Commentaries: Art. 118b

The Confederation shall legislate on research on human beings where this is required in order to protect their dignity and privacy. In doing so, it shall preserve the freedom to conduct research and shall take account of the importance of research to health and society.
The Confederation shall adhere to the following principles in relation to biological and medical research involving human beings:
1. It is a requirement for any research project that the participants or their legal representatives have given their informed consent. The law may provide for exceptions. A refusal is binding in every case.
2. The risks and stress for the participants must not be disproportionate to the benefits of the research project.
3. A research project involving persons lacking the capacity to consent may be conducted only if findings of equal value cannot be obtained from research involving persons who have the capacity to consent. If the research project is not expected to bring any immediate benefit to the persons lacking the capacity to consent, the risks and stress must be minimal.
4. An independent assessment of the research project must have determined that the safety of the participants is guaranteed.