How am I protected if I take part in a research project?

Research projects can involve risks for participants. For example, there may be a risk of adverse effects associated with the experimental treatment. Various safeguards are in place to ensure the best possible protection for participants.

The most important safeguards for the protection of participants are as follows:

1. The Swiss Human Research Act (HRA):

This Act regulates research involving human beings, health-related data and biological material. It specifies the requirements which must be met by research teams wishing to carry out human research. The Act also defines participants’ rights.

2. Mandatory authorisation:

Each research project requires authorisation from an ethics committee, and in some cases also from Swissmedic (Swiss Agency for Therapeutic Products). These two bodies assess whether the participants are adequately protected. They also assess, for example, whether the quality of the new treatment (e.g. a drug) is good enough, or whether the project is sufficiently well designed from a scientific viewpoint. Only if all the requirements are met will the project be given the go-ahead.

3. Informed consent and voluntary participation:

Before any research project involving persons can be carried out, the participants must be thoroughly informed about the project. Having been informed, individuals are free to decide whether or not they wish to participate. If they do, they will sign an informed consent form. For research projects involving existing data or biological samples, one-off consent for various projects is usually sufficient (this is known as general consent). Please note that consent can be revoked by participants at any time.

4. Insurance:

Persons participating in a clinical study or an observational study are insured against any damage they may suffer in connection with the project.

5. Data protection:

Any information which could directly identify a participant will be coded. For example, names or dates of birth are replaced by codes so as to make identification impossible. The code is securely stored.

These safeguards ensure that you are protected if you participate in research.