41 Management of Security for Clinical Trials During Emergencies

Virtually all emergency clinical research in infectious disease outbreaks involves risks—ranging from suspicion and resentment on the part of local populations, and sometimes local officials, to operations amid violent conflict, as in the northeastern Democratic Republic of the Congo (DRC) during the 2018–2020 Ebola outbreak. Before any such research can begin, project planners must assess the threat environment and organize and implement protective measures. In general, such strategies should include establishing and rehearsing security procedures for all staff so that everyone knows where they should be and what they should be doing in an emergency, and arranging to guard research sites at all times, especially areas where pharmaceuticals and valuable equipment are held. Information and communications security is also vital to operations.