Research Ethics in China:Research Ethics in China:

Development and Challenge Development and Challenge

Xiaomei ZHAI Ph.D.Xiaomei ZHAI Ph.D.Professor and Director, Center for BioethicsProfessor and Director, Center for Bioethics

Chinese Academy of medical Sciences / Peking Union Medical CollegeChinese Academy of medical Sciences / Peking Union Medical College Beijing ChinaBeijing China

The 8The 8thth Global Forum on Bioethics in Research Global Forum on Bioethics in Research

JUNE 27-29 June, 2007. Vilnius JUNE 27-29 June, 2007. Vilnius

REGULATING REGULATING

• Regulation is the most important factor for the effective resRegulation is the most important factor for the effective research ethics infrastructure in Chinaearch ethics infrastructure in China

• A series of rules, guidelines and regulations governing the rA series of rules, guidelines and regulations governing the research involving human being promulgated in China since esearch involving human being promulgated in China since 1998, such as 1998, such as

– Rules on Protecting Human Genetic Resources , Ministry of SciencRules on Protecting Human Genetic Resources , Ministry of Scienc

es and Technology / Ministry of Health, 1998.)es and Technology / Ministry of Health, 1998.)

– GCP (State Food and Drug Administration, 1999)GCP (State Food and Drug Administration, 1999)

– Ethical Ethical Guidelines Guidelines for Human Embryonic Stem Cell Research for Human Embryonic Stem Cell Research (MO(MO

ST/MOH, December 2003).ST/MOH, December 2003).

REGULATING REGULATING （（ cont’dcont’d ））• NEW Regulation on Ethical Review of Biomedical Research NEW Regulation on Ethical Review of Biomedical Research

involving Human Subjects (involving Human Subjects ( MOH, on MOH, on 11 Jan. 2007 11 Jan. 2007 ):• All researches with human subjects in China governed undAll researches with human subjects in China governed und

er the regulation er the regulation • Legal status of IEC and system of ethical review establisheLegal status of IEC and system of ethical review establishe

d d • Three levels of EC: National, Provincial, institutional EC Three levels of EC: National, Provincial, institutional EC

with different functionswith different functions– National: guidance, monitoring , National: guidance, monitoring , counselingcounseling, , training ,review (spe, , training ,review (spe

cial international cooperative projectcial international cooperative project ) )– Provincial: governing and monitoring institutional EC, reviewProvincial: governing and monitoring institutional EC, review– Institutional : review Institutional : review

REGULATING REGULATING （（ cont’dcont’d ））• NEW Regulation on Ethical Review of Biomedical Research NEW Regulation on Ethical Review of Biomedical Research

involving Human Subjects (involving Human Subjects ( MOH, on MOH, on 11 Jan. 2007 11 Jan. 2007 ):

• Review should be based on national law, regulations/rules Review should be based on national law, regulations/rules and recognized bioethical principles and recognized bioethical principles

• The national system of registry and authorization is being The national system of registry and authorization is being established established

TRAININGTRAINING

• A lot of Ethics training for researchers and members of EA lot of Ethics training for researchers and members of E

Cs has been provided recent years although it is far from eCs has been provided recent years although it is far from e

noughnough

• The training outline and textbook is being drafted by natiThe training outline and textbook is being drafted by nati

onal ethics committee onal ethics committee

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 the chairpersons of IEC are the head of the institutes or hospitals in

particular. particular. – The other hand, can not distinguish the independence of moral judgThe other hand, can not distinguish the independence of moral judg

ment from dependence on the support from the institutes .ment from dependence on the support from the institutes .

• Lack of qualified personnel resource Lack of qualified personnel resource – Some ECs / members start their work without or with little formal trSome ECs / members start their work without or with little formal tr

aining. Hard to obtain Continuing education on research ethicsaining. Hard to obtain Continuing education on research ethics– Hard to take quality control to the training courses and the lectures iHard to take quality control to the training courses and the lectures i

nclude that provided outside of China, provided through internetnclude that provided outside of China, provided through internet

CHALLENGE (cont’d)

• Financial supportFinancial support / / compensationcompensation & time support …… & time support …… N N

ot available in most situationsot 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 suRubber stamp: some review is to stamp,: no reject , no su

ggestions to revision ggestions to revision • Can be possible for a joint / regional EC if there are only Can be possible for a joint / regional EC if there are only

few research projects need to be reviewed per year in sofew research projects need to be reviewed per year in so

me institution?me institution?

Thank you very Thank you very much much

for your for your patience !patience !