• The investigators are responsible for the trial and for the rights, health and welfare of the subjects in the trial.

• All investigators and health providers involved in the study should have appropriate expertise, qualifications and competence to undertake a proposed study. It is recommended that a team be organized which includes acupuncture practitioners and professional health workers, as knowledge of both acupuncture and the special field for which the effectiveness of acupuncture will be evaluated will be needed for preparing and conducting a reliable clinical study.

• The investigative group must be aware of the following responsibilities:

1. appropriate and ongoing care of patients in the study;

2. ethical requirements for the study (for instance the need to terminate protocol treatment if the patient appears to be harmed by the continuation of the study);

3. knowledge of acupuncture; and

4. an appreciation of research methodology.