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Health and Research ethics Health and Research ethics in WHO/SEARin WHO/SEAR
Ong-arj Viputsiri
STP-RPC
Regional Conference on InternationalCollaborative Research and Health Ethics
NIH-WHO/SEARO-ICMRJakarta, 29 November-1 December 2005
RPC-SEARO
PRESENTATION OVERVIEW
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
RPC-SEARO
RPC SEARO
WHO SOUTH EAST ASIA REGION (WHO-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
RPC-SEARO
SCOPE OF WORK OF “RESEARCH POLICY AND COOPERATION” IN SEA REGION
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
RPC-SEARO
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 to ensure medical
ethical propriety but also to avoid possible litigation.
1978 the South-East Asia Region at 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"
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
• 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.
• 1994 The XXVIIIth Conference of CIOMS in Ixtapa, Mexico
on "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.
ETHICS IN HEALTH RESEARCH (cont)
ETHICS IN HEALTH RESEARCH (cont)
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
RPC-SEARO
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.
ETHICS IN HEALTH RESEARCH (cont)
• 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
RPC-SEARO
Teaching Guidelines
on Health
Ethics
ELSI in Genomics and Health
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
RPC-SEARO
Ethical Review Committees 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
RPC-SEARO
The National Ethical Guidelines
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
RPC-SEARO
The National Ethical Guidelines
Issues and challenges in research ethics
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
RPC-SEARO
Issues and challenges in research ethics
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
RPC-SEARO
Issues and challenges in research ethics
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
RPC-SEARO
Issues and challenges in research ethics
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
RPC-SEARO
The road to the future
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.
RPC-SEARO
The road to the future
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
RPC-SEARO
What is Research?
Resource Research Result
A systemic search for information& new knowledge
Research & Health System
Resources
Resources
Results
Results
Research process
Health system management process
Evaluating Health Interventions
InterventionsAccessibility?
Acceptability?
Affordability?
Healthneeds
Healthresources
Ethics?Efficiency?Effectiveness?
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.”
Key Themes• Strengthening of health research systems and Strengthening of health research systems and
research capacity in developing countriesresearch capacity in developing countries• Resource flows in health research (10/90 gap)Resource flows in health research (10/90 gap)• Production, translationProduction, translation & & utilization utilization of researchof research• Ownership of knowledge ?Ownership of knowledge ? incentives for R&D incentives for R&D• Communication & dissemination of researchCommunication & dissemination of research• Ethical and equity issuesEthical and equity issues• Restoring public confidence in scienceRestoring public confidence in science• New paradigms for international cooperationNew paradigms for international cooperation
Strategy
Research &Research ðicsethics
Capacity Capacity StrengtheningStrengthening
Consensus Consensus Partnership BuildingPartnership Building
Investment Investment FundFund
PublicPublic EngagementEngagement
World Report on KnowledgeWorld Report on Knowledgefor Better Health &for Better Health &
World Ministerial SummitWorld Ministerial Summiton Health Research on Health Research
SEARO/WPRO Bi-Regional ConsultationSEARO/WPRO Bi-Regional Consultation
Bangkok, March 27-29, 2004Bangkok, March 27-29, 2004
Health Research to Achieve the MDG’sHealth Research to Achieve the MDG’s
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
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
WHO/SEAR
The drum beater beats the drum
for others to dance.
RPC-SEARO
Thank you