Innovative interim ethical procedures in fragile and shock-prone settings
Myanmar has a fragile and weak health system, buckling under the burdens of political instability and non-communicable and infectious diseases such as COVID-19, malaria, TB and HIV.
Before the military coup in February 2021, health-related research was conducted in collaboration with respective public health programs aiming towards policy impact. Ethical review was an important step in the research process and health-related research went through an in-country ethical review process by the Research Ethics Committees (RECs) under the Ministry of Health. However, a review conducted in 2020 on local RECs stated that changes were required in “organizational commitment, membership composition, need for ethics training and continuing review with better REC resources…” (Zaw Zaw Oo et al. 2020). At that time all RECs were led by the government and were not independent. After the military coup the RECs became dysfunctional and many of the trained ethical experts in the health field who sat on these committees left the government service as part of the civil disobedience movement.
What problem is being addressed?
Conducting research in fragile and shock-prone settings (FASP) settings is particularly challenging for reasons including rapidly changing safety and security issues, access constraints, collaboration challenges, lack of trust in the research process, and limited research application (Woodward et al. 2017). However, research evidence from such settings serves as an important source of knowledge and learning for other settings dealing with fragility and shocks. Robust ethical review processes should be followed for all research that includes people as participants, to protect the well-being of both research participants and researchers and the reputation of the academic institutions.
Many research institutes, funding bodies and journals require ethical review before research is conducted and published. It is critically important in FASP settings that research protocols are reviewed by local reviewers who are knowledgeable about the context and culture, including safety and security issues. Many FASP settings do not have in-country RECs, or established RECs cease to function when the government loses its legitimate power to govern, as is the case in Myanmar.
What did we do?
The Burnet Institute is a research organization that has been conducting work in Myanmar for nearly two decades. As part of the ReBUILD for Resilience programme, the Burnet team developed a study protocol looking at the role of non-state actors in health service delivery. Faced with the problem of no functioning in-country RECs, the Burnet team explored possible options for ethical review which would both be robust and include critical local perspectives and understanding.
Knowing that conducting the proposed ReBUILD research was sensitive, and the situation was compounded by security concerns for research participants, researchers and ethics reviewers, the Burnet team discussed the issues with researchers from other fragile and conflict-affected settings and in-country research partners. Three possible ways to address the problem were identified:
- Ethical review and approval by an international research ethics committee outside Myanmar with the inclusion of people from Myanmar as independent review members in the committee.
- Ethical review and approval by an international research ethics committee with comments and a review process by independent Myanmar researchers included.
- Establishment of a new, independent ethical review committee with local Myanmar researchers, for the review and approval of research.
The third option was not considered feasible in the current context, so the other two options were taken into consideration. The Burnet team first developed a list of eminent public health professionals who had experience of conducting health research but who were not currently working in the government sector. Following discussions with research ethics experts, the Burnet team refined this list to 13 researchers with public health and research ethics knowledge. The team contacted all the individuals in the list and sensitively explained the situation and process. The anonymity of all the individuals contacted was protected to ensure their safety. Ten of the 13 list members agreed to participate in the process.
The REBUILD study protocol was submitted to Liverpool School of Tropical Medicine’s (LSTM) REC. ReBUILD’s LSTM research team and the Burnet team explained the difficult country situation to LSTM REC, how it was not feasible to conduct an in-country REC review and discussed the options. LSTM REC agreed that two local reviewers should assess the protocol independently. The local reviewers’ comments were sent to the LSTM REC, who considered the important local contextual knowledge that the independent reviewers contributed.
As the chair of LSTM REC explained, “When it came to the two reviews from Myanmar, I read these first and once I was reassured that they were content with the proposal then I was able to read the proposal knowing it was acceptable locally. In short, the local reviewers were absolutely critical and held the casting vote in my mind.” The LSTM REC also asked for detailed measures to mitigate risk to participants and research staff, which the team provided. The study was approved by the LSTM REC.
After the success of this first application using the new model, the process was discussed within the Burnet Institute, and it was agreed it could be used at the institute level on other research projects conducted in Myanmar with other collaborators. The risk inherent in conducting the study was extensively considered and safety protocols and risk mitigation procedures were also discussed. The Myanmar team’s work has now gone through the Alfred Research Ethics Committee in Australia using the same approach, and ethical approval has been obtained for three further research studies. The REBUILD team learnt that even in the challenging environment faced in Myanmar it was still possible to conduct research studies in an ethical way with the input of local reviewers who understood the context.
Under this established ethical review process, the Myanmar team has now successfully conducted four separate research projects, despite the continuing extremely challenging context. As the research studies have proceeded, other research organizations have approached the team to ask about the process and are considering replicating it in other settings. The reviewer list remains confidential, but in discussion with these organizations Burnet has conveyed the importance of local reviewers’ inputs for understanding not only the technical situation but also the context in which the research will take place.
Learning from this experience is also contributing to the development of LSTM’s policy on research in conflict areas.
The whole process showed that conducting research in a FASP setting with a sound ethical review process is possible if researchers adopt a sensitivity, awareness, and understanding of the context. The inclusion of local reviewers who understand the research ethical principles of integrity, autonomy, beneficence and justice, and have a willingness to innovate is also essential.
There’s information on all of the Burnet team’s ReBUILD studies and outputs here.
Image: Adolescent young women in a rural project area. From the study ‘Young people’s mental health and psychosocial wellbeing in a fragile setting: formative research to strengthen community mental health systems in Myanmar’. Image: Maung Aye Chan