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/
Chulalongkorn Univ. Vietnam National Univ. Universiti Sains Malaysia University of the Philippines Lüneburg University Lancaster University Friedrich-Schiller-Universität Jena University of the Basque Country Collaboration
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 19-23, 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 23-25, 2005
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 Training Session Topics
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
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 Co-ordination
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’. Meeting International Standard
Problem Currently, there is no regulation of research performed by non-medical 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 Research by Non-Medical Professionals
Problem As mentioned before, there is no formal regulation monitoring research done by non-medical scientists Proposed Solutions National law requiring all research on human subjects in the kingdom be approved by an accredited ERC. Arguments for and against Should there be a law?
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.