1. 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 Beijing China The 8 th 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 ChinaRegulation 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 asA 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 contd REGULATING contd NEW Regulation on Ethical Review of Biomedical Research involving Human Subjects ( MOH, on 11 Jan. 2007NEW 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 regulationAll researches with human subjects in China governed under the regulation Legal status of IEC and system of ethical review establishedLegal status of IEC and system of ethical review established Three levels of EC: National, Provincial, institutional EC with different functionsThree 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 contd REGULATING contd NEW Regulation on Ethical Review of Biomedical Research involving Human Subjects ( MOH, on 11 Jan. 2007NEW 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 principlesReview should be based on national law, regulations/rules and recognized bioethical principles The national system of registry and authorization is being establishedThe 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 enoughA 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 committeeThe training outline and textbook is being drafted by national ethics committee

6. CHALLENGES Lack of the tradition/culture to challenge the authorities: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 resourceLack 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 (contd) Financial support / compensation & time support …… Not available in most situationsFinancial support / compensation & time support …… Not available in most situations No monitoring to the project after review.No monitoring to the project after review. No monitor and inspection to ECsNo monitor and inspection to ECs Rubber stamp: some review is to stamp,: no reject, no suggestions to revisionRubber 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?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 ! for your patience !