Near misses and research subjects

As in clinical care, the highest priority of clinical research is to protect participants from any undue harm. There are inherent risks involved in any human experiment, but careful analysis of several research related fatalities has clearly shown that human error and system failures contributed to these events.1,2 While clinical medicine has embraced organizational based approaches to patient safety, much of the clinical research safety process remains narrowly focused. This focus has resulted from the traditional “protocol-centric” approach for managing clinical research risk. Both Institutional Review Boards and Data Safety Monitoring Boards predominately review safety problems on a study by study basis. While these traditional approaches have been remarkably successful, their narrow scope may limit their ability to identify and manage clinical research risks comprehensibly.

Clinical research and clinical care share many similar risks. Both involve analogous procedures, many of which are invasive, and both use pharmacological agents with known and unknown toxicities. Patient safety research has identified system failures as important contributors to adverse drug events, nosocomial infections, and procedural mishaps. These same latent failures may also contribute towards adverse events within clinical research. For …