Aufgaben der Ethikkommission

Author(s): Rehak, P.H.
Document type: PDF document prepared by the author (not online)
Pages: 63
Source: Individual teacher/presenter: Prof. Dr. P.H. Rehak, Universitäts Klinik für Chirurgie, Auenbruggerplatz 29, A-8036 Graz, Austria
Language(s): German

Classification

National background: Austria
Category: EU Training Material for Research Ethics
Subject areas: Human experimentation
Content: Important codes; Legal background
Issues touched: Ethics committees, research protocols
Audience: Members of ethics committees
Classification remarks: Prepared by the author for the university course "Klinischer Prüfarzt", the document summarizes the duties of local ethics commitees in Austria. In a schematic overview the author compares different national and international guidelines, explains the concept of risk and benefit assesement, etc. Important parts of the Declaration of Helsinki, the ISH-Guideline on GCP as well as the EU Dir. 2001/20/EG are annexed.

Estimation

Didactical quality: Material collection, didactically prepared
Didactical quality remarks: App. 5/6 of the document are excerpts from national legislation and international guidelines, relatively few comments and remarks are provided.
Overall estimation: worth considering
Estimation remarks: As a basis for courses on research ethics (irrespective of the specific context it is prepared for) the material collection is not appropriate. Nevertheless it is a good example of an individually prepared collection.