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system and experiences in health research ethical review in Vietnam

system and experiences in health research ethical review in Vietnam. - Square: 332,600 Km2 Population : 81,727,400 Urban: 25,1% Annual growth rate: 1,32%. Life expectancy (years) : 71,3 Ethnic groups: 54 (87% Kinh)

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system and experiences in health research ethical review in Vietnam

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  1. system and experiences in health research ethical review in Vietnam

  2. - Square: 332,600 Km2 • Population : 81,727,400 • Urban: 25,1% • Annual growth rate: 1,32%. • Life expectancy (years) : 71,3 • Ethnic groups: 54 • (87% Kinh) • - Twomain religions : Buddhism & Catholicism • City and Province : 64 • Capital: Hanoi • Districts: 643 • Communes: 10,753 • GDP per capita: 500 US$ • (Source: Statistics office 2004)

  3. 2222 (2000

  4. DEVELOPMENT of ETHICAL REVIEW REGULATION • In 2001: WHO’s guidelines on establishing Ethical Review Committee • By 2002: all researches were reviewed by scientificcommittee • 19 December,2002: Regulation covering the organization and operation of ethicalreviewcommittee for biomedical researches

  5. principal All biomedical researches conducted in Vietnam must be reviewed by the Ethical Review Committee for Biomedical Research (ECBR)

  6. Biomedical researches includes: • Pharmaceutical products: pharmaceutical materials, modern medications, traditional medication • Biological products: vaccine and other biological products • Non-medication therapies: radiological therapy, medical procedures, operations, medical equipment… • Biological samples: blood samples, specimens, breast milk… • Epidemiological, social and psychological surveillance conducted in human being.

  7. The committees are established in accordance with: • Applicable laws for Governmental institutions - Values and interests of the communities

  8. LEVELS: - Institution level + Established by director of institutions + Responsible for Institutional and provincial levels. - Ministry of Health level + Established by Minister of Health + Responsible for state level, ministry, Ministry-level institutions, Governmental belonging institutions, domestic or foreign organizations

  9. Process for research approved at Ministry level Ethics Committee Research proposal DST- MoH for approval DST- MoH Scientific Committee

  10. Process for Clinical trial approved at institutional levels Ethics Committee Study proposal Institution for approval Institution Scientific Committee

  11. Advantages Almost researchers know well regulation and follow strictly in study designs Protection for subjects involving in all studies Difficulties Almost the members of commitees work part-time Some of members should be trainned more on research methodologies Skills of researchers in ethical practices are still limited Experiencesin 3 years performing THE regulation

  12. Thank you for your attention!

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