Health and Research ethics in WHO/SEAR

1. Health and Research ethics in WHO/SEAR RPC-SEARO • Ong-arj Viputsiri • STP-RPC • Regional Conference on International • Collaborative Research and Health Ethics • NIH-WHO/SEARO-ICMR • Jakarta, 29 November-1 December 2005

2. PRESENTATION OVERVIEW RPC-SEARO • WHO SEARO regional profile • Principles of health research ethics • Promoting research ethics in the South East Asia Region • Issues and Challenges in research ethics • The road to the future

3. RPC SEARO

4. WHO SOUTH EAST ASIA REGION (WHO-SEARO) RPC-SEARO • 11 member states: Bangladesh, Bhutan, DPR Korea, Nepal, India, Indonesia, Myanmar, Maldives, Sri Lanka, Thailand, Timor Leste • 25% of world’s population (WHO, Geneva1998) • WHOSEARO: 1 Regional Director, 4 directors • Evidence for Information and Policy (HQ/EIP) • Research Policy and Cooperation ( RPC ) unit also regional focal point for health ethics

5. SCOPE OF WORK OF “RESEARCH POLICY AND COOPERATION” IN SEA REGION RPC-SEARO • National health research systems • Ethics in health research • Health research capacity building • Effective utilization of knowledge gained • Partnerships in health research • Health research information system • Ethical-legal-social implications (ELSI) of genomics and health

6. WHO and Medical Ethics • 1974: proposed establishment of ACMR (A note – SEA/RC28/20) • 1975: 1st meeting of ACMR • 1976-77 Special Programs of WHO Headquarters (HRP & TDR)developed as to the necessity outcome for increasing attention to research involving human subjects resulted, not only toensure medical ethical propriety but also to avoid possible litigation. • 1978 the South-East Asia Regionat its Fourth Session, ACMR (now termed Regional Advisory Committee on Health Research – ACHR start set up in 1976) discussed on "Ethics of Medical Experimentation involving Human Subjects"

7. WHO/SEAR and Bio-ethics resolutions: • collaborate between the ACMRs, CIOMS and WHO in promoting the development of bio-ethics • the review of the experience in countries with established ethical review procedures • preparing guidelines for the establishment of appropriate bodies in member countries and elaborating criteria that such bodies could use in the review of research proposals involving human subjects

8. 1979 develop and establish general guidelines for ethical observance in medical research • 1993 publication of the International ethical guidelines by CIOMS. Suggested actions include: (a) distribution of the 1993 guidelines to member countries; (b) promotion of national meetings; (c) technical support of WHO and participation of the regional office at national meetings; (d) regional synthesis of national activities for distribution and sharing information (e) presentation of report to ACHR, MRCs meetings, WRs meeting, Regional Committee, etc., as appropriate. Review of situation periodically with evaluation of progress.

9. ETHICS IN HEALTH RESEARCH (cont) • 1994 The XXVIIIth Conference of CIOMS in Ixtapa, Mexicoon "Poverty, Vulnerability and the Value of Human Life and the Emergence of Bioethics" covered this broader context of health care. The conference developed "A Global Agenda for Bioethics : Declaration of Ixtapa.

10. ETHICS IN HEALTH RESEARCH (cont) RPC-SEARO • 1996 :research ethics discussed in the SEA ACHR meeting • 1996: Ethical issues in health reviewed • 1997: Establishment of SEAHEN (South East Asia Health Ethics Network) • 1997: Effective strategy for promoting research results • 1998: Multi-centric baseline study on ethical values in 7 SEAR countries, 3 volume publications • 1999: Health Research Policy formulation, implementation and evaluation • 1999: Partnership in Health research

11. SWG meeting for health policy research strategies and priorities • 1999 Meeting of specific working group (SWG) on formulation of national health policy research and strategies; and issues in heath policy research • 1999 SWG on criteria for setting health research priorities. • 1999 SWG on management and coordination on health research activities in the SEAR countries.

