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Meeting Report

22–23 October 2019Wellington, New Zealand

SECOND ASIA-PACIFIC REGIONAL MEETING FOR NATIONAL ETHICS/BIOETHICS

COMMITTEES

WORLD HEALTH ORGANIZATION

REGIONAL OFFICE FOR THE WESTERN PACIFIC

RS/2019/GE/39(NEZ) English only

MEETING REPORT

SECOND ASIA-PACIFIC REGIONAL MEETING FOR NATIONAL

ETHICS/BIOETHICS COMMITTEES

Convened by:

WORLD HEALTH ORGANIZATION

In collaboration with:

UNITED NATIONS EDUCATION, SCIENTIFIC AND CULTURAL

ORGANIZATION; AND KĀHUI MATATIKA O TE MOTU - NEW ZEALAND

NATIONAL ETHICS ADVISORY COMMITTEE

Wellington, New Zealand

22 – 23 October 2019

Not for sale

Printed and distributed by:

World Health Organization

Regional Office for the Western Pacific

Manila, Philippines

December 2019

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NOTE

The views expressed in this report are those of the participants of the Second Asia-Pacific

Regional Meeting for National Ethics/Bioethics Committees and do not necessarily reflect the

policies of the conveners.

This report has been prepared by the World Health Organization Regional Office for the Western Pacific

for Member States in the South-East Asia and Western Pacific Regions and for those who participated

in the Second Asia-Pacific Regional Meeting for National Ethics/Bioethics Committees in Wellington,

New Zealand, from 22 to 23 October 2019.

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CONTENTS

SUMMARY ............................................................................................................................................ 4

1. INTRODUCTION .............................................................................................................................. 5

1.1 Meeting organization ..................................................................................................................... 5

1.2 Meeting objectives ........................................................................................................................ 5

2. PROCEEDINGS ................................................................................................................................. 6

2.1 Opening session ............................................................................................................................. 6

2.2 Technical Sessions ........................................................................................................................ 6

3. CONCLUSIONS AND RECOMMENDATIONS ........................................................................... 14

3.1 Conclusions ................................................................................................................................. 14

3.2 Recommendations ....................................................................................................................... 14

3.2.1 Recommendations for Member States .................................................................................. 14

3.2.2 Recommendations for WHO ................................................................................................ 15

ANNEXES ............................................................................................................................................ 16

Annex 1. List of participants

Annex 2. Meeting programme

Annex 3. Summary of Conclusions from Group Work

Annex 4. Session 5: Ways Forward – Country Worksheets

Keywords: Bioethics / Education, Public health professional – ethics / Regional health planning

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SUMMARY

The Second Asia-Pacific Regional Meeting for National Ethics/Bioethics Committees (AP-NEC2)

was organized to support Member States in strengthening their health ethics frameworks, including

through the development of National Ethics/Bioethics Committees (NECs). AP-NEC2 was chaired by

Kāhui Matatika o te Motu - the National Ethics Advisory Committee of New Zealand (NEAC), with

support from the World Health Organization (WHO) in collaboration with the United Nations

Educational, Scientific and Cultural Organization (UNESCO). The meeting was attended by 34

delegates from 22 countries, including 18 from the Western Pacific Region and five from the South-

East Asia Region.

The theme for AP-NEC2 was reducing inequities through solutions-orientated bioethics. Health

equity is a concept based on the ethical notion of distributive justice. Pursuing health equity means

minimizing inequalities in health and in the key determinants of health. Key determinants of health

include modifiable social and physical conditions as well as medical-based care; both need to be

addressed to achieve health equity. Health equity issues were considered at AP-NEC2 in the context

of three technical topics: climate change, emerging technologies and indigenous populations; and

discussed through the three streams of health ethics: public health ethics, clinical care ethics, and

health research ethics.

Participants agreed that climate change, emerging technologies and the health of indigenous

populations presented distinct sets of ethical challenges. However, they recognized that the topics

were inter-related and that strengthening the capacities of NECs through improved

policy development, continued revision and review of guidelines, frameworks and standard operating

procedures (SOPs), strengthening accountability over Institutional Review Boards (IRBs) and other

research oversight bodies, and strengthening national and regional networking for ethics/bioethics,

were important to reducing health inequities through solutions-orientated bioethics.

Member States were encouraged to strengthen NECs through improved policy, administrative

support, financing and prioritizing challenges and opportunities in significant areas, including climate

change, emerging technologies and the health of indigenous populations. They suggested the

development of ethics preparedness, the reviewing and revising protocols for research conducted in

post-emergency settings to support evidence-based responses to climate change; the development of

climate-change leadership; strengthening knowledge of emerging technologies for NEC members; the

development of ethical frameworks for data- and benefit-sharing that minimize harm and misuse; the

use of culturally competent ethical guidance and training for researchers and health professionals,

including the use of alternative ethical principles, such as Te Ara Tika, which reflect local values; the

development of wholistic guidelines on community engagement; and addressing unethical behaviours

in research, e.g. ethics dumping. NECs should seek to engage more proactively with the public,

including through civil society. Recognizing that health equity impacts and is impacted by many

sectors beyond health, NECs should increase national collaboration with government agencies in

addition to ministries of health. Moreover, NECs should evaluate the way that they are working and

promoting health ethics when presented with challenges where the current paradigm of solutions, such

as the development of guidelines and/or reports, may be inadequate or ill-suited.

WHO was requested to provide support to provide assistance to Member States in advancing actions

for health ethics, such as through supporting the establishment of NECs, support for specialist training

on technical areas and ethics processes, e.g. writing guidelines; the facilitation of country-to-country

learning; and the development of international guidelines and standards on specialist topics, e.g. use

of artificial intelligence in health and climate change–related ethical guidance. Member States

expressed interest participating in future health ethics meetings, including in the 13th Global Summit

of National Ethics/Bioethics Committees in 2020 and the next Asia-Pacific Regional Meeting for

National Ethics/Bioethics Committees, possibly in 2021.

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1. INTRODUCTION

Bioethics promotes the consideration of values in the prioritization and justification of actions by

health professionals, researchers, and policymakers that may impact the health and well-being of

patients, families, and communities. Bioethics is an interdisciplinary field encompassing a broad

range of domains and issues.

A bioethics framework provides for a systematic analysis and resolution of conflicts through an

evidence-based application of general ethical principles, such as respect for personal autonomy,

beneficence, justice, utility, and solidarity. Bioethics provides a framework of values and principles,

through which the ethical significance of key health issues can be understood, analysed and

appropriate solutions can be developed.

Equity is an ethical principle that aligns with and is closely related to human rights principles, and

particularly the right to health, that is the enjoyment of the highest attainable standard of physical and

mental health. Equity in health is the absence of avoidable or remediable differences among groups of

people, whether those groups are defined socially, economically, demographically or geographically.

These differences often determine the health status of individuals, either by directly influencing their

health, or indirectly by influencing their ability to access health care. Global change underpins issues

of health inequity, among these are the issues of climate change, emerging technologies and the health

and well-being of indigenous populations.

Bioethics has a role to play in in addressing health inequity at both nationally and internationally.

Solutions-orientated bioethics draws on the practical aspects of bioethics, where real world situations

are analysed using a bioethics framework. Bioethical analysis is an important tool in addressing and

resolving health inequities.

To ensure that the practice of solutions-orientated bioethics is integrated into how health inequity is

addressed, there is a need to work with and strengthen the roles of national ethics/bioethics

committees across the areas of public health, clinical care and health research. As such, reducing

health inequities is reinforced by robust systems that develop health ethics, both in principle and in

practice.

1.1 Meeting organization

The Second Asia-Pacific Regional Meeting for National Ethics/Bioethics Committees (AP-NEC2)

was convened in Wellington, New Zealand, from 22 to 23 October 2019. AP-NEC2 was chaired by

Kāhui Matatika o te Motu - the National Ethics Advisory Committee of New Zealand (NEAC), with

support from the World Health Organization (WHO) in collaboration with the United Nations

Educational, Scientific and Cultural Organization (UNESCO). AP-NEC2 was attended by 34

delegates from 22 countries, including 18 from the Western Pacific Region (Brunei Darussalam,

Cambodia, China, Cook Islands, Fiji, Japan, Malaysia, Mongolia, New Zealand, Palau, Philippines,

Papua New Guinea, Republic of Korea, Samoa, Singapore, Solomon Islands and Viet Nam) and five

from the South-East Asia Region (Bangladesh, Bhutan, Indonesia, Nepal, Thailand). Delegations

comprised the chairs of national ethics/bioethics committees (NECs) or equivalent advisory groups

that guide the government on health ethics issues and senior officers in the Ministry of Health (MoH)

or other government agencies responsible for the development, implementation and/or evaluation of

health ethics policies, guidelines and programmes.

1.2 Meeting objectives

The objectives of the meeting were:

(1) To highlight the role of health ethics in reducing inequities, in the context of priority global,

regional and national issues;

(2) To develop solutions, including to identify opportunities for multisectoral engagement and

international cooperation towards advancing action on priority issues; and

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(3) To strengthen national capacities for bioethics, including through national ethics/bioethics

committees.

2. PROCEEDINGS

2.1 Opening session

The meeting was opened by a formal Mihi (greeting) and karakia. A welcome address was delivered

by the Honourable Jenny Salesa, the Associate Minister of Health, New Zealand. She focused on the

timely nature of the theme of the meeting and the need to focus on solutions to bring about

meaningful health. She noted that the theme of the meeting was ambitious in scope highlighting that

in the face of climate change, emerging technologies and the needs of indigenous populations, which

held particular importance to New Zealand, that significant changes needed to be made in the

allocation of resources to health and the design and delivery of health services to ensure a more

sustainable and fairer health system. Following the Minister’s remarks was a Waiata (song) from the

Ministry of Health New Zealand and NEAC members and formal welcome remarks from Dr Neil

Pickering, Chairperson of NEAC, Mr Irakli Khodeli from UNESCO and Dr Tasnim Azim from

World Health Organization Regional Office for South East Asia Region (SEARO).

Mr Darryl Barrett for WHO Regional Office for the Western Pacific (WPRO) delivered an

introductory presentation setting out the objectives of the meeting for participants. Building on the

First Asia-Pacific Regional Meeting for National Ethics/Bioethics Committees held in Seoul,

Republic of Korea, from 24 to 25 October 2017, the presentation highlighted the three main streams

of health ethics: public health, clinical care ethics and health-related research ethics and introduced

the three topic areas for AP-NEC2: climate change, emerging technologies and indigenous

populations and health, and underscored the relationship each topic has with health equity. Whereas

NECs have a role in ensuring that health policies and procedures and protocols in clinical care and

research centred health equity, AP-NEC2 aimed at strengthening the role that NECs can play in their

countries’ paths to sustainable development.

