The Act regulates research with healthy and sick persons of all age groups, whereby there are special provisions for particularly vulnerable groups such as children, pregnant women, persons lacking capacity, persons in emergency situations or prisoners. Research on deceased persons is also regulated, as is research on embryos (in vivo) and foetuses after abortion or stillbirth. Also within the purview of the Act is research involving human body parts (“biological material”) and health-related personal data.
The Act does not, however, apply to research projects involving IVF embryos – which are governed by the Stem Cell Research Act (StRA) – nor to research projects involving anonymised biological material or anonymously collected or anonymised health-related data.
The Act does not apply to individual attempts to treat patients or case studies that result in no generalisable findings. Nor does the Act regulate questions that do not concern either diseases or basic research. However, if such a research project involves an intervention in or an impact on the human body, for example an operation, blood sample or diagnostic imaging (computed tomography or magnetic resonance imaging), the Act is again applicable.
Development and entering into force
Article 118b of the Federal Constitution (Cst), which was adopted by the electorate on 7 March 2010 with a 77.2% majority, endows the Federal Government with expanded authority for regulating human research. It provided the constitutional basis for the development of the Federal Act on Research Involving Human Beings (Human Research Act, HRA), which Parliament adopted on 30 September 2011, as well as corresponding ordinances, i.e. the Human Research Ordinance (HRO), the Clinical Trials Ordinance (ClinO) and the HRA Organisation Ordinance (OrgO-HRA). These four legislative texts entered into force 1 January 2014.
On 20 September 2013, the Federal Council issued implementation ordinances which regulate specific items of the law in detail.
Clinical trials are the subject of the Clinical Trials Ordinance, which spells out the requirements for the conduct of such trials and regulates the authorisation and notification procedures, the duties and responsibilities of ethics committees, Swissmedic and the Federal Office of Public Health in connection with the authorisation and notification procedures, the registration of clinical trials and public access to the register.
The Human Research Ordinance determines “the requirements for the conduct of human research projects with the exception of clinical trials” and regulates the authorisation and notification procedures for such projects.
The HRA Organisation Ordinance, finally, regulates, as its name suggests, the organisation of the research ethics committees and the coordination office.
The cantonal ethics committees and the Agency for Therapeutic Products (Swissmedic) are the agencies primarily responsible for enforcement of the Act. The enforcement bodies make sure the statutory requirements are complied with. They review the applications, authorise the projects and monitor their conduct.