1. Capacity Building: Training for Research Ethics in China at the Global Forum Plenary Session on Building an Infrastructure through training: Best Practices and Lessons 28 June 2007 Vilnius, Lithuania QIU Renzong Ethics Committee, MOH Institute of Philosophy/Centre for Applied Ethics, CASS

2. Background Research involving human subjects quite new.Research involving human subjects quite new. Since 1999 regulation on GCP (norms of drug clinical trial) promulgated by SFDA, ethical training conducted as a part of quality control of clinical trials by SFDA. It was inadequate.Since 1999 regulation on GCP (norms of drug clinical trial) promulgated by SFDA, ethical training conducted as a part of quality control of clinical trials by SFDA. It was inadequate. Ethical review and ethical norms were not required in research involving human subjects other than drug clinical trials (except the projects collaborative with US-European countries) until 11 January 2007 when the regulation on ethical review of biomedical research involving human subjects was promulgated by MOH.Ethical review and ethical norms were not required in research involving human subjects other than drug clinical trials (except the projects collaborative with US-European countries) until 11 January 2007 when the regulation on ethical review of biomedical research involving human subjects was promulgated by MOH.

3. Training workshops It is Prof. Ruth Macklin who first gave lectures on research ethics in China.It is Prof. Ruth Macklin who first gave lectures on research ethics in China. During 2004-2006 training workshops were organised by bioethicists at universities/colleges (Center for Bioethics, PUMC, Center for Bioethics, HUST, Fudan University and Health Science Center, Peking University)During 2004-2006 training workshops were organised by bioethicists at universities/colleges (Center for Bioethics, PUMC, Center for Bioethics, HUST, Fudan University and Health Science Center, Peking University) Co-organised by Harvard School of Public Health (International Biomedical and Health Research Program), and universities of Yale, Chicago, Minnesota and USFCo-organised by Harvard School of Public Health (International Biomedical and Health Research Program), and universities of Yale, Chicago, Minnesota and USF

4. Training workshops Sponsored by Forgaty Center, NIH and Chinese Medical Board (Bioethics Leadership Program); supported by Department of Ethics, Trade, Health Law and Human Right, WHOSponsored by Forgaty Center, NIH and Chinese Medical Board (Bioethics Leadership Program); supported by Department of Ethics, Trade, Health Law and Human Right, WHO Lecturers: WHO expert (A. Capron), US and Chinese senior or qualified bioethicists, scientists, chair of EC etc (R. Cash, D. Wikler, S. Putney, R. Levine, B. Lo, J. Kahn, M. Siegler et. Al.)Lecturers: WHO expert (A. Capron), US and Chinese senior or qualified bioethicists, scientists, chair of EC etc (R. Cash, D. Wikler, S. Putney, R. Levine, B. Lo, J. Kahn, M. Siegler et. Al.) Venue: Shanghai, Hefei, Beijing, Wuhan, Hangzhou, Chengdu, Xi an.Venue: Shanghai, Hefei, Beijing, Wuhan, Hangzhou, Chengdu, Xi an. Participants: average 40-60 each workshop, including PI, members of IECs, medical ethics teachers and health care administrators.Participants: average 40-60 each workshop, including PI, members of IECs, medical ethics teachers and health care administrators.

5. Workshops and short courses China s CDC (Centre for STD/HIV & Centre for MIH) in collaboration with Center for Bioethics, PUMC organized two days workshops and a series of short training courses in Beijing, and provinces such as Yunnan, Anhui, Guangxi, Sichuan, Shanxi, Shandong etc.China s CDC (Centre for STD/HIV & Centre for MIH) in collaboration with Center for Bioethics, PUMC organized two days workshops and a series of short training courses in Beijing, and provinces such as Yunnan, Anhui, Guangxi, Sichuan, Shanxi, Shandong etc. Some provincial or municipal government or medical college also took initiative in organizing training workshops.Some provincial or municipal government or medical college also took initiative in organizing training workshops.

6. New regulation by MOH Regulation on Ethical Review of Biomedical Research Involving Human Subjects promulgated by MOH on January 11, 2007.Regulation on Ethical Review of Biomedical Research Involving Human Subjects promulgated by MOH on January 11, 2007. Ethical review shall comply with the country s laws/ regulations/rules, and recognised bioethical principles. The review process shall be independent, objective, just and transparent. (Article 4) Ethical review shall comply with the country s laws/ regulations/rules, and recognised bioethical principles. The review process shall be independent, objective, just and transparent. (Article 4)

7. Three levels of ethics committees Institutional, provincial and national EC.Institutional, provincial and national EC. Provincial and national committees have the role to provide the guidance to, and oversight/monitoring of lower levels of ECs.Provincial and national committees have the role to provide the guidance to, and oversight/monitoring of lower levels of ECs. All have responsibilities to do training. All have responsibilities to do training. Central and provincial health care administrations have the duty to govern research involving human subjects and ethical review.Central and provincial health care administrations have the duty to govern research involving human subjects and ethical review.

