BACKGROUND Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools a...

BACKGROUND Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. DISCUSSION Research ethics committees face numerous obstacles to achieving their goal of improving research participant...

AIM To evaluate the impact of the new European paediatric regulatory framework on the activities of Ethics Committees operating in Europe and to assess their involvement and interest in paediatric research. METHODS Task-force in Europe for Drug Development for the Young Network of Excellence and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trial...

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 f...

OBJECTIVES To report the outcome of applications to 43 research ethics committees. SETTING Four regional health authorities in England. FINDINGS The research ethics committees varied considerably in their practices. The time lapse until notification of the outcome of the approval ranged from just under one week to 23 weeks with a mean of 8.6 weeks. Four research ethics committees failed to ...

Dr. Mitchell is chairperson, Department of Biomedical Ethics, School of Graduate Medical Education, Seton Hall University, South Orange, NJ. He is also director, Institute for Ethics, a division of the Catholic HealthCare Partnership of New Jersey. I n 1999 the Institute for Ethics, a division of the Catholic HealthCare Partnership of New Jersey, launched a program to assist institutional ethic...

Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most impor...

The research ethics committees are collegiate bodies whose main purpose is to evaluate and rule, approving or not approving, the protocols that going be carried out in human beings; likewise, they assist authorities monitoring compliance with health legislation. They constitute a guarantee of respect for people who participate as subjects legitimize those carry this procedure. mandatory all est...