Bioethics and the Pan Asian SNP Project Regulation from Within

1. Bioethics and the Pan Asian SNP ProjectRegulation from Within Maude E. Phipps, Ph.D. 8th Asian Bioethics Conference Bangkok 19 March 2007

2. Asia - the world's largest continent, 17,139,000 sq mi (44,390,000 sq km), with about 3.3 billion people, nearly three fifths of the world's total population

3. Pan Asian Single NucleotidePolymorphism initiative • Combined effort by researchers in public institutions in Korea, Malaysia, Singapore, China, Taiwan ROC, Japan, Indonesia, Philippines, India, Mongolia and Thailand • Document the precise level of genetic diversity in 65 distinct Asian ethnic groups • Current databases document mainly Caucasian or very regional Asian populations. Knowledge of Asia’s genetic composition will create major benefits.

4. An Anthropological and Genomics Perspective of Four Pribumi Groups in Malaysia PASNP Initiative Creation : 2004 Publications : April 2007 - Created in 196 BC, Discovered by French in 1799, Translated in 1822.

5. Benefits • Determination, with high resolution, the genetic relatedness of Asian populations • Patterns of human migration across Asia • Creation of a freely accessible Asian SNP database to assist association studies and the genetic stratification of case-control subjects. • Develop collaborative networks and training of scientists from less developed countries • Improve scientific expertise across Asia.

6. PRB Vision Statement • What we’re doing must be scientifically sound, in line with technological advances involve international collaborative efforts and be ethically acceptable, in our quest for greater knowledge and wisdom of the human genome, evolution and health

7. Pan Asian Single NucleotidePolymorphism initiative

8. Genomics and Health in Indigenous Peoples of Malaysia-Towards the Pan Asian SNP Initiative P2 Distribution of Indigenous groups in Malaysia A Kensiu man from Kampung Lubuk Legong, Kedah A Jehai woman from RPS Banun, Grik Bidayuh ladies in their traditional costumes A Semai man with 2 Jehai children Temuan schoolgirls from Kuala Pilah, Negeri Sembilan SABAH SARAWAK

9. Consultations • Researchers • IRBs • Indigenous Affairs departments /organization • Chieftains / Batin • Participants

10. PRB - Terms of Reference • Identification of relevant ELSI parameters • Consultation, engagement and discussion (bioethicists, researchers, policy makers, etc, within HUGO, other agencies and stakeholders) • Policy formulation and periodic review for the duration of the initiative • Collation of documentary evidence – Informed consent, approvals of IRBs, other regulatory authorities . • Addressing of ethical concerns relevant to research findings, publications and implications, especially in the Asia Pacific

11. Bioethics Instruments / Guidelines applicable to the PRB-PASNPI • International • UNESCO • Universal Declaration on Bioethics and Human Rights • Universal Declaration on the Human Genome and Human Rights (2000) • Bioethics Committee at Work – Procedures and Policies (2005) • WHO • Genomics and World Health (2002) Summary and Guidelines – Adv. Comm. Health Res. - T. Pang, D. Weatherall, D. Brock and H.L.Chee • National / Institutional • National Regulatory Frameworks, Organizations, IRBs, etc and Policies therein

12. International Articles relevant to Human Genome research • Article 10 (Informed Consent, IRB) • No research or research applications concerning the human genome, in particularly the fields of biology, genetics and medicine, should prevail over respect for human rights, fundamental freedoms and human dignity or where applicable of groups of people. • Article 12 (Research and Benefits Sharing) • Benefits from advances in biol, gen., med., shall be made available to all….. • Freedom of research, ….. progress of knowledge … freedom of thought. Appl. of res...human genome… shall seek to offer relief from suffering and improve the helath of individuals and humankind as a whole.

13. Benefits Sharing

14. Intl. Articles relevant to Solidarity and Intl. Cooperation • Articles 17, 18, 19 • refer to intl. scientific, cultural cooperation, genetically based and genetically influenced diseases, human diversity and genetic research, industrial and developing countries. • Existing scientific collaborations among investigators and institutions • Technology transfer and Sustainability • Benefits Sharing

15. PRB – Bioethics indicators • IRB approvals* (each investigator / institution) • Mandatory • Copy of the IRB approval reference code / number kept at the Secretariat in PRB records (for each researcher /group) • Informed consent* (volunteers & archived samples) • Translations into language and terms easily understood by participants • Mandatory and responsibility of each investigator/group. • A copy/copies of a signed and verified IC to be submitted for PRB records *PASNPI Phase I

16. PRB – Bioethicsindicators • ‘Conflict of Interest’ issues • Public fund utilization and accountability • Translation into research / training / tech transfer / capacity building / intl. cooperation, other output • Public and institutional database access and utility • Private sector partnerships and developments • PANSPI : Public Inst. + Affymetrix • Other partners • IPR, patents, commercial spin-offs / activities • Can we dev. of novel mechs. for IP management, mutual benefits ? PASNPI Phase I & II

17. Bioethicschallenges • Benefits Sharing • Community outreach in developing countries / populations • Mechanisms / experiences of members • Best Practice • Regional preferences • Global benefits sharing agreements • Tangibles • Intangibles

18. Thank You