Research projects subject to the HRA must be approved by the relevant authorities. The bodies responsible for enforcement are the cantonal ethics committees and also – depending on the type of research project –Swissmedic and the FOPH.
Note: The links to the respective authorities for a research project submission can be found at the very end of this page under the ‘Links’ tab.
Submissions to the ethics committee
Researchers must submit their application via the submissions portal BASEC to the ethics committee responsible for their research site. The ethics committee will review the application and grant the researchers authorisation to carry out the project if it meets the legal requirements.
In the case of projects with research sites in more than one canton, after being reviewed by the ethics committee responsible for the main research site (the so-called lead committee), the application will also be reviewed by the ethics committee(s) responsible for the other site(s).
Submissions to other enforcement bodies
In the case of clinical trials of Category B and C therapeutic products, authorisation is required not only from the ethics committee, but also from Swissmedic (the Swiss Agency for Therapeutic Products). Researchers must therefore also submit their application via the Swissmedic portal. Depending on the circumstances, when reviewing the application, Swissmedic may consult the Radiation Protection Division of the FOPH or the Federal Office for the Environment (FOEN).
For research projects investigating transplantation, the researchers must submit their application to the ethics committee responsible and also, in the case of a Category C project, to the Transplantation Section of the FOPH.
If a research project includes accompanying examinations involving ionising radiation, then in certain cases the application must also be submitted to the Radiation Protection Division of the FOPH.
Notification of events and reporting
In the case of research projects involving persons, the researchers are required to notify the ethics committee, and if appropriate also Swissmedic or the FOPH (transplantation), of any notable events occurring during the conduct of the project. In addition, in the case of clinical trials, the researchers are required to submit reports to the enforcement bodies at regular intervals.
Registration and publication
In addition, the following transparency requirements are applicable for clinical trials:
- Authorised clinical trials must be registered by the researchers in advance and be published.
- The researchers must publish a summary of the results within a year after completion of the trial.
Further information on the transparency requirements can be found under “Searching for studies on Human Research Switzerland” and on the BASEC website.
Pilot trials with cannabis
For pilot trials with cannabis, authorisation must be obtained from the FOPH. Further information can be found under Authorisation of pilot trials under Art. 8a NarcA.
Further information and templates for submissions
Further information and detailed guidelines on the submission of applications and on other project-related obligations can be found on the swissethics and Swissmedic websites.From these websites, you can also download the relevant templates for documents (e.g. protocol, information sheet and informed consent form, notification of events, etc.).
If it is not clear whether a research project requires authorisation from an ethics committee, a request for clarification of responsibility can be submitted to the ethics committee concerned.
Last modification 31.03.2025
Contact
Federal Office of Public Health FOPH
Biomedicine Division
Human Research Section
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 51 54