Ensuring the safety of research participants during times of war is unique to the situation of each individual participant and must consider multiple aspects of each individual and the situation they are in.
The article was originally published in DIA Global Forum in April 2023
Learning from Past Experience
“When we realized we couldn’t continue studies in east Ukraine … in 2014 because it was just too dangerous, it was right to say: we are not able to safely bring participants back to the site for their visits, we are not able to continuously deliver medication and have samples taken for the safety and efficacy of the trial. It was just too dangerous. We reached out to several participants and told them: Here’s a list of sites in Ukraine where you can continue participation. If you are holding onto this location just because that’s where your trial is, you don’t have to. We can’t help you with the relocation financially. But if you want to continue participation, here’s what you can do. Here are the phone numbers. Here’s where you can go.
“About eight of those 12 or 14 participants decided to go [back in 2014]. This suggested they were almost held back by the clinical trial: They knew that the drug was working for them, there was no placebo arm, the drug was very close to registration, it was really working. That’s what was making them stay behind.
“It is worth considering: Are participants staying behind because of that treatment? We offer information on where the trial is conducted, but we are not encouraging relocation. We say: If you want to relocate, tell us where you’re going, and we’re going to find a way to make it happen. Even if there isn’t a trial in that specific place, we look at the area. If they relocate to Germany but very close to Austria, or vice versa, maybe there is some transborder short commute we can offer if they decide to continue. So, participants don’t choose their location based on where the trial is, but after they choose a location, we can offer help in continuing their participation.” – Agata Bloswick