ABSTRACT
Over the years, the role of ethics committees (ECs) in the review process of clinical trial applications (CTAs) has changed from being a collegial advisory body to a patient protection organisation with an authority character. While the law governing the medical profession in Germany only provides for an obligation for physicians to ask for an EC review in biomedical research on human beings, a negative opinion on the CTA does not lead to the inadmissibility of the research project from a legal point of view. In contrast, the German Medicinal Product Act (Arzneimittelgesetz, AMG) requires a favourable opinion as an approving assessment by the competent EC.The AMG defines both the elements of a clinical trial application to be reviewed by the EC as well as the principle grounds of non-acceptance to reject a favourable opinion. ECs that assess CTAs must be constituted in accordance with the state law and must be composed of interdisciplinary medical specialists, lawyers and methodologists. The main assessment criteria are a medically acceptable risk-benefit ratio, the appropriateness of the methods used, including biometric aspects, the requirements to be met by the study participants, such as their ability to give consent, the suitability of the investigators and trial facilities as well as the appropriateness of the written information with which the study participants are to be informed and give their consent.In spite of the already high degree of regulation, the applicability of the European Clinical Trial Regulation will result in even more detailed legal requirements for the composition and working procedures of an EC with the aim of further harmonising the assessment of CTAs in the EU.
