The term “researcher” refers to the investigator – i.e. the person conducting the study – as well as the sponsor, that is to say the initiator of the project. In investigator-initiated studies, the investigator is also the sponsor. Every research project that falls within the scope of the Act must be authorised before it can be conducted – the researchers are thus obligated to submit an application for their research project with the authorities.
Furthermore, researchers are obliged to duly inform research participants in advance about the research project and obtain their voluntary consent to participate. During the project, they are also obliged to report any unusual incidents to the authorisation authorities.
The term “research participants” refers to persons who are taking part in a project. They participate in a project of their own free will and after they have been duly informed in advance by the researchers. They have the right to withdraw from the project at any time. As long as they are taking part in the research project, however, they are obliged to adhere to the guidelines.
The term “authorisation authorities” refers, on the one hand, to the cantonal ethics committees and, on the other hand, to the Swiss Agency for Therapeutic Products (Swissmedic) and, in some cases, to the Federal Office of Public Health (FOPH) and the Federal Office for the Environment (FOEN). The authorities review the applications and authorise the research projects. During the project, they are regularly informed by the researchers about unforeseen events, and they have the opportunity to intervene if necessary and, in extreme cases, discontinue a research project.
As a fourth stakeholder, the Federal Government dictates the framework conditions with the Human Research Act, also undertaking a coordinating role by way of the Coordination Office for Human Research (kofam) and providing information. Researchers can, for example, find out about authorisation procedures, and individuals can search a clinical trial register for research projects.