Research ethics in china development and challenge
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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

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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?


Research ethics in china development and challenge

Thank you very much

for your patience !


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