An International Conference on
Transparency and Accountability in Health Research: Towards
an Ethics of Responsibility in Human Subject ProtectioninPhuket, Thailand
29-30 November 2006
FERCAP General Assembly – 1 December 2006

Forum for Ethical Review Committees
in Asia & the Western Pacific
FERCAP/SIDCER

Strategic Initiative for Developing Capacity for EthicalReview
with support from
UNICEF/ UNDP/ World Bank/ WHO Special Programme for Research andTraining in Tropical Diseases (TDR)

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FERCAP International Conference on
Transparency and Accountability in Health Research: Toward an Ethics of Responsibility inHuman Subjects Protections
Phuket,Thailand, November 29-30, 2006

Introduction
International guidelines and national laws have been formulated to protect humansubjects in research. But the implementation of such documents is dependent on thewillingness of various stakeholders to uphold the highest standards of integrity,
accountability and transparency in the implementation of health research. The intent
to uphold the highest standards of research should also be reinforced through thecreation of systems in the various stages of the research process.
This conference will examine the various paradigms to define the roles andresponsibilities of various research stakeholders including national health authorities,sponsors, investigators, editors and their relationship with ethics committees to ensureaccountability and transparency in research. Through plenary and parallel sessions,group discussions and country reports, the full range of the system to ensureaccountability and transparency is explored.
Objectives
The primary objective of the Conference is to describe the roles and responsibilities ofvarious research stakeholders to ensure accountability and responsible behaviour inthe performance of their tasks in order to develop and improve the ethical framework
for research and further ensure the protection of research participants and theircommunities.
In support of this aim, the conference also has the following specific objectives:• to describe and compare the roles of and responsibilities of various researchstakeholders related to the creation of an ethical infrastructure that supports
accountability and transparency in the Asian and Western Pacific region;• to examine the impact of current international guidelines to make research
procedures more transparent;• to identify and share best practices to address problems and barriers in creating
accountable and transparent health research systems that protect human subjects
and research participants;• to consider best practices in research ethics 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 among important research stakeholders andEthics Committees;• to develop a relevant Asian model of an ethical research infrastructure thatencourages accountable and transparent health research policies within the context
of diverse 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 healthPage 2 of 82

FERCAP International Conference on
Transparency and Accountability in Health Research: Toward an Ethics of Responsibility in
Human Subjects Protections
Phuket,Thailand, November 29-30, 2006

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 International Conference on
Transparency and Accountability in Health Research: Toward an Ethics of Responsibility inHuman Subjects Protections
Phuket,Thailand, November 29-30, 2006

FERCAP 2006 Conference AgendaDraft Program
Day 1: Wednesday, 29 November 2006
8:00 – 9:00

Registration

9:00 - 9:10

Welcome Address: Establishing Research Objectives for Public
Accountability of Health Research
Suchai Charoenratanakul, Deputy Prime Minister of Thailand
Plenary Session 1: Proposing a Framework for Accountability and Transparency
in Biomedical Research
Chairpersons: Vichai Chokevivat, Chairman, FERCAP
Suriadi Gunawan, Member, FERCAP Steering Committee (Indonesia)
9:10 – 9:20

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

9:20 – 9:35

Keynote Address: The Role of Health Stakeholders towards
Developing Transparency and Accountability in Health ResearchSamlee Plianbanchang, Regional Director, World Health Organization
Southeast Asia Regional Office

9:35 – 9:50

Professionalism as Key Issue the Conduct of Health Research
Greg Koski, Chair, American Society of Health Reserch Professionals

