Ethics committee

Ethics committees of medical universities and state medical associations evaluate and approve clinical studies and research on humans. Ethics committees implement the Declaration of Helsinki and are based on the Medicines Act (AMG) § 40 and the Medical Devices Act (MPG) § 20. The aim is to ensure ethical and legal foundations and to protect study participants. Particularly strict standards apply to clinical studies with children and to studies with adults who are unable to give consent (Vulnerable Subjects). The Ethics Committee also evaluates research with epidemiological data or blood and advises sponsors or manufacturers or investigators on questions of professional ethics and their implementation.

Before the start of an interventional clinical trial, a submission to the responsible ethics committee must be made. The study may only be started after the ethics committee has given its approval. In the case of non-interventional studies (NIS), a notification to the ethics committee is sufficient, whereby a positive evaluation should be available before the start of the study.

The ethics commissions are organised as follows: There is a "Central Ethics Commission for the Protection of Ethical Principles in Medicine and its Border Areas" at the German Medical Association. According to § 1 of the statute, it represents on the one hand ethical principles according to the Declaration of Helsinki and on the other hand the values of the Basic Law. There are 19 ethics commissions of the State Medical Associations, which are organized in the Working Group of Medical Ethics Commissions, and more than 30 ethics commissions at medical universities.

Ethics committees are also responsible for the approval of animal experiments. One third of the committee is made up of members from animal protection organisations and two thirds of the participating investigators and institute members and persons proposed by them.