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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. The 8 th Global Forum on Bioethics in Research JUNE 27-29 June, 2007. Vilnius .

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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

The 8th Global Forum on Bioethics in Research

JUNE 27-29 June, 2007. Vilnius

regulating
REGULATING
  • Regulation 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 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).
regulating cont d
REGULATING (cont’d)
  • NEW 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 regulation
  • Legal status of IEC and system of ethical review established
  • Three 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
regulating cont d1
REGULATING (cont’d)
  • NEW 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 principles
  • The national system of registry and authorization is being established
training
TRAINING
  • A 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 committee
challenges
CHALLENGES
  • 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 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
challenge cont d
CHALLENGE (cont’d)
  • Financial support / compensation & time support …… Not available in most situations
  • No monitoring to the project after review .
  • No monitor and inspection to ECs
  • Rubber 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?
slide8
Thank you very much

for your patience !

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