal in determining the authorisation procedure and the restrictions concerning the project’s execution.
The kofam website provides a categoriser to assist in assigning and categorising research projects. Further information is available here.
The key points on the requirement to obtain an authorisation, classification and submission of applications are summarised here: