ETHICS IN MEDICAL RESEARCH ETHICS IN MEDICAL RESEARCH IN MYANMARIN MYANMAR

Kyaw MoeKyaw Moe11, New NweYee, New NweYee22 and Khin Wai and Khin Wai33

11Department of Medical Research (Lower Myanmar),YangonDepartment of Medical Research (Lower Myanmar),Yangon22Department of Medical Research (Central Myanmar), PyinmanaDepartment of Medical Research (Central Myanmar), Pyinmana

33Department of Medical Research (Upper Myanmar), Pyin Oo LwinDepartment of Medical Research (Upper Myanmar), Pyin Oo Lwin

Ministry of HealthMinistry of HealthMinistry of Health

National Ethical Review Committee on Medical ResearchNational Ethical Review Committee on Medical Research

Dept of Health

Services

Dept ofMedicalScience

Dept of Med Res(Lower M)

Dept of Med Res(Upper M)

Dept of Med Res(Central M)

Dept of HealthPlanning

Dept ofTraditionalMedicine

Universities of Medicine(4), Dental Medicine (2), Paramedical Sciences (2), Pharmacy (2), Nursing (2), Community Medicine (1)

Univ. of Traditional Medicine

Departmental Ethical Review CommitteesDepartmental Ethical Review Committees

University Ethical Review CommitteesUniversity Ethical Review Committees

National Ethical Review Committee National Ethical Review Committee on Medical Researchon 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)

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

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)

Functions of the National Ethical Functions of the National Ethical

Review CommitteeReview 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 Departmental and University

Ethical Review CommitteesEthical Review Committees

• 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

Members

Functions of the Departmental and Functions of the Departmental and

University Ethical Review CommitteesUniversity 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 Undergraduate Curriculum for Medical Ethicsfor Medical Ethics

To produce basic doctors who have the ability to analyze and judge the ethical and legal issues relevant to the practice of medicine

AIMAIM

Cognitive domainCognitive 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

OBJECTIVESOBJECTIVES

Psychomotor DomainPsychomotor 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 DomainAffective Domain

• To nurture the importance of ethical principles in every

professional decision making

Recent Workshops and Seminars Recent Workshops and Seminars

on Medical Ethicson 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