The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12(th) Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or ...

In response to the need for a more structured approach toward the enhancement of and preparation for case consultation, the Portland Service Area (PSA) of the Providence Health System Oregon Region implemented a "special team" system. These teams--an extension of the ethics committees already in place--underwent training in areas such as an overview of ethics, patient decision making, professio...

OBJECTIVE To identify and describe the current state of clinical ethics support services in the UK. DESIGN A series of questionnaire surveys of key individuals in National Health Service (NHS) trusts, health authorities, health boards, local research ethics committees and health professional organisations. Interviews with chairmen/women of clinical ethics committees identified in the surveys....

BACKGROUND In 2001 a report on the provision of clinical ethics support in UK healthcare institutions identified 20 clinical ethics committees. Since then there has been no systematic evaluation or documentation of their work at a national level. Recent national surveys of clinical ethics services in other countries have identified wide variation in practice and scope of activities. OBJECTIVE...

Ethics committees are the primary mechanism for dealing with ethical issues in hospitals in the United States today [1-3]. Present in nearly every US hospital, ethics committees were virtually nonexistent in the 1960s and ’70s and, as recently as the early 1980s, were present in only 1 percent of US hospitals [4]. By the late 1980s, however, ethics committee presence had expanded to over 60 per...

Cluster randomised trials have unique features that complicate the application of standard ethics guidelines for research. The Ottawa Statement on the ethical design and conduct of cluster randomised trials was developed to provide detailed guidance to researchers, research ethics committees, regulators, and sponsors as they seek to fulfil their respective roles.This article describes the devel...

Clinical research is important to improve medical quality, and ethics review is essential to conduct clinical research. Since the establishment of the first Japanese ethics committee at the University of Tokushima in 1982, Japanese ethics committees have increased. In this study, we surveyed the status of clinical studies and ethics committees in one Japanese region. The survey was conducted in...

The proliferation of clinical ethics in health care institutions around the world has raised the question about the qualifications of those who serve on ethics committees and ethics consultation services. This paper discusses some of weaknesses associated with the most common educational responses to this concern and proposes a complementary approach. Since the majority of those involved in cli...

OBJECTIVES To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN A prospective study of 100 applications. SETTING Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES Protocol-related features, characteristics of research ethics commi...