David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
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)|
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.
Citations of this work BETA
No citations found.
Similar books and articles
Hans-Peter Graf (2013). Are the Votes of Ethics Committees in Germany for the Protection of Clinical Study Trial Subjects “Sovereign Acts?”. Science and Engineering Ethics 19 (2):341-354.
Diane E. Hoffmann (1992). The Maryland Institutional Ethics Committee Resource Ethics Committee Resource Network. Cambridge Quarterly of Healthcare Ethics 1 (2):180.
Jonathan D. Moreno (1988). Ethics by Committee: The Moral Authority of Consensus. Journal of Medicine and Philosophy 13 (4):411-432.
Allen E. Buchanan (1996). The Controversy Over Retrospective Moral Judgment. Kennedy Institute of Ethics Journal 6 (3):245-250.
Teresa Moore & Kristy Richardson (2013). The Low Risk Research Ethics Application Process at CQUniversity Australia. Journal of Academic Ethics 11 (3):211-230.
H. E. Baron Hermann von Richthofen (1993). FOCUS: The New Germany a United Germany in the New Europe. Business Ethics 2 (2):53–57.
Lyle Estill (1990). Unfree Enterprise. Journal of Business Ethics 9 (1):39-43.
Ruth Macklin (1996). Disagreement, Consensus, and Moral Integrity. Kennedy Institute of Ethics Journal 6 (3):289-311.
Linda S. Scheirton (1992). Determinants of Hospital Ethics Committee Success. HEC Forum 4 (6):342-359.
Hans Henrik Brydensholt (2000). The Legal Basis for the Danish Committee on Scientific Dishonesty. Science and Engineering Ethics 6 (1):11-24.
Charles C. Engel (1992). Exploring the Role of the Ethics Committee Psychiatrist. HEC Forum 4 (6):360-371.
Timothy Caulfield, Ross Upshur & Abdallah Daar (2003). DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model. [REVIEW] BMC Medical Ethics 4 (1):1-4.
Christine Halse (2011). Confessions of an Ethics Committee Chair. Ethics and Education 6 (3):239 - 251.
Nancy E. Kass & Jeremy Sugarman (1996). Are Research Subjects Adequately Protected? A Review and Discussion of Studies Conducted by the Advisory Committee on Human Radiation Experiments. Kennedy Institute of Ethics Journal 6 (3):271-282.
Added to index2010-09-13
Total downloads47 ( #88,764 of 1,796,162 )
Recent downloads (6 months)4 ( #209,906 of 1,796,162 )
How can I increase my downloads?