Regulations for Good Clinical Practice Article 25

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.