Human research: approval of research projects

Research projects covered by the Human Research Act (HRA) can only be carried out if they have been approved by the relevant authorities.

Types of research

In the area of human research, three types of research are to be distinguished:

• Research projects involving persons for which an approval is required
• Research projects involving further use for which an approval is required
• Research projects for which an approval is not required (not subject to the HRA)

In addition, research projects involving persons are divided into different categories according to the degree of risk for participants.

Before a research project subject to the HRA can be carried out, an approval must be granted by an ethics committee. For a clinical trial, in certain cases, an approval is also required from Swissmedic or the FOPH.

Anyone wishing to carry out a research project must determine in advance:

• whether or not the project falls under the HRA (if so, an approval is required)
• if the project falls under the HRA: what type of research project it is (clinical trial, non-clinical trial involving persons, further use of data or biological material)
• for research projects involving persons: what category the project falls under

If it is not clear whether an approval is required or not, researchers may submit a request for clarification of responsibility to the ethics committee concerned.

More information on the submission of applications can be found under Submission of applications for research projects.

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Research projects involving persons for which an approval is required

Projects involving persons for which an approval is required can be divided into two groups – clinical and non-clinical trials.

In clinical trials, the participants undergo active interventions (involving medicinal products, medical devices, or other types of intervention), so that the effects of the intervention on health or on the structure and function of the human body can be investigated.

In non-clinical trials (often called observational studies), the research participants are not subjected to any active interventions. Here, either personal health data is collected or biological material (e.g. saliva or blood) is sampled.
 
In both cases – i.e. in clinical and non-clinical trials – the participants must provide their written informed consent in advance. 

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Research projects involving further use for which approval is required

In projects involving further use for which an appoval is required, research is carried out using existing health-related data or biological material, which can generally only be traced back to the persons concerned via a code.

For further use of health-related data or biological material, either consent must be obtained from the person concerned (for research involving genetic data and biological material), or the person must be informed about the intended further use and has a right to withhold their consent (for research involving non-genetic health-related data).

In hospitals, consent to further use of data or biological material for research purposes is often obtained directly from patients undergoing treatment, even if it is not yet known for what research projects covered by the Human Research Act the data or material will subsequently be used. This is known as general consent.

If research is to be carried out using samples or data for which consent has not previously been obtained, researchers have the option of obtaining post hoc consent from the persons concerned. If researchers are unable to contact the persons concerned directly, they may in justified exceptional cases submit an application to the ethics committee for proxy consent. If this is granted, then further use may be made of the data or biological material in a research project.

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Projects for which an approval is not required (not subject to the HRA)

Research projects involving anonymised data sets or anonymised samples do not fall under the HRA and thus do not require an approval. However, the HRA  does specify requirements for the anonymisation process. The persons concerned must be informed in advance about – and have a right to object to – the planned anonymisation of genetic data or biological material for research purposes. Prior notification is not required in the case of anonymisation of non-genetic data for research purposes. 

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Links

Website Human Research Switzerland

Legislation

Last modification 01.03.2025