1. system and experiences in health research ethical review in Vietnam 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) (87% Kinh) - Two main religions : Buddhism & Catholicism - City and Province : 64 - Capital: Hanoi - Districts: 643 - Communes: 10,753 - GDP per capita: 500 US$ (Source: Statistics office 2004)

3. (20002222

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

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

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

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

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

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

11. Experiences in 3 years performing THE regulation Advantages Advantages - Almost researchers know well regulation and follow strictly in study designs - Protection for subjects involving in all studies Difficulties 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

12. Thank you for your attention!