Research involving human participants
Research projects involving human participants and personal data are subject to specific rules, regulations, and ethical standards.
To determine which legal rules and ethical processes apply to your project, and what internal support the University of Fribourg can offer you, it is necessary to establish whether your research project falls under the Human Research Act (HRA).
The Human Research Act applies to research projects or clinical trials involving persons, biological material, or health-related personal data that meet the following criteria:
- research on diseases (research on the causes, prevention, diagnosis, treatment, and epidemiology of impairments of physical and mental health in human beings) or
- research on the structure and function of the human body (basic research, in particular on human anatomy, physiology, and genetics, and non-disease-related research concerning interventions and impacts on the human body)
If you have any doubts about whether the research project falls within the scope of the HRA, you may submit a clarification of responsibility to the Swiss ethics committees. You may also contact the Data Protection Officers.
The following table summarises the main differences between HRA and non-HRA projects.
| Research projects falling under the Human Research Act | Research projects outside the scope of the Human Research Act | |
| Type of research | Research on diseases and on the structure and function of the human body | Other research involving human participants or personal data |
| Legal framework | Human Research Act and subsidiarily Data Protection Regulation | Data Protection Regulation |
| Ethical process | Mandatory authorization from a Swiss ethics committee (CER-VD or KEK-BE) | Possible approval from an internal ethics committee (depending on the department/faculty) |
Further Resources
Projects falling under the Human Research Act
Projects falling outside the scope of the Human Research Act
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