Ethics committee

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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.

Contents 1 Europe 2 UK 3 USA 4 See also 5 References 6 External links

[edit] Europe

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.

[edit] UK

All clinical reseach within the NHS must be submitted to local ethics committees.

[edit] USA

In the US ethics committees are known as Institutional Review Boards. The APA published its own Ethics Committee Rules and Procedures.

[edit] See also

• Preparing a proposal for an ethics committee
• EudraLex
• Directive 2001/20/EC
• Directive 2005/28/EC
• Qualified Person
• Institutional Review Board (IRB)
• Regulation of therapeutic goods
• European Medicines Agency
• Investigator's Brochure

[edit] References

• 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.

[edit] External links

• National ethics committees (EU)
• Central Office for Research Ethics Committees (COREC, UK)
• Research Ethics Committees - Documents

This page uses content from the English-language version of Wikipedia. The original article was at Ethics committee. The list of authors can be seen in the page history. As with Psychology Wiki, the text of Wikipedia is available under the GNU Free Documentation License.