2.2 Technical Sessions

2.2.1 Session 1: Climate Change, Ethics, Equity and Health

2.2.1.1 Technical presentation: Climate Change and Health Ethics

Dr Rhys Jones, Senior Lecturer

Faculty of Medical and Health Sciences, University of Auckland

The technical presentation discussed the need to respond to the serious ethical questions raised by

climate change within public health, health research and clinical care. The unequal health impact from

climate change exists between nations and within nations. The health care sector has a role in

contributing to climate change and has responsibility in mitigating and adapting to climate change.

There is an opportunity to improve health and address the underlying inequity that contributes to ill-

health through climate change adaptation e.g. through investment in active transport and sustainable

homes and buildings. Equity behoves nations to not simply continue on a path that is the same but a

little greener, but instead to move forward in a spirit of environmental and health justice. An honest

consideration of the context of colonialism, racism, disenfranchisement and oppression is part of

considering justice, in developing bodies of knowledge that are inclusive and can serve marginalized

populations. Participants were urged to consider their roles and embrace their potential in dismantling

inequities to improve health whilst addressing climate change.

2.2.1.2 Report: Results of the Country Survey on Climate Change and Health Ethics

in the Asia-Pacific Region

Ms. Dena Kirpalani, Consultant, Health Law & Ethics Unit

Division of Health Systems, WHO Regional Office for the Western Pacific

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An overview of the key conclusions from the country survey that was circulated to participants prior to

the meeting was presented. The survey asked participants to identify who held responsibility for ethics-

based decision making on a topic, what steps countries had made to use ethics or ethics institutions to

tackle the subject and identify what they perceived to be key ethical challenges within the topic and

specifically as those challenges relate to equity to orientate the participants to the theme of solutions

orientated bioethics.

Many countries in the region had specialist bodies, plans and strategies in place to address and

coordinate climate change responses. The impact of climate change on marginalized populations, the

impact of pre-existing health inequity and living status disparities were cited as key ethical concerns.

2.2.1.3. Country Panel

Country participants were invited to provide reflections and updates on health ethics,

inequity and climate change from their country perspectives:

2.2.1.3.1. Bangladesh: Research ethics and climate change: knowledge of

research ethics among doctors

Research was undertaken in Bangladesh to assess medical knowledge of

ethics amongst doctors. There was a gap between an awareness and

understanding of ethics, its application within clinical care, research and in

public health issues e.g. climate change. It recommended integration of ethics

into the curriculum for health professionals.

2.2.1.3.2. Nepal: Role of national organization in climate change adaptation

and mitigation

Climate change will have an impact on health in Nepal e.g. diminished food

security. Coordination was required between stakeholders, policies and

guidelines needs to be resourced and implemented.

2.2.1.3.3. Republic of Korea: Climate change-related strategic plan in the

Republic of Korea – inequities and privacy issues

The Korean Centre for Disease Control (KCDC) has established a division of

Future Disease Preparedness to support responses to climate change. The

Framework Act on Low Carbon, Green Growth, Climate Change Adaptation

Plan and Framework Act on Health and Medical Services all support climate

change responses.

2.2.1.3.4. Fiji

Small island states (SIS) face enhanced challenges from climate change.

There is a need for emergency preparedness and an analysis of ethics in post-

disaster situations as the frequency of natural disasters increases due to climate

change.

2.2.1.4. Group Work 1: Climate Change, Ethics, Equity and Health

Participants were organized into three self-selected groups based on each stream of health

ethics: public health ethics, research ethics and clinical ethics. They were each asked to identify

challenges and actions to reduce inequities in health status that related to or impacted by

climate change. Outcomes from the group work are summarised in the table at Annex 3.

2.2.2. Session 2: Emerging Technologies, Ethics, Equity and Health

2.2.2.1. Technical presentation: People centric approaches to ensure equity in the

development of ethical guidelines for biomedical and health research in

emerging technologies

Dr Roli Mathur, Scientist F & Head of ICMR Bioethics Unit

National Centre for Disease Informatics and Research

Innovative technologies hold the possibility of improving health, shifting our understanding of systems

and information. However, technological progress does not guarantee equitable health outcomes. Equity

needs to be integrated into the way that research is conducted. This is especially urgent as new

technologies challenged established frames of privacy and confidentiality, bodily autonomy and

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equitable benefit sharing. Research, and guidelines and processes for research need to people centric

that is research needs to be for the people, by the people and with the people. Greater knowledge of new

technologies is needed to monitor and assess the impact of new technologies. Policy pathways should

ensure justice.

2.2.2.2. Report: Results of the Country Survey on Emerging Technologies and Health

Ethics in the Asia-Pacific Region



There was an interest in a range of emerging technologies and their impact. New legislation, regulation,

protocols and guidelines had been developed to address concerns arising from emerging technologies.

Potential inappropriate use, exploitation of marginalized populations, privacy, confidentiality and data

security and appropriate and adequate delivery of new technologies needed to be addressed in the work

of NECs and MoH.


Country participants were invited to provide reflections and updates on health ethics, inequity and

emerging technologies from their country perspectives:

2.2.2.3.1. China: Establishing National Ethics Committee on Science &

Technology – Update from China

The National Ethics Committee on Science and Technology is responsible for

coordinating ethics and harmonizing responses between research institutions. It

supports capacity-building and ethics education for research institutions. It monitors

the development of new technologies and develops regulations for the implementation

of new technologies.

2.2.2.3.2. Japan: Second report on the revision of the “Basic Principles on

Handling of Human Embryos” (2019)

The Cabinet Office tackles high-level policy questions on both basic and health

research. It has developed a framework on the handling of human embryos in research.

2.2.2.3.3. Mongolia: Health equity in Mongolia

MoH is working on the reduction of financial barriers to health services to improve

equitable access to health technologies e.g. haemodialysis. Guidelines on that support

health equity and governance are also being supported.

2.2.2.3.4. Singapore: Translation of emerging technology into clinical practice:

a case study on PGS in Singapore

The transition of emerging technologies from research to clinical application quires

guidance. Singapore has a licensing and regulatory framework for health professionals

and institutions carrying out pre-implantation genetic screening (PGS). The framework

was developed through an assessment of the risks and potential benefits, supported by

a pilot program and an effort to create an inclusive criteria for pilot participants.

2.2.2.3.5. Indonesia: Ethics of Emerging Technologies

Four areas within emerging technologies were highlighted: the disruptive power of new

technologies and how to understand these, the on-going challenge of equitable

distribution of benefits and burdens, how to govern technological innovation when it

happens outside the purview of governments, and how to keep pace with innovation.

2.2.2.3.6. Vietnam: Review process of Investigational New Drug (IND) studies

in Vietnam

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Vietnam has a legal and regulatory system in place for processing ethical approvals for

drug and vaccine trails on human subjects. Vietnam has relied on WHO Guidelines to

develop this system that has approval levels at the institutional, provincial and central

levels.

2.2.2.3.7. Philippines: Stem cell facility regulation in the Philippines

The Bioethics Advisory Board Committee developed a regulatory framework for stem

cell facilities. They considered contentious ethical, scientific, legal issues in stem cell

and cellular-based research and therapeutics. The regime provides facility based

regulatory oversight and distinguishes between facilities involved in research versus

clinical application. It has developed a bench-marking system for assessing facilities.

2.2.2.3.8. Thailand: Ethics of Science and Technology for Sustainable

Development

Thailand is discussing a draft law on climate change to reduce greenhouse gas

emissions and to provide financing for climate change solutions. An understanding of

climate change and human rights is a means of supporting scientific integrity to achieve

the Sustainable Development Goals (SDGs).

2.2.2.3.9. Fiji

Fiji engaged in a review of their ethics policies and SOPs. It is working to develop an

accreditation system for IRBs. Stronger IRBs provide oversight for projects (domestic

and international) and to address concerns around the use of new technologies and to

reduce the risk of unethical practices e.g. ethics dumping. Regional support can help

address in-country capacity limitations and reduce forum shopping by researchers

looking for the least restrictive jurisdiction.

2.2.2.4. Group Work 2: Emerging Technologies, Ethics, Equity and Health




emerging technologies. Outcomes from the group work are summarised in the table at Annex

3.

2.2.3 Session 3: Indigenous Populations, Ethics, Equity and Health

2.2.3.1. Technical presentation: Supporting equity in Health Ethics with Indigenous

Populations: The Aotearoa New Zealand Experience

Mr. Maui Hudson, Associate Professor

Faculty of Māori and Indigenous Studies, University of Waikato

The topic of indigenous populations is linked to both climate change and emerging technologies. The

New Zealand experience has integrated indigenous viewpoints within an understanding of health

equity. This has a relevance to other country experiences in both understanding the position of ethics

and cultural minorities and other marginalized populations, and in confronting and deconstructing

histories of colonialization and their impacts on public health and health systems. The Te Ara Tika

Guidelines for Māori Research Ethics and the National Standards for Health and Disability Ethics

(the Guidelines) is an example of how indigenous values or alternative ethical principles are

increasingly relevant in bioethical analyses and integrated into health-related ethical guidance. The

Guidelines developed a cultural principles framework which integrated key Māori ethical concepts

and were developed with structured Māori participation. This was also reflected in He Tangata Kei

Tua: Guidelines for Biobanking with Māori and Te Mata Ira: Guidelines for Genomic Research with

Māori. Four points at the intersection between indigenous populations and health and health equity

were highlighted: (1) incorporating indigenous values (2) supporting indigenous participation (3)

addressing equity and indigenous outcomes and (4) enhancing indigenous control of indigenous data.

2.2.3.2. Report: Results of the Country Survey on Indigenous Populations and Health

Ethics in the Asia-Pacific Region

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There was an interest in understanding the topic by participants. There were recent developments in

legislation and regulation and the development of protocols and guidelines across the region that

focused on equitable engagement with indigenous populations within health-related research. The

inequitable health outcomes for indigenous populations in some jurisdictions was also a concern.


Country participants were invited to provide reflections on updates on health ethics, inequity and

indigenous populations from their country perspectives:

2.2.3.3.1. Palau: Promoting ethics and reducing inequities in small island states

Palau’s National Institutional Research Board (NIRB) was established in 2018 and has

a role in safeguarding the rights and interests of the people of Palau. It has a role in

protecting the people of Palau from exploitative research and to ensure that benefits

from research are shared. There is an integration of traditional forms of consent and

knowledge into the NIRB’s processes.

