Dr Aliukonis is a practising doctor-surgeon and a former clinical research specialist for the Lithuanian Bioethics Committee. He teaches medical ethics at Vilnius University.
The outbreak of war introduces unforeseen challenges for clinical trials, whether they are already underway or in development. Military conflicts can cause supply chain disruptions, challenges in recruiting and retaining staff, and limited patient access to clinical trials. More importantly, ensuring participant safety and maintaining a positive harm-benefit ratio — something paramount to human research — cannot be fully assured. As a result, in circumstances where the destruction of research centers is a real threat, patient safety, data collection and reliability becomes nearly impossible. Patients losing access to healthcare and drugs because of a conflict is something nobody wants. So how are clinicians dealing with an impossible question?
There are very few guiding principles in the context of military aggression. However, recently the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published guidelines that should be followed in a military conflict. In addition to the guidelines mentioned above, we can draw knowledge from existing ones, like CIOMS guidelines. Although not directly intended for military conflicts, the CIOMS guidelines also provides some materials relevant to military situations.
Different guidelines help us see issues through a different prism. CIOMS guidelines emphasize the need for research to respond to the health needs and priorities of the affected population. During a military conflict, being responsive means a clinical trial is designed to address the specific health challenges faced by those affected by the conflict, ensuring that the trials are relevant, timely, and beneficial to those in need. EMA guidelines draw parallels between the challenges of war and those encountered during the Covid pandemic. For instance, monitoring subjects becomes problematic when the safety of patients or study personnel necessitates relocation. Additionally, preserving essential medical supplies is challenging due to logistical constraints. As a result, some recommendations are adapted from guidelines established for COVID-19 research.
COVID-19 and military guidelines also overlap in some other ways: they recommend using remote technologies for data collection, storage, or research ethics committee activities. In case of necessary changes to the protocol, everything must be clearly and transparently described. Researchers must be open to changing research centers or transferring research participants to other centers.
While some similarities exist between the pandemic and any war, there are also important differences. During the pandemic, some COVID-19 related research, such as vaccine trials, was deemed essential for stopping the pandemic. In contrast, finding a single “essential” study or clinical research during military conflicts is hard. However, while research on injuries characteristic to military conflicts, like gunshot wounds or burns, can be conducted during peacetime, the higher frequency of such injuries during conflicts provides invaluable data. While full-scale research may be too complicated to conduct, the data that has been collected might offer crucial insights for medical professionals and researchers.
Scholars disagree on the most appropriate path for research in the context of military aggression. Some argue that it is ethically justified to exclude new patient recruitment from the study or stop it entirely. CIOMS guidelines stress that research should only be conducted if the potential benefits outweigh the risks and burdens and that research cannot be conducted outside the affected area. The guidelines also emphasize that the need for research does not justify compromising ethical principles. On the other hand, some authors claim that it would be unacceptable for those who seek peace and aid to abandon clinical research because of war.
Despite the numerous challenges, researchers have shown resilience and adaptability, continuing to advance scientific knowledge while prioritizing the safety and well-being of research participants. Examples exist where researchers in the affected country have quickly implemented suggestions from guidelines, such as utilizing remote work options for research ethics committee tasks, swiftly replacing research ethics committee members when necessary, and allowing single opinions for multicenter clinical trials in exceptional cases.
The world is just starting to catch its breath after COVID-19. However, we must remember that numerous threats can happen. There is an urgent need for guidance to scientists worldwide, and projects like PREPARED – intended to maintain and accelerate research without sacrificing ethics and integrity, will undoubtedly become increasingly necessary. Lessons learned from these experiences can serve as a foundation for future guidelines and best practices, ensuring the ethical conduct of research during difficult times and contributing to improving global health.