DOI: 10.11648/j.her.20261105.16 ISSN: 2578-935X

Research Ethics Governance and Responsible Conduct of Research at the Defence Services Medical Academy, Myanmar: A Documentary Analysis

Ye Aung, Myo Thu, Aung Thu, Thant Zin, Zin Htike, Zaw Myint, Mo Than
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Ethical Review Committees (ERCs) require both formal governance mechanisms and continuing capacity building to support consistent ethical review and responsible research conduct. The Defence Services Medical Academy (DSMA), Myanmar, has maintained institutional standard operating procedures (SOPs) for its Ethical Review Committee and has conducted recurring workshops on responsible conduct of research (RCR). To describe the longitudinal evolution of research ethics governance and RCR capacity building at DSMA using available institutional documentary sources. A retrospective descriptive documentary analysis was undertaken using available DSMA ERC SOPs dated 2017 and 2022, a separate 2022 SOP for principal investigators, the 2024 third-edition SOP, and RCR/research-ethics workshop programmes from 2018, 2022, 2023, 2024 and 2026. Documents were reviewed using predefined domains: governance and committee structure; review procedures; participant protection; informed consent; post-approval oversight; investigator guidance; data and material governance; documentation; and research-ethics capacity building. Changes were interpreted as documentary evidence of formalization, differentiation or expansion; no causal inference regarding research quality or participant outcomes was made. The documentary series demonstrated progressive formalization of ERC governance and expansion of operational guidance. The 2017 SOP already addressed committee functions and composition, vulnerable participants, review procedures, informed consent, expedited review, decision-making, monitoring and archiving. By 2022, the institutional SOP incorporated specific guidance for medical education and genetic research and additional operational forms, while a separate PI-oriented SOP provided investigator-facing guidance and multiple consent templates. The 2024 third edition reorganized the SOP into thematic chapters and expanded guidance for survey, records, qualitative and genetic research; waiver of consent; material transfer; data ownership/transfer/use; conflict-of-interest declaration; annual reporting; and final reporting. In parallel, RCR workshops documented from 2018 through 2026 repeatedly addressed research integrity, informed consent, data ethics, research misconduct and investigator responsibility, frequently using group work and discussion. Available documents indicate an evolution at DSMA from a broad institutional ethics-review framework toward a more differentiated governance system combining committee procedures, investigator guidance, research-specific ethical considerations, post-approval documentation and recurring RCR education. Future evaluation should assess implementation, review performance, investigator competence, protocol quality and outcomes of post-approval oversight.

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