Research on Humans & Clinical Trials
Research on Humans is governed by the Federal Human Research Act (HRA) and its Ordinances. It comprises scientific research in areas such as medicine, psychology and biology. The main goal of the legislation is to protect the involved people, their dignity, privacy and their health.
Clinical trials are mainly governed by the HRA and the Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO). The latter regulates the requirements for the conduct of clinical trials, the authorisation and notification procedures, the duties and responsibilities of ethics committees, Swissmedic and the Federal Office of Public Health (FOPH) with regard to the authorisation and notification procedures and the registration of clinical trials as well as public access to that registry.