Ethics-committee authorization in Germany

Journal of Medical Ethics 21 (4):229-233 (1995)
On 9 August 1994 the German legislature revised the German Drug Law (AMG). Included in the revision is a passage requiring, for the first time, that the sponsors and investigators of clinical studies involving human subjects first obtain the approval of an ethics committee before carrying out such studies. According to the legislation, which takes effect on 17 August 1995, approval is to come from 'an independent ethics committee, set up and administered according to state law [emphasis added]' (1). Although it is clear according to the text that the 16 federal states have been empowered to establish ethics committees within their jurisdictions, this does not mean that the state governments are free to transfer exclusive authority in the matter to their respective medical associations, a step that would effectively abolish Germany's private ethics committees. First, the legislation does not rule out the authorization of private ethics committees. Second, as legal scholars attest, the exclusive control of ethics committees by the medical associations would constitute an illegal monopoly. Third, it is arguable that medical-association ethics committees fail to meet the one prior federal requirement, that of independence. There is a great deal of confusion in Germany today about which kinds of ethics committees (public and/or private) the states will sanction before 17 August 1995. In an attempt to sort things out we present a brief explanation of how ther came to be two kinds of ethics committees in Germany, review the legal battle between the two over the issue of authorization, point out how the German legislature, in passing the recent bill, has missed an opportunity to clarify the issue and, finally suggest why the administration of ethics committees by the medical associations may be incompatible with the requirement that ethics committees be independent
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1136/jme.21.4.229
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history
Request removal from index
Download options
Our Archive

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 26,702
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library
References found in this work BETA

No references found.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles
Ethics by Committee: The Moral Authority of Consensus.Jonathan D. Moreno - 1988 - Journal of Medicine and Philosophy 13 (4):411-432.
The Controversy Over Retrospective Moral Judgment.Allen E. Buchanan - 1996 - Kennedy Institute of Ethics Journal 6 (3):245-250.
Unfree Enterprise.Lyle Estill - 1990 - Journal of Business Ethics 9 (1):39-43.
Disagreement, Consensus, and Moral Integrity.Ruth Macklin - 1996 - Kennedy Institute of Ethics Journal 6 (3):289-311.
Confessions of an Ethics Committee Chair.Christine Halse - 2011 - Ethics and Education 6 (3):239 - 251.

Monthly downloads

Added to index


Total downloads

59 ( #87,677 of 2,158,464 )

Recent downloads (6 months)

1 ( #354,692 of 2,158,464 )

How can I increase my downloads?

My notes
Sign in to use this feature

There  are no threads in this forum
Nothing in this forum yet.

Other forums