IRB: Ethics & Human Research
Monitoring Reportable Events and Unanticipated Problems: The PHAROS and PREDICT Studies of Huntington Disease
We describe a process developed to anticipate and identify new potential risks of harm to research participants who are at risk for Huntington disease but have not developed symptoms. An Event Monitoring Committee was designed to monitor predetermined, reportable, and unanticipated events that subjects participating in two HD observational studies might experience. The Committee, composed of a diverse group of individuals from many disciplines, utilizes the special expertise of its members to identify potential risks and to communicate with investigators, IRBs, and steering committees. It also provides a mechanism to reconcile discrepancies between different sites in interpreting risks faced by participants. The event monitoring process may be valuable to other research projects, especially those involving multicenter trials or genetically at-risk populations.
Key words/concepts: observational studies, risk identification, adverse events, genetic risk protections, event monitoring, Huntington disease