Transcript Capacity Building in Research Ethics

Capacity Building in Research
Ethics
Experiences from Thailand
Soraj Hongladarom
Department of Philosophy, Chulalongkorn University
Bangkok, Thailand
Outline
The general situation in Thailand
The ASEAN-EU LEMLIFE Project
Activities of the Project related to research
ethics
What was discussed and outcomes
General Situation
The Medical Profession Act (1982)
The Medical Council is authorized to issue
directives to set standards of the medical
profession, and part of the standards concern
research on human subjects.
Requirement that such research need to be
approved by an ethical review committee
(ERC).
ERCs in Thailand
There are several ERCs working at
different levels.
All IRCs are set up as part of a health care
organization—hospitals, medical schools,
research institutions within the Public
Health Ministry
CIOMS guidelines are generally followed,
but there are variations.
Capacity Building Initiatives
Forum for Ethical Review Committees in
Thailand (FERCIT)
Trainings organized by various agencies
Different departments in the Ministry of Public
Health
Hospitals
Universities
Research Institutes
The ASEAN-EU LEMLIFE Project
 Initiative of the ASEAN University Network
(AUN) and the European Union
 ASEAN-EU University Network Programme
(AUNP)
 Objectives
Develop training programs and content on bioethics
Institutionalize the programs as a master’s program at
Chulalongkorn University
Disseminate the knowledge and awareness in bioethics
to the general public
Website
http://www.asean-eu-lemlife.org/
Collaboration
 Chulalongkorn Univ.
 Vietnam National
Univ.
 Universiti Sains
Malaysia
 University of the
Philippines
 Lüneburg University
 Lancaster University
 Friedrich-SchillerUniversität Jena
 University of the
Basque Country
Main Outcome
An international MA in bioethics program
at Chulalongkorn University
Currently being reviewed by the
administration
Interdisciplinary—philosophy, law,
management, economics, sociology
Close collaboration with the UNESCO
Continuing Activities
Further networking and collaborative
activities
Asia-Link project
The 8th Asian Bioethics Conference, March 1923, 2007, Chulalongkorn University
Center for Ethics of Science and
Technology
Research unit, seed funding given by the
university
Research Ethics Education
Course syllabus on the topic part of the
output of the LEMLIFE project
Research ethics to be a course in the MA
program
Training Session on “Introductory
Bioethics: Research Ethics”,
Chulalongkorn University, November 2325, 2005
Training Session Topics
 History
 Ethical Principles
 Framework for
Protection of Human
Subject
 Clinical Care and
Clinical Research
 Informed Consent
 Ethical Issues in Genetic
Research
 Ethical Issues in
International Research
 Roles and
Responsibilities of the
Investigator
 ICMJE Guidelines and
Registration of Clinical
Trials
The Meeting
Part of the CU Academic Festival
Attended by 90+ people
Speakers:
Soraj Hongladarom
Chaichana Nimnuan
Nandana Indananda
Tada Sueblinwong
“Management of ERCs in the
University”
 Brainstorming meeting, Friday, November 25,
2005, 13:30-16:00 Chulalongkorn Univ.
 Agenda:
Co-ordination of the various ERCs within the university
Adaptation for meeting international standard
Monitoring of research done by non-medical
professionals
Possible need of a legal mechanism specifically on
research ethics
Lab animals
Co-ordination
 Problems
Many ERCs even at
Chulalongkorn
Protocols already
approved by one, but
disapproved by another
Lack of uniform
procedures
 Proposed Solutions
Increased
communication
Sharing of procedure
manuals
Meeting International Standard
 Problems
Many ERCs in the
country apparently are
in need of more
capability building.
Difficulty in recruiting
ERC member
Lack of knowledge
 Proposed Solutions
More activities which
are geared toward
increasing the
capability
Use of information
technology
Biggest obstacle still is
recruiting ‘outsiders’.
Research by Non-Medical
Professionals
 Problem
Currently, there is no
regulation of research
performed by nonmedical scientists.
 Proposed Solutions
The public need to be
aware of possible
breach of ethics by
such persons—social
sanction.
National level law and
‘common rules’
Regulations demanding
ER in basic scientific
research
Should there be a law?
 Problem
As mentioned before,
there is no formal
regulation monitoring
research done by nonmedical scientists
 Proposed Solutions
National law requiring
all research on human
subjects in the kingdom
be approved by an
accredited ERC.
Arguments for and
against
Humans and Animals
Strange scenario?
The draft of the National Research on
Laboratory Animals Act is being deliberated in
the Thai parliament, with the distinct possibility
that it will become law within two years.
However, there is not even an attempt to draft
the National Research on Human Subjects Act
yet.
Thank you for your attention!