Civil liability of the promoter in clinical studies

Abstract

Clinical research is increasingly recognised as a regulated field that enables high-quality studies to be conducted while ensuring the safety and protection of participants’ rights. The aim is to develop biological or medical knowledge, initiated by the promoter with the assistance of the research physician. The process involves preparing the study protocol, obtaining authorisation from the minister responsible for the pharmaceutical industry and adhering to legally specified conditions. Participants must also give their informed consent after being made aware of the associated benefits and risks. The promoter’s civil liability arises as soon as harm occurs to an individual participating in the study.