The Ethics Committee of the Medical University of Graz was established on the basis of the Universities Act 2002 and is the main ethics committee for multicenter drug tests.
The Ethics Committee reviews clinical tests of drugs and medical devices, the application of new medical methods and applied medical research on humans in compliance with the principles of the Declaration of Helsinki, the ICH GCP guidelines and the regulations of the Austrian Medicines Act, Austrian Medical Devices Act, the Stmk. Krankenanstaltengesetz (Styrian Hospital Act), the Bundesgesetz über Krankenanstalten und Kuranstalten (Federal Act on Hospitals and Sanatoria) and all other applicable legal provisions for their ethical harmlessness.
The Ethics Committee is registered at the Office for Human Research Protections of the US Department of Health and Human Services: IRB00002556.
According to the rules of procedure, all informants and biased committee members must leave the meeting room during the committee's internal discussion and decision-making process. In the event that applicants and investigators are present, they are informed immediately about the result of the consultations. The decision is normally communicated in writing no later than two days after the meeting. If changes/additions to the agenda, patient information, etc. are made during the meeting, they must be presented within a period of three months, otherwise the project is considered to be withdrawn and must be resubmitted.
