(1995; 68 pages)
Ethics review board
The protocol should be considered by an ethics review board. The board will generally be established at an institutional level, but boards existing at a regional or national level can also be used. The board will be an independent body made up of both medical and non-medical members who are not involved in the experimental activity of evaluation under review. The board will verify that the rights of patients participating in the evaluation are protected and that the trial is justified in both medical and social terms. The board will also consider the suitability of the protocol as it relates to patient selection and patient protection, and the issues of informed consent for patients. However, this board should not promote methodological guidance unless it has appropriate expertise in acupuncture research. The work of the board should be guided by the Helsinki Declaration (see Appendix 2) and other related documents prepared by the individual country or institutions. If beneficial effects are demonstrated for the experimental group, patients allocated to the control group should be offered the possibility of receiving the experimental treatment.