2.2.3.3.2. Philippines: Mainstreaming health research involving indigenous

peoples

Indigenous populations in the Philippines have inequitable health outcomes. Research

with and within indigenous communities requires authentic representation from

indigenous peoples. Reforms were being undertaken in the Philippines to empower

indigenous peoples to participate meaningfully in research, improve the awareness of

researchers and the public and require that research studies integrate indigenous

considerations to acquire clearance for research.

2.2.3.3.3. Cook Islands: Injuries – research ethics

The Pacific Health Ministers Meeting 2019 emphasised the impact of climate change

on the Pacific, the need to indigenize research and ensure that climate change research

benefited SISs. Cook Islands is exploring the creation of a national interdisciplinary

committee to develop research guidelines that protect Cook Islanders and create access

to the benefits of the research, such as the ability to use research in policy development

and decision-making.

2.2.3.3.4. Cambodia: How to address effectively the ethical issues in Cambodia?

Cambodia’s National Ethics Committee for Health Research (involving human

subjects) was established in 2002. Its most important documents are its National Ethical

Guidelines and SOPs that were developed in 2008. The Committee is currently

updating its SOPs. Health professional councils have some oversight over clinical care

ethics. There is no body committed to consideration of public health ethics.

2.2.3.3.5. Bhutan: Research ethics

Bhutan’s framework for regulating traditional medicine and research in traditional

medicine incorporates indigenous values. The integration of religious and

philosophical aspects of traditional medicine is important for the application of

traditional medicine in Bhutan. There is a need to develop global ethical standards

within traditional medicine research that ensures the incorporation of indigenous value

systems, including protection of benefit sharing and accessibility of results.

2.2.3.4. Group Work 3: Indigenous populations, Ethics, Equity and Health




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indigenous populations and indigenous values. Outcomes from the group work is summarised

in the table at Annex 3.

2.2.4. Session 4: Challenges and opportunities in strengthening national capacities for

health ethics

Both WHO and UNESCO support countries in strengthening capacities for NECs

2.2.4.1. Technical presentation: UNESCO and Global Bioethics: from International

Standard-Setting to National Capacity-building

Mr. Irakli Khodeli, Social and Human Sciences Sector

UNESCO Science Bureau for Asia and the Pacific

UNESCO is involved in: (1) global standard setting and instruments e.g. Universal Declaration on

Bioethics and Human Rights (2) global reflection e.g. UN Inter-Agency Committee on Bioethics and

(3) capacity-building action at the national level e.g. UNESCO’s Ethics Education Program.

2.2.4.2. Technical presentation: Supporting Member States in Strengthening

National Capacities for Health Ethics

Dr Ki-hyun Hahm, Technical Officer, Health Law and Ethics Unit, Division of

Health Systems, WHO Regional Office for the Western Pacific

Dr. Changgyo Yoon, Technical Officer, WHO Representative Office for the South

Pacific

Dr. Tasnim Azim, Regional Adviser, Department of Communicable

Diseases, WHO Regional Office for South-East Asia

WHO’s objectives include articulating ethical and evidence-based policy options. Strengthening

capacities for research ethics directly in countries and through regional programs remains a key part of

delivering this objective. WHO ethics related initiatives and resources at the global level include: WHO

Ethics Review Committee, Public Health Ethics Consultative Service, WHO Collaborating Centres for

Bioethics Network and Global Summits.


Country participants were invited to provide reflections on updates on changes and opportunities to

strengthen national capacities for health ethics from their country perspectives:

2.2.4.3.1. Nepal: National Ethical Guideline, SOP & Operation Modality

The Nepal National Ethics Committee (NNEC) was established under the Nepal Health

Research Council Act 1991. The volume and scope of research undertaken in Nepal

has grown. The NNEC recently revised national ethical guidelines for health research

with support from WHO and ICMR. The NNEC has also developed a web-portal

system for submissions of research proposals. It has a monitoring and evaluation

framework in place to assess research proposals which include an obligation to protect

marginalized people from harm under the research process. Nepal is applying for

FERCAP-SIDCER accreditation.

2.2.4.3.2. Solomon Islands: Strengthening Provincial Health Research System:

Utilizing the Research Capacity Building Initiative

A research capacity survey was conducted in the Solomon Islands in 2009. It found

that research was almost exclusively led by external researchers, so the wealth of data

collected was not being used to the benefit of local populations. Solomon Islands

established a health research and ethics review board to review applications for

research within the Solomon Islands in 2012. The board however has limited capacity

to coordinate between the capital and the provinces. There has been an investment in

research training capacity building to improve provincial skills and coordination.

2.2.4.3.3. India: Central Ethics Committee on Human Research – National

Ethics Committee

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The Indian Council of Medical Research (ICMR) promotes and formulates biomedical

and health research and is situated within the Ministry of Health. The Central Ethics

Committee on Human Research (CECHR) is appointed by the Director General of

ICMR to develop guidance for biomedical and health research. CECHR produces

guidance, policy and regulations, works on capacity building for researchers, students,

research institutes etc. and supports health and science collaboration and

communication. The CECHR’s upcoming activities include focus on the use of

advanced directives, do not attempt resuscitation (DNAR) requests, withdrawal or

withholding of treatment and end of life care, a review of the guidelines for multicentre

research, developing a national conflict of interest policy and national guidelines for

research on tribal populations.

2.2.4.3.4. New Zealand: Developing National Standards for Health and

Disability Research and Quality Improvement

The development of the national Standards for Health and Disability Research and

Quality Improvement included a few public consultations that incorporated four major

themes: inclusion, representation and fairness, appropriate safeguards, and accessibility

and commitment to advancing knowledge. The result of the consultations was an

identification of shortcomings in the data on Māori populations and the need for

dynamic standards to respond to technological development. Part of the solution was

to make the Standards a living document, that is it would not be printed and would be

updated periodically to keep pace with changes in design and technology.

2.2.4.3.5. Singapore: Incorporating the Bioethics Advisory Committee’s

guidelines into Singapore’s Human Biomedical Research Act (2015)

The Bioethics Advisory Committee (BAC) is an independent advisory committee that

was established in 2000 as Singapore’s national advisory body with a mandate to

address the ethical, legal and social issues arising from biomedical research and

develop and recommend policies to the Singaporean government. The BAC has three

work streams: advisory, international engagement and education over a range of

biomedical topics from gene-editing and data privacy before formulating its guidelines

on biomedical research. Its recommendations led to the development of the Human

Biomedical Research Act 2015.

2.2.4.3.6. Papua New Guinea: PNG National Health Plan 2011 – 2020

The PNG National Health Plan 2011 – 2020 hopes to tackle eight (8) key areas and

requires research strengthening to support these and their associated outcomes. It is

part of current reforms to introduce a role delineation model of service delivery.

2.2.4.3.7. Indonesia: Legitimate Health Research by International Ethical

Standard

Indonesia has developed a consolidated website for all its IRBs. It is also training IRBs

and their members. The Indonesian National Ethics Committee (INEC) provides a

three-day basic training course and all IRB members must be certified by the INEC.

The INEC also has facility for IRBs to submit their protocols electronically for approval.

Indonesia will roll out a program for accrediting IRBs from 2020.

2.2.4.3.8. Samoa

Samoa has two bodies overseeing health research ethics: the National Health Research

Committee (NHRC) that reviews and approves research studies, and the National

University of Samoa Ethics Committee that reviews and approves university research

projects. Professional ethics are overseen by the Public Service Commission (labour).

Medical ethics are addressed by the Samoa Medical Association (medical ethics).

There is a recognition that the NHRC’s work requires greater visibility and

transparency, and there is a need to ensure indigenous populations are protected during

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research. Samoa’s system is rudimentary and there is a need to train local researchers,

educate populations and strengthen policies and regulation for health-related research.

2.2.5. Session 5: Ways Forward

Participants engaged in a country planning exercise. They planned out their immediate, short and long-

term objectives, how they intended to achieve them and what support from WHO or UNESCO could

support them utilizing the conclusions from the group work exercises over the course of the meeting

(See Annex 4). The goal was to take the learnings from the meeting and translate this to concrete actions.

The results were sent to the WHO for collation. The priorities identified are summarised in the

conclusion.

2.2.6. Closing Ceremony

Mr Barrett, Dr Azim, Mr Khodeli and Dr Pickering provided closing remarks to the room. They thanked

the participants for their engagement, their dedication to realizing health equity within their roles and

the practical suggestions that would be taken forward from the meeting. A formal closing was given by

Maui Hudson.

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3. CONCLUSIONS AND RECOMMENDATIONS

3.1 Conclusions

Participants agreed on the following:

(1) Considerable variation continues to exist among countries in their institutional arrangements

and capacities for health ethics, but there are opportunities for collaboration among countries

to establish and strengthen national capacities/

(2) Countries with more advanced systems for health ethics expressed a wish to continue to provide

support for countries that are developing their national health ethics frameworks.

(3) Countries and national ethics/bioethics committees should continue to develop, review and

revise their guidelines, frameworks and SOPs, and strengthen their expertise and networks so

they are responsive to the new challenges presented by climate change and emerging

technologies, develop processes that incorporate consultation with local populations, address

industry influence and conflicts of influence, and develop culturally competent ethics training

and education.

(4) Countries should improve coordination between ministries, NECs and other research oversight

bodies and their engagement with other stakeholders on matters of health, inequities and

specific areas such as climate change, emerging technologies and indigenous populations.

(5) Countries and national ethics/bioethics committees should support transparency and

accountability mechanisms over institutional review boards (IRBs) and/or other research

oversight bodies to ensure standards and guidelines align with international standards and

guidelines.

3.2 Recommendations

3.2.1 Recommendations for Member States

Member States are encouraged to do the following:

(1) to continue to work towards the establishment of national ethics/bioethics committees or other

oversight bodies, as appropriate, where these do not exist;

(2) to continue to revise/update guidelines and frameworks and create SOPs, as appropriate;

(3) to strengthen national ethics/bioethics committees through improved policy, administrative

support, financing and better integration with challenges and opportunities in priority areas,

including climate change, emerging technologies and the health of indigenous populations, such

as through:

3.1. the development of ethics preparedness, the reviewing and revising protocols for research

(including multi-country research) conducted in post-disaster and post-emergency settings to

allow for rapid approval of research needed to gather data and respond to climate change;

3.2. the development of climate-change leadership in health care and health research;

3.3. the strengthening of knowledge of emerging technologies for members of national ethics

committees;

3.4. the development of ethical frameworks for data- and benefit-sharing that minimize harm and

misuse, and facilitate equitable health outcomes;

3.5. the development and integration of culturally competent ethical guidance and training for

researchers and health professionals;

3.6. the development of wholistic guidelines on community engagement for researchers,

including on matters of informed consent, and appropriate support for communities

engaging in research; and

3.7. the development of processes to address unethical processes in research, e.g. ethics dumping

and exploitation of indigenous populations in research, and the safeguarding of local

15

populations;

(4) to strengthen accountability over IRBs and other research oversight bodies;

(5) to develop ethics training and, if not already in place, introduce ethics into the curricula for

health professionals and researchers, linking such training and guidance with WHO and

UNESCO frameworks, and integrating cultural competencies into such training and guidance, as

appropriate; and

(6) to strengthen national and regional networking and sharing for ethics/bioethics.

