Transcript Slide 1

ETHICS IN MEDICAL RESEARCH
IN MYANMAR
Kyaw Moe1, New NweYee2 and Khin Wai3
1Department
of Medical Research (Lower Myanmar),Yangon
2Department of Medical Research (Central Myanmar), Pyinmana
3Department of Medical Research (Upper Myanmar), Pyin Oo Lwin
Ministry of Health
Ministry
Health
National Ethical Review Committee on Medical Research
Departmental Ethical Review Committees
Dept of
Health
Services
Dept of
Medical
Science
Dept of
Med Res
(Lower M)
Dept of
Med Res
(Upper M)
Dept of
Med Res
(Central M)
Dept of
Health
Planning
Dept of
Traditional
Medicine
University Ethical Review Committees
Universities of Medicine(4), Dental Medicine (2), Paramedical
Sciences (2), Pharmacy (2), Nursing (2), Community
Medicine (1)
Univ. of
Traditional
Medicine
National Ethical Review Committee
on Medical Research
Members
• Deputy Minister of Health
• Director General, Department of
Medical Research (Lower Myanmar)
• Director General, Department of Health
• Director General, Department of Medical
Science
• Director General, Department of Health
Planning
• Director General, Department of Traditional
Medicine
• Director General, Department of
Medical Research (Upper Myanmar)
• Director General, Department of
Medical Research (Central Myanmar)
Chairperson
Vice-chairperson
Member
Member
Member
Member
Member
Member
Members (contd.)
• Director General, National Archives Department
• Deputy Director-General, Department of Medical
Research (Lower Myanmar)
• Representative, Directorate of Medical Services,
Ministry of Defence
• Representative, Attorney General’s Office
• Representative, Myanmar Women’s Affairs
Association
• Advisor, Department of Medical Research
(Lower Myanmar)
• Director, Livestock Breeding and Veterinary
Department
• Professor of Psychology, Yangon University
• Professor of Medicine, University of Medicine(1),
Yangon
• Professor of Surgery, University of Medicine (1),
Yangon
• Professor of Obstetrics and Gynaecology,
University of Medicine (1), Yangon
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Members (contd.)
• Professor of Child Health, University of Medicine (2),
Yangon
• Professor of Pharmacology, University of Medicine (2),
Yangon
• Professor of Forensic Medicine, University of Medicine (1),
Yangon
• Director (Biomedical Research), Department of Medical
Research (Lower Myanmar)
Member
Member
Member
Secretary
Functions of the National Ethical
Review Committee
• To lay down guidelines for the departmental and university
ethical review committees (ERCs)
• To confirm the proposed members of the departmental
and university ERCs
• To assess the research proposals approved by the
departmental and university ERCs
• To review the research proposals forwarded by the
departmental and university ERCs for approval by the
National ERC
Departmental and University
Ethical Review Committees
Members
•
•
•
•
•
Head of Department or University
Directors or Professors (~ 3-4 nos.)
One or more intellectual non-medical
persons
One or more intellectual ladies
Director of Professor
Chairperson
Members
Member
Member
Secretary
Functions of the Departmental and
University Ethical Review Committees
• To follow guidelines laid down by the National Ethical
Review Committee for Medical Research
• To review research proposals submitted to the committee
by researchers
• To approve outright or after recommended alterations or
reject the submitted research proposals
• To forward research proposals that need review and
approval by the National ERC
• To submit a list of approved research proposals to the
National ERC
Operational Guidelines for ERCs
Operational Guidelines for the Ethical
Review Committees for Medical Research are
based on the three fundamental ethical
principles of respect for persons, beneficences
and justice, and also on national regulations and
international recommendations
The Operational Guidelines for the Ethical
Review Committees for Medical Research
are based on the following references:
• World Health Organization. Operational Guidelines for Ethics
Committees That Review Biomedical Research
• World Health Organization. Surveying and Evaluating Ethical
Review Practices (complementary guideline to above)
•Council for International Organizations of Medical Sciences
(CIOMS), International Guidelines for Biomedical Research
Involving Human Subjects
• World Medical Association Declaration of Helsinki. Ethical
Principles for Medical Research Involving Human Subjects
• 1991 International Guidelines For Ethical Review Of
Epidemiological Studies
Undergraduate Curriculum
for Medical Ethics
AIM
To produce basic doctors who have the ability
to analyze and judge the ethical and legal issues
relevant to the practice of medicine
OBJECTIVES
Cognitive domain
• To understand basic ethical theories and principles
• To understand and analyze ethical problems in patients,
their families and society within the context of Myanmar
culture
• To promote logical and critical thinking in ethical issues in
patient’s care
Psychomotor Domain
• To develop ability to judge and make systematic ethical
decisions
• To apply ethical principles in medical practice in health
care
• To impart information to the patient regarding
management options in order that patients can participate
in decision making
• To develop ability to counsel the patient properly
Affective Domain
• To nurture the importance of ethical principles in every
professional decision making
Recent Workshops and Seminars
on Medical Ethics
• Workshop on Ethical Issues in Research in
Reproductive Health, 5-8 September, 2005, Yangon
• Seminar on Teaching of Medical Ethics, 22-24 August
2005, Yangon
• Workshop on Awareness Raising of Medical Ethics,
22 -24 June, 2005, Yangon
• Seminar on Ethical Issues in Medical Practice and
Research, 21-22 October 2003, Yangon