Milestones of Ethics Review at the Department of Medical Research (DMR)
In 1980, the Ethics Review Committee for Biomedical Research involving human subjects was established aat DMR nd picked up its high momentum. By that time, the Ethics Review Committee at the Department of Medical Research (ERC-DMR) was the only ERC under the Ministry of Health and the reviews by the committee were done in an ad-hoc basic and were limited only to the protocols from Departments under the Ministry of Health. Since 1992, the ERC has extended its reviews not only on research proposals submitted by the local, but as well as by the international NGOs. In 2003, in order to enable the ERC to efficient decisions, the ethical guidelines and the standardized format were laid down for submission of proposals in accordance with those of Council for International Organizations of Medical Sciences (CIOMS).
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 the “National Ethics Committee on Medical Research” (အမ်ိဳးသားေဆးသုေတသနစမ္းသပ္မႈဆိုင္ရာက်င့္၀တ္ေကာ္မတီ). It was chaired by the Deputy Minister for Health and members were Directors Generals from departments under MOH, Director (Attorney General Office), Director (National Archives Department), one representative from Myanmar Women’s Federation, Director (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.
In 2012, the reform of ERC composition took place with an independent chairman leading the committee that included Director General, Deputy Director General, one technical Director, external members, community representatives or lay persons and one attorney as members. In the same year, the ERC of DMR has become internationally recognized by attaining the Federal Wide Assurance (FWA 00018816) registration at the Office of Human Research Protections (OHRP), USA. This Assurance applies whenever the Institutions become 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.
Following the recognition as an accredited ERC (DMR) by SIDCER-FERCAP at the General Assembly, in November 2018, there has been a restructuring process in terms of its functions. Since its recognition, there are updates in its standard operating procedures, submission checklist, the ‘Reviewer Assessment Form’, ‘Letter of Communication to Principal Investigators’ and in organizing Full Committee Review Meetings and Expedited Review Meetings. The Ministry of Health and Sports, Myanmar has reformed and reorganized the structure of ERC (DMR) as the ‘Institutional Review Board’ (DMR) in 2019 with 15 members (at least 8 members including one non-affiliated community member to fulfill the quorum) and rejuvenated with young members to work cohesively with senior and experienced members. Seven experienced members and three Secretariat members of former ERC (DMR) remained as a Chair and member status in the recently reformed IRB (DMR) together with five new members with diverse expertise in biomedical, clinical, public health and social science. A new Secretariat team formed in 2019 comprises three permanent members and three rotating researchers every three months.
Mission of IRB