HUMAN USE APPROVAL SUMMARY 1 SPEAKERS Andy Wolpert Casey - - PowerPoint PPT Presentation

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HUMAN USE APPROVAL SUMMARY 1 SPEAKERS Andy Wolpert Casey - - PowerPoint PPT Presentation

Feb 05, 2024 190 likes •725 views

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

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HUMAN USE APPROVAL SUMMARY

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Andy Wolpert City of Columbus Program Manager adwolpert@columbus.gov

SPEAKERS

Casey Cooper-Fenske HNTB Smart Mobility Consultant ccooperfenske@hntb.com Alyssa Chenault City of Columbus Communications Program Manager anchenault@columbus.gov

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PURPOSE OF THIS WEBINAR

  • Share human use activities from Smart Columbus with stakeholders

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

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

TODAY’S AGENDA

01 | 02 | 03 |

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SMART COLUMBUS OVERVIEW

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$40 MILLION

78 APPLIED • COLUMBUS WON

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VISION: T

  • empower our residents to live their best lives through

responsive, innovative and safe mobility solutions. MISSION: T

  • demonstrate how an intelligent transportation system and

equitable access to transportation can have positive impacts

  • n every day challenges faced by cities.

OUTCOMES:

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USDOT PORTFOLIO

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USDOT PORTFOLIO

Connected Vehicle Environment

  • 100+ roadside units
  • 1,500-1,800 on-board units
  • 1,240 light duty vehicles
  • 430 transit vehicles
  • 110 emergency vehicles
  • 12 freight vehicles

Connected Electric Autonomous Vehicles

  • Scioto Mile Deployment (May Mobility)
  • December 2018-September 2019
  • 6 vehicles
  • Linden Deployment (EasyMile)
  • January 2020-January 2021
  • 2 vehicles

Smart Mobility Hubs

  • 6 locations to facilitate first-

mile/last-mile connections

  • Anchored by an interactive

kiosk

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USDOT PORTFOLIO

Operating System

  • Big data and complex data

exchange

  • Analytics and visualization
  • Data aggregation, fusion and

consumption

  • Replicable and scalable

Mobility Assistance

  • Research study with app for

turn-by-turn navigation

  • Increase independence
  • Up to 30 participants

Multimodal Trip Planning App

  • Publicly available app (Pivot)
  • Backed by Common Payment System

Prenatal Trip Assistance

  • Research study to improve

transportation for moms-to-be

  • Up to 500 participants

Event Parking Management

  • Publicly available app (ParkColumbus)
  • Probability of on-street parking
  • Reserve private lot/garage spaces
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HUMAN USE APPROVAL SUMMARY: DOCUMENT OVERVIEW

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  • Summarizes Institutional Review Board

(IRB) activities by program and project

  • Describes coordination of IRB activities

and other project engineering and development activities

  • Identifies dependencies and constraints
  • Considers events and activities that

could create future IRB need

DOCUMENT OBJECTIVE

Research Human Subjects Provides protection of human subjects IRB Oversight

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BACKGROUND ON THE USE OF HUMAN SUBJECTS

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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
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RESEARCH PRINCIPLES

1979 Belmont Report

  • Respect for persons: informed consent
  • Beneficence: benefits vs. risks
  • Justices: equity of distribution of benefits/risks
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Common Rule, 49 CFR Part 11

  • Covered research
  • Institutional Review Board
  • Exemptions and Expedited Review

RULES AND GUIDANCE

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SUMMARY OF HUMAN USE APPROVAL PROCESS

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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)

DEFINITIONS

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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

ROLES AND RESPONSIBILITIES

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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

  • Safety Management
  • Human Use Approval for components using human participants

SCOPE

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Components of Human Use Approval Task

  • Initial application to IRB and supporting documents
  • Recruitment materials
  • Informed consent document
  • Surveys
  • Feedback and modifications
  • Exemption or approval

SCOPE

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IRB Approach: use

  • f multiple IRBs both

public and private:

  • If lead by OSU

researchers, required to use OSU IRB

  • If not by OSU

researchers, commercial IRB selected (Advarra)

SCOPE

Program-Level Outcomes OSU Advarra Environment Mobility Opportunity Customer Satisfaction Projects OSU Advarra CVE MMTPA/CPS MAPCD PTA SMH EPM CEAV

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SCOPE

IRB review type per 49 CFR 11:

Full Expedited Exempt

Full: more than minimal risk; does not fit expedited or exempt categories Projects: PTA, MAPCD Expedited: no greater than minimal risk; fits one of the expedited review categories Projects: CVE Exempt: less than minimal risk; fits one of the exempt categories Projects: SCOS, MMTPA/CPS, SMH, EPM, CEAV

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What is submitted

  • Research protocol
  • Personnel and qualifications/training
  • Objectives
  • Methodologies
  • Subject recruitment plan/methods
  • Risk vs. benefits
  • Surveys/interview scripts
  • Communication materials (ads, flyers, etc.)
  • Informed consent document (form)

