For the purpose of clinical trials review, an institution shall establish an Ethics Committee consisting of members, with the qualifications and experiences to review and evaluate the science, medical aspects and ethics of the proposed trial.
The Ethics Committee should include at least five members, with at least one member with non-scientific background, and at least one member who is independent of the institution.
The Ethics Committee should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings.
The constitution and operation should be in compliance with the regulations stipulated by the Competent Authority.

The Ethics Committee should make its decision in accordance with the regulations specified in the paragraph 4 of the preceding Article.

Members who do not participate in the Ethics Committee review and discussion should not vote or provide their opinion.

The investigator may provide information on any aspect of the trial, but should not participate in the deliberations, decision or vote of the Ethics Committee.
The Ethics Committee may invite nonmembers with expertise in special areas for assistance.

The Ethics Committee should retain written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, correspondence and any other relevant records for a period of at least 3 years after completion of the trial and make them available upon request from the Competent Authority.
The Ethics Committee may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. Upon requests, the Ethics Committee shall not reject.