The IRB has posted updated policies regarding reviews and determinations about reports of potential noncompliance and potential UPIRTSOs. These processes are described in IRB Policy 12.5, Reports of Potential Noncompliance and Potential UPIRTSOs, and 12.6, IRB Determinations of Noncompliance and UPIRTSOs. We’ve also posted a revised IRB Policy 2.6, which describes the IRB’s procedures for reporting reportable events to federal agencies, funders/sponsors, the institutional official, and our accrediting agency
Most of the changes relate to formatting and to adding references to each policy. IRB Policy 2.6, however, does include one more substantive change. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) now wants to hear from us when, basically, we receive bad news from a federal agency (such as a warning letter or other negative action from a federal oversight agency), a lawsuit or settlement related to our HRPP, or any negative press publicity about our HRPP.