Research Determination

Project Determination

Transportation Safety Resource for Action Tool Development

Project ID:	0900f3eb82453022
Accession #:	NCIPC-ASB-9/27/24-53022
Project Contact:	Rebecca Naumann
Organization:	NCIPC/DIP/ASB
Status:	Project In Progress
Intended Use:	Project Determination
Estimated Start Date:	09/30/24
Estimated Completion Date:	09/29/25
CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:	0920-1154
End of Human Research Date:

Description

Priority

Standard

Date Needed

10/15/24

CDC Priority Area for this Project

Not selected

Determination Start Date

09/27/24

Description

Transportation crashes remain a leading cause of fatal and nonfatal injury, with persistent and growing disparities for certain road user types and segments of the population. While there is currently unprecedented recognition for the need to understand and intervene on transportation injury as a public health problem, there is an extreme gap and dearth of tools and resources available to states and local communities to help select and prioritize public health-focused programs, policies, and practices that are most likely to result in safety gains. This project directly responds to this gap by conducting formative work to eventually inform the development of a comprehensive, cohesive, and user-friendly tool for public health and transportation decision-makers to use in understanding and selecting equity-centered, evidence-based interventions for their states and communities.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission

No

IMS Activation Name

Not selected

Submitted through IMS clearance matrix

Not selected

Primary Scientific Priority

Not selected

Secondary Scientific Priority (s)

Not selected

Task Force Responsible

Not selected

CIO Emergency Response Name

Not selected

Epi-Aid Name

Not selected

Lab-Aid Name

Not selected

Assessment of Chemical Exposure Name

Not selected

Goals/Purpose

The purpose of this non-research project is to conduct formative evaluation work for a transportation safety evidence synthesis tool for public health and transportation decision-makers to use in understanding and exploring equity-centered, evidence-based interventions that may be of use in their states and communities.

Objective

Specific objectives will include formative tasks to help shape development of a tool, including identifying the specific types of programs, practices, and policies to be included in the new tool/resource, defining the types of information to present (e.g., injury prevention estimates, key implementation components, costs), and mocking-up a specific plan and flow for the tool, articulating specific inputs and outputs of the tool. Specifically, this work will involve: 1) Conducting an evaluation of CDC’s current Motor Vehicle Prioritizing Interventions and Cost Calculator for States (MV PICCS) tool and potential conceptualization of a future tool by collecting formative evaluation information via semi-structured interviews with state public health and transportation staff. Professional associations and organizations who frequently work with state public health and transportation partners, when providing technical assistance and advice about project prioritization, will also be included in this formative evaluation data collection. 2) Conducting a synthesis of effective and Safe System-consistent transportation safety programs, practices, and policies that could be embedded in the new tool. The emphasis of the synthesis will be to describe the effectiveness of each program, practice, or policy for reducing transportation injuries and deaths, including and importantly any effects that could address disparities and improve health equity. The scan might also include program, practice, and policy costs, potential organizations that would need to be involved for successful implementation (e.g., public health, engineers, policymakers), and other intervention characteristics that would be most useful to state agency staff and decisionmakers selecting potential transportation safety programs, practices, and policies for implementation.

Does your project measure health disparities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project investigate underlying contributors to health inequities among populations/groups experiencing social, economic, geographic, and/or environmental disadvantages?

No

Does your project propose, implement, or evaluate an action to move towards eliminating health inequities?

Yes

Activities or Tasks

New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented

Other-Transportation and public health professionals

Tags/Keywords

Transportation; Policy; Decision Making; Health Equity

CDC's Role

CDC employees will provide substantial technical assistance or oversight; CDC is providing funding

Method Categories

Individual Interviews (Qualitative)

Methods

For the formative evaluation data collection, we will interview no more than 20 non-federal partners (approval will be sought under a Gen IC package to conduct this data collection). The sampling strategy will include a purposive snowball sampling approach. It will be purposive in that we will engage known contacts whose role at least partly involves designing, administering, or evaluating transportation safety practices, programs, policies. Specifically, respondents will include people from state transportation and public health agencies, who currently use the MV PICCS Tool or may use a revised version in the future. UNC, ASTHO, and CDC will all provide suggestions to the initial list of participants that will be contacted. We will also reach out to professional associations and organizations who frequently work with state public health and transportation partners when providing technical assistance and advice about project prioritization. The interviews will be virtual and will not exceed 50 minutes. Data will be analyzed using qualitative thematic analysis of semi-structured interview data. Any data transmitted to CDC will be free of personally identifying information (PII). For the formative task of synthesizing effective and Safe System-consistent transportation safety programs, practices, and policies that could be embedded in the new tool, the search will include peer-reviewed publications but may also involve reputable sources from the “grey” literature. These interrelated objectives will ultimately constitute formative work to help inform tool development.

