Guidance document for the researchers for the conduct of basic research projects
It is often unclear whether a basic research project falls within the scope of the Human Research Act (HRA) or not. This depends on whether it is research according to the definition of the HRA (generation of generalisable knowledge), whether it is a research into the function and structure of the human body and whether biological, human material and the data are used in uncoded, coded or anonymised form. In order to clarify the essential questions in this regard, swissethics publishes a guidance document which is intended to support researchers as to whether or not the project in basic research falls within the scope of the HRA and must be approved by an ethics committee. The most important questions for a correct submission are addressed (informed consent, statistics, storage of samples, etc.), so that a correct dossier can be prepared and the approval by the ethics committee is facilitated for both parties.