Suchergebnisse

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.

The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors and practitioners, pharmaceutical industry associations and professional bodies

In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the "normal" constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.

Institutional ethics committees (lECs) in health care facilities now create moral policy, provide moral education, and consult with physicians and other health care workers. After sketching reasons for the development of IECs, this paper first examines the predominant moral standards it is often assumed lECs are now using, these standards being neo-Kantian principles of justice and utilitarian principles of the greatest good. Then, it is argued that a feminine ethics of care, as posited by Carol Gilligan and Nel Noddings, is an unacknowledged basis for /EC discussions and decisions. Further, it is suggested that feminine ethics of care can and should provide underlying theoretical tools and standards for lECs.