150.115 Clinical and Research Human Subject Central Incident Response Plan
This document is intended to set institutional standards for the reporting, coordinating, and independent investigation of a reportable event as defined in this Clinical and Research Human Subject Central Incident Response Plan (the “Response Plan”). The purpose of this document is to ensure that reportable events involving human subjects/patients/constituents are properly disclosed by an applicable department, division or unit, and is reviewed by the Clinical and Research Human Subject Central Incident Response Team (the “Response Team”) described below. This Plan is not intended to supersede or replace existing policies, protocols, or mandated reporting requirements, but rather is intended to coordinate efforts when a reportable event occurs.
This Plan also establishes a prevention-first framework, adding near-miss reporting and a proactive Risk & Safety Impact Assessment (RSIA) requirement prior to launching any new or materially changed endeavor.
