Ethics committee (European Union)
The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.
With the Clinical Trials Directive, the European Union (EU) envisioned a harmonisation of research ethics committees (RECs) across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account.
- Directive 2001/20/EC
- Directive 2005/28/EC
- Qualified Person
- Institutional Review Board (IRB)
- Regulation of therapeutic goods
- European Medicines Agency
- Investigator's Brochure
- Directive 2001/20/EC of the European Parliament and of the Council.
- Implementing texts for Directive 2001/20/EC
- A Hedgecoe, F Carvalho, P Lobmayer and F Raka, Research ethics committees in Europe: implementing the directive, respecting diversity, Journal of Medical Ethics 2006;32:483-486.