Transcript PENINGKATAN KESEHATAN KELOMPOK RAWAN DALAM MASA …

RPC-SEARO
Health and Research ethics
in WHO/SEAR
Ong-arj Viputsiri
STP-RPC
Regional Conference on International
Collaborative Research and Health Ethics
NIH-WHO/SEARO-ICMR
Jakarta, 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
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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
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.
ETHICS IN HEALTH RESEARCH (cont)
• 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)
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
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)
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
Teaching
Guidelines
on Health
Ethics
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
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
RPC-SEARO
The National Ethical Guidelines
 All follows the international ethical guidelines
 National principles for proposing-conductingmonitoring - 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
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
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.
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
What is Research?
A systemic search for information
& new knowledge
Resource
Research
Result
Research & Health System
Resources
Resources
Research process
Health system
management process
Results
Results
Evaluating Health
Interventions
Health
needs
Health
resources
Interventions
Accessibility?
Acceptability?
Affordability?
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
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
Strategy
Capacity
Strengthening
Research &
ethics
Public
Engagement
Consensus
Partnership Building
Investment
Fund
SEARO/WPRO Bi-Regional Consultation
Bangkok, March 27-29, 2004
Health Research to Achieve the MDG’s
World Report on Knowledge
for Better Health &
World Ministerial Summit
on Health Research
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