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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 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. In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...
A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. ...
Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. ...
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.
See also
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. ...
Qualified Person (QP) According to the European Union regulations (http://pharmacos. ...
An institutional review board/independent ethics committee (IRB/IEC) is an appropriately constituted group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. ...
The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. ...
The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ...
// CLINICAL TRIAL INVESTIGATORS BROCHURE (IB) The Investigators Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. ...
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.
External links - National ethics committees (EU)
- Central Office for Research Ethics Committees (COREC, UK)
- Research Ethics Committees - Documents
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