From Moving Beyond Compliance to Quality to Moving Beyond Quality to Effectiveness: Realities and Challenges.

Abstract

In 2007, Taylor proposed to move beyond compliance to develop measures for assessing the ethical quality of institutional review board (IRB) reviews. To date, no such tool has been developed. In 2018, Lynch et al. proposed to move beyond quality to advance effective research ethics oversight. Instead of providing a set of measures, they proposed to define and specify ways to measure the effectiveness of IRBs in protecting human subjects. They further claimed that any attempts to measure the quality and performance of IRBs without using such measures, to be developed by them in the unforeseeable future, were not helpful. The realities are that nearly 50 years after its establishment, there has been no systematic assessment of the quality and performance of IRBs, and that nearly two decades after the deaths of Jesse Gelsinger and Ellen Roche and the implementation of reform processes to improve our system of protecting human subjects, there is still plenty of room for improvement. The challenges today are for Taylor to come up with a tool to measure the ethical quality of IRB reviews, for Lynch et al. to develop measures for assessing the effectiveness of IRBs in protecting human subjects, and for the IRB community to decide whether to continue to wait for Taylor and Lynch et al. to develop their promised tools or to start taking advantage of performance measurements to improve the quality and performance of IRBs by using existing IRB performance metrics or to improve those existing performance metrics.