Category Archives: February 2018

New Feature: Capture Study-Specific Local Context from Participating Sites

IREx released a local context/local considerations module to allow Reviewing IRBs to centrally capture study-specific local considerations for each site, using standardized surveys and questions aligned with national sIRB initiatives.

The local considerations module has two surveys: 1) The Human Research Protections (HRP) survey asks about requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local site ancillary reviews, relevant to the specific study or trial that would affect the conduct or approval of the research at your institution, as well as the consent form for this study. This is completed by the Participating Site HRPP Liaison; and 2) the PI survey asks about the conduct of the study at your site and is completed by the Participating Site PI. The Participating Site HRPP must verify the PI survey responses.