A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investiga...

The requirement for ethics review of studies submitted to Implementation Science has been unclear. Therefore, in this editorial, we set out our requirements for ethics committee review of experimental and non-experimental studies. For any study that meets the criteria of human subject research (which includes research on healthcare providers), irrespective of study design, we will require proof...

The Patient-Centered Medical Home: An Ethical Analysis of Principles and Practice Clarence H. Braddock III, MD, MPH, Lois Snyder, JD, Richard L. Neubauer, MD, and Gary S. Fischer, MD For the American College of Physicians Ethics, Professionalism and Human Rights Committee and The Society of General Internal Medicine Ethics Committee* Stanford School of Medicine, Stanford, USA; Center for Ethics...

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...

In a number of countries throughout the world attention is being paid to the ways in which health and social care research is undertaken and regulated. In the United Kingdom, new research governance frameworks are intended to promote improvement in research quality. This paper draws on our experiences of seeking research ethics committee approval for two investigations with the same research de...

The creation of a national ethics committee in Britain has been proposed to overcome some of the problems that researchers conducting multi-center trials encounter in dealing with numerous local ethics committees. Drury identifies three disadvantages to this proposal: 1) it might weaken the authority of local committees; 2) the present system works well by creating ad hoc ethics committees to...

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. Good quality, ethically sound research is needed in order to better understand, appropriately respond to, and reduce the incidence of suicide. There is, however, a lack of clarity around the nature of ethical problems associated with suicide research and how to resolve them. This is a formidable challenge for ethics committee members in approving and monitoring research. Aims. To de...