Construction and Operation of the Human Research Protection Program for Clinical Research on Traditional Chinese Medicine / 中国医学伦理学

ABSTRACT

It is the responsibility of a clinical research institution to protect the rights and interests of research subjects. For the full process supervision of clinical research projects, the construction of a Human Research Protection Program (HRPP) which is suitable to the hospital’s situation can gradually improve the ethical review quality, and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process. Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM), this paper introduced the construction of an HRPP system that highlights TCM characteristics. At the same time, this paper systematically analyzed the division of responsibilities, communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system, improve the quality of TCM clinical research and the protection level of the HRPP system, in order to achieve the goal of promote the healthy, orderly and scientific development of clinical research.