Submission of applications for human research projects involving persons

In Switzerland, submission of applications for human research projects involving persons takes the following course:

Researchers must submit their application directly to their local ethics committee. The ethics committee reviews the application and grants the researchers authorisation to conduct their project, provided it fulfils the statutory requirements. During the study, researchers are obliged to report any unusual incidents to the ethics committee.  

In the case of projects where research is being conducted in several locations in Switzerland, after initial formal review by the lead ethics committee, researchers must also submit their application to the other ethics committees affected.

In the case of clinical trials, once the application is approved, researchers must publish their project in the research register SNCTP.

In the case of projects that require authorisation by Swissmedic, researchers must also submit their application to Swissmedic. Depending on the situation, when reviewing the application, Swissmedic may consult with the FOPH or the FOEN. The duty for researchers to report unusual incidents also applies with regard to Swissmedic.

In the case of projects where transplants or investigations involving radiation sources are performed, researchers must also submit their application to the FOPH.

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Submission of applications for human research projects involving persons

Depending on the type of research project, the application must be submitted to one or several ethics committees as well as, if applicable, to Swissmedic and the FOPH.

Submission of applications for human research projects without persons

In Switzerland, submission of applications for human research projects with health-related personal data or biological material takes the following course:

Researchers must submit their application directly to their local ethics committee. The ethics committee reviews the application and grants the researchers authorisation to conduct their project, provided it fulfils the statutory requirements. During the study, researchers are obliged to report any unusual incidents to the ethics committee.

In the case of projects where research is being conducted in several locations in Switzerland, after initial formal review by the lead ethics committee, researchers must also submit their application to the other ethics committees affected.

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Submission of applications for human research projects without persons

Depending on the type of research project, the application must be submitted to one or several ethics committees.

Compilation of application dossier

Information on how to compile a dossier is available on the Swissethics and Swissmedic websites, where the corresponding templates for preparing each document (e.g. protocol, information sheet and declaration of consent, etc.) can be downloaded.

The kofam website, furthermore, provides a categoriser to assist in assigning and categorising research projects. Further information is available here.