(Preliminary Draft Programme)

An International Conference on
Defining the Roles, Responsibilities, and Relations between
National Health Authorities and Ethics Committees
in Health Research
Pattaya, Thailand
12-13 December 2005

Forum for Ethical Review Committees
in Asia & the Western Pacific
FERCAP/SIDCERFERCAP General Assembly – 14 December 2005

Introduction
Abuses in the conduct of clinical trials have resulted in public indignation leading toincreased regulation of health research. This development marked the advent of stateinterest and intervention in biomedical research for the protection of human subjects.
Henceforth, national health authorities have assumed important functions and havebecome important actors in the field of bioethics.
This conference will examine the various paradigms to define the roles andresponsibilities of national health authorities in health research, particularly theirrelationship with ethics committees. Through plenary and parallel sessions, group
discussions and country reports, the full range of government involvement is explored,from its conceptual underpinning to its role in day-to-day regulation and thedevelopment of national systems of ethical review.
Objectives
The primary objective of the Conference is to examine the roles, responsibilities, andrelations of National Health Authorities and ethics committees in Asia & the Western
Pacific in order to develop and improve the ethical framework for research and further
ensure the protection of research participants and their communities. In support of thisaim, the conference also has the following objectives:• to describe and compare the roles of and responsibilities of national healthauthorities related to the creation of an ethical infrastructure in the Asian andWestern Pacific region;
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FERCAP 2005 Annual Conference
Pattaya, Thailand, 12-13 December 2005(preliminary draft programme)

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to examine the impact of current international guidelines in ethics on national
legislation, guidelines, regulation, and research procedures;to identify and share best practices in creating effective health research systems
that protect human subjects, research participants;
to consider best practices against a background ofo clear-cut and relevant guidelines and policies related to research ethics;
o value sharing among various research stakeholders;o synergy among major international, regional and national health decision
makers;o effective working relationships between National Health Authorities andEthics Committees;
to develop a relevant Asian model of ethical research infrastructure that integrates
health research policies with national healthcare programs within the context ofdiverse Asian cultures and religions alongside pluralistic socio-economic andpolitical systems.

Conference Methodology
The conference participants are drawn from the various sectors and disciplines
involved in health research. The participants are from Asia and the Western Pacificregions, as well as invited international guests. Representatives of National Health
Authorities, ethics committees, researchers and their institutions, and the bio-pharmaindustry.
Conference Sessions
The conference is composed of plenary sessions for the examination of critical topics
and information exchange. These plenary sessions are support by working groups
where specific issues explored in-depth and position papers developed.
Conference Outcome
The primary outcome of the conference is the development of a position paper on thepotential contribution of Asian and Western Pacific governments to national standards
for Good Ethical Review Practice.

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FERCAP 2005 Annual Conference
Pattaya, Thailand, 12-13 December 2005(preliminary draft programme)

FERCAP 2005 Conference Agenda

Day 1: Monday, 12 December 2005
8:00 - 8:30

Registration

Plenary Session 1: Proposing a Framework for Governance, Ethics andBiomedical Research
Chairpersons: Vichai Chokevivat, Chairman, FERCAP
Suriadi Gunawan, Member, FERCAP Steering Committee
8:30 - 8:45

Conference Overview and Introduction of the Ministerial Guests
Vichai Chokevivat, Chairman, Forum for Ethical Review Committees
in Asia & the Western Pacific (FERCAP) & Director General,
Department for the Development of Thai Traditional and Alternative
Medicines, Thailand

8:45 - 9:00

Welcome Address: Establishing Research Objectives for Public
Health in Asia & the Western PacificSuchai Charoenratanakul, Minister of Public Health, Thailand

9:00 - 9:15

Developing a National Framework for Human Subjects
Protections in Health Research
Minister for Science, India

9:15 – 9:35

Government Support and Development for Ethical Review
Committees
Xu Jiajqi, Deputy Director General, Safety Inspection Department,
State Foods and Drugs Administration (SFDA), China

8:35 – 9:50

Good Clinical Practice Inspections and Ethical Review:
Complimentatry Activities for Human Subjects Protections
Ahwini Kumar, Drug Controller General, India

