Monitoring human research is an important imperative that has received increasing attention. This presentation addresses the pros and cons of real-time monitoring of research, through either a Data and Safety Monitoring Board with additional functions, Research Subject Advocates, or a new board, what we call a Research Monitoring Board (RMB). The talk addresses why, in certain circumstances, we might want real-time monitoring-e.g. unforeseen circumstances may call for additional ethical scrutiny. The talk also addresses when real-time monitoring should be used-e.g. the research is very high risk, or the subject is very vulnerable. It also addresses what a real-time monitoring board would do-e.g. observe and evaluate the consent process and monitor the progress of individual subjects to determine when they should be disenrolled. The talk finally addresses who would serve on a real-time monitoring board. Real-time monitoring, in the end, can be seen as part of a balance: it adds to the costs of studies but may help ensure ethical research and therefore increase the likelihood of acceptance from patients, their families, and the community-at-large.
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