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 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

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) Medical Research (Central Myanmar)

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 Professor of Obstetrics and Gynaecology, Member University of Medicine (1), Yangon

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

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 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

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

To develop ability to judge and make systematic ethical 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