Pharmaceutical Research

Pharmaceutical research and clinical research are necessary to investigate the efficacy and safety of drugs and other therapeutic approaches. For this purpose, clinical studies that have previously been submitted to an ethics committee for review are performed on patients or healthy volunteers. The vote of the ethics commission is legally binding for studies conducted in accordance with the German Medicines Act or the Medical Devices Act; for so-called "other studies", the (mandatory) vote of the ethics commission is of advisory nature. Particular attention is paid to the ethical aspects of research involving persons unable to give their consent. On the one hand, these persons must be protected from instrumentalisation; on the other hand, a complete ban on research means that these persons (e.g. children, people with disabilities, people affected by dementia) are excluded from advances in medicine. In this context, a distinction is made between participation in studies with an individual benefit for the person concerned, research of benefit to the group, and research of benefit to others. Ethically relevant for human research is the Helsinki Declaration.