chapter  13
7 Pages

Faster Medical Miracles

WithSean T. Manion, Yaël Bizouati-Kennedy

The human research protection regulations that govern clinical research are crucial for protecting patients and their privacy. The critical step of receiving regulatory approval for each new clinical trial is a time-consuming process governed by an institutional review board (IRB) convened at each research facility where they meet only periodically. This creates a paperwork-heavy and detail-heavy process involving several parties, repeated verification of key documents and signoffs, and frequent auditing both randomly and for cause to ensure all standards are being met. Some federal funding agencies in the United States have begun requiring lead IRB for multi-site studies to minimize this burden and try to streamline the process, and many organizations have begun adopting electronic document systems to expedite regulatory approval. As Arrieta at the US Department of Health & Human Services puts it, “cancer researchers should not spend their time learning processes and regulations.