SWITZERLAND

Legislation

Human research legislation

Constitutional article on research on humans (118b BV)
Communication regarding the Federal Act on Research Involving Human Beings
Human Research Act (HRA, HFG)
Human Research Ordinance (HRO, HFV)
Clinical Trials Ordinance (ClinO, KlinV)
HRA Organisation Ordinance (OrgO-HRA, OV-HFG)

Further legal resources

Therapeutic Products Act (TPA, HMG)
Ordinance concerning Medical Devices (MepV)
Transplantation Act
Federal Act on Data Protection (FADP, DSG)
Reproductive Medicine Act (RMA, FMedG)
Stem Cell Research Act (StRA, StFG)
Federal Act on Human Genetic Testing (HGTA, GUMG)
Radiological Protection Act (RPA, StSG)
Radiological Protection Ordinance (RPO, StSV)

Research Ethics Committees

I. Functions and number of research ethics committees (ECs)

There are seven ECs in Switzerland, two in the French-speaking part, one in the Italian-speaking part and four in the German-speaking part of Switzerland. The ECs are responsible for a) clinical trials, b) other research projects with/on human subjects and for c) the further use of health-related data and biological material for research purposes with and in the absence of informed consent. The ECs must consider whether the research project complies with the ethical, legal and scientific requirements of the Human Research Act (HRA). In particular, they must ensure that the dignity, privacy and the health of the persons involved in research is protected. They can also advise researchers on ethical issues and give opinions on research projects for which they are not responsible (e.g. projects that are carried out abroad). Additionally, since January 2019, the ECs give an advisory opinion for a temporary authorization on the use of therapeutic products when certain criteria set by the law are met.

II. Organisation and procedure

The ECs are subordinate to the cantons. Members (at least seven) are elected by the canton and serve for a fixed term. They work according to the militia system (community service) and their decisions are independent. Depending on the particular EC, meetings are held from one to four times a month. Depending on the nature and the risk of the research project, there are three different procedures: a) full procedure with at least seven members, for research projects that involve greater than minimal risks and stresses or involve non-authorised drugs and medical devices, b) simplified procedure with three members, for research projects with minimal risks/stresses or with authorised drugs and medical devices and c) presidential procedure for research with health-related data or biological material with an existing informed consent of the research subject.

The scientific secretariats of the ECs with scientific, legal, medical or pharmaceutical backgrounds are responsible for assessing research projects for their form and content, i.e. whether they are formally complete and can therefore be submitted to the EC for assessment, and whether their content complies with the legal requirements of the HRA.

The ECs are funded partly by fees and partly by the cantons. The fees are determined by a corresponding regulation that applies uniformly throughout Switzerland.

III. Multicentre trials

For studies that are carried out at several trial sites in Switzerland, there is a multicentre approach with a lead EC and participating ECs; the latter committees only assess the local conditions with a presidential procedure, and inform the lead EC of their views. The lead EC then makes a legally binding decision for all trial sites (decrees). The location of the lead EC corresponds with that of the coordinating investigator (researcher). The applicant (investigator or sponsor) has the right of appeal against decisions. The competent body for appeals is usually the canton.

IV. Deadlines

For clinical trials that fall under the scope of the Clinical Trials Ordinance (ClinO), and for research projects under the Human Research Ordinance (HRO), the formal preliminary assessment by the scientific secretariat must be completed within 7 days. The period allowed for the decision of the EC is 30 days for single-centre trials, and 45 days for multicentre trials for the lead EC. International multicentre trials but with only one participating centre in Switzerland are treated as single-centre trials.

For clinical trials conducted under the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) the formal preliminary assessment by the scientific secretariat must be completed within 10 days. The EC make its decision within 40 days of confirming receipt of the formally correct application documents. If the EC demands additional information, the 40-day period is paused until the information is received.

V. Coordination and harmonisation

The ECs are coordinated by the Federal Office of Public Health and by swissethics, the umbrella organization of the 7 cantonal ECs. The purpose is to harmonize all research proposals with uniform templates for applications and an electronic portal (BASEC) for submissions. The BASEC portal also provides a tool (for internal use by the EC) that simplifies the administrative work of the EC secretariats and generates consistent annual statistics.