o understand the impact of armed conflict on research ethics, and the obligation to involve the war-affected population in these ethical discussions, we must understand the impact of war on research itself.

Research is typically conducted by a group of researchers affiliated with a research institute, hospital, or academic institution. These researchers can plan because they have funding, know what the funded items are, have the study population, have the study area, and everything is generally settled. Ethical oversight is done by a regular institutional review board (IRB) which assesses each study protocol against national and international guidelines, a set of principles very standardized in terms of consent, respect for privacy, confidentiality, and data protection. There’s monitoring and follow-up. Publication ethics and standards are clear.

Wartime Shifts the Approach to Research

However, these things are different in times of war. There is geographic and demographic change as some areas quite literally just disappear. We have seen this in most armed conflicts and in Ukraine. Some of the selected research areas are no longer there or are inaccessible. The people could have moved to other places as internally displaced persons or as refugees to other countries near or far. The institutions themselves are disrupted and sometimes destroyed. We have seen hospitals and academic institutions attacked weekly. Priorities for funds move from research to humanitarian aid and helping people on the ground.

Regulatory aspects of clinical research move from peacetime ethical guidelines and regulations to wartime laws—for example, international humanitarian law. This is accompanied by a shift in stakeholders, such as the involvement of humanitarian aid agencies. We can also see the shift in the vulnerability and risks associated with these research participants. Now they are internally displaced people within Ukraine or refugees in neighboring countries. The host communities are also affected by that.

Questions for Continuing Research in Warzones

Many of the wartime regulatory and ethical considerations for clinical trials in Ukraine and their participants depend upon which phase the research is in. These study protocols were planned according to the pre-war situation. Who should review them now? The research ethics committees (RECs) within Ukraine or in the countries where the Ukrainian participants moved? What kinds of guidelines are there to guide us? How applicable are guidelines tailored to a peaceful setting in the wartime context?

Which regulations are to be followed? Should clinical research proceed? Should studies be stopped or moved? And according to what criteria? To what extent could soldiers and prisoners of war be theoretically recruited into this or that study? Which principles are to guide us: for example, the autonomy and the rights of the participant to continue or not? Or the safety of the participants and the researchers? Or perhaps a sponsor’s financial decision from the cost-effectiveness point of view?

What if the study is just finished or is about to finish? Do the same ethical standards of publications still apply? What if certain ethical standards were not met because of the war or perhaps because part of the methodology that was supposed to be followed was not? What are the ethical standards for asking and answering these questions?

For all these questions, we can find the temptation to sit as experts and give advice for this or that guideline. The starting point for me at an earlier phase of my interest in armed conflict research ethics was as someone who believed in autonomy, in personal freedom, and that the researcher should follow guidelines and respect the REC/IRB model. However, as part of my doctoral thesis, the people, the regulatory bodies, the researchers, the NGOs, and the humanitarian aid workers in the field told a completely different story. They have described a very meticulous, quite sophisticated review model which is perhaps more comprehensive than the classical REC/IRB model. And it was not about informed decisions or autonomy, at least in the way we deal with it in the global North. What matters to them most is the issue of trust. They had to trust the researchers first. Research was not a separate entity of activities but a part of the overall humanitarian work.

Step 3. Listen to the participants.
We must talk to the clinical trial participants or the communities that host them. We need to talk to parents, children, and minorities, and translate their input into the development of these guidelines to truly meet their needs in these challenging times.

We need to understand their priorities and their ethical standards. When we talk to these people, it’s for them to say what is important to them, what matters to them, and what ethical principles matter to them. Then the guidelines can be accordingly changed.

Step 4. Document lived experiences.
We need to document the lived experiences of participants through case studies and success stories in reviewing and conducting research. This is very important, although difficult in an active war.

When we have empirical evidence to suggest a change to study protocols or guidelines, these suggestions should at least be supported by the opinions or experiences of the affected people. This is the key message: We need to give a voice to the unheard. This is one of the roles of bioethics as a field: to empower people and to give voice to those who otherwise would be unheard. Ethical consideration of these participants in these circumstances is essential to ensuring their protection.

Step 5. Call for change.
Once the evidence is developed, a firm rationale for change can be used to guide discussion and the development of modernized approaches to clinical trials and research.