During the Session 5, participants identified country-specific actions they considered undertaking at

the conclusion of the meeting. These are contained in the documents included at Annex 4.

3.2.2 Recommendations for WHO

WHO is requested to do the following:

(1) to provide assistance to Member States in advancing actions for health ethics,

such as through:

1.1. the establishment of national ethics/bioethics committees;

1.2. support for specialist training on technical areas and ethics processes, e.g.

writing guidelines or reviewing existing guidance and policies;

1.3. the facilitation of country-to-country learning; and

1.4. the development of international guidelines and standards on specialist topics,

e.g. use of artificial intelligence in health, treatment of human biological data,

data- and benefit-sharing, and climate change–related ethical guidance;

(2) to support the organization of the Third Asia-Pacific Regional Meeting for National

Ethics/Bioethics Committees in 2021.

16

ANNEXES

Annex 1. List of participants, temporary adviser, observers/representatives and Secretariat

1. PARTICIPANTS

Mahmood Uz Jahan, Director, Bangladesh Medical Research Council, Dhaka, Bangladesh.

E-mail: [email protected]

Kinley Dorjee, Assistant Research Officer, Health Management and Information Unit, Ministry of

Health, Thimpu, Bhutan. E-mail: [email protected]

Suzylawati PG Ismail, Deputy Senior Legal Counsel, Ministry of Health,

Bandar Seri Begawan, Brunei Darussalam. E-mail: [email protected]

Alice Moi Ling Yong, Endocrinologist Consultant, Ministry of Health, Bandar Seri Begawan,

Brunei Darussalam. E-mail: [email protected]

Chap Seak Chhay, Deputy Director General, Administration and Finance, Member, Secretariat of the

National Ethics Committee for Health Research Involving Human Subjects in Cambodia

Ministry of Health, Phnom Penh, Cambodia. E-mail: [email protected]

Liu Guisheng, Division Chief, Planning and Evaluation, Division of Asian, American and Multilateral

Affairs, Department of Science, Technology and Education, National Health Commission

Beijing, People’s Republic of China. E-mail: [email protected]

Zhai Xiaomei, Executive Director, Center for Bioethics, Peking Union Medical College

Beijing, People’s Republic of China E-mail: [email protected]

Nuhisifa Seve-Williams, Research Manager, Ministry of Health, Rarotonga, Cook Islands.


Eric Rafai, Head, Research & Innovation, Data Analysis and Management, Ministry of Health &

Medical Services, Suva, Fiji. E-mail: [email protected]

Triono Soendoro, Head, National Health Ethics and Development, Ministry of Health

Jakarta, Indonesia. E-mail: [email protected]

Mika Shigematsu, Deputy Director, Science and Technology Policy, Bureau of Science, Technology

and Innovation, Tokyo, Japan. E-mail: [email protected]

Bang-ook Jun, Department of Biology, Gangneung-Wonju National University

Wonju, Republic of Korea. E-mail: [email protected]

Eun Kyoung Choi, Human Material Policy Research, Korea National Institute for Bioethics Policy

Seoul, Republic of Korea. E-mail: [email protected]

Hannah Moon, Human Material Policy Research, Korea National Institute for Bioethics Policy

Seoul, Republic of Korea. E-mail: [email protected]

17

Douangdao Soukaloun, President, National Ethics Committee for Health Research of Lao PDR,

Vientiane, Lao People’s Democratic Republic. E-mail: [email protected]

Salina Binti Abdul Aziz, Chairperson, Medical, Research, Ethics Committee, Ministry of Health

Kuala Lumpur, Malaysia. E-mail: [email protected]

Mohd Noor Musa, Special Officer, Institute of Islamic Understanding Malaysia, Kuala Lumpur,

Malaysia. E-mail: [email protected]

Enebish Oyunsuren, Officer, Research and Innovation and Technology, Ministry of Health,

Ulaanbaatar, Mongolia. E-mail: [email protected]

Prakash Ghimire, Chair, Ethical Review Board, Nepal Health Research Council, Kathmandu, Nepal.


Aarati Shah, Chair, Ethics Committee, National Academy of Medical Sciences, Bir Hospital,

Kathmandu, Nepal. E-mail: [email protected]

Neil Pickering (Chair of AP-NEC2), Chair, National Ethics Advisory Committee, Otago,

New Zealand. E-mail: [email protected]

Nic Aagaard, Principal Advisor, Ethics, Quality Assurance and Safety, Health System Improvement

and Innovation, Ministry of Health, Wellington, New Zealand. E-mail: [email protected]

Gaafar Sers Jose Uherbalau, Administrator, Health Policy, Research and Development Office

Ministry of Health, Koror, Palau. E-mail: [email protected]

Maluo Magaru, Technical Adviser, Hospital Operations, National Department of Health,

Port Moresby, Papua New Guinea. E-mail: [email protected]

Leonardo de Castro, Chair, Philippine Health Research Ethics Board, Department of Philosophy

University of the Philippines, Quezon City, Philippines. E-mail: [email protected]

Kathleen Grace Lentija, Secretariat, Bioethics Advisory Board Committee for the Regulation of

Health Facilities Engaging in Human Stem-cell, Cell-based or Cellular Therapies in the Philippines

Licensing Officer III, Department of Health, Manila, Philippines. E-mail: [email protected]

Filipina Amosa-Lei Sam, Pathologist, Meaole Hospital, Ministry of Health, Apia, Samoa.


Richard Magnus, Chair, Bioethics Advisory Committee, Ministry of Health, Singapore.


Sharon Bala Krishnan-Thomas, Deputy Director, Precision Medicine and Research Branch,

Regulatory Policy and Legislation Division, Ministry of Health, Singapore.


18

Devanand Anantham, Deputy Chair, National Medical Ethics Committee, Singapore.


Hsi-Yen Loke, Medical Officer, Bioethics Advisory Committee Secretariat, Ministry of Health

Singapore. E-mail: [email protected]

Raymond Chua, Group Director, Health Regulation Group, Ministry of Health, Singapore.


Freda Pitakaka, Chief Research Officer, Solomon Islands Health Research and Ethics Review Board

Secretariat (SIHRERB), Ministry of Health Medical Services, Honiara, Solomon Islands.

Email: [email protected]

Yuthavong Yongyuth, Advisor, National Committee on Ethics of Science and Technology

Bangkok, Thailand. E-mail: [email protected]; [email protected]

Nguyen Ngo Quang, Acting Director, Administration of Science, Technology and Training

Ministry of Health, Hanoi, Viet Nam. E-mail: [email protected]

2. TEMPORARY ADVISERS

Maui Luke Hudson, Associate Professor, Faculty of Maori and Indigenous Studies, University of

Waikato, Hamilton, New Zealand. E-mail: [email protected]

Rhys Jones, Senior Lecturer – Medical, Faculty of Medical and Health Sciences, University of

Auckland, Auckland, New Zealand. E-mail: [email protected]

Roli Mathur, Scientist F and Head, ICMR Bioethics Unit, National Centre for Disease Informatics and

Research, Bengaluru, India. E-mail: [email protected]

3. OBSERVERS/REPRESENTATIVES

Colin Gavaghan, Advisory Committee for Assisted Reproductive Technologies, New Zealand

Helen Walker, Central Health and Disability Ethics Committee, New Zealand

Rochelle Style, Health and Disability Ethics Committee, New Zealand

Huia Tomlins-Jahnke, Health Research Council Ethics Committee, New Zealand

Maureen Holdaway, National Ethics Advisory Committee, New Zealand

Wayne Miles, National Ethics Advisory Committee, New Zealand

Liz Richards, National Ethics Advisory Committee, New Zealand

Hope Tupara, National Ethics Advisory Committee, New Zealand

19

Dana Wensley, National Ethics Advisory Committee, New Zealand

Mary-Anne Woodnorth, National Ethics Advisory Committee, New Zealand

Gordon Jackman, National Ethics Advisory Committee, New Zealand

Manuka Henare, Northern A Health and Disability Ethics Committee, New Zealand

Kate O’Connor, Northern B Health and Disability Ethics Committee, New Zealand

Lynley Anderson, eOtago University Bioethics Centre, New Zealand

Sarah Gunningham, Southern Health and Disability Ethics Committee, New Zealand

Angela Ballantyne, University of Otago, New Zealand

4. SECRETARIAT

World Health Organization

Darryl Barrett, Coordinator, Health Law and Ethics, Division of Health Systems and Services, WHO

Regional Office for the Western Pacific, Manila, Philippines. E-mail: [email protected]

Ki-Hyun Hahm (WHO Responsible Officer for AP-NEC2), Technical Officer, Health Law and

Ethics, Division of Health Systems and Services, WHO Regional Office for the Western Pacific,

Manila, Philippines. E-mail: [email protected]

Dena Kirpalani, Consultant, Health Law and Ethics, Division of Health Systems and Services, WHO

Regional Office for the Western Pacific, Manila, Philippines. E-mail: [email protected]

Changgyo Yoon, Technical Officer, WHO Representative Office for the South Pacific, Suva, Fiji.


