The study of traditional Chinese medicine for ethical review certification time:

the first 2015-09-07

source: China's traditional Chinese medicine to the author: wei min report from our correspondent (reporter wei min), Chinese medicine hospital in hubei province, longhua hospital affiliated to Shanghai university of traditional Chinese medicine, guangdong hospital, shuguang hospital affiliated to Shanghai university of traditional Chinese medicine, Chinese medicine hospital of jiangsu province, the Chinese people's liberation army (PLA) changhai hospital affiliated to second military medical university, the Chinese people's liberation army (PLA) fourth military medical university affiliated hospital of xiking such seven major of traditional Chinese medicine and western medicine hospital through the first batch of "traditional Chinese medicine research ethics review system certification" (hereinafter referred to as CAP certification) and obtain certification plaque, logo with Chinese characteristics of traditional Chinese medicine research ethics review system authentication work officially set sail. This work is by the state administration of traditional Chinese medicine, national certification and accreditation supervision and administration commission, the world federation of Chinese medicine jointly promote.

CAP certification program is a national certification and accreditation regulatory commission on December 29, 2014, formally approved the first field certification program of Chinese medicine, is the only national certification program in the domestic field of medical ethics and international within the scope of the first traditional medicine research ethics system and certification program. The world federation of Chinese medicine is the only legitimate certification body to CAP certification, certification of CAP in the prophase, commissioned by the state administration of traditional Chinese medicine is the world zhonglian conducted by "Chinese medicine clinical research ethics review platform evaluation" (CAP assessment) project.

CAP certification according to the technical standards, is approved by state certification and accreditation administration for the record "involves people of biomedical research ethics review system", its content includes medical and health care organizations, ethics committee, the ethics committee office, researchers and other four parts requirements.

Passed the certification of CAP, marks the medical and health institutions have established ethical review system and effective operation, the ability and level of ethical review to suit the requirements of certification standards.

The push in recent years, the state administration of traditional Chinese medicine of traditional Chinese medicine research ethics review system, deployed in 2008 TCM clinical research ethical review study, 2010 promulgated "Chinese medicine clinical research ethical review management norms", was established in 2011, bureau of traditional Chinese medicine ethics committee of experts, released "Chinese medicine clinical research ethical review platform construction specification" "Chinese medicine clinical research ethical review platform construction quality assessment points", commissioned in 2012 the world zhonglian ethical review committee to carry out "in traditional Chinese medicine clinical research ethics review platform construction assessment". Ethical review committee was established in 2011, the world zhonglian, 2013 issued a "ethical review system evaluation criteria". By 2014, there are 37 passed the CAP assessment of traditional Chinese medicine and western medicine hospital.

Deputy director general of the state administration of traditional Chinese medicine slurry sampling, said xu junming CAP start the certification program is of great significance, marks the ethical review platform construction of traditional Chinese medicine has made breakthrough progress, also marks the traditional Chinese medicine in the world of traditional medicine and medical research ethics review will be set up with Chinese characteristics in the field of independent certification brand, will bring into the history of the development of China's medical research ethics review. Hope project as soon as possible to the world, become the world's ethical review certification brand with international influence.

World zhonglian, vice chairman and secretary general Li Zhenji said CAP approved certification bodies and auditors, make traditional Chinese medicine research ethics review construction achieved from sector assessment to the crossing of national certification, this is traditional Chinese medicine research ethics review standardized management innovation and breakthrough. Next, the world zhonglian will rely on the international academic organization of traditional Chinese medicine academic resources and experts at home and abroad, further study on mechanism, strengthen management, create CAP certification brand, strive to will CAP certification into traditional Chinese medicine in international exchanges, support the "new name card" of TCM scientific and technological achievements to the world.

CAP up and implementation of the certification, the ministry of science and technology, national health and family planning commission, the state food and drug supervision administration and national certification and accreditation supervision and administration commission, the support of relevant ministries and commissions such as the state administration of traditional Chinese medicine. CAP authentication and ethical review committee BBS in the asia-pacific region (FERCAP), the human research protection program (AAHRPP) and other international certification association similar organizations maintain close contact, especially with Chinese APEC cooperation (APEC) fund project support.