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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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 &ethicsethics

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