SCOPE

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  • Responsibility to minimize

risk to human subjects while maximizing benefits to participants and society

  • Explanation of risks and

benefits included in the ICD for each project

BENEFITS AND RISKS

BENEFITS

  • Mobility
  • Opportunity
  • Customer

satisfaction

  • Environment

RISKS

  • Physical safety
  • Data privacy
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PROCESS

Required As needed Initial IRB Application Feedback & Modifications Determination Exemption

(no IRB oversight required)

IRB Review Full IRB Review Expedited IRB Review Additional Submissions/ Feedback/Modifications Approval

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DEPENDENCIES AND CONSTRAINTS

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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
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IRB SUMMARY BY PROJECT

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IRB SUMMARY – PROGRAM LEVEL

Performance Measurement Outcome Is IRB Oversight Needed? Environment Yes; application in progress Surveys planned:

  • 1. Community survey
  • 2. Intercept survey (at

SMH kiosks) Mobility Opportunity Customer Satisfaction Application Feedback & Modifications Determination IRB Review Feedback & Modifications Approval

IRB Status

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IRB SUMMARY - PROJECTS

Application Feedback & Modifications Determination (Exempt) IRB Review Approval Feedback & Modifications

Demo Performance Measurement

SCOS MMTPA/CPS SMH CEAV CVE SCOS CVE MMTPA/CPS SMH EPM CEAV MAPCD PTA EPM MAPCD PTA

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PROGRAM-LEVEL PERFORMANCE MEASUREMENT

Dependencies and Constraints

  • Program/project documentation and schedule
  • SMP, DMP, DPP, PfMP

Outcome PI Materials for Review Environment Battelle TBD Mobility OSU Protocol, surveys Opportunity OSU Protocol, surveys Customer Satisfaction OSU Protocol, surveys Future IRB Needs

  • IRB feedback, changes to project needs

IRB Status

Risks

  • Data privacy

Application (preparation) Feedback & Modifications Determination IRB Review Feedback & Modifications Approval

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OPERA TING SYSTEM

Dependencies and Constraints

  • Program/project documentation and schedule
  • SMP, DMP, DPP, PfMP

Roles And Responsibilities Task PI Materials for Review Demonstration Accenture Protocol Performance Measures Battelle Surveys Future IRB Needs

  • Changes to surveys, changes to project needs

Risks

  • Data collection, anonymization, re-identification,

security, data patching/updates, system recovery

IRB Status

Application Feedback & Modifications Determination - Exempt IRB Review Feedback & Modifications Approval

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Dependencies and Constraints

  • Program/project

documentation and schedule

  • SMP, DMP, DPP, PfMP

Future IRB Needs

  • IRB feedback, changes to

project needs

PTA

Roles And Responsibilities Task PI Demonstration OSU Performance Measures OSU Application Feedback & Modifications Determination IRB Review Feedback & Modifications Approved

IRB Status

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PTA

Materials for review

  • Protocol – demo and

evaluation

  • Surveys
  • Recruiting materials
  • Medicaid and MCO materials
  • Informed consent document
  • Application user guide

IRB feedback

  • None received

Risks

  • Trip delay/cancellation
  • Mobile app availability
  • PII and de-identification
  • Driver behavior
  • Car seat

installation/availability

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MAPCD

Dependencies and Constraints

  • Program/project

documentation and schedule

  • SMP, DMP, DPP, PfMP

Future IRB Needs

  • IRB feedback, changes to

mobile app Roles And Responsibilities Task PI Demonstration OSU Performance Measures OSU Application Feedback & Modifications Determination IRB Review Feedback & Modifications Approved

IRB Status

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MAPCD

Materials for review

  • Protocol
  • Recruiting materials
  • Informed consent

document

  • Surveys

IRB feedback

  • Reorganize study

phases

  • Clarify Wayfinder
  • bjective/description
  • Increase number of

participants

  • Change participant

incentive amount

  • Provide additional

details on data collected and potential confidentiality breaches

Risks

  • Inaccurate/incomplete

traveler instructions

  • Out of date

maps/traffic info

  • Communication

failure

  • Traveler

distraction/confusion

  • Mobile app availability
  • PII and de-

identification

  • ADA route compliance
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MMTPA/CPS

Dependencies and Constraints

  • Program/project documentation and schedule
  • SMP, DMP, DPP, PfMP

Future IRB needs

  • IRB feedback, changes to mobile app

Risks

  • Traffic/emergencies, mode/mobile app availability, ability

to fund CPS account, PII privacy, location data, user account information Roles And Responsibilities Task PI Materials for Review Demonstration City of Columbus Protocol, surveys Performance Measures OSU Protocol, surveys

IRB Status

Application Feedback & Modifications Determination - Exempt IRB Review Feedback & Modifications Approval

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CEA V

Dependencies and Constraints

  • Program/project documentation and schedule
  • SMP, DMP, DPP, PfMP

Future IRB needs

  • IRB feedback, changes to project needs

Risks

  • Vulnerable road users, operator/passenger

behaviors, higher-speed traffic, maintenance Roles And Responsibilities Task PI Materials for Review Demonstration MBI Protocol, surveys Performance Measures OSU Protocol, surveys

