On 1 January 2014, a new Act regarding research on humans will enter into force in Switzerland. The Act will be accompanied by three Regulations, regarding clinical trials, regarding research on humans other than in clinical trials and an organisational regulation. This new body of law will replace the existing collection of federal and cantonal laws and regulations, national and international guidelines and self-regulation, and will fill a number of gaps and inadequacies.
The new Act is broader in scope than comparable EU-level regulation. It covers not only clinical trials, but all research on human disease and the structure and function of the human body that is carried out on living or deceased individuals, embryos and foetuses, with biological material or with health related personal data. On the other hand, it does not apply to research on in vitro embryos according to the Act on Stem Cell Research of 19 December 2003, nor to research with anonymised biological material or with anonymously collected and anonymised health-related personal data.
Key to the approach taken in the new Act is the protection of the dignity, personality and health of the individual. This is laid down in Article 1 paragraph 1 of the Act. The interests, health and comfort of the individual must be given priority over the interests of science and society. The rights of individuals participating or being asked to participate in research projects are strengthened. Special provisions are laid down for all research on children, minors and adults lacking legal capacity, not just in the context of clinical trials as presently. The Act also contains provisions on concrete measures for protecting individuals involved in research, for example through:
the principle that research may only be conducted on humans if there is no alternative means of achieving the same results, the requirements for information to be provided to the individual, the requirements for informed consent, to be given in writing after an appropriate period of reflection, the permissible relationship between risk and benefit in a research project, the restrictions on use of placebos in research projects, the prohibition on paying individuals for participation in research with an expected direct benefit for the individual, and on having individuals pay to participate in research, and the requirements of ethics committee review. The entity instigating a research project is liable for the damage...