9:50 – 10:10 Scientific Advancement, Ethics and Regulation: DevelopingNational Regulations for Health Research
Hon Geun-Tae Kim, Korean Minister of Health and Welfare
10:10 – 10:30 Discussion
10:30 – 11:00 Tea and Coffee BreakPlenary Session 2: Creating Ethics Infrastructure in Asia and the WesternPacific: National Legislation and Guideline Formulation andAlternative Mechanisms
Chairpersons: Anoja Fernando, Member, FERCAP Steering Committee, Sri Lanka
Thongchai Thavichachart, President, Thailand Center of Excellence forLife Sciences (TCELS)
10:20–10:40 International Developments in Good Clinical Practice and Ethics
in Health Research: Toward Societal Responsibility in ResearchFrancis P. Crawley, Secretary General, European Forum for Good
Clinical Practice (EFGCP)

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FERCAP 2005 Annual Conference
Pattaya, Thailand, 12-13 December 2005(preliminary draft programme)

10:40 – 11:00 Research, Ethics, and National Development: The Role of National
Health Authorities
Vasantha Muthuswamy, Deputy Director General of the IndianCouncil for Medical Research; FERCAP Secretary General
11:00 – 11:20 Legal Implications of International Guidelines in Biomedical
Research: The Role of Regulatory Authorities
Colin Thomson. Professorial Fellow, Faculty of Law, University ofWollongong, New South Wales, Australia
11:20 - 11:40 Industry Perspective Regarding Appropriate Mechanisms forEthical ReviewHarvey Bale, Director General, International Federation ofPharmaceutical Manufacturers Association
11:40–12:00 Triple Burden and Triple Opportunity: Ethics and National
GovernanceAlex Capron, Director, Department of Ethics, Trade, Human Rights,and Health Law, WHO
12:00 – 12:20 Approaches in Developing a National Ethical Infrastructure:
Legislation vs. Guideline Formulation
Leonardo de Castro, Vice-President, FERCAP
12:20-12:30

Discussion

12:30-13:30

Lunch / Viewing Poster Exhibit

13:30-16:00

Roundtable Discussion I: Reports from Asian & Western PacificCountries: The Current Status of Guidelines and Legislation
Related to Research EthicsChairpersons: Sopit Thamaree, Secretary, Forum for Ethical Review Committees inThailand (FERCIT)
Kenji Hirayama, FERCAP Steering Committee Member, Japan
Panelists: Representatives from Australia, Cambodia, India, Indonesia,Japan, Korea, Laos, Malaysia, Mongolia, Nepal, Pacific Island States,
Peoples Republic of China, Philippines, Singapore, Sri Lanka, TaiwanChina, Thailand, Vietnam
Guiding Questions• Are there local laws, regulations, and guidelines related to ethicalreview of protocols? What regulatory documents or guidelines areused by ethics committees to review protocols?
• Are current laws and guidelines sufficient to protect humanresearch participants in research?
• Is there a national ethics committee? What is its relationship tostate authorities? What is its current organizational structure andfunctions?
• What are the current modes of structural and functionalrelationships between national health authorities and other ethics
committees in each country? Are ethics committees
registered/accredited by state authorities?
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FERCAP 2005 Annual Conference
Pattaya, Thailand, 12-13 December 2005(preliminary draft programme)•••
16:00-16:15
16:15-18:00

What is the role of ethics committees in the national healthresearch system and the implementation of the national research
agenda?
What is the role of ethics committees related to guideline
formulation and national legislation?
What steps should be undertaken to improve ethical review of
research in each country?

Coffee/Tea BreakParallel Session 1: Developing Research Guidelines for theVulnerable Population
The parallel sessions highlight concepts, case studies, research results,and experiences related to research ethics. The outcomes of the parallelsessions will be considerations on specific guidance for various typesof researches.
Activities during the Parallel Sessions:a. Paper Presentationb. Position Papers for Guideline Formulation
Session A: HIV-AIDS Research
Chairperson: Representative, Paediatric AIDS Foundation,
Session B: Children as Research Subjects
Chairperson: WHO/IVR Representative
Session C: Ensuring Care in Research for Critically Ill Patients
Chairperson: WHO Representative
Session D: Research on Refugees and Victims of Wars andDisasters
Chairperson: WPRO Representative/ Migration Health, International
Organization for Migration (IOM)

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FERCAP 2005 Annual Conference
Pattaya, Thailand, 12-13 December 2005(preliminary draft programme)

