1. RESEARCH ON HUMAN GENETIC MATERIAL Ethical Perspective From Indonesia Experience

2. INTRODUCTION The increasingly of collaboration research between developed and developing countries, in particular the molecular and genetic research Such study some time have been greeted with caution and suspicion by most developing countries Highlighted a number of new ethical issues

3. ETHICS PRINCIPLES Autonomy Beneficence Non-maleficence Justice

4. STORED HUMAN GENETIC MATERIAL RESEARCH The use of human tissue has been integral to health research for many years Different view emerged on ethical aspects Decision have to be taken by those in lawful possession of the material –What will be in best interest of the community? –What will show the greatest respect to those people from whom this material was taken in the first place, in all probability without their consent?

5. INDONESIA EXPERIENCE Increasing collaborative research, as globalization increases –Infectious diseases –Clinical research –Genetic research (population genetic, pharmacogenomic, etc) Limited attention has been paid to human genetic material, and the ethical issues involved in their continued usage.

6. INDONESIA EXPERIENCE We have more than 500 ethnics with different genetic, language, culture and geographic background The richness of this genetic diversity could be used to understand the risk of population to specific diseases, or response to different drugs Limited attention has been paid to human genetic material, and the ethical issues involved in their continued usage.

7. Eijkman Institute Malay (n = 49) Sundanese (n = 102 ) Javanese (n = 66 ) BugisMakass (n = 23) Cd 8-9 - - 7 - Cd 15 2 - - - Hb Malay18 - - - HbE12103835 Cd 30 - - 3 - IVS1-1 2.5 5 2 - IVS1-5337024 3.5 Cd 35 - -12 3.5 Cd 41-42 8 - 2 - Filipino  5 - -17 Hb Lepore - - -23 SPECTRUM OF  -THALASSEMIA MUTATIONS IN INDONESIA (% alleles)    

8. CYP2C19 Genotype Frequencies in Indonesia Populations

9. 0.04 11 Sunda Bima Dayak Kajang Thailand Malay Javanese Bugis Philippines Australian Aborigine Vanuatu Caucasian Saudi Arabian Chinese KoreanJapanese Yusuf. I, et al. Adv Exp Med Biol, 2003

10. PUBLIC HEALTH IMPLICATIONS The most significant potential impact of CYP2C19 PM in patient care, therefore, would be in SEA where there is a combination of high population densities and significantly increased risk associated with PM. The recognition of the high frequency of IM and PM individuals amongst SEA is important for medical practitioners in SEA but also those in Europe, Middle East, and USA where the frequencies of EM individuals predominate. Racial differences in the response to drugs not only have practical importance for the choice and dose of drugs but should also alert physicians to the important underlying genetic determinants of drug response if used in populations with different genetic backgrounds.

11. POINTS TO CONSIDER FOR CONFIDENTIALITY IN GENETIC RESEARCH Points to be considered by IRB: –Nature of research; –Intended use of the samples; –Secondary uses; –Legal context; –Balance of privacy protection with the objectives of the research

12. THE ETHICAL PROBLEMS How the using of human genetic material derived from developing countries relevant to them? Should there be prior informed consent, from the people donating genetic material or products derived from there? Is it sufficient to obtain the consent from the person donating the material or should consent be obtained from others sharing characteristics of the materials? Should donors or a group to which they belong share any benefits from the research on that the material derived? Should the original donors of genetic material on which research are based have any influence on how those material are exploited?

13. RECOMENDATIONS Ethical regulations over genetic research should be internationally institutionalised. Informed consent of individuals and groups should be appropriately complied with during all human genetic research There are circumstances when samples are anonymised or informed consent is not possible because samples were collected previously. It should be recognised that biomedical advances represented by increased knowledge about human diseases must be shared between all peoples in developing and developed countries.