12. ETHICS IN HEALTH RESEARCH (cont) RPC-SEARO • 2000: Establishment of FERCAP (Forum for Ethical Review Committee of SEA – Pacific ) • Training module workshops for ERB members • Mapping and profiling ERBs in some SEA countries • 2000 - to date: Development of national ethical guidelines, legalizing the guidelines • 2000 - 03: CD Rom: teaching guidelines on medical ethics, 70 case studies from SEA countries, field tested, finalization • 2002: Compendium of regional case studies for training research ethics

13. Teaching Guidelines on Health Ethics

14. ELSI in Genomics and Health RPC-SEARO • 2001:Scientific debate in SEA-ACHR • Contribution to the making of WHO Report: “Genomic & World Health ”launched in 2002 • 2002: Post-launch : public debate India and Thailand, Oct, Nov. 2002 • 2003: scientific debate on Thalassemia SEAR-EMR bi-regional meeting • 2003: 5 countries workshop on regional framework of human genetics research and its ELSI • 2004: CD Rom: teaching guidelines on health ethics vol. 4

15. Ethical Review Committees RPC-SEARO • National ERCs • size: 4-16, balance/imbalance in age, gender, community reps., disciplines and expertise, non medicals • appointment of 2-4 years • financial support for operations: MOH,none • no charge to PI, no honorarium for ERC members • ethical review or technical+ethical review • approval-revision-rejections • no monitoring or follow-up once cleared

16. The National Ethical Guidelines RPC-SEARO • All follows the international ethical guidelines • National principles for proposing-conducting-monitoring - evaluating research involving human • National ethical guidelines : Nepal, India , Indonesia, Thailand • Content: Technical context and guidelines for forming, operationalizing, evaluating ethical review board

17. The National Ethical Guidelines

18. Issues and challenges in research ethics RPC-SEARO General: • SEAR: heavily populated, tropical zone countries, poverty, sensitive for transmissible disease, high need for research • increased # or research --> increased complexities in research ethics • face the research investment 10/90 gap

19. Issues and challenges in research ethics RPC-SEARO General: • research ethics: in the developing stage, yet catching up • inadequate health system, stigmatization, neglect, discrimination • communities/ people more equipped -> more conscious about health --> higher demand on autonomy

20. Issues and challenges in research ethics RPC-SEARO Specific: • mushrooming collaborative research involving human as subject • little awareness and little understanding on existing guidelines • guidelines not widely distributed • Inadequate regional / national forum for debate on research ethics

21. Issues and challenges in research ethics RPC-SEARO Specific: • variations in the strength of ERCs • ethical review based on individual experiences, issues on honorarium, monitoring ethical aspect of research • informed consent improperly done

22. The road to the future RPC-SEARO • Research and research ethics : important component in health development --> to continue • prioritizing issues/ problems in research ethics • ethics = complex issue, iceberg phenomen --> multidisciplinary, multi –sector collaboration.

23. The road to the future RPC-SEARO WHO role: • initiate collaborative steps to promote and strengthen health system research and research ethics • develop standards, guidelines in research ethics • encourage, support development of national ethical guidelines on research ethics • support capacity building • facilitation of updated information on research ethics • liase, honest broker, advocacy role with UN and other agencies having similar interests in research ethics

24. Research Resource Result What is Research? A systemic search for information & new knowledge

25. Research & Health System Research process Resources Results Health system management process Results Resources

26. Evaluating Health Interventions Interventions Accessibility? Acceptability? Affordability? Health needs Health resources Ethics? Efficiency? Effectiveness?

27. MacQueen KM, Buehler JW. Ethics, Practice, and Research in Public Health. Am J Pub Health. 94:928, 2004. “…if the primary [sic] intent is to contribute to “generalizable” knowledge, then the project is deemed to represent research….if a project is not done in the context of a public health agency’s role in preventing or controlling disease…then it is deemed to represent non-research or public health practice.”

28. Key Themes • Strengthening of health research systems and research capacity in developing countries • Resource flows in health research (10/90 gap) • Production, translation & utilization of research • Ownership of knowledge ? incentives for R&D • Communication & dissemination of research • Ethical and equity issues • Restoring public confidence in science • New paradigms for international cooperation

29. Strategy Capacity Strengthening Research & ethics Consensus Partnership Building Public Engagement Investment Fund

30. SEARO/WPRO Bi-Regional Consultation Bangkok, March 27-29, 2004 World Report on Knowledgefor Better Health &World Ministerial Summiton Health Research Health Research to Achieve the MDG’s

31. Report : 7 Key Messages (1) • Science must be turned into action to improve people’s health; it must focus more on the “how” rather than the “why”, “where” or “what” • Knowledge must be accessible to all, in a form which is useful and can be acted upon by different people and groups • All countries must create an environment in which research for health is seen as a systematic effort, and will thus flourish

32. Report : 7 Key Messages (II) • Research must be conducted according to universal ethical standards thus ensuring that it will improve equity in health • Broader, more inclusive view of health research is needed and civil society has a vital part to play • Research is an investment, not a cost, and governments must spend on it • Action Plan needed-now

33. WHO/SEAR • The drum beater beats the drum for others to dance.

34. RPC-SEARO Thank you