All research involving human subjects must be conducted in accordance with three basic ethical principles, namely respect for persons, beneficence and justice (Declaration of Helsinki). It is generally agreed that these guidelines, which in principle have equal moral force, guide the conscientious preparation of proposals for scientific studies.
Furthermore, research involving human subjects should be carried out only by, or strictly supervised by, suitably qualified and experienced investigators and in accordance with a protocol that clearly states: the aim of the research; the reasons for proposing that it involves human subjects; the nature and degree of any known risks to the subjects; the sources from which it is proposed to recruit subjects; and the means proposed for ensuring that subjects will be adequately informed and will voluntarily give their consent (Informed Consent). The protocol should be scientifically and ethically established by one or more suitably constituted review bodies, independent of the investigators.
Self-Assesment of your research proposal
You can use the kofam (Swiss Coordination office for research involving humans) Wizard to categorize your research project. The Wizard will tell you what type of research project it is and which category the project or the clinical trial must be allocated to, and which type of authorization must be requested.