HUMAN USE APPROVAL SUMMARY 1
SPEAKERS Andy Wolpert Casey Cooper-Fenske Alyssa Chenault City of Columbus City of Columbus HNTB Program Manager Smart Mobility Consultant Communications Program Manager anchenault@columbus.gov adwolpert@columbus.gov ccooperfenske@hntb.com 2
TODAY’S AGENDA 01 | PURPOSE OF THIS WEBINAR • Share human use activities from Smart Columbus with stakeholders 02 | WEBINAR CONTENT • Smart Columbus program overview • Document purpose and overview • Background on oversight of human use and summary of human use approval process • Dependencies and constraints • Human use approval for Smart Columbus (program and project) • Lessons learned • How to stay connected • Stakeholder Q&A 03 | WEBINAR PROTOCOL • All participant lines have been muted during the webinar in order to reduce background noise • Questions are welcome via chatbox during the Q&A Section • The webinar recording and presentation materials will be posted on the Smart Columbus website 3
SMART COLUMBUS OVERVIEW 4
$40 MILLION 78 APPLIED • COLUMBUS WON VISION: T o empower our residents to live their best lives through responsive, innovative and safe mobility solutions. MISSION: T o demonstrate how an intelligent transportation system and equitable access to transportation can have positive impacts on every day challenges faced by cities. OUTCOMES: 5
USDOT PORTFOLIO 6
USDOT PORTFOLIO Connected Vehicle Environment Smart Mobility Hubs • • 100+ roadside units 6 locations to facilitate first- mile/last-mile connections • 1,500-1,800 on-board units • Anchored by an interactive • 1,240 light duty vehicles kiosk o 430 transit vehicles o 110 emergency vehicles o 12 freight vehicles Connected Electric Autonomous Vehicles • Scioto Mile Deployment (May Mobility) o December 2018-September 2019 o 6 vehicles • Linden Deployment (EasyMile) o January 2020-January 2021 o 2 vehicles 7
USDOT PORTFOLIO Operating System Multimodal Trip Planning App • • Big data and complex data Publicly available app (Pivot) exchange • Backed by Common Payment System • Analytics and visualization • Data aggregation, fusion and Prenatal Trip Assistance consumption • Research study to improve • Replicable and scalable transportation for moms-to-be • Up to 500 participants Mobility Assistance • Research study with app for Event Parking Management turn-by-turn navigation • Publicly available app (ParkColumbus) • Increase independence • Probability of on-street parking • Up to 30 participants • Reserve private lot/garage spaces 8
HUMAN USE APPROVAL SUMMARY: DOCUMENT OVERVIEW 9
DOCUMENT OBJECTIVE • Summarizes Institutional Review Board (IRB) activities by program and project Provides protection of • Describes coordination of IRB activities human subjects and other project engineering and development activities • Identifies dependencies and constraints • Considers events and activities that could create future IRB need Human IRB Research Subjects Oversight 10
BACKGROUND ON THE USE OF HUMAN SUBJECTS 11
RATIONAL FOR OVERSIGHT Key historical examples of gross human test subject abuses in the name of science or the greater good: • Nazi medical experiments during WWII • Tuskegee Experiment 12
RESEARCH PRINCIPLES 1979 Belmont Report • Respect for persons: informed consent • Beneficence: benefits vs. risks • Justices: equity of distribution of benefits/risks 13
RULES AND GUIDANCE Common Rule, 49 CFR Part 11 • Covered research • Institutional Review Board • Exemptions and Expedited Review 14
SUMMARY OF HUMAN USE APPROVAL PROCESS 15
DEFINITIONS Institutional Review Board (IRB): Organization authorized to review and monitor research involving human subjects Human Subject: “...a living individual about whom an investigator (whether professional or student) conducting research obtains information...” (49 CFR Part 11) 16
ROLES AND RESPONSIBILITIES Project Manager (PM) • Planning/execution of project activities • Develop/maintain schedule • Support PI requests for information Principal Investigator (PI) • Actively monitoring the HUA process • Updating IRB applications/amendments • Coordinating with other project- and program-level activities Program Management Office (PMO) • Summarizing HUAS process • Sharing Information (per Cooperative Agreement with USDOT) • Developing the HUA Summary 17
