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

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

  • 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)

  • 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’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

  • 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

  • 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)

  • 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?


Thank you very much

for your patience !


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