9:50 – 10:10 Tea and Coffee BreakPlenary Session 2: Encouraging Accountability and Transparency in HealthResearch: A Muti-Stakeholder Perspective
Chairpersons: Dr. Vasantha Muthuswamy, Senior Deputy Director General, IndianCouncil for Medical Research and FERCAP Secretary
10:10–12:30 Panel Discussion: Perspectives in Ensuring Accountability inClinical Trials and Health Research
10:10 - 10:25 An Industry Perspective
Allan Johansen, Head, Pharma Development Quality, Roche
10:25 - 10:40 Funding Agency Perspective
Robert Ridley, WHO TDR
10:40 – 10:55 International Organization Perspective
Tikki Pang, WHO Geneva
10:55 – 11:10 Investigator Perspective
Khanchit Limpakarnjanarat
11:10 – 11:25 Ethics Committee Perspective
Kerry Breen

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4FERCAP International Conference onTransparency and Accountability in Health Research: Toward an Ethics of Responsibility in
Human Subjects Protections
Phuket,Thailand, November 29-30, 2006

11:25 - 11:40 Regulatory Perspective
Vasantha Musthuswamy
11:40 - 11:55 Patient/ Community Perspective
Beatrice Loff
11:55 - 12:30 Open Forum
12:30-13:30

Lunch BreakParallel Session 1: Group Discussion: Addressing Problematic Issues in
Accountability and Transparency of Stakeholders in HealthResearch
Chairpersons: Suriadi Gunawan, FERCAP Steering Committee Member
Ock-joo Kim, FERCAP Steering Committee Member
13:30-14:30 Group Discussions
Group 1 – Sponsor Responsibility
Chair: Detlef Niese, Novartis
Group 2 – Investigator Responsibility
Chair – Kenji Hirayana, FERCAP
Group 3 – Ethics Committee Responsibility
Bradley Waite, WIRBGroup 4 – International Organization Perspective
Tikki Pang, WHO, Geneva
14:30 - 15:30 Group Reports: Identifying Stakeholder Responsibilities in HealthResearch
15:30 – 15:45 Coffee BreakPlenary Session 3: Addressing Specific Issues related to Accountability andTransparency in Health Research
Chairpersons: Marita Reyes, FERCAP Steering Committee Member
15:45-16:00

Balancing Human Subject Protection and Facilitating Research: ADeveloping Country Perspective
Suwit Wiboolpolprasert, Senior Adviser, Ministry of Public Health,Thailand

16:00 16:45 Using ‘Respectful Methodologies’ in Research among Vulnerable
Populations
Zosimo Lee, Dean, College of Social Science and Philosophy,
University of the Philippines
16:45 – 17:00 Addressing Conflicts of Interest Issues during Ethical Review ofProtocols
David Foster, Vice President, Western Institutional Review Board
17:00 – 17:15 Issues and Interventions to Address Scientific Misconduct
Sang-Goo Shin, Professor, College of Medicine, Seoul National
University

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FERCAP International Conference on
Transparency and Accountability in Health Research: Toward an Ethics of Responsibility inHuman Subjects Protections
Phuket,Thailand, November 29-30, 2006

17:15 – 17:30 Ethical Issues in the Publication of Health Research
Barbara Sina, Health Science Administrator, Fogarty InternationalCenter, US National Institutes of Health
17:30 – 18:00 Discussion and Open ForumDay 2: Thursday, 30 November 2006
8:30 - 10:30

Roundtable Discussion I: Reports from Asian & Western PacificCountries / Areas
The Current Status of Guidelines and Ethical Review Systems:
Towards Public Accountability in Research
Chairperson: Anoja Fernando, Member, FERCAP Steering Committee, Sri Lanka
Reports from: Representatives from Australia, Cambodia, India,Indonesia, Japan, Korea, Laos, Malaysia, Mongolia, Myanmar, Nepal,Papua New Guinea, Peoples Republic of China, Philippines, Singapore,
Sri Lanka, Taiwan, Thailand, Vietnam
Guide Questions• What mechanisms and interventions are used in your country toensure public accountability in health research?
• What government and non government organizations are involved
to ensure accountability and transparency in health research?
• Are there new local laws, regulations, and guidelines related to
ethical review of protocols?
• Describe the ethical review structure in your country/area• What regulatory documents or guidelines are used by ethics
committees to review protocols?
• What steps should be further undertaken to improve ethical reviewof research?
10:30-10:50

