Home Contact Sitemap Imprint Deutsch [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query Federal law consolidated: Entire legal regulation for the Ethics Committee Regulation, version of 02/18/2020 Print preview Other formats: long Title Ordinance of the Federal Minister for Health and Women regarding the special requirements for ethics committees in the context of multicentre clinical trials (lead ethics commission regulation) StF: BGBl. II No. 214/2004 modification BGBl. II No. 23/2020 Preamble / Promulgatory According to Section 41b (1) of the Medicinal Products Act, Federal Law Gazette No. 185/1983, last amended by Federal Law Gazette I No. 35/2004, the following is prescribed: text § 1. An ethics committee for the assessment in the context of a multi-center clinical trial has the criteria and in §§ 2 to 7 Requirements. § 2. In organizational terms, the ethics committee has to 1. an office that is open to the public and staffed on fixed working days, and 2. sufficient capacities to process applications within the time limits specified in the Medicinal Products Act, feature. § 3. (1) The ethics committee must have sufficient experience in assessing clinical trials in a variety of representative different ways Special subjects. This is the case if the ethics committee - or its legal predecessor - has existed for at least three years and during this time has assessed a large number of clinical trials in different phases. (2) For cases in which the expertise of the members is not sufficient for assessment, the ethics committee, taking into account those in the Medicinal Products Act to have a procedure for involving external experts. § 4. The ethics committee must have taken precautions that, in the event of the reporting of serious side effects, for the safety of the test participants the continuation of the clinical trial can be assessed without unnecessary delay. § 5. (1) The ethics committee must have rules of procedure published in full on the Internet. (2) The rules of procedure must in any case provide: 1. the procedure according to which decisions and decisions are made, 2. rules in the event of a conflict of interests of its members, 3. Measures to ensure the confidential handling of members with those who have become known in the course of their work in the ethics committee Data, and 4. The areas for which standard operating procedures (SOPs) are to be defined. (3) The meeting dates and cut-off dates provided for in accordance with Section 41a of the Medicinal Products Act are to be published on the Internet. § 6. Within the framework of the organization, internal quality assurance measures are to be provided, particularly the regularity of the processes and procedures to ensure. § 7. The Ethics Committee has - apart from the short version of the protocol and the documents provided for the exam participants in German Language - Accept documents in German and English. § 8. Beyond the criteria explicitly mentioned in this regulation, every activity of an ethics committee has to comply with the requirements of Article 9 of the directive 2001/20 / EG guidelines issued by the Commission. to the top © 2020 Federal Ministry for Digitization and Business Location