SCOPE Cooperative Agreement Task F: Safety Management and Safety Assurance • Identification of underlying safety needs associated with the safety of all travelers, subjects and other personnel associated with the Smart City Demonstration o Safety Management o Human Use Approval for components using human participants 18
SCOPE Components of Human Use Approval Task • Initial application to IRB and supporting documents o Recruitment materials o Informed consent document o Surveys • Feedback and modifications • Exemption or approval 19
SCOPE Program-Level Outcomes OSU Advarra Environment IRB Approach: use Mobility of multiple IRBs both Opportunity public and private: Customer Satisfaction • If lead by OSU researchers, Projects OSU Advarra required to use CVE OSU IRB MMTPA/CPS • If not by OSU MAPCD researchers, commercial IRB PTA selected (Advarra) SMH EPM CEAV 20
SCOPE IRB review type per 49 CFR 11: Full: more than minimal risk; Projects: PTA, MAPCD does not fit expedited or Full exempt categories Expedited: no greater than Projects: CVE minimal risk; fits one of the Expedited expedited review categories Exempt: less than Projects: SCOS, minimal risk; fits one of MMTPA/CPS, Exempt the exempt categories SMH, EPM, CEAV 21
SCOPE What is submitted • Research protocol o Personnel and qualifications/training o Objectives o Methodologies o Subject recruitment plan/methods o Risk vs. benefits • Surveys/interview scripts • Communication materials (ads, flyers, etc.) • Informed consent document (form) 22
BENEFITS AND RISKS • Responsibility to minimize risk to human subjects while maximizing benefits to participants and society RISKS BENEFITS • Physical safety • Mobility • Data privacy • Opportunity • Explanation of risks and • Customer benefits included in the satisfaction ICD for each project • Environment 23
PROCESS Initial IRB Feedback & Determination Exemption (no IRB oversight Application Modifications required) IRB Review Full IRB Expedited Review IRB Review Additional Submissions/ Feedback/Modifications Approval Required As needed 24
DEPENDENCIES AND CONSTRAINTS 25
DEPENDENCIES & CONSTRAINTS Cooperative Agreement with USDOT Systems engineering documents • Concept of Operations (ConOps) • System Requirements Specifications (SyRS) • Demonstration Site Map and Installation Schedule Program-level documents • Safety Management Plan (SMP) • Data Privacy Plan (DPP) and Data Management Plan (DMP) • Performance Measurement Plan (PfMP) • Program Schedule 26
IRB SUMMARY BY PROJECT 27
IRB SUMMARY – PROGRAM LEVEL IRB Status Performance Measurement Outcome Is IRB Oversight Needed? Application Environment Feedback & Modifications Yes; application in progress Mobility Determination Surveys planned: 1. Community survey Opportunity IRB Review 2. Intercept survey (at SMH kiosks) Customer Satisfaction Feedback & Modifications Approval 28
IRB SUMMARY - PROJECTS Feedback & Determination Feedback & Approval Application IRB Review (Exempt) Modifications Modifications MAPCD SCOS CVE PTA Demo EPM MMTPA/CPS SMH CEAV Measurement SCOS Performance MAPCD CVE PTA MMTPA/CPS SMH EPM CEAV 29
PROGRAM-LEVEL PERFORMANCE MEASUREMENT IRB Status Outcome PI Materials for Review Environment Battelle TBD Application (preparation) Mobility OSU Protocol, surveys Feedback & Modifications Opportunity OSU Protocol, surveys Determination Customer Satisfaction OSU Protocol, surveys IRB Review Feedback & Modifications Dependencies and Constraints • Program/project documentation and schedule Approval • SMP, DMP, DPP, PfMP Future IRB Needs • IRB feedback, changes to project needs Risks • Data privacy 30
OPERA TING SYSTEM IRB Status Roles And Responsibilities Task PI Materials for Review Application Demonstration Accenture Protocol Feedback & Modifications Performance Measures Battelle Surveys Determination - Exempt Dependencies and Constraints IRB Review • Program/project documentation and schedule Feedback & Modifications • SMP, DMP, DPP, PfMP Approval Future IRB Needs • Changes to surveys, changes to project needs Risks • Data collection, anonymization, re-identification, security, data patching/updates, system recovery 31
PTA IRB Status Roles And Responsibilities Task PI Application Demonstration OSU Feedback & Modifications Performance Measures OSU Determination Dependencies and Constraints IRB Review • Program/project documentation and schedule Feedback & Modifications • SMP, DMP, DPP, PfMP Approved Future IRB Needs • IRB feedback, changes to project needs 32
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