Day 2: Tuesday, 13 December 2005
8:00 – 9:00

Group Reports from Parallel Sessions: Proposed Guidelines for
the Vulnerable Population

Plenary Session 3:

Perspectives on the Role of the Government in theDevelopment of National Health Research Systems
Chairpersons: Gopal P. Acharya, Chairman, Nepal Health Research Council,
Kathmandu, Nepal
Ock-Joo Kim, Secretary, Korean Association of the Institutional
Review Boards (KAIRB)
9:00 - 9:20

The Role of Health Research Ethics in National Healthcare
Programs
Samlee Plianbangchang, Southeast Asia Regional Director, WHO

9:20 - 9:40

Addressing the 10/90 Gap: The Role of National HealthAuthorities
Rob Ridley, Director, Special Programme for Research and Trainingin Tropical Diseases

9:40 – 10:00 National Health Research Priority Setting: Strategies towards aRelevant Research Agenda
Mary Ann Lansang, Board Member, Special Programme for Researchand Training in Tropical Diseases
10:00 – 10:20 Health Resource Allocation and Research Ethics
Viroj Tangchareonsathien, Senior Researcher, Health Systems
Research Institute, Ministry of Public Health, Thailand
10:20 – 10:40 Defining the Role of Regulatory Agencies in Health Research
Melody Lin, Deputy Director and International Director, Office for
Human Research Protections, Department of Health & HumanServices, USACoffee/Tea BreakPlenary Session 4: Sharing Responsibilities: Defining the Role of Ethics
Committees in the Development of National Quality in Human
Research Protections
Chairpersons: Benjamin Kuo, FERCAP Steering Committee Member and Secretary
General, Forum for Institutional Review System in Taiwan (FIRST)
Beat Widler, Head of PDQ, Roche Pharmaceuticals, Basel,
Switzerland
10:40 - 11:00 The Development of a National Forum for Good Clinical Practice
Dhananjay Bakle, Indian Forum for Good Clinical Practice (InFoGCP)
11:00 – 11:20 Empowering Communities: Sharing Ethical Responsibilities withResearch Participants CommunitiesDuduzile Biyela, Chairperson, Community Advisory Board, Africa
Centre for Health & Population Studies, South Africa
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FERCAP 2005 Annual Conference
Pattaya, Thailand, 12-13 December 2005(preliminary draft programme)

11:20 – 11:40 The Socio-Political Functions of Ethics Committees in Developing
Countries: Expanding Roles and Expectations
Cristina E. Torres, FERCAP Coordinator
11:40 – 12:00 Strategies for Strengthening National Ethical Review Systems
Marcel Kenter, Executive Director, Central Committee for Research
Involving Human Subjects (CCMO), The Netherlands
12:00 – 12:20 Ensuring Relevance and Quality in Research: The SIDCER
Assessment and Recognition Process
Juntra Karbwang, Clinical Coordinator, Special Programme for
Research and Training in Tropical Diseases (WHO/TDR)
12:20 - 1230 Discussion
12:30 – 13:30 Lunch
13:30 – 15:30 Parallel Session 2: Developing Relevant Research Guidance forSpecial Types of Research
Session E: Biotechnology
Chairperson: Nancy Hathaway, PATH
Session F: Genetic Research
Chairperson: Representative from India
Session G: Stem Cell Research
Chairperson: Researcher from Korea
Session H: Traditional Medicine
Chairperson: Representative from China
15:30 – 16:00 Coffee / Tea Break
16:00 – 16:30 Group Reports from Parallel Sessions: Considering the Need for
Guidance in Special Types of Research
Chairpersons: Jie Chen, Professor, School of Public Health, Fudan University,Shanghai, China
Reijo Salmela, Officer for Situation Analysis for Policy
WHO Western Pacific Regional Office
16:30 – 16:50 Proposal for a Conference Position Paper on the potential
contribution of Asian and Western Pacific governments to nationalstandards for Good Ethical Review Practice
Cristina E. Torres, FERCAP CoordinatorFrancis P. Crawley, Secretary General, European Forum for Good
Clinical Practice (EFGCP)
16:50 – 17:00 Closing Remarks
Vichai Chokevivat, Chairman, Forum for Ethical Review Committees
in Asia & the Western Pacific (FERCAP)

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