Society

Guideline on medical ethics committee issued

(Xinhua)
Updated: 2010-11-09 06:32

BEIJING - China on Monday issued its first guidelines regarding the operation and power of the medical ethics committee, which would strengthen the committee's role of supervision and protecting the rights and interests of human subjects involved in clinical medical trials.

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The guidelines, posted on the website of the State Food and Drug Administration (SDFA), stipulate that a medical ethics committee should be composed of members with different disciplinary educational backgrounds and equal numbers of males and females. It should also has personnel not related to the unit that launched the clinical trial.

A medical ethics committee is usually an independent body consisting of medical professionals and non-medical members. The responsibility of the committee is to protect the rights and safety of human subjects involved in clinical trials.

Members of the committee can voice opinions regarding the selection of investigators in the trial, the adequacy of facilities, and the methods and documents to be used to inform trial subjects and obtain their informed consent.

The guidelines also note the committee' s members and their work should be free from the influence of any human subject.