On 1 May 2004 research ethics committees became legally accountable to a new government body, the United Kingdom Ethics Committee Authority. This marks the end of the self regulation of research ethics. This paper describes how this change in research ethics committee status has come about and explores the implications for research subjects, researchers, institutions, and for regulation of rese...

In Bulgaria, a legal commission on academic ethics has been operating since recently; it is subsidiary body to the Minister of Education and Science. The regulations this special are structured through Law Academic Staff Development Republic Bulgaria. Its functions related implementation certain control procedures for obtaining educational scientific Doctor degree Science degree, as well positi...

Since 1997 British studies involving five or more centres have required approval from both a multicentre research ethics committee and the local research ethics committee for each centre. A local committee can reject the protocol for local reasons but cannot amend it. Some researchers have criticised the process of obtaining ethical approval for multicentre studies, but little is known about th...

OBJECTIVES Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment. DESIGN Cross-sectional national survey of general hospitals to identify all ethics co...

Objectives: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients’ Rights Act. We studied the development of ethics committees in this legal environment. Design: Cross-sectional national survey of general hospitals to identify all ethics co...

This paper examines the UK's response to a recent European Clinical Trials Directive, namely the Department of Health, Central Office for Research Ethics Committee guidance, Governance Arrangements for NHS Research Ethics Committees. The revisions have been long awaited by researchers and research ethics committee members alike. They substantially reform the ethical review system in the UK. We ...

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive su...