Tasnim Azim, Regional Adviser, Department of Communicable Diseases, WHO Regional Office for

South-East Asia, New Delhi, India. E-mail: [email protected]

New Zealand Ministry of Health

Margaret Earle, Principal Advisor, Office of the DDG Population Health and Prevention, Ministry of

Health, Wellington, New Zealand

Kirsten Forrest, Senior Advisor, Ethics, Quality Assurance and Safety, Health System Improvement

and Innovation, Ministry of Health, Wellington, New Zealand

Mark Joyce, Advisor, Ethics, Quality Assurance and Safety, Health System Improvement and

Innovation, Ministry of Health, Wellington, New Zealand

20

Tristan Katz, Advisor, Ethics, Quality Assurance and Safety, Health System Improvement and


Martin Kennedy, Senior Policy Analyst, Ethics, Quality Assurance and Safety, Health System

Improvement and Innovation, Ministry of Health, Wellington, New Zealand

Rob McHawk, Manager, Ethics, Quality Assurance and Safety, Health System Improvement and


Courtney Parnell, Administrator, Ethics, Quality Assurance and Safety, Health System Improvement

and Innovation, Ministry of Health, Wellington, New Zealand

Hayley Robertson, Senior Advisor, Ethics, Quality Assurance and Safety, Health System

Improvement and Innovation, Ministry of Health, Wellington, New Zealand

Clyde Smith, Policy Analyst, Maori Health, Strategy and Policy, Ministry of Health, Wellington, New

Zealand

Joel Tyrie, Advisor, Ethics, Quality Assurance and Safety, Health System Improvement and


United Nations Educational, Scientific and Cultural Organization

Irakli Khodeli, Programme Specialist, Social and Human Sciences Sector, UNESCO Jakarta Office

Jakarta, Indonesia. E-mail: [email protected]

21

Annex 2. Programme of the meeting

DAY 0 – Monday 21 October 2019

DAY 1 – Tuesday 22 October 2019

Venue Icon Room, Museum of New Zealand Te Papa Tongarewa, 55 Cable Street, Te Aro

09:00 – 10:15 Opening Ceremony Moderator: Neil Pickering

Notetaker: Clyde Smith

• Mihi (greeting) and karakia (10m)

• Welcome remarks (10m) by the Honourable Jenny Salesa, Associate Minister of Health, New Zealand

• Waiata (song) - Purea Nei e Te Hau

• Welcome remarks (5m) by Neil Pickering, Chair, National Ethics Advisory Committee, New Zealand

• Opening remarks (5m) by Irakli Khodeli, Programme Specialist, Social and Human Sciences Sector, United Nations

Education, Science and Cultural Organization (UNESCO) Jakarta Office, Indonesia

• Opening remarks (5m) by Tasnim Azim, Regional Advisor for Health Research Policy, World Health Organization

Regional Office for South East Asia Region (WHO SEARO), India

• Opening Remarks + Introductory Presentation: “The Role of Ethics in Reducing Health Inequities and Advancing

Universal Health Coverage” (15m) by Darryl Barrett, Coordinator for Health Law & Ethics, World Health

Organization Regional Office for the Western Pacific (WHO WPRO), Philippines

• Self-introductions of participants (15m)

• Meeting overview and administrative announcements by Nic Aagaard, Principal Advisor, Ethics, Ministry of

Health, New Zealand (5m)

• Group photo (5m)

10:15 – 10:45 Karakia mō te kai (Blessing the food) + Tea Break

Venue Ministry of Health, 133 Molesworth Street, Thorndon

Those attending the Meeting of the Steering Committee and Secretariat are kindly requested to

arrange their own transportation (e.g., taxi) to the Ministry of Health (expected travel time from QT

Hotel: 10m).

16:30 – 17:30 Meeting of the Steering Committee and Secretariat – invitation only (Meeting Room G.C.2)

17:30 Group shuttle from QT Hotel to Ministry of Health

18:00 – 20:00

Welcome Reception – all participants

• Welcome remarks by Ashley Bloomfield, Director General, Ministry of Health

• Refreshments

20:00 Group shuttle from Ministry of Health to QT Hotel

22

10:45 – 12:00 Session 1: Climate Change, Ethics, Equity

and Health

Moderator: Aarati Shah

Notetakers: Courtney Parnell, Margaret Earle

Climate change will affect health, both the requirements for health such as the provision of clean water and air as

well as the distribution of health impacts. Particular populations may be disproportionately affected by climate

change including outdoor workers, and those in coastal or low-lying riverine zones. A number of countries in the

region are among those with the highest level of long-term climate change risk.

Objectives:

- Provide an overview of the current status of climate change and health ethics in the region

- Discuss key health ethics issues and challenges facing the region in the context of climate change

- Identify health ethics solutions and strategies to reduce avoidable gaps in health status and health impact

between groups arising from climate change

• Technical presentation (20m): “Climate Change and Health Ethics” by Rhys Jones, Senior Lecturer in Måori

Health, University of Auckland; Co-convenor of Orataiao (New Zealand Climate and Health Council)

• Report (5m): “Results of Country Survey on Climate Change and Health Ethics in the Asia-Pacific Region” by Dena

Kirpalani, Consultant, Health Law & Ethics Unit, WHO WPRO

• Country Perspectives Panel

- Bangladesh (Mahmood Uz-Jahan): Research ethics and climate change - knowledge of research ethics among

doctors (5m)

- Nepal (Prakash Ghimire): Role of national organisations in climate change adaptation and mitigation (5m)

- Republic of Korea (Eun-Kyung Choi): Climate change-related strategic plan in Korea - inequities and privacy issues

(5m)

- Fiji (Eric Rafi): Public health ethics (5m)

• Plenary discussion (30m)

12:00 – 13:00 Group Work 1 Moderator: Rhys Jones

Notetakers: Courtney Parnell, Margaret Earle

• Parallel breakout sessions (30m)

Stream Facilitator Notetakers Venue

A: Clinical Ethics Mahmood Uz-Jahan Mark Joyce, Changgyo Yooon Angus Rooms

B: Public Health Ethics Dana Wesley Margaret Earle, Ki-Hyun Hahm Icon Room

C: Research Ethics Aarati Shah Hayley Roberton, Dena Kirpalani Blue Whale

• Report back + Plenary discussion (30m)

13:00 – 14:30 Karakia mō te kai (Blessing the food) + Lunch + Networking

23

14:30 – 16:00 Session 2: Emerging Technologies, Ethics, Equity and Health

Moderator: Bang-Ook Jun

Notetaker: Hayley Robertson

States’ abilities to manage bioethical challenges and to identify the ethical, legal and social implications of emerging

technologies and their application will affect health and impact the distribution of their health impacts. Countries in

the region are investigating how emerging technologies can be utilized to address needs whilst tackling the risks

associated with emerging technologies such as privacy, consent and inequity of access.

Objectives:

- Provide an overview of the current status of emerging technologies and health ethics in the region

- Discuss key health ethics issues and challenges facing the region in the context of emerging technologies

- Identify health ethics solutions and strategies to reduce avoidable gaps in health status and health impact

between groups arising from emerging technologies

• Technical presentation (20m): “People-centric Approaches to Ensure Equity in the Development of Ethical

Guidelines for Biomedical and Health Research in Emerging Technologies” by Roli Mathur, Scientist F & Head,

ICMR Bioethics Unit, National Centre for Disease Informatics & Research, Indian Council of Medical Research,

Department of Health Research, Ministry of Health and Family Welfare, India

• Report (5m): “Results of Country Survey on Emerging Technologies and Ethics in the Asia-Pacific Region” by

Dena Kirpalani, Consultant, Health Law & Ethics Unit, WHO WPRO

• Country Perspectives Panel - China (Xiaomei Zhai): Ethics of emerging technologies (5m) - Japan (Mika Shigematsu): Progress of bioethics issues for genome editing technology use on human

fertilised cell for research purposes (5m) - Mongolia (Enebish Oyunsuren): Equity and health technology (5m) - Singapore (Devanand Anantham): Pre-implantation genetic screening (5m) - Indonesia (Triono Soendoro): Ethics of emerging technologies (5m) - Vietnam (Quang Nguyen Ngo): Management of research on stem cell, cellular and gene therapy

products (5m) - Thailand (Yuthavong Yongyuth): Research ethics (5m) - Fiji (Eric Rafai): Research ethics (5m)


16:00 – 17:00 Group Work 2 + Karakia mō te kai (Blessing the food) + Working Tea Break

Moderator: Roli Mathur

Notetaker: Hayley Robertson



A: Clinical Ethics Lynley Anderson Martin Kennedy, Irakli Khodeli Angus Rooms

B: Public Health Ethics Bang-Ook Jun Kirsten Forrest, Darryl Barrett Icon Room

C: Research Ethics Mahmood Uz Jahan Mark Joyce, Tasnim Azim Blue Whale Room


17:00 – 18:00 Free Time

24

18:30 – 19:00 Informal Reception

Venue Signs of a Nation, Museum of New Zealand Te Papa Tongarewa, 55 Cable Street, Te Aro

19:00 – 21:00 Karakia mō te kai (Blessing the food) + Welcome Dinner + Cultural Event

Venue Te Marae , Museum of New Zealand Te Papa Tongarewa, 55 Cable Street, Te Aro

DAY 2 – Wednesday 23 October 2019

Venue Icon Room, Museum of New Zealand Te Papa Tongarewa, 55 Cable Street, Te Aro

09:00 – 09:15

• Recap of Day 1 and Outlook for Day 2 by Nic Aagaard, Ministry of Health, New Zealand (5m)

• Reflections from the Chair (5m)

• Comments by Participants (5m)

09:15 – 10:30 Session 3: Indigenous Populations, Ethics, Equity and Health

Moderator: Mahmood Uz-Jahan

Notetaker: Margaret Earle

The health of indigenous persons can be impacted by their status as members of indigenous populations. Structural inequity shapes the health of indigenous peoples globally, and oft times deeply embedded in a history of individual and institutional racism, and inequitable social policies and practices, including the participation of indigenous persons in health-related research and public health campaigns. A number of countries and indigenous groups in the region are employing strategies for promoting equity in health care and research for indigenous populations.

Objectives:

- Provide an overview of the current status of indigenous populations and health ethics in the region - Discuss key health ethics issues and challenges facing the region in the context of emerging technologies - Identify health ethics solutions and strategies to reduce avoidable gaps in health status and health impact

between groups arising from emerging technologies

• Technical presentation (20m): “Supporting Equity in Health Ethics with Indigenous Populations: The Aotearoa New Zealand Experience” by Maui Hudson, Associate Professor, Faculty of Maori and Indigenous Studies, University of Waikato, New Zealand

• Report (5m): “Results of Country Survey on Indigenous Populations and Ethics in the Asia-Pacific Region” by Dena Kirpalani, Consultant, Health Law & Ethics Unit, WHO WPRO

• Country Perspectives Panel - Palau (Gaafar Sers Jose Uherbalau): Promoting ethics and reducing inequities in small island states (5m) - Philippines (Leonardo de Castro, Kathleen Grace Lentija): Mainstreaming health research involving

indigenous peoples (5m) - Cook Islands (Nuhisifa Seve-Williams): Injuries – research ethics (5m) - Cambodia (Chap Seak Chhay): How to address effectively the ethical issues in Cambodia? (5m) - Bhutan (Kinley Dorjee): Research ethics (5min) - Lao PDR (Latsamy Siengsounthone): Public health ethics (5m)


25

10:30 – 11:30 Group Work 3 + Karakia mō te kai (Blessing the food) + Working Tea Break

Moderator: Maui Hudson




A: Clinical Ethics Neil Pickering Kirsten Forrest, Changgyo Yoon Angus Rooms

B: Public Health Ethics Clyde Smith Hayley Robertson, Ki-Hyun Hahm Icon Room

C: Research Ethics Roli Mathur Rob McHawk, Dena Kirpalani Blue Whale Room


11:30 – 13:00 Karakia mō te kai (Blessing the food) + Lunch + Networking

13:00 – 14:15 Session 4: Challenges and opportunities in strengthening national capacities for health ethics

Moderator: Neil Pickering

Notetaker: Rob McHawk

Strengthening national capacities for health ethics – including the respective capacities of national ethics/bioethics committees and their government counterparts, as well as the communication and coordination between them – is critical to ensure robust assessment of issues and offer empirically informed identification of ethical solutions and policy recommendations.

