WFCMS.ORG
LoginCH
Assessment Standard for Ethics Review of Biomedical Research with Human Participants

【Release time】:Jun,20th,2014    【Source】:WFCMS Secretariat

 

Foreword 15
Introduction 17
1 Scope 15
2 Terms and Definitions 15
2.1 Ethics Review System 15
3 Basic requirements for assessment 15
3.1 Basic requirements for medical and health organizations 15
3.2 Basic requirements for REC 15
3.3 Basic requirements for REC Office 15
3.4 Basic requirements for clinical professional departments and investigators 16
4 Assessment elements for ethics review system 16
4.1 Assessment elements for medical and health organizations 16
4.2 Assessment elements for REC 20
4.3 Assessment elements for REC Office 23
4.4 Assessment elements for clinical professional departments and investigators 27
Bibliography 29

 

Foreword

The standard is formulated in order to assess Ethics Review System of biomedical research with human participants, and prescribes basic requirements and assessment elements for Ethics Review System.
Chief Drafting Organization: Committee of Ethics Review of WFCMS
Chief Draftsmen: Xiong Ningning, Wang Sicheng
Drafting and reviewing personnel: Wang Yongyan, Li Zhenji, Su Gangqiang, Li Yu, Chen Ken, Liu Baoyan, Zhang Jinzhong, Hu Jingqing, Jiang Jian, Tang Xudong, Liu Haitao, Wu Jing, Hu Jinhong, Zheng Jin, Liang Weixiong, Song Bailin, Zou Hejian, Xi Yiqun, Wang Baohe, Fan Minsheng, Duan Junguo, Cao Yi, Xu Chunbo, Deng Xiaochuan, Greg Koski, Marjorie A.Speers, Huang Jin, Li Ji, Bai Hua, Qiao Jie, Chen Xiaoyun
Participating Draftsmen (hereinafter alphabetized):
China:Bai Caizhen, Bao Wenhu, Cai Ying, Cao Yun, Chen Ronghu, Fang Zhuyuan, Fang Min, Gao Hongwei, Gao Yueqiu, Gu Xiaojing, Guan Xin, Guo Luyi, Guo Zhihua, He Chengshi, He Liyun, Jia Jingyun, Jiang Guangli, Li Bo, Li Fengsen, Li Guoxin, Li Na, Li Tao, Li Wenjie, Li Xiaoling, Li Zhen, Li Jiangbin, Liang Zhaohui, Liu Hua, Liu Jian, Liu Jianping, Liu Jun, Liu Kezhou, Liu Songjiang, Lv Xiaodong, Lv Yuan, Miao Qiansen, Qiu Yue, Ren Peijuan, Ruan Longde, Shan Ailian, Shang Jianwei, Sun Sulun, Tao Yong, Tao Youqing, Tian Kan, Tian Ning, Wang Hua, Wang Meihong, Wang Shu, Wang Shuoren, Wang Xianmin, Wang Chunfang, Wang Xiangping, Wang Xiaoning, Wang Xiaoyun, Wang Xueqin, Wang Yanping, Wei Jinming, Wei Ming, Weng Weiliang, Xia Xia, Xie Pengyan, Xie Qi, Xiong Zhibo, Xue Mingxin, Yu Ping, Yu Shijia, Yu Tiecheng, Zhang Jianfeng, Zhang Xiaoming, Zhang Yacheng, Zhao Caiyun, Zhao Yanling, Zhou Jianwei, Zhu Min
This standard solicit the views of the following persons:
America:Bradley E. Waite, June Rae Merwin, Karen M. Hansen, Sue Middle, Tom Widger
Belgium:Francis P. Crawley
Britain:Bob Simpson, Susan Bull
China Taiwan:Bai Yamei, Chen Jianren, Su Yahui, Wang Jianxing, Wang Shuhui, Xu Mingneng
Global MD Organization:Tim Shi
India:Roger Jeffery,S.Ramalingam,Sunil Kugare,Y.S.Sivan
Indonesia:Muchtaruddin Mansyur
Japan:Kenji Hirayama
Korea:Greg W.Smith,Im Hee Shin,Young-Mo Koo
Philippines:Cristina E. Torres, Vicente Belizario
Sri Lanka:Vajira H.W.Dissanayake
Thailand:Arthur Navarro, Jarupim Soongswang, Juntra Karbwang, Somboom Kietinun, Sriwimon Manochiopinig, Varang Khang Triyasut


Assessment Standard for Ethics Review System of Biomedical Research with Human Participants is drafted in accordance with the rules given in the SCM0001-2009 Working Regulation for Formulation and Publication of Standard.
Sep 22nd, 2013, draft of “Assessment Standard for Ethics Review System of Biomedical Research with Human Participants” is adopted by the Council Members on The Fifth Meeting of The Third Council of WFCMS.
The Standard is issued by the World Federation of Chinese Medicine Societies. All rights reserved by the World Federation of Chinese Medicine Societies.
 
Introduction

Many institutions have not established an administrative system of ethics review in biomedical research with human participants yet. Moreover, these Research Ethics Committees (RECs) have significant differences in the experiences, trainings, institutional supports, human and financial resources, and ethics review abilities. In order to help the institution to build up a high-level ethics review system of biomedical research, and promote its level and ability, we formulated “Assessment Standard for Ethics Review system of Biomedical Research with Human Participants”. The standard will provide the principles and basis for the quality assessment of ethics review system.
Ethics review system consists of four aspects, medical and health institution (clinical entity of medicine and health, research institution, university, etc.), REC, REC office, research departments and investigators. In this framework, the relevant departments and personnel follow the laws, regulations and guidelines, and cooperate with each other to achieve the goal of a high-level ethics review and human subjects protection in biomedical research.
The standard has referred to relevant laws and regulations, guidelines and standards, and taken into account the characteristics of ethics review of traditional Chinese Medicine (TCM) research. Its basic principles are to make sure the continuing improvement of the ethics review quality and protecting human subjects.
This standard applies to guide relevant administration bureau, or authorized entities to conduct the assessment for ethics review system of biomedical research with human participants, and also applies to guide the relevant institutions to set up their ethics review system, formulate administrative policies and operating procedures, establish quality management indicators, clarify responsibilities of relevant departments and personnel, and improve the working process.

 
Assessment Standard for Ethics Review of Biomedical Research with Human Participants
1 Scope
This standard prescribes basic requirements and assessment elements for ethics review system.
The standard is applicable to assessment of ethics review system.
2 Terms and Definitions
The following terms and definitions are applicable to this document.
2.1 Ethics Review System
Ethics Review System is founded by research institution according to related laws, policies and guidelines. This system consists of four aspects, medical and health institution (clinical entity of medicine and health, research institution, university, etc.), REC, REC office, research departments and investigators. In this framework, the relevant departments and personnel follow the laws, regulations and guidelines, and cooperate with each other to achieve the goal of a high-level ethics review system and human subjects protection in biomedical research.
……


If you need the formal version, please contact us.
Department of Sci-tech and Standardization
World Federation of Chinese Medicine Societies
Tel: 86-10-58650016
E-mail:
kjybzb@163.com