Ethics Review Committee
Department of Medical Research

Ministry of Health and Sports

Republic of the Union of Myanamr

Achievements of Ethics Review Committee (ERC)

Department of Medical Research (DMR)

 

The Ethics Review Committee for Biomedical Research involving human subjects was established and picked up its high momentum starting from the 1980. At first , the Department of Medical Research, Ethics Review Committee (DMR ERC) was the only ERC under the Ministry of Health and Sports and the reviews by the committee were done on an ad-hoc basic and were limited only to the protocols from Departments under the Ministry of Health and Sports. Since 1992, the ERC has extended its reviews not only on research proposals submitted by the local, but as well as international NGOs.  In 2003, in order to enable the ERC to efficient decisions, the ethical guidelines and standardized formats were laid down for submission of proposals in accordance with those of Council for International Organizations of Medical Sciences (CIOMS).

Reform of ERC composition took place in 2012 with an independent chairman leading the committee with the Director General, Deputy Director General, one technical Director, external members, community representatives or lay persons and one attorney as members. The ERC of DMR has become internationally recognized on attaining the Federal Wide Assurance (FWA 00018816) registration in 2012. This Assurance applies whenever the Institutions becomes engaged in research on human subjects conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects. With advancing science and increasing complexity of nature of research, more in-depth scrutiny is being made in areas like, safe guarding of not only the subjects but also of the community by judging risk-benefit ratio, importance of consent and accent forms and also the impact and applicability of research on health care policy. DMR (ERC) has reviewed 601 proposals in 2010- 2016 including proposals submitted by scientists form DMR as well as researchers from other Departments of Ministry of Health and Sports, UN agencies, NGOs and INGOs.

DMR scientists also serve as ERC members in Medical Universities for postgraduate research and conduct seminars and talks on Research Ethics as an effort for capacity building in this field. The Director General of the Department of Medical Research acted as the secretary of the National Ethical Committee on Clinical Research (formed on 21st   April, 1994) in assessing research issues which need wider and deeper scope of scientific and policy reviews. On 2nd November 2004, a national level ERC was reformed as “National Ethics Committee on Medical Research” (အမျိုးသားဆေးသုတေသန စမ်းသပ်မှုဆိုင်ရာကျင့်ဝတ် ကော်မတီ). It was chaired by the Deputy Minister of Health and members were Directors Generals from departments under MOH, Director from Attorney General office, Director from National Archives Department, one representative from Myanmar Women's Federation, Director from FDA, one woman outsider, 6 professors from various clinical disciplines, one representative from military research and Director (Research) from DMR (LM) acted as the secretary.