Objectives:

- Discuss challenges and opportunities for strengthening national capacities in the region, including support from UNESCO and WHO at the global, regional, and national levels

- Share experiences from countries in strengthening national capacities for health ethics

• Technical presentation (10m): “UNESCO support to countries in strengthening national capacities for health ethics” by Irakli Khodeli, Programme Specialist, Social and Human Sciences Sector, United Nations Education, Science and Cultural Organization (UNESCO) Jakarta Office, Indonesia

• Technical presentation (10m): “WHO support to countries in strengthening national capacities for health ethics” by Tasnim Azim, Regional Advisor for Health Research Policy, WHO SEARO, India + Ki-Hyun Hahm, Technical Officer for Health Law & Ethics, WHO WPRO, Philippines + Changgyo Yoon, Technical Officer, WHO Representative Office for the South Pacific, Fiji

• Country Perspectives Panel - Nepal (Prakash Ghimire): ERB process for FERCAP accreditation through WHO technical support (5m) - Solomon Islands (Freda Pitakaka): Strengthening health research system at the provincial level (5m) - India (Roli Mathur): Establishment/operationalization of national ethics committees (5m) - New Zealand (Nic Aagaard): National ethical standards for health research and quality improvement (5m) - Vietnam (Quang Nguyen Ngo): Circular on organisation, function and duty of ethics committees (5m) - Singapore (Richard Magnus): Incorporating BAC’s guidelines into Human Biomedical Research Act (5m) - Indonesia (Triono Soendoro): Legitimate Health Research by International Ethical Standard (5m) - Papua New Guinea (Maluo Magaru): PNG experience (5m)


26

14:15 – 15:30 Session 5: Ways Forward + Working Tea Break

Moderators: Tasnim Azim + Darryl Barrett


Objectives:

- In subregional groupings, reflect on the issues discussed over the course of the meeting to identify common priority themes and emerging themes

- In country teams, draft country action plans to identify next steps towards strengthening national capacities for health ethics and reducing health inequities on priority issues through health ethics strategies and solutions

• Session Overview (5m)


Grouping Facilitator Notetakers

A: Bangladesh, Bhutan, Nepal Tasnim Azim Icon Room

B: Brunei Darussalam, Indonesia, Malaysia, Mongolia, Philippines

Irakli Khodeli Icon Room

C: Japan, Republic of Korea, New Zealand, Singapore Ki-Hyun Hahm Blue Whale

D. Cambodia, China, Lao PDR, Thailand, Viet Nam Darryl Barrett Angus Room

E. Cook Islands, Fiji, Palau, Papua New Guinea, Samoa, Solomon Islands

Changgyo Yoon Rangimarie Room


• Round of closing remarks from WHO WPRO, WHO SEARO, UNESCO, Ministry of Health, Chair (10m)

27

Annex 3. Summary of Conclusions from participants’ group work

31

Annex 4. SESSION 5: WAYS FORWARD – COUNTRY WORKSHEETS

In sub-regional groupings, participants reflect on the issues discussed over the course of the meeting and considered common priorities and themes relevant to

their country context. They completed worksheets to identify potential next steps towards country planning in strengthening national capacities for health

ethics in line with the central theme of AP-NEC 2: reducing inequities through solutions-orientated bioethics. These are contained in this Annex in

alphabetical order.

32

BANGLADESH

Immediate e.g. One Week to 4 weeks after AP-NEC2

Short Term e.g. three (3) months after AP-NEC 2 (Jan 2020)

Medium – Long Term e.g. one year+ after AP-NEC 2 (October 2020)

What? What are the next steps to be taken within this time frame?

Intra official discussion and sharing the AP-NEC 2 outcomes with the members of the National Research Ethics Committee (NREC) The suggestion from findings of the meeting to go forward

Discussion meeting with relevant stakeholders regarding existing ethical guidelines, laws & legislation, way of policy implication Identifying the common challenges and opportunities and possible way of solution May arrange a discussion meeting/round table discussion Inclusion of recommendation from APNEC 2 in National Health Research Strategy

Arrange a national meeting IRB’s personal. Dissemination of National Ethical guideline and National Health Research Strategy in respect of country region Formation of Research Monitoring cell.

Who? Who are the key stakeholders?

NREC Members of NREC; policy makers from MOH&FW; representative from relevant ministries such as ministry of Environment, Ministry of disaster management and relief; Forest and Climate changes, representative from WHO section, representative from DGDA, DGDA, Professional bodies, Medical Education, relevant INGOs and NGOs

Members of NREC, Members from the respective ministries; representative from WHO section, Director General of DGHS, Director General of DGDA, president of professional bodies, Director from CME and representative from relevant INGOs and NGOs

Resources What is needed to accomplish these steps?

Documents on Ethics. Available resources on existing ethical guideline related to climate changes, emerging technologies and indigenous population Financing

Available existing guideline of medical ethics and research ethics of relevant topics Available country region information based on climate change, emerging technologies and indigenous population

Available guideline on ethics relevant with emerging technologies for distribution Available guideline on ethics relevant with Climate changes for distribution Available guideline on ethics relevant with indigenous population for distribution Feedback template Pen, paper, power point

Support What resources or support do you need from WHO/UNESCO?

Intellectual support such as clinical, public health and research ethics experts Financial support such as Honorium for resources persons & participants, refreshment for meeting attendance, and other associates to arrange a meeting,

Consultative support Intellectual support relevant with ethics experts Financial support for Training

Training-long term & short-term training on relevant topics Consultative meeting with representative of WHO/UNESCO before arranging the programme

• Sharing the updating knowledge and resources

• Intellectual support relevant with ethics experts

• Financial support

• Ongoing monitoring support for maintaining the quality of programme and implementing research work

33

Outcomes What are your desired outcomes?

Sensitization of NREC members. Increase awareness on relevant topics Identifying the priority areas accurately as per needs.

Update of existing Ethical guideline & SOP’s. Properly work distribution among stakeholders Outline of feedback mechanism Assist to policy makers and relevant stakeholders for initiation of next steps.

Implementation of Guideline properly Strengthening the capacity of NREC Strengthening the capacity build-up of Researcher, Reviewers

34

BHUTAN





Sharing the issues discussed during the AP-NEC with the health research unit and other relevant stakeholder to incorporate the issues of climate change, emerging technology and indigenous people during the review

Website development for Research ethics board of health to improve data sharing and access to ethical review

Ensuring and strengthening the Health Technology Assessment guideline to include ethical component

Develop ethical framework and guidelines for data sharing


REBH, Research unit and health management information unit

National environment commission, Ministry of agriculture and forests, ministry of health, Royal University of Bhutan, National referral hospital, policy and planning division Research ethics board of health, ICT division of health, health management and information unit, policy and planning division

Ministry of health, national environment commission, department of hydro-met services, ministry of economic affairs, ministry of agriculture and forests


[No additional resources] Financial resource and technical support in developing the website; resources for the capacity building of the HTA panellist on ethics and health technology

[No additional resources]


[No additional support requested] Financial support for development of website and web management fee; Technical support for development of guideline

[No additional support requested]


Issues discussed and disseminated to all Website for REBH developed Ethics incorporated in HTA guideline

National data sharing framework

35

BRUNEI DARUSSALAM

Immediate e.g. One Week after AP-NEC2




Share meeting report together with recommendations with MOH, Brunei

Sharing of recommendations with stakeholders Setting up national research framework

Multi-sectoral discussion/s re national research framework established Drafting of policies/guidelines


Ministry of Health MHREC IRB (University)

Ministry of Health MHREC IRB (University)

Ministry of Health Other ministries and government agencies- MHREC IRB (university)


Documentation Funding (MOH) Technical assistance Funding


[No additional support requested] Research capacity building training and technical assistance to set up research framework

Technical assistance


Endorsement of recommendations from MOH Dialogue set up established Draft national research framework

National research framework established Policies/guidelines established

36

CAMBODIA





Make report to chair of NECHR Capacity building Emerging technologies

Capacity building of NECHR involving human subjects, training and training of trainers Emerging technology Revise ethical guidelines and SOPs of the NECHR


NECHR chair and members NECHR Researchers Policy makers Teachers Professors

NECHR (National Ethics Committee for Health Research) Researchers Policy-makers Teachers Professors


Computer and electricity Finance and human resources / Funding and training

Financial and human resources Funding and training


All materials of conferences Technical and financial resources Technical and financial resources


Well-informed NECHR

Competent for NECHR and teachers and professors High quality standards of reviews Quality in teaching ethical practices for students

Competent for NECHR and for teachers/professors Up to date guidelines and SOPs High quality of reviews Quality in teaching ethical practices for students

37

CHINA





Release an ethical Guideline on Clinical Research Make a plan for Training Program

Provide training courses in research ethics Initial supervision system

Implementation Start to check the quality via the system


Policy-makers Professionals IRB members Trainers

Hospitals, doctors, researchers (both basic scientists and clinical researchers)

Strengthen the education program on bioethics at medical universities


Bioethicists who have the knowledge about substantial ethics and have knowledge and capacity for reasoning and argument for special ethical issues. Not only do it via their tuition. WHO and UNESCO specialists.

