Ethics committees

It is necessary to obtain ethics approval from the appropriate ethics committees using their standard application forms. The following points should be borne in mind when completing the form.

♦ Ethics committees include lay members; it is essential to use non-technical language.

♦ Ensure that all abbreviations are explained.

♦ Answer all questions; do not rely on referring to the protocol.

♦ Include sufficient information for a thorough ethics review to be made.

Ethics committees generally expect to receive protocols that have already been subjected to critical scientific evaluation. Thus, if the trial management group have made sure that the scientific case for a trial has been well argued, that the protocol has been appropriately designed and independently evaluated, and if the ethics application form has been correctly completed, the committee is most unlikely to raise major objections. It is not uncommon, however, for them to request minor changes or to ask for clarification on some details.

If, during the conduct of a trial, the protocol has to be modified, the ethics committee must be informed. If major modifications effectively change the trial into a different trial or will affect trial participants, the ethics committee are likely to need to review the protocol.

The UK Central Office for Research Ethics Committees (COREC) web site (http://www.corec.org.uk) is a useful source of information on ethical issues related to clinical trials. It is updated regularly, it reproduces the Declaration of Helsinki, and it provides a valuable statement of compliance with the ICH GCP Guideline.

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