Beck N
Ethik-Kommission/Institut für Rechtsmedizin, Universitätsklinikum Magdeburg A. ö. R, Deutschland.
Zentralbl Chir. 2015 Feb;140(1):63-6. doi: 10.1055/s-0033-1360297. Epub 2014 Mar 18.
Ethical committees or institutional review boards are interdisciplinary committees to assess the ethical, social, legal and medical aspects of research involving human subjects. The ethics commission is to protect both the patient as well as the investigators and other personnel involved in the implementation of scientific projects. According to the professional code (Berufsordnung) every physician is obliged to consult an ethics committee to get a an approval before carrying out a research project. Concerning the Declaration of Helsinki, the advice of physicians is an international standard before carrying out a research project. In addition to the advisory function the ethics committee has an authorisation function within the pharmaceutical and medical device law. In the present publication the advisory and authorisation functions of an German ethics committee are briefly explained.
伦理委员会或机构审查委员会是跨学科委员会，旨在评估涉及人类受试者的研究在伦理、社会、法律和医学方面的问题。伦理委员会旨在保护患者以及参与科学项目实施的研究人员和其他人员。根据专业守则，每位医生在开展研究项目之前都有义务咨询伦理委员会以获得批准。关于《赫尔辛基宣言》，医生的建议是开展研究项目之前的一项国际标准。除咨询职能外，伦理委员会在药品和医疗器械法方面还具有授权职能。在本出版物中，简要解释了德国伦理委员会的咨询和授权职能。