Same as immediate term System and capacity building


Specialists on bioethics Specialists on bioethics Specialists on bioethics


Help scholars in China set up a unified ethical standard and guidelines according to international guidelines

Implementation (long term work) Implementation

38

COOK ISLANDS





Write a report to MoH on meeting Write ethics guidelines for humans Set up ethics committees

Climate change on the national agenda Research priorities identified


MoH MoH MoH


Access to online materials Time to write Government buy-in

Government buy-in


Access to presentation materials Online materials

We need funding to support training of ethics committee and writing of ethical guidelines

Funding to support priorities, workshops and to support research


Completion of tasks Committee meets to review applications Research terminology is defined by Cook Islands understandings

Grassroots understanding of climate change research and research ethics

39

FIJI





Provide feedback on climate change & health unit in the Ministry Provide feedback to Health Research Ethics reviewers and Ministry of Health executives Provide feedback to indigenous ministry of ethics committee

Development of interdisciplinary ethics committee; engage with climate change team on KPIs for the plan Conduct consultation with climate change and health unit on draft policy for research ethics Participate in indigenous research ethics committee and invite a representative from the indigenous ministry to be part of the health research committee

Work with FEMAT on EMT policy (expedited review) that governs all visiting EMT (incl. research teams for disasters) Engagement with national research council through an inter-disciplinary research committee Establishment of MoU with UNESCO and WHO on capacity building on research ethics committees


Climate Change & Health Committee Ministry of Itaukei research ethics focal point National health researcher reviewer and committee

National health research committee reviewers and members Ministry of education and Ministry of Indigenous affairs focal points Other Pacific countries' ministries of health interested in strengthening bioethics

National disaster management office, FEMAT, National research council, WHO and UNESCO focal points, Ministry ESU, bioethics focal points of ministries of health of other countries


Communication via email and on-line sharing of technical documents and survey report

Consultation workshop, face to face meetings and trainings

Policy development in peri-disaster period, Memorandum of Understanding with UN agencies


On-line resources e.g. dropbox link, complete results of the survey to share with the respective units

WHO technical assistance; workshop funding; contracted technical expertise

WHO and UNESCO technical contractors; training funds (3 years) and ethics committee members mentorship


Create awareness on the outcomes, outputs of the meeting and consensus on 'problems & solutions' on the three major themes of discussion

Establishment of an interdisciplinary ethics committee in government and the ministry of health

Strengthened capacity for bioethics committee with support of WHO and UNESCO for 3 years

40

INDIA





Present the meeting report to ICMR Identify stakeholders for AI ethics and Tribal Populations Develop plan for ethics curriculum

Appoint subcommittees to draft ethical guidelines for research on tribal populations Plan the AI ethics consultation with experts including data scientists and civil society & others Appoint subcommittee to draft various sections for ethics curriculum for teaching at various levels students, researchers and ethics committees

Draft national guidelines for research on tribal groups Hold artificial intelligence expert consultation meeting meeting to finalize the ethics curriculum for India (researchers, ethics committee) regional meeting for SEA on ethics/ ethics training for SEA Region


Ethics committee members, bioethicists, researchers, medical scientists working on AI, data scientists, members of civil society, scientists working with tribal groups, tribal population representatives




[No additional resources] Budget for consultative meetings, budget for development of curriculum

AI consultative workshops/ meetings, ethics curriculum finalization meeting budget


[No additional support requested] WHO can support consultation for AI meetings and UNESCO can support ethics curriculum development

WHO can support consultation for AI meetings and ethics training for SEA region and UNESSCO can support ethics curriculum development


[None stated] Expert and public consultations and engagement to get feedback from various stakeholders

Finalization of a guidelines document and ethics curriculum

41

INDONESIA





Make an evaluation/ research plan for strengthening NEC (National Ethics Commission of Ministry of Health) Develop instruments for accreditation for all IEC

Submit evaluation research proposal Prepare validity instruments for accreditation Continue training and supporting IEC/IRB

On-going research evaluation activities Pilot test evaluation for accreditation


NEC, IEC, academic and hospital member NEC, IEC, academic and hospital member NEC, IEC, academic and hospital member


Financial support Financial support Financial support; materials of bioethics/ climate change


[No additional support requested] Financial as well as technical support Financial as well as technical support


[None stated] Documents: proper design evaluation research Dissemination and publication

42

JAPAN





Preparation of the Trip Report for the relevant directors and deputy-directors in the Cabinet Office. Preparation of the short-focused report of the meeting to share with relevant section of the MoH and MEXT. Preparation for the formal internal report included recommended action forward.

Provide official report to the Expert Panel for Bioethics, Council for Science, Technology and Innovation, Cabinet Office, Japan Preparation of the hand over material for the next AP-NEC logistics and an informative material for the Global Summit attendee. Frame work recommendation for assessment by IRB on research project using genome modification on human embryos from the Expert Panel for Bioethics to the Council for Science, Technology and Innovation may published (which currently under discussion).

Discussion of "bioethics governing", WHO is responsible for what bioethical topic and collaboration frame work for relevant Ministries by subjects. Or new idea of setting up the one independent NEC for all ethical issues if Government decides. Completion of the development or revision of the series of national guidelines for the basic and clinical researches using genome modification technology on human embryos. Including the guidance for the establishment of the system/structure for the research protocol and ELSI assessment in the country (expansion of IRB TOR, revision of IRB member requirements etc)


Cabinet office senior managers, MoH and MEXT PI working with genome modification technologies, Medical facilities and Universities and research institutions where those PI affiliate, MEXT, MoH, society

PI working with genome modification technologies, Medical facilities and Universities and research institutions where those PI affiliate, MEXT, MoH, society


My time and effort Time, summary report from the 2nd AP-NEC meeting

Not sure


Ideal if the official report for the meeting comes out in time to attached with some prospect on practical action the Region may able to take for the next step (sounded it is still at the level of each country effort to make).

[No additional supported requested] Support on providing IRB training may be of possibility if it could be done by mother tongue and if the Panel recommend to seek training to all IRB members in research entities (either to pose new "qualification" and/or modify current requirement is currently under discussion at the Expert Panel)., but it is after being decided the direction by the Panel.


Succeed to convince the importance to collaborate with regional countries working on bioethics issues will benefit to clarify the standard for the research bioethics practice for the emerging technology application, such as genome modification and AI in health.

Expert Panel recommendations Any conclusion will be accepted given it comes out from in-depth discussion by the Expert Panel for Bioethics. (Current suggestions for genome editing technology involved research include; 1) all assessment should be done at IRBs in the research facilities where PI belongs with additional

43

requirements to call in internal or external bioethics specialists on board, 2) 1+subject to the National Bioethics Board (newly establish technical committee?), 3) all to the National Committee, 4) or other)

44

REPUBLIC OF KOREA





KPIs for cross-sectoral action Collect ethnicity data

NECs should develop a lot of ethics preparedness and review protocols Increased interaction and coordination between NECs and other research oversight bodies & public health authorities Identification of risk, lack of clinical research expertise, early roll out Decentralization and diversification of research, blurring line between clinical application and quality, public health Knowledge gap between researchers and others (public, government, NECs) is widening, research literacy and understanding of state of current technology is limited

Climate change ethics to global level for leadership Develop ethical framework for data sharing internationally Ensure adequate treatment facilities, financing, national bodies need to intervene Number, complexity and pace of new technologies is outpacing ethical guidelines/ law Increased global inequity through improving health of some but not all Influence of industry and politics including technology introduced but not licenced in country


Ministry of Health

National Ethics Committees, Ministries of Health, Academic Societies Researchers, public practitioners, policy-maker, national bioethics committee, public

Academics –Medical School/ UPNG Institute of Medical Research


Political resources

Conference, media

Human resources, financial resources Law enforcement, building guidelines


[No additional support requested] Examples from other countries

Global ethical and legal frameworks


Developing climate-action leadership in healthcare

NEC-initiated protocols regarding climate change preparedness Building reliable, safe and efficacy of the emerging technology Building mutual understanding in the various stakeholders

Ethical framework for data sharing Narrowing the divide between technology, ethics and law

45

MALAYSIA





National Ethics Committee Bring together all ethics committee under one platform To get political and administrator buy-in

Regular training of Ethical members Increased interaction and coordination between NECs and other research oversight bodies & public health authorities

National Guideline on Research in Malaysia Strengthen the Compliance Audit on Research approved in Malaysia


Ministry of Health Ministry of Education, and other related Ministries

Ministry of Health Ministry of Education

Ministry of Health NERCIM Ministry of Education


Human resource Funding Human Resource

Funding Human Resource for capacity building


WHO/UNESCO Ministry of health Registration of NERCIM (Network of Research Committee in Malaysia)

WHO/UNESCO Ministry of Health NERCIM National Ethics committee


National Ethics Committee NERCIM

ETTC training done Guideline on Research in Malaysia Regular compliance audit done

46

MONGOLIA





National Ethics Committee Bring together all ethics committee under one platform To get political and administrator buy-in

Regular training of Ethical members Increased interaction and coordination between NECs and other research oversight bodies & public health authorities

National Guideline on Research in Malaysia Strengthen the Compliance Audit on Research approved in Malaysia


Ministry of Health Ministry of Education, and other related Ministries

Ministry of Health Ministry of Education

Ministry of Health NERCIM Ministry of Education


Human resource Funding Human Resource

Funding Human Resource for capacity building


WHO/UNESCO Ministry of health Registration of NERCIM (Network of Research Committee in Malaysia)

WHO/UNESCO Ministry of Health NERCIM National Ethics committee


National Ethics Committee NERCIM

ETTC training done Guideline on Research in Malaysia Regular compliance audit done

47

NEPAL





Dissemination of the meeting presentations and report to NHRC/MOHP/Nepal

Interaction/consultation with responsible agencies in climate change, indigenous population and emerging technologies Review and revise the specific Guideline/SOP's Initiate process for Capacity building training

Finalization of the revision of Guideline/SOP Initiate Implementation of the project as per revised guideline/SOP Capacity building Trainings on ethical conduct of research, review & assessment of research protocols, monitoring of the ethical practice in research


Prof Dr Prakash Ghimire, & Prof Dr Aarati Khanal Shah

ERB/NHRC/MOHP/ICMR/WH MOHP/GON/ICMR/WHO


Meeting logistic Consultative meetings & Training plan Consultative workshops and Training


NHRC NHRC/WHO/UNESCO NHRC/WHO/UNESCO


Updates on health research /bioethics progress and challenges in the Asia and pacific (country & region)

Discussion and feedback from the AP-NEC meeting with the country responsible officials on good practices and opportunities. Initiation of process for capacity building collaboration

Finalization of the Guideline, SOP and Capacity building trainings

48

NEW ZEALAND





Brief the Ministry of Health, NEAC and interested collaborators on APNEC II findings and topics. Review Pacific contacts from APNEC and liaise with Ministry of Foreign Affairs on developing a training program for research ethics.

Set work program for 2020, addressing need to strengthen clinical ethics infrastructure in relation to emerging technologies (AI), and in public health – gene editing. Scan current NZ work on ethics of climate change, noting recent climate bill was passed. Conduct training for all researchers and ethics committees on new ethical standards for research, focusing on indigenous populations ethics.

