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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 submi