Connected Vehicle Pilot Deployment Program Phase 1, Human Use Approval Summary – Tampa (THEA)

This document presents the Human Use Approval (HUA) Summary for the Tampa Hillsborough Expressway Authority (THEA) Connected Vehicle (CV) Pilot Deployment. The purpose of this report is to document the process used by THEA in the Tampa CV Pilot Deployment as required in Phase 1, Task 8 in preparation for deployment involving human subjects – auto drivers, pedestrians and bicyclists, and transit drivers - in Phases 2 and 3. Institutional Review Board (IRB) approval of the research protocol is necessary before human subjects can participate in federally-funded CV Pilot research experiments. This HUA Summary document describes the selection of Salus IRB, information used in the IRB application and resolution of comments made by the IRB. Information used in developing the project Research Protocol Document (RPD), Informed Consent Documents (ICDs) and IRB application was derived from tasks already complete or ongoing in Phase 1, including Concept of Operations (Task 2), Security Management Operational Concept (Task3), Safety Management Plan (Task 5), Performance Measurement and Evaluation Support Plan (Task 5), Participant Training and Stakeholder Education Plan (Task 9) and Outreach Plan (Task 11). This information was integrated into a Phase 1, high-level concept Research Protocol and ICDs that safeguard, over the course of the participant’s lifecycle, the recruitment, selection, registration, informed consent, training, installation of equipment, safety needs and personal identification security requirements of participants. Salus IRB’s determination resulted in approval of the Research Protocol, ICDs for auto drivers, pedestrians and Hillsborough Area Regional Transit and a decision in favor of Expedited Review. The approval is limited to the study’s progress to date. Amendments and continuing review are expected for recruitment, training, revisions to ICDs, and wherever changes are made to the approved Research Protocol.