Why is this change happening?

As you know, all research that receives a data security level (DSL) assignment of 3, 4, or 5 requires review by HUIT. While HUIT DSL 3 must be reviewed within a one-year time frame, HUIT review of DSL 4 and DSL 5 has been required prior to IRB approval. With the recent changes to the federal regulations governing human subject protections, many studies that received a DSL 3 used the continuing review timepoint as a “due date” for the DSL 3 HUIT review. As continuing review is no longer a requirement for many studies, a working group has been thinking about ways to revisit this practice.

Starting June 1, 2019, and lasting through the summer, a pilot of a revised HUIT practice will take place. Studies that receive a DSL 3 will follow the review practice of DSL 4 and DSL 5 such that HUIT review will be required before IRB approval. When HUIT review is required, IRB staff will notify HUIT through ESTR (our online system) and monitor the review. The good news is that this revised practice will provide greater monitoring, better documentation, improve the timing of consultation, and access to necessary tools for all HUIT reviews.

Questions?  Please contact the HUA IRB office at cuhs@harvard.edu or 617-496-2847