IRB Status

Application Feedback & Modifications Determination - Exempt IRB Review Feedback & Modifications Approval

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SMH

Dependencies and Constraints

  • Program/project documentation and schedule
  • SMP, DMP, DPP, PfMP

Future IRB needs

  • IRB feedback, survey development, changes to project

needs, changes to kiosk Risks

  • Emergencies, kiosk availability, traveler behavior,

mode availability/accuracy, weather

  • PII, data security tools/processes/policies

IRB Status

Application (preparation) Feedback & Modifications Determination IRB Review Feedback & Modifications Approval Roles And Responsibilities Task PI Materials for Review Demonstration MBI Protocol, surveys Performance Measures OSU Protocol, surveys

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CVE

Dependencies and Constraints

  • Program/project documentation

and schedule

  • SMP, DMP, DPP, PfMP

Future IRB needs

  • IRB feedback, development of

surveys, and changes to equipment

IRB Status

Application Feedback & Modifications Determination IRB Review Feedback & Modifications Approval Roles And Responsibilities Task PI Demonstration City of Columbus Performance Measures WSP

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CVE

Materials for review

  • Protocol
  • Informed consent

document

  • Equipment information
  • Training materials
  • Recruitment materials
  • Surveys

IRB feedback

  • Submit all protocol

components prior to review

  • Include "Key Information"

section in ICD

  • Provide detailed

equipment info, value/removal costs

  • Elaborate on PI's

research experience

  • Clarify setting/plan for IC

discussion at auto shops

  • Differentiate IC forms for

different audiences

Risks

  • PII deidentification
  • Unauthorized access to

system/OBU

  • Equipment malfunction
  • Communication failure
  • Participant

misconception/distraction

  • Vehicle positioning errors
  • Weather-related issues
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EPM

Dependencies and Constraints

  • Program/project documentation and schedule
  • SMP, DMP, DPP, PfMP

Future IRB needs

  • IRB feedback, changes to system or

mobile app Risks

  • Mobile app availability, parking facility accessibility
  • PII privacy, account information/ user

preferences, anonymization, system security

IRB Status

Application (preparation) Feedback & Modifications Determination IRB Review Feedback & Modifications Approval Roles And Responsibilities Task PI Materials for Review Demonstration City of Columbus Protocol, surveys Performance Measures HNTB Protocol, surveys

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LESSONS LEARNED

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LESSONS LEARNED – IRB PROCESS

  • Build in time for IRB review, feedback and modifications in project schedule (ex.

IRB review required before survey deployment)

  • Identify IRB board meeting interval/frequency upfront and incorporate into

schedule

  • Example: do they meet once/month or multiple times per week?
  • Clarify training needed for anyone involved in IRB or HUA processes and

document completion/certifications

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LESSONS LEARNED – IRB PROCESS

  • Submit all documentation, including surveys and participant communication

materials, with initial application to avoid delay in initial review

  • Okay to submit more materials for review than are initially planned for use;

approving contingency materials

  • (ex. recruitment materials for different scenarios) in advance helps avoid delay, if they

are needed.

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LESSONS LEARNED – HUAS PROCESS

  • Develop HUA Summary outline early to orient teams and promote proactive

information sharing

  • Track all submittals, feedback, modifications, approvals and exemptions as they

are developed/received to minimize duplication of efforts during HUA Summary development

  • Anticipate questions or information needs based on different target audiences
  • Example: research funders, program evaluators, organizations replicating or scaling

similar projects, etc.

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WRAP UP

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PUBLIC COMMENTS NEEDED

Public comment period open for the Human Use Approval Summary is:

  • March 26 to April 12

Where to find it: 1. View the Human Use Approval Summary at: View the Human Use Approval Summary at: https://d2rfd3nxvhnf29.cloudfront.net/2020- 03/SCC-F-Human%20Use%20Approval%20Summary-Draft%20- %203.24.2020.pdf 2. Scroll to Program Plans 3. Click Smart Columbus Human Use Approval Summary

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PUBLIC COMMENTS NEEDED

How to comment: 1. Please email comments to: kldepenhart@columbus.gov 2. Subject line: HUAS Comments 3. Include your contact information 4. State whether or not you represent a vendor interest

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STAY CONNECTED

Webinar recording and materials will be available at ite.org and smart.columbus.gov

HOW TO STAY CONNECTED

SMART COLUMBUS INQUIRIES: Alyssa Chenault, Communications Project Manager anchenault@columbus.gov SMH Test Results and Launch MMTPA/CPS - CPS Test Results + Presentation of Combined MVP + Lessons Learned Upcoming Smart Columbus Webinars: Check ITE website for webinar dates at: https://www.ite.org/events-meetings/event-calendar/

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QUESTIONS?

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SIGN UP FOR OUR E-NEWSLETTER

Contact: SmartColumbus@columbus.gov Smart.Columbus.gov

@SmartCbus LEARN MORE

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This material is based upon work supported by the U.S. Department of Transportation under Agreement No. DTFH6116H00013. Any opinions, findings, and conclusions or recommendations expressed in this publication are those of the Author(s) and do not necessarily reflect the view of the U.S. Department of Transportation.

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