Efficiency and Effectiveness in Research Ethics Review - Lessons from Recent Scandals

Research ethics committees are tasked with protecting participants from harm, while at the same time processing applications efficiently and in a way that does not unduly impede socially valuable scientific research. Achieving this balance is a perennial challenge for oversight systems. This challenge has recently come to the fore of international discourse with the revelation of previously-unreported deaths in China from two gene editing trials, as reported by Science/Retraction Watch and STAT News. Prevention of such catastrophic outcomes is part of what ethics oversight systems are designed to prevent.

This interactive expert panel discussion will use those cases as a starting-off point to consider how IRBs can appropriately balance efficiency and effectiveness in ethics review. The cases raise serious questions such as: What level of scrutiny of pre-clinical evidence is needed in IRB review? What level of transparency is required? How can we speed up review while not exacerbating risk of harm? What consequences should follow when a study does not comply with appropriate standards? Can payment by participants ever be acceptable? Panelists will draw on expertise in ethics, science, medicine and regulation to consider these and further issues of IRB review. The discussion will also be relevant to researchers in designing studies that have an adequate level of protection, as well as an interest in ensuring IRB approval is not unnecessarily delayed.