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
Background
• 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.
• 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.
Training workshops
• 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)
• Co-organised by Harvard School of Public Health
(International Biomedical and Health Research
Program), and universities of Yale, Chicago,
Minnesota and USF
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, 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.)
• 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.
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.
• Some provincial or municipal government or
medical college also took initiative in
organizing training workshops.
New regulation by MOH
• 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)
Three levels of ethics committees
• 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.
• All have responsibilities to do training.
• Central and provincial health care
administrations have the duty to govern
research involving human subjects and
ethical review.
Regulation: IEC and ethical review
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Composition of IEC
Scope of authority (competence) of IEC
Responsibilities of IEC
Principles of ethical review
Contents of ethical review
Procedures of ethical review
Guidance and oversight/monitoring of IEC
Report of misconduct
Penalty for violating the Regulation
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.
• 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.
Experiences/lessons
• 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).
Success of training
• Success of training depends upon the quality
• Quality assurance:
- Enrolment of participants who are relevant: PIs,
members (chairs) of ECs, medical ethics teachers and
health care administrators
- Qualified lecturers
- Essential topics combined with native issues
- Cases developed in native country
- Equal weight to lecturing and case discussion
/exercises (exercise of writing inform consent form and
mock review)
• Duration: 2 or 3 days for PIs, IEC members and
health care administrators; longer for training
trainers
Opportunities
• 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.
• More and more professionals and institutions as
well as health care administrators are aware of the
importance of research ethics.
Opportunities
• The implementation of new regulation
requires, and also depends upon training.
• 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.
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.
• 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?
Challenges
• 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;
- 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?
Challenges
• How to assure the quality of training?
－ Identify qualified lecturers
－ Identify required topics
－ Identify pedagogic method
－ Develop standard teaching outline and
edit textbook based on Chinese
experiences and lessons with Chinese
language
Challenges
• How 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).
• Enhance the capacity to train Ph.D./Master
student in bioethics.
Thank you for
your attention