The actors involved in human research (researchers, research participants, enforcement authorities and the public) are presented graphically, and their roles and responsibilities are explained. This should promote a better understanding of the functioning of the Human Research Act.
Interaction model
Relationship between research participants and researchers
The relationship between research participants and researchers is at the centre of the human research legislation. Research participants expose themselves to risks and burdens in the interests of researchers and research. To protect the participants, the legislation defines in particular researchers’ obligations and participants’ rights.
Legal foundations
In Switzerland, human research is regulated at three levels. In the Federal Constitution, overarching principles are defined concerning the protection of human beings in research. The HRA fulfils the legislative mandate set out in the constitutional article; it formulates the fundamental requirements to be observed in research involving human beings. The requirements of the HRA are elaborated in practical terms in three Ordinances.
Enforcement and coordination
The enforcement authorities are responsible for monitoring the activities of researchers and ensuring compliance with legal requirements. In Switzerland, responsibility for enforcement is assigned to authorities at the cantonal and federal level. The cantonal ethics committees are responsible for the assessment and approval of research applications and the monitoring of projects. Depending on the type of project, Swissmedic, the Federal Office of Public Health or the Federal Office for the Environment may also need to be involved in the authorisation procedure. The Coordination Office for Human Research (kofam; part of the FOPH) has a legal mandate to harmonise enforcement, thus ensuring legal certainty and favourable conditions for research in Switzerland. To this end, it promotes regular exchanges between enforcement authorities and researchers. In addition, an umbrella organisation (swissethics) formed by the cantonal ethics committees before the HRA came into force also plays a coordinating role.
Research results
In the HRA, research is defined as a method-driven search for generalisable knowledge. Such knowledge is the real purpose of research. Human research involves in particular biomedical basic research and research concerning diseases which is designed to improve treatment options. The HRA contributes, firstly, to the quality of research by specifying scientific requirements, compliance with which is assessed by the authorities. Secondly, the HRA contributes to the transparency of research by making the registration of clinical trials mandatory. The public and, in particular, professionals thus have an opportunity to evaluate the quality of research in Switzerland.
Context
Human research in Switzerland is embedded in a complex national and international environment. All the factors related to this have an influence on research and also on the effectiveness of human research legislation.
