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Individual differences |
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An ethics committee is usually a locally elected/delegated body, consisting of healthcare professionals and non-medical members, whose responsibility it 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, Directive 2001/20/EC,, 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.
All clinical reseach within the NHS must be submitted to local ethics committees.
In the US ethics committees are known as Institutional Review Boards. The APA published its own Ethics Committee Rules and Procedures.
- Clinical research ethics
- Directive 2001/20/EC
- Directive 2005/28/EC
- European Medicines Agency
- Guidelines for human subject research
- Human subject research
- Investigator's Brochure
- Monitoring in clinical trials
- Qualified Person
- Preparing a proposal for an ethics committee
- Regulation of therapeutic goods
- 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.
- National ethics committees (EU)
- Central Office for Research Ethics Committees (COREC, UK)
- Research Ethics Committees - Documents
Research participant rights
|Human subject research|
|Guidelines for human subject research|
|Monitoring in clinical trials|
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