8. Regulation: IEC and ethical review Composition of IECComposition of IEC Scope of authority (competence) of IECScope of authority (competence) of IEC Responsibilities of IECResponsibilities of IEC Principles of ethical reviewPrinciples of ethical review Contents of ethical reviewContents of ethical review Procedures of ethical reviewProcedures of ethical review Guidance and oversight/monitoring of IECGuidance and oversight/monitoring of IEC Report of misconductReport of misconduct Penalty for violating the RegulationPenalty for violating the Regulation

9. New momentum of training 8-10 June 2007 the first training workshop after new regulation was organised by Center for Bioethics, PUMC, Department of Clinical Bioethics, NIH and Research Directorate-General EU and sponsored by the Bureau for Science and Education, MOH and Ethics Committee MOH.8-10 June 2007 the first training workshop after new regulation was organised by Center for Bioethics, PUMC, Department of Clinical Bioethics, NIH and Research Directorate-General EU and sponsored by the Bureau for Science and Education, MOH and Ethics Committee MOH. Over 100 participants (far more than planned 60) came from more than 20 provinces (PI, members of IECs and PECs, health care administrators, medical ethics teachers).Over 100 participants (far more than planned 60) came from more than 20 provinces (PI, members of IECs and PECs, health care administrators, medical ethics teachers). The most successful training workshop.The most successful training workshop.

10. Experiences/lessons Training enhanced the awareness and capacity for research ethics in PIs, EC members and administrators and improved the performance of IECs.Training enhanced the awareness and capacity for research ethics in PIs, EC members and administrators and improved the performance of IECs. Training fostered the draft and promulgation of new regulation and the latter in turn gave a new momentum for training: Please help us organising training before setting up provincial EC and IECs in our province. (Interview with Mr. Geng, health care administrator of Guangxi Province).Training fostered the draft and promulgation of new regulation and the latter in turn gave a new momentum for training: Please help us organising training before setting up provincial EC and IECs in our province. (Interview with Mr. Geng, health care administrator of Guangxi Province).

11. Success of training Success of training depends upon the qualitySuccess of training depends upon the quality Quality assurance:Quality assurance: - Enrolment of participants who are relevant: PIs, - Enrolment of participants who are relevant: PIs, members (chairs) of ECs, medical ethics teachers and members (chairs) of ECs, medical ethics teachers and health care administrators health care administrators - Qualified lecturers - Qualified lecturers - Essential topics combined with native issues - Essential topics combined with native issues - Cases developed in native country - Cases developed in native country - Equal weight to lecturing and case discussion - Equal weight to lecturing and case discussion /exercises (exercise of writing inform consent form and /exercises (exercise of writing inform consent form and mock review) mock review) Duration: 2 or 3 days for PIs, IEC members andDuration: 2 or 3 days for PIs, IEC members and health care administrators; longer for training health care administrators; longer for training trainers trainers

12. Opportunities The government committed to protect human subjects.The government committed to protect human subjects. A number of bioethicists who possess the expertise of bioethics and familiar with Chinese laws, regulations and rules as well as practical issues in ethical review and ECs. They played a key role in drafting the new Regulation.A number of bioethicists who possess the expertise of bioethics and familiar with Chinese laws, regulations and rules as well as practical issues in ethical review and ECs. They played a key role in drafting the new Regulation. More and more professionals and institutions as well as health care administrators are aware of the importance of research ethics.More and more professionals and institutions as well as health care administrators are aware of the importance of research ethics.

13. Opportunities The implementation of new regulation requires, and also depends upon training.The implementation of new regulation requires, and also depends upon training. Mass media and the public concern research be in compliance with ethical requirements.Mass media and the public concern research be in compliance with ethical requirements. Foundations and institutions in external countries and international organisations are interested in supporting training in China.Foundations and institutions in external countries and international organisations are interested in supporting training in China.

14. Challenges Training is an essential part of building infrastructure for research ethics. How about other parts? The implementation of the new Regulation is a formidable work.Training is an essential part of building infrastructure for research ethics. How about other parts? The implementation of the new Regulation is a formidable work. Tremendous work to train all members of ECs (now already about 500), PIs and health care administrators concerned of 30 provinces. Resources shortage: qualified lecturers, and budget limit.Tremendous work to train all members of ECs (now already about 500), PIs and health care administrators concerned of 30 provinces. Resources shortage: qualified lecturers, and budget limit. Training of trainers. How many trainers enough? How to train them?Training of trainers. How many trainers enough? How to train them?

15. Challenges How to assure the quality of training? Anything goes? Anybody can do it?How to assure the quality of training? Anything goes? Anybody can do it? - A US geneticist did ethical training in China who is not qualified and she has produced groundless and fabricated allegation against an honest Chinese scientist; - A US geneticist did ethical training in China who is not qualified and she has produced groundless and fabricated allegation against an honest Chinese scientist; - An external organisation did training in China and provided accreditation to IEC: Are they qualified? Do they know China s regulations well? Should it itself be accredited by some authoritative body (especially a system of registry and accreditation will be established in China)? Is it necessary for an external person or body to do ethical training in China to get through some due procedure for quality assurance? - An external organisation did training in China and provided accreditation to IEC: Are they qualified? Do they know China s regulations well? Should it itself be accredited by some authoritative body (especially a system of registry and accreditation will be established in China)? Is it necessary for an external person or body to do ethical training in China to get through some due procedure for quality assurance?

16. Challenges How to assure the quality of training?How to assure the quality of training? Identify qualified lecturers Identify qualified lecturers Identify required topics Identify required topics Identify pedagogic method Identify pedagogic method Develop standard teaching outline and Develop standard teaching outline and edit textbook based on Chinese edit textbook based on Chinese experiences and lessons with Chinese experiences and lessons with Chinese language language

17. Challenges How to evaluate the quality of training? Need to follow-up: post-training performance of participantsHow to evaluate the quality of training? Need to follow-up: post-training performance of participants How to make training sustainable? Use of native resources is possible (a provincial health care administrator said: Please assure the quality).How to make training sustainable? Use of native resources is possible (a provincial health care administrator said: Please assure the quality). Enhance the capacity to train Ph.D./Master student in bioethics.Enhance the capacity to train Ph.D./Master student in bioethics.

18. Thank you for your attention