Capacity Building: Training fCapacity Building: Training for Research Ethics in Chinaor Research Ethics in China

at the Global Forum Plenary Session at the Global Forum Plenary Session on on

Building an Infrastructure through tBuilding an Infrastructure through training: raining:

Best Practices and LessonsBest Practices and Lessons 28 June 200728 June 2007

Vilnius, Lithuania Vilnius, Lithuania

QIU RenzongQIU RenzongEthics Committee, MOHEthics Committee, MOH

Institute of Philosophy/Centre for Institute of Philosophy/Centre for Applied Ethics, CASSApplied Ethics, CASS

BackgroundBackground

• Research involving human subjects quite new. Research involving human subjects quite new. • Since 1999 regulation on GCP (norms of drug clSince 1999 regulation on GCP (norms of drug cl

inical trial) promulgated by SFDA, ethical traininical trial) promulgated by SFDA, ethical training conducted as a part of quality control of cliing conducted as a part of quality control of clinical trials by SFDA. It was inadequate.nical trials by SFDA. It was inadequate.

• Ethical review and ethical norms were not requEthical review and ethical norms were not required in research involving human subjects otheired in research involving human subjects other than drug clinical trials (except the projects cr than drug clinical trials (except the projects collaborative with US-European countriesollaborative with US-European countries)) until until 11 January 2007 when the regulation on ethical 11 January 2007 when the regulation on ethical review of biomedical research involving humareview of biomedical research involving human subjects was promulgated by MOH. n subjects was promulgated by MOH.

Training workshopsTraining workshops

• It is Prof. Ruth Macklin who first gave lectIt is Prof. Ruth Macklin who first gave lectures on research ethics in China.ures on research ethics in China.

• During 2004-2006 training workshops werDuring 2004-2006 training workshops were organised by bioethicists at universities/e organised by bioethicists at universities/colleges (Center for Bioethics, PUMC, Centcolleges (Center for Bioethics, PUMC, Center for Bioethics, HUST, Fudan University aer for Bioethics, HUST, Fudan University and Health Science Center, Peking Universind Health Science Center, Peking University) ty)

• Co-organised by Harvard School of Public Co-organised by Harvard School of Public Health (International Biomedical and HeaHealth (International Biomedical and Health Research Program), and universities of lth Research Program), and universities of Yale, Chicago, Minnesota and USFYale, Chicago, Minnesota and USF

Training workshopsTraining workshops

• Sponsored by Forgaty Center, NIH and Chinese MSponsored by Forgaty Center, NIH and Chinese Medical Board (Bioethics Leadership Program); supedical Board (Bioethics Leadership Program); supported by Department of Ethics, Trade, Health Laported by Department of Ethics, Trade, Health Law and Human Right, WHOw and Human Right, WHO

• Lecturers: WHO expert (A. Capron), US and Lecturers: WHO expert (A. Capron), US and Chinese senior or qualified bioethicists, Chinese senior or qualified bioethicists, scientists, chair of EC etc (R. Cash, D. scientists, chair of EC etc (R. Cash, D. Wikler, S. Putney, R. Levine, B. Lo, J. Kahn, Wikler, S. Putney, R. Levine, B. Lo, J. Kahn, M. Siegler et. Al.) M. Siegler et. Al.)

• Venue: Shanghai, Hefei, Beijing, Wuhan, HangzVenue: Shanghai, Hefei, Beijing, Wuhan, Hangzhou, Chengdu, Xi’an.hou, Chengdu, Xi’an.

• Participants: average 40-60 each workshop, incluParticipants: average 40-60 each workshop, including PI, members of IECs, medical ethics teacherding PI, members of IECs, medical ethics teachers and health care administrators. s and health care administrators.

Workshops and short coursesWorkshops and short courses

• China’s CDC (Centre for STD/HIV & China’s CDC (Centre for STD/HIV & Centre for MIH) in collaboration with Centre for MIH) in collaboration with Center for Bioethics, PUMC organized Center for Bioethics, PUMC organized two days workshops and a series of shtwo days workshops and a series of short training courses in Beijing, and prort training courses in Beijing, and provinces such as Yunnan, Anhui, Guanovinces such as Yunnan, Anhui, Guangxi, Sichuan, Shanxi, Shandong etc.gxi, Sichuan, Shanxi, Shandong etc.

• Some provincial or municipal governSome provincial or municipal government or medical college also took initment or medical college also took initiative in organizing training workshoiative in organizing training workshops.ps.

New regulation by MOHNew regulation by MOH

• Regulation on Ethical Review of Regulation on Ethical Review of Biomedical Research Involving Biomedical Research Involving Human Subjects promulgated by Human Subjects promulgated by MOH on January 11, 2007. MOH on January 11, 2007.

• ““Ethical review shall comply with the cEthical review shall comply with the country’s laws/ regulations/rules, and reountry’s laws/ regulations/rules, and recognised bioethical principles. The reviecognised bioethical principles. The review process shall be independent, objectivw process shall be independent, objective, just and transparent.” (Article 4)e, just and transparent.” (Article 4)

Three levels of ethics commThree levels of ethics committeesittees

• Institutional, provincial and national EC.Institutional, provincial and national EC.• Provincial and national committees have tProvincial and national committees have t

he role to provide the guidance to, and ovehe role to provide the guidance to, and oversight/monitoring of lower levels of ECs.rsight/monitoring of lower levels of ECs.

• All have responsibilities to do training. All have responsibilities to do training. 　　• Central and provincial health care Central and provincial health care

administrations have the duty to administrations have the duty to govern research involving human govern research involving human subjects and ethical review.subjects and ethical review.