Coffee/Tea BreakPlenary Session 4: Working towards Public Accountability in Research: A
Health Systems Approach
Chairperson: Benjamin Kuo, Secretary General, Joint Institutional Review Board ofTaiwan and FERCAP Vice Chair
10:50-11:10 Integrating Research Ethics into Health Systems Research
Reijo Salmela, World Health Organization, Western Pacific Region(WPRO)
11:10-11:30 Public Perception of Transparency Issues in Drug Registration
Sirinart Vasanvathana, Food and Drug Administration, Ministry ofPublic Health, Thailand

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FERCAP International Conference on
Transparency and Accountability in Health Research: Toward an Ethics of Responsibility inHuman Subjects Protections
Phuket,Thailand, November 29-30, 2006

11:30-11:50

11:50-12:10

12:10-12:30

12:30-13:00
13:00-14:00

The Role of Data Safety Monitoring Boards to Ensure
Accountability in ResearchFrancis Crawley, GCP Alliance, Belgium
Improving Public Trust in Health Research: Implementing GCP
Compliant Researches
Juntra Karbwang, Clinical Coordinator, WHO-TDR
The Role of Regulatory Authorities to Address Commercializationof Research
Bernard Schwetz, Director, OHRP
Discussion
Lunch BreakParallel Session 2: Addressing Transparency Issues in Various Types ofResearch
Chairperson: Kenji Hirayana, FERCAP Steering Committee Member
14:00-16:00 Parallel Session A: Informed Consent Issues
Parallel Session B: Conflicts of Interest Issues
16:00-16:20 Coffee Break
16:20-17:00 Group Reports
Plenary Session 5: Towards Sustaining Initiatives for Public Accountability inResearch
Chairperson Gemiliano Aligue, FERCAP Steering Committee Member:
17:00-17:20 Proposal for a Conference Position Paper on the Potential
Contribution of Asian and Western Pacific Governments toNational standards for Good Ethical Review Practice
Cristina E. Torres, FERCAP Coordinator
Renato Manaloto, Assistant Professor, Philosophy
Department, University of the Philippines
17:20-17:30 Closing Remarks
Vichai Chokevivat, Chairman, Forum for Ethical Review Committees
in Asia & the Western Pacific (FERCAP)

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FERCAP International Conference on
Transparency and Accountability in Health Research: Toward an Ethics of Responsibility in
Human Subjects Protections
Phuket,Thailand, November 29-30, 2006

5th FERCAP General Assembly
Tuesday, 28 November 2006

Plenary Session 1: Reviewing the Impact of FERCAP at the National, Regionaland International Levels
10:00-10:15

FERCAP-SIDCER Partnership: Towards Global Capacity
Building in Ethical Review
Vichai Chokevivat, Chairman, Forum for Ethical Review Committees
in Asia & the Western Pacific (FERCAP) & Director General,
Department of Development of Thai Traditional and AlternativeMedicines, Thailand

10:15-11:15 Round Table Discussion I: Building Capacity of National Forumtowards Quality Ethical Review
Chairpersons:• FERCIT
•

FERCI

•

FIRST

•

FERCAP Phil.

•

FERCI

•

FERCIM

11:15 -12:00 Awarding of SIDCER Recognition to Ethics Committees
Compliant with International and National Standards
12:00 – 12:15 Report of the Treasurer and Discussion of the FERCAP Accounts
and Budget
Kesara Na-Bangchang, Treasurer, FERCAP Steering Committee
12:15-12:30 FERCAP Plans for 2007
12:30-12:35

Date and place of the next Assembly

12:35-12:45

Close of the General Assembly
Vichai Chokevivat, FERCAP Chair

12:45-14:00

Lunch

14:00

Tour of Vientiane

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