Support the Ministry of Health in revising the NZ Ethics Landscape, reviewing the scope of ethical review of national ethics committees. Support the Minister in developing gene editing in health / NZ. Review impact of ethical standards for research work and seek international engagement in assisting pacific countries with their standards.


Bioethics committees, Ministry of Health, MFAT, Minister of Health

District health boards, Ministry, Health and Safety Quality Commission, Health Research Council, National Ethics Committees, other GOVT agencies.

District health boards, Ministry, Health and Safety Quality Commission, Health Research Council, National Ethics Committees, other GOVT agencies.


Guidance on training ethics in other countries.

Expert advice from technical advisors on new technologies and climate change.

Expert advice from technical advisors on new technologies and climate change.


Advice and guidance on how to assist other countries with bioethics capacity

Share work and experience on emerging tech and gene editing from WHO and UNESCO international committees.

[No additional support requested]


Strengthen relationships with pacific neighbours, increase value and impact of NZ ethics work, share knowledge and build inter-govt and civil society relationships

Build relationships with WHO and UNESCO to advance NZ as a regional leader in bioethics. Build NZ capacity in clinical ethics.

Strengthen ethics environment, normalize ethics in govt work.

49

PALAU





Review all Conference materials to identify what can be utilized by the Palau IRB with its development. Contact fellow colleagues from the Pacific region to initiate/continue dialogue on potential partnership and networking. Prepare report for Palau IRB board members on the findings/results of the 2nd AP-NEC Conference.

Proceed with Palau IRB proposed calendar of events and tasks as assigned by the IRB Board. Review and approve proposed IRB protocols; regulations; and fees, as developed by local consultant. Identify potential archiving system/database/repository system for Palau IRB to archive protocols and study results.

Conduct process evaluation on Palau IRB protocols and regulations as developed and approved by IRB Board.


Palau IRB Secretariat (Gaafar Uherbelau, Health Policy, Research & Development Office); Palau IRB Board members; Other Pacific Island delegates who attended the 2nd AP-NEC Conference.

Palau IRB Board; Palau IRB Secretariat; Consultant (local)

Palau IRB Board; Palau IRB Secretariat


AP-NEC2 Dropbox shared files; Time & Date coordination for zoom/conference calls.

Request for proposal for local consultancy on IRB regulation development.

External entity/ethics committee expertise


WPRO/WHO Suva to assist in forming a Pacific sub-regional group for information and best practices sharing amongst Pacific Island states

Assist Palau IRB Secretariat to identify suitable archiving/data repository system to be used to archive protocols and research data and results.

Identify potential external evaluator to review Palau IRB protocols and regulations.


Summary of relevant conference documents and findings to present to Palau IRB Board members; Initiate dialogue on potential regional partnerships on NEC/IRB development.

Reviewed and endorsed Palau IRB regulations and protocols; List create for IRB Board review of potential archiving systems that Palau IRB could utilize.

Enhanced Palau IRB regulations and protocols.

50

PAPUA NEW GUINEA





Compiling the workshop report and dissemination

Consultative meet with Climate Change team and Medical Research Advisory Committee

Consultative meetings/Country workshop/ Attend Portugal and Nepal next Ethics/Bio Ethics meeting


Public Health Team Clinical Chiefs/Medical Standards Team

Climate Change team/Medical Research Advisory Committee Line Departments

Senior Executive Management Public Health and Medical Standards Team Academics –Medical School/ UPNG Institute of Medical Research


Workshop material/Presentation Climate Change literatures/Policies and Strategies. Country meeting reports

Financial Support/Materials of Bio-ethics/Climate Change


Workshop session materials from the meeting in New Zealand

Ethics consultants Financial Support/ Ethics Consultant from the region


Workshop report completed, presented and disseminated

Committees established with TORs Policies and Strategies established Workshops conducted in country and Present country brief in next meeting

51

PHILIPPINES





Provide feedback to the respective agencies/offices what have transpired during the meeting Mapping out of existing Ethics Committees from different agencies, offices (internal)

Establish and strengthen networking among the stakeholders and internal key actors (DENR) and other existing Ethics Committees Plan joint capacity building

Capacity building/workshops/bench marking


DOH PHREB

DOH PHREB WHO UNESCO Other partner agencies Asia-Pacific Country

DOH PHREB WHO UNESCO Other partner agencies Asia-Pacific Country


[No additional resources] [No additional resources] Budget allocation if not sponsored


[No additional support requested] [No additional support requested] Experts from WHO/UNESCO


To ensure proper dissemination of information of what have transpired and recommended during the meeting

Timetable for plan of activities To be included in the lists of ethics committees with corresponding representation from their respective agencies/office as part of networking

Capacitated Ethics Committee Members and Secretariat Developed policies/guidelines to serve as a basis for strengthened regulation for proper implementation Shared information and updates for Ethical issues

52

SAMOA





Meet the chair of the Health Research Committee (HRC) to discuss about this meeting and its outcomes including recommendations. Present findings from this meeting to the HRC

Review HRC policy Meet or consult with other relevant ministries, stakeholders including Universities to discuss about the formation of a National Ethics/Bioethics Advisory Committee

Follow up on the formation of a "National Ethics/ Bioethics Advisory Committee" Request for capacity building training /workshop for HRC and National Ethics/ Bioethics Advisory Committee Create a National Ethics Committee that looks after ethics of all areas, especially with respect to research, health, climate change etc.


Chair of HRC, who is also the Director General, and health research committee members

Ministry of Health and Councils regulated under the MoH (e.g. medical, dental, pharmacy etc.) Health related NGOs, Ministry of Environment and other relevant ministries and donor partners such as WHO and UNESCO

Ministries and relevant ministers, and their stakeholders, donor partners (WHO, UNESCO, MFAT, DFAT etc.)


None None

Technical assistance on 'ethics' and funds


[No additional support requested] Technical assistance with the review of existing polities and/or consultations

Technical assistance and to advocate from the global and regional level for 'bioethics'


To receive support or blessing from the chair and HRC to support the development intended to improve the role of the HRC and introduce collaboration with other ministries or institutions that also regulate ethics and research, use of new technologies, monitor climate change and health

To update the HRC policy and to ensure the formation of a national body to oversee, monitor and regulate standards and ethics with regards to research, new technologies, climate change and other important values that influence and affect human (people) and health

To ensure the formation of a national body to oversee, monitor and regulate standards and ethics with regards to research, new technologies, climate change, equity and other things that will become important to use in the future

53

SINGAPORE





Identify and prioritise new emerging technologies we want to consider examining

[None stated] Partnerships with neighbour governments on bioethics and clinical ethics issues, capability and capacity Exhibitions to build public awareness of medical and bioethics / equity issues Collaboration with WHO and UNESCO to develop medical ethics and bioethics capability / initiatives


[None stated] Legal profession, clinicians, scientists, youth groups, students, IRBs, religious groups

[None stated]


Partnerships [No additional resources] Ethics Research


UNESCO /WHO- tapping into the experts [No additional support requested] Build a national ethics network for education and practice


[None stated] Competency, capacity, capability Regional Centre of Excellence for Medical ethics and Bioethics

54

SOLOMON ISLANDS





Draft and present a meeting report with recommendations to the Ministry of Health and WHO Office in Honiara Individual consultations with the Ministry of Health & WHO to gain support & their perspectives on the short-term-medium & long-term plans Finalizing recommendations for submission & endorsement to the Ministry of Health for WHO final review & endorsement

WHO to finalize contract with James Cook University to facilitate the second cohort of Research Capacity Building fellows WHO to review & finalize consultancy contract for the review of the Solomon Islands National Health Research Policy & the Operational manual for the Solomon Islands Health Research Ethics & Review Board (SIHRERB) in 2020 as per the Research Department Annual Operational Plan Formalize external /south-south institutional partnership for ongoing MHMS research & ethics capacity building

To facilitate the Research Capacity Building workshop for the second cohort of MHMS staff To develop operational tools (guidelines, ToRs) for the establishment of provincial level research hub To strengthen the National research ethics system by establishing electronic database for ethics


Solomon Islands (SI) Ministry of Health & WHO country Office

SI Ministry of Health, WHO Country Office, James Cook University, Solomon Islands National University & WPRO Research Office

SI Ministry of Health, WHO Country Office, James Cook University & Solomon Islands National University


Human resources, including Technical Time & Human Resources, including technical & funding support

Time & human resources, including technical & funding support


Technical Technical & Funding Support Technical & Funding Support


To obtain support from stakeholders in order to move on to the next phase of having the short-term plans achievable

To formalize agreements & support for the set of short-term plans

To train 20 local research fellows To establish 3 research hubs in 3 selected highly researched provinces Establish an electronic database with all 8 ethics members attended at least an ethics training annually in their two years of membership

55

THAILAND





Notify National committee Submit agenda for reducing inequities

Country draft plan on reducing inequities through solutions orientated bioethics

Final plan submitted to national economic and social development board of relevant bodies


People's groups and civil societies, government agencies, private sector




None

Budget from Ministry of Higher Education, Science, Research and Innovation (MHESI)

Budget from Ministry of Higher Education, Science, Research and Innovation (MHESI)


None Short term consultant

Short term consultant Training


Approval of proposal by National Committee for Promotion of ethics of Science and Technology

Approval by National Committee and MHESI

Approval by National Economic Social Development Board & Relevant Bodies Funding of programmes

56

VIET NAM





Disseminate the content of the course to researchers, ethic committee members, authorities

Develop guidelines for reducing inequities through solutions-orientated bioethics Develop a training programme for researcher on equity and efficacy in health research Develop a training programme for ethic committee member on equity and efficacy in reviewing and assessing health research.

Complete the legal framework for bioethics Strengthen the capacity of ethic committees Improve the capacity of researchers in bioethics research


Ethic committee members, researchers, authority Ethic committee members, researchers, authority, sponsor

Ethic committee members, researchers, authority, sponsor, research sites/hospitals


Literature review, disseminate meeting, website of national ethic committee

Technical support, workshops for contributing opinions

Project on strengthening national capacities for health ethics, focus on reducing inequities through solutions-orientated bioethics


Related documents International consultants, workshops, study visit for ethic committee members and ministry of health officers

Technical and financial support for the above project


All key stakeholders understand well the content of the course, especially the content of inequities in bioethics research.

A guideline for reducing inequities has been approved and disseminated by Ministry of Health and an advanced training programme on health ethics, focus on reducing inequities for researchers and for ethic committee members has been developed

Complete the national system for health ethics

www.wpro.who.int

Meeting Report