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.

Every accredited American hospital is required to have a mechanism for handling ethical concerns; most hospitals satisfy this requirement by constituting an institutional healthcare ethics committee (HEC), a pattern which is repeated in most western countries. This text provides definitive, comprehensive guidance for members of healthcare ethics committees who find themselves confronted with ethically challenging situations. Each chapter includes learning objectives, clinical case studies and questions to stimulate discussion among committee members. Particular emphasis is given to consultation, as this often presents the greatest challenges to committee members. Each chapter stands alone as a teaching module, as well as forming part of a comprehensive volume. Written and edited by nationally and internationally recognized experts in bioethics, this is essential reading for every member of a healthcare ethics committee

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

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

For the first 25 years of their existence in the United Kingdom research ethics committees were left more or less in peace by the Department of Health. Since the publication of the "red book" in 1991, 1 however, they have undergone a continual process of radical change, from the introduction of multicentre research ethics committees in 1997, through research governance, to various legislative reforms of research practice including the clinical trials regulations of 2004. 2–4 Ethical review has been extended to more and more kinds and locations of research. At the same time, ethics committees have been subject to continuous criticism from researchers and public and private sector sponsors of research. Criticism from patients and the public has been less audible. Some of the criticism of research ethics committees has focused on issues for which they can bear no responsibility, such as the interpretation of the Data Protection Act 1998 or the operation of trusts' research governance procedures. Ethics committees have been the lightning rod for the frustration researchers have felt about the bureaucratisation of research. Yet much of this frustration is reasonably directed at ethics committees. They can be slow, idiosyncratic, and poorly informed about research methods or guidelines on the ethics of research. And researchers can reasonably feel that many of the reforms since 1991, while intended to simplify ethics review of research, have actually made matters worse. This criticism appears to be common across Europe, with wide variations in approval times and required amendments being reported by many researchers. 56 Late last year Lord Warner, then a junior health minister, commissioned an ad hoc advisory group to review the operation of NHS research ethics committees in the health and social care sector. The group's findings were published in June. 7 The group's principal conclusions are that independent ethical review of research is important but that it needs to be efficient and timely and to concentrate on ...

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.

"In 1992, The Joint Commission on Hospital Accreditation (The Joint Commission) began requiring every accredited hospital to have a mechanism to handle ethical concerns within its institution. In response to this (and other cultural forces in medicine), hospitals across America have come to satisfy the requirement by constituting an institutional Healthcare Ethics Committee (HEC)1. Physicians, nurses, administrators, social workers, chaplains, community volunteers and others populate these committees. Yet by their own admission, many of these individuals, while well intentioned and personally invested, have neither training in ethics nor have the tools at their disposal to aid in their ethical considerations. Even more basically, many members of an HEC, not to mention a healthcare institution writ-large, are comfortable explaining what constitutes an ethical consideration. So, while these individuals are the people both medical professionals and patients turn to for ethical insight into the complexities of medical decision-making, they themselves recognize that they are often underprepared to handle the depth and complexity of many moral2 problems raised by health care"--