ETHICS IN MEDICAL RESEARCH IN MYANMAR

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

2. Ministry of Health Ministry of 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

3. National Ethical Review Committee on Medical Research Members • Deputy Minister of Health Chairperson • Director General, Department of Vice-chairperson • Medical Research (Lower Myanmar) • Director General, Department of Health Member • Director General, Department of Medical Member • Science • Director General, Department of Health Member • Planning • Director General, Department of Traditional Member • Medicine • Director General, Department of Member • Medical Research (Upper Myanmar) • Director General, Department of Member • Medical Research (Central Myanmar)

4. Members (contd.) • Director General, National Archives Department Member • Deputy Director-General, Department of Medical Member • Research (Lower Myanmar) • Representative, Directorate of Medical Services, Member • Ministry of Defence • Representative, Attorney General’s Office Member • Representative, Myanmar Women’s Affairs Member • Association • Advisor, Department of Medical Research Member • (Lower Myanmar) • Director, Livestock Breeding and Veterinary Member • Department • Professor of Psychology, Yangon University Member • Professor of Medicine, University of Medicine(1), Member • Yangon • Professor of Surgery, University of Medicine (1), Member • Yangon • Professor of Obstetrics and Gynaecology, Member • University of Medicine (1), Yangon

5. Members (contd.) • Professor of Child Health, University of Medicine (2), Member • Yangon • Professor of Pharmacology, University of Medicine (2), Member • Yangon • Professor of Forensic Medicine, University of Medicine (1), Member • Yangon • Director (Biomedical Research), Department of Medical Secretary • Research (Lower Myanmar)

6. 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

7. Departmental and University Ethical Review Committees Members • Head of Department or University Chairperson • Directors or Professors (~ 3-4 nos.) Members • One or more intellectual non-medical Member • persons • One or more intellectual ladies Member • Director of Professor Secretary

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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