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Research Ethics in China: Development and Challenge

Research Ethics in China: Development and Challenge . Xiaomei ZHAI Ph.D. Professor and Director, Center for Bioethics Chinese Academy of medical Sciences / Peking Union Medical College Beijing China. The 8 th Global Forum on Bioethics in Research JUNE 27-29 June, 2007. Vilnius .

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Research Ethics in China: Development and Challenge

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  1. Research Ethics in China:Development and Challenge Xiaomei ZHAI Ph.D. Professor and Director, Center for Bioethics Chinese Academy of medical Sciences / Peking Union Medical College Beijing China The 8th Global Forum on Bioethics in Research JUNE 27-29 June, 2007. Vilnius

  2. REGULATING • Regulation is the most important factor for the effective research ethics infrastructure in China • A series of rules, guidelines and regulations governing the research involving human being promulgated in China since 1998, such as • Rules on Protecting Human Genetic Resources , Ministry of Sciences and Technology / Ministry of Health, 1998.) • GCP (State Food and Drug Administration, 1999) • Ethical Guidelines for Human Embryonic Stem Cell Research (MOST/MOH, December 2003).

  3. REGULATING （cont’d） • NEW Regulation on Ethical Review of Biomedical Research involving Human Subjects ( MOH, on 11 Jan. 2007 ): • All researches with human subjects in China governed under the regulation • Legal status of IEC and system of ethical review established • Three levels of EC: National, Provincial, institutional EC with different functions • National: guidance, monitoring , counseling, , training ,review (special international cooperative project ) • Provincial: governing and monitoring institutional EC, review • Institutional : review

  4. REGULATING （cont’d） • NEW Regulation on Ethical Review of Biomedical Research involving Human Subjects ( MOH, on 11 Jan. 2007 ): • Review should be based on national law, regulations/rules and recognized bioethical principles • The national system of registry and authorization is being established

  5. TRAINING • A lot of Ethics training for researchers and members of ECs has been provided recent years although it is far from enough • The training outline and textbook is being drafted by national ethics committee

  6. CHALLENGES • Lack of the tradition/culture to challenge the authorities: • the chairpersons of IEC are the head of the institutes or hospitals in particular. • The other hand, can not distinguish the independence of moral judgment from dependence on the support from the institutes . • Lack of qualified personnel resource • Some ECs / members start their work without or with little formal training. Hard to obtain Continuing education on research ethics • Hard to take quality control to the training courses and the lectures include that provided outside of China, provided through internet

  7. CHALLENGE (cont’d) • Financial support / compensation & time support …… Not available in most situations • No monitoring to the project after review . • No monitor and inspection to ECs • Rubber stamp: some review is to stamp,: no reject , no suggestions to revision • Can be possible for a joint / regional EC if there are only few research projects need to be reviewed per year in some institution?

  8. Thank you very much for your patience !

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