[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].
Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).
Wessler
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Ethik-Kommission der Landesärztekammer Rheinland-Pfalz, Pharmakologisches Institut der Universität, Mainz. wessler@laek-rlp.de
Burger
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R
Doppelfeld
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E
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational / Q000627:therapeutic use; D017041:Ethics Committees / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D005060:Europe; D005062:European Union; D005858:Germany; D019983:Guideline Adherence; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug / Q000458:organization & administration; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000458:organization & administration; D012107:Research Design
D015507:Drugs, Investigational