Regulation: IEC and ethical Regulation: IEC and ethical reviewreview

• 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 review Procedures of ethical review • Guidance and oversight/monitoring of IECGuidance and oversight/monitoring of IEC• Report of misconduct Report of misconduct • Penalty Penalty for violating the Regulationfor violating the Regulation

New momentum of New momentum of trainingtraining

• 8-10 June 2007 the first training workshop afte8-10 June 2007 the first training workshop after new regulation was organised by Center for r new regulation was organised by Center for Bioethics, PUMC, Department of Clinical BioetBioethics, PUMC, Department of Clinical Bioethics, NIH and Research Directorate-General Ehics, NIH and Research Directorate-General EU and sponsored by the Bureau for Science anU and sponsored by the Bureau for Science and Education, MOH and Ethics Committee MOd Education, MOH and Ethics Committee MOH.H.

• Over 100 participants (far more than planned Over 100 participants (far more than planned 60) came from more than 20 provinces (PI, me60) came from more than 20 provinces (PI, members of IECs and PECs, health care administrmbers of IECs and PECs, health care administrators, medical ethics teachers). ators, medical ethics teachers).

• The most successful training workshop. The most successful training workshop.

Experiences/lessonsExperiences/lessons

• Training enhanced the awareness and capTraining enhanced the awareness and capacity for research ethics in PIs, EC membeacity for research ethics in PIs, EC members and administrators and improved the prs and administrators and improved the performance of IECs.erformance of IECs.

• Training fostered the draft and promulgatiTraining fostered the draft and promulgation of new regulation and the latter in turn on of new regulation and the latter in turn gave a new momentum for training: “Pleagave a new momentum for training: “Please help us organising training before settise help us organising training before setting up provincial EC and IECs in our provinng up provincial EC and IECs in our province.” (Interview with Mr. Geng, health carce.” (Interview with Mr. Geng, health care administrator of Guangxi Province).e administrator of Guangxi Province).

Success of training 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 andmembers (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 traininghealth care administrators; longer for training trainerstrainers

OpportunitiesOpportunities

• The government committed to protect The government committed to protect human subjects.human subjects.

• A number of bioethicists who possess A number of bioethicists who possess the expertise of bioethics and familiar the expertise of bioethics and familiar with Chinese laws, regulations and with Chinese laws, regulations and rules as well as practical issues in rules as well as practical issues in ethical review and ECs. They played a ethical review and ECs. They played a key role in drafting the new Regulation. key role in drafting the new Regulation.

• More and more professionals and institutioMore and more professionals and institutions as well as health care administrators are ns as well as health care administrators are aware of the importance of research ethics.aware of the importance of research ethics.

OpportunitiesOpportunities

• The implementation of new regulation rThe implementation of new regulation requires, and also depends upon training.equires, and also depends upon training.

• Mass media and the public concern Mass media and the public concern research be in compliance with research be in compliance with ethical requirements. ethical requirements.

• Foundations and institutions in external Foundations and institutions in external countries and international organisatiocountries and international organisations are interested in supporting training ns are interested in supporting training in China. in China.

ChallengesChallenges• Training is an essential part of Training is an essential part of

building infrastructure for research building infrastructure for research ethics. How about other parts? The ethics. How about other parts? The implementation of the new implementation of the new Regulation is a formidable work.Regulation is a formidable work.

• Tremendous work to train all Tremendous work to train all members of ECs (now already about members of ECs (now already about 500), PIs and health care 500), PIs and health care administrators concerned of 30 administrators concerned of 30 provinces. Resources shortage: provinces. Resources shortage: qualified lecturers, and budget limit.qualified lecturers, and budget limit.

• Training of trainers. How many Training of trainers. How many trainers enough? How to train them?trainers enough? How to train them?

ChallengesChallenges• How to assure the quality of training? How to assure the quality of training?

Anything goes? Anybody can do it? Anything goes? Anybody can do it? - A US geneticist did ethical training in - A US geneticist did ethical training in

China who is not qualified and she has China who is not qualified and she has produced groundless and fabricated produced groundless and fabricated allegation against an honest Chinese allegation against an honest Chinese scientist; scientist;

- An external organisation did training in - An external organisation did training in China and provided accreditation to IEC: Are China and provided accreditation to IEC: Are they qualified? Do they know China’s they qualified? Do they know China’s regulations well? Should it itself be regulations well? Should it itself be accredited by some authoritative body accredited by some authoritative body (especially a system of registry and (especially a system of registry and accreditation will be established in China)? accreditation will be established in China)? Is it necessary for an external person or body Is it necessary for an external person or body to do ethical training in China to get through to do ethical training in China to get through some due procedure for quality assurance? some due procedure for quality assurance?

ChallengesChallenges

• How to assure the quality of training?How to assure the quality of training?

－ － Identify qualified lecturersIdentify qualified lecturers － － Identify required topicsIdentify required topics － － Identify pedagogic methodIdentify pedagogic method － － Develop standard teaching outline Develop standard teaching outline

andand edit textbook based on Chineseedit textbook based on Chinese experiences and lessons with experiences and lessons with

ChineseChinese languagelanguage

ChallengesChallenges

• How to evaluate the quality of How to evaluate the quality of training? Need to follow-up: post-training? Need to follow-up: post-training performance of participantstraining performance of participants

• How to make training sustainable? How to make training sustainable? Use of native resources is possible (a Use of native resources is possible (a provincial health care administrator provincial health care administrator said: Please assure the quality). said: Please assure the quality).

• Enhance the capacity to train Enhance the capacity to train Ph.D./Master student in bioethics.Ph.D./Master student in bioethics.

Thank you for

your attention