Clinical trials internet resource
Research Ethics Committees
November 2004
When planning a trial, the investigators must write a protocol that sets out in detail the procedure to be followed during the trial.
An appropriately constituted research ethics committee (Local Research Ethics Committees and Multi-centre Research Ethics Committees) must authorise this protocol before the trial can commence. The process involves evaluating the proposed experiment design, assessing the written consent forms and explanatory literature, ensuring that the procedure for obtaining informed consent complies with relevant regulations, and checking for compensation provisions and insurance arrangements. In addition to authorising clinical trials, ethics committees are increasingly expected to monitor the progress of the trials throughout each phase.
The Central Office for Research Ethics Committees (COREC) -go to the website here, provides more information, including contact details for local research ethics committees.
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