The Human Research Act (HRA) defines the principles that must be observed in relation to a research project involving human subjects. The primary objective of the legislation is to protect the individual’s dignity, psychological integrity and health in the context of research.

Secondary objectives of the HRA are to provide favorable conditions for research and to increase its quality and transparency.

• The Ordinance on Clinical Trials in Human Research (ClinO) includes regulations on clinical trials. A clinical trial is a research project involving human subjects to whom a particular health-related intervention has been allocated, e.g. administration of a medication. The aim of a clinical trial is to investigate the effects of such an intervention on the health or structure and function of the human body.

• The Ordinance on Human Research with the Exception of Clinical Trials (HRO) governs all human research projects that are not classified as clinical trials. These include the collection of health-related data and research on biological material.

• A major innovation in the field of human research legislation is the categorization of research projects involving human subjects according to the extent of the anticipated risk for participants. This categorization is carried out by researchers at the time of submission and is reviewed by the ethics committee. Depending on the category, requirements differ according to the documentation that needs to be submitted, the insurance required, the applicable approval procedure and the extent of event notification required during the period of the studies. Only studies investigating drugs in a new indication, population or dosage form, as well as those involving drugs or medical devices that are not available on the Swiss market, must also be approved by the authority Swissmedic.

• Research projects with anonymized biological materials and anonymously collected or anonymous health-related personal data are exempt from the requirement for approval.

• The Department of Clinical Research can advise and support you in all regulatory matters concerning your clinical research project.