Collection of Info, Data, or Bio specimens

Data collection will include purposive selection of key informants, as noted above. Respondents will be contacted up to three times by email to inquire about their willingness to participate. The email will provide general information about the study, that there are no known risks to participating, and the completely voluntary nature of the data collection. We will let potential respondents know that the purpose of the data collection is to gather information on the features and elements of MV PICCS that should be retained and integrated into a new transportation safety tool, as well as to gather information on new features and elements that end users desire in a new tool to help inform their transportation safety decision-making. Project staff conducting the data collection will have access to PII, specifically names and email address, in order to contact potential participants. PII will be accessible only to the project-specific research staff. Data collection will occur via a web-based interview (e.g., over Microsoft Teams or Zoom) using a semi-structured interview guide. UNC will lead the development of the interview guide with CDC and ASTHO providing input and edits. The interview guide is composed of questions with corresponding probes to allow for open-ended verbal responses and feedback. Interviewers will take notes during the interview, and respondents will be asked if the interview can be recorded to support filling in any gaps in notetaking. If they agree, the interview will be recorded. If they do not agree to be recorded but agree to be interviewed, the interview will be conducted and only notes will be taken. UNC will conduct the interviews. Data collected, including notes and any recordings, will be kept on secure computer servers with access restrictions to only project staff (not at CDC). UNC will analyze the data using qualitative thematic analysis of semi-structured interview data. Any data transmitted to CDC will be free of PII.

Expected Use of Findings/Results and their impact

Information from the formative semi-structured interviews and literature synthesis will be used to inform the eventual design of a Transportation Safety Resource for Action Tool that best meets the needs of partners. The project will gather information on the features and elements of an older tool that should be retained and integrated into the new tool, as well as new features and elements that end users desire in the new tool to help inform their transportation safety decision-making.

Could Individuals potentially be identified based on Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the Identifiers (including coded data)?

No

Is this project covered by an Assurance of Confidentiality?

No

Does this activity meet the criteria for a Certificate of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the release of identifiers?

No

Funding
Funding Type	Funding Title	Funding #	Original Fiscal Year	# of Years of Award	Budget Amount
CDC Cooperative Agreement	Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nations Health	24-0080	2024

HSC Review

HSC Attributes

Other - formative evaluation data collection

Yes

Regulation and Policy

Do you anticipate this project will require review by a CDC IRB or HRPO?

No

Will you be working with an outside Organization or Institution? Yes

Institutions
Institution	FWA #	FWA Exp. Date	Funding	Funding Restriction Amount
Association of State and Territorial Health Officials	FWA00026823	08/25/28	Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nations Health - 24-0080
University of North Carolina at Chapel Hill	FWA00004801	02/12/29	Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nations Health - 24-0080

Institution	Funding Restriction Percentage	Funding Restriction Reason	Funding Restriction has been lifted
Association of State and Territorial Health Officials
University of North Carolina at Chapel Hill

Institution	Institution Role(s)	Institution Project Title	Institution Project Tracking #	Prime Institution
Association of State and Territorial Health Officials	Receiving Direct HHS Support (Prime Awardee); Providing Technical Assistance
University of North Carolina at Chapel Hill	Obtaining Consent; Designing or Developing Project and/or Data Collection Instrument(s); Recruiting Subjects

Institution	Regulatory Coverage	IRB Review Status
Association of State and Territorial Health Officials	IRB Review is Not Required
University of North Carolina at Chapel Hill	IRB Review is Not Required

Institution	Registered IRB	IRB Registration Exp. Date	IRB Approval Status
Association of State and Territorial Health Officials
University of North Carolina at Chapel Hill

Institution	IRB Approval Date	IRB Approval Exp. Date	Relying Institution IRB
Association of State and Territorial Health Officials
University of North Carolina at Chapel Hill

Staff
Staff Member	SIQT Exp. Date	Citi Biomedical Exp. Date	Citi Social and Behavioral Exp. Date	Citi Good Clinical Exp. Date	Citi Good Laboratory Practice Exp. Date	Staff Role	Email	Phone #	Organization/ Institution
AaronGrober	07/24/2026	05/08/2020	07/12/2021			Contract Officer Representative	[email protected]	770-488-0787	APPLIED SCIENCE BRANCH
BethanyWest	03/16/2026		10/07/2027			Individual Investigator	[email protected]	770-488-0602	TRANSPORTATION SAFETY TEAM
CaitlinLanghorne Griffith	n/a	n/a	n/a	n/a	n/a	Institution Primary Contact	[email protected]		Association of State and Territorial Health Officials
RebeccaNaumann	06/22/2026					Individual Investigator	[email protected]	770-488-3688	APPLIED SCIENCE BRANCH
SethLaJeunesse	n/a	n/a	n/a	n/a	n/a	Institution Primary Contact	[email protected]		University of North Carolina at Chapel Hill

DMP
Proposed Data Collection Start Date	11/01/24
Proposed Data Collection End Date	09/30/25
Proposed Public Access Level	Public, Non-Public
Reason for not Releasing the Data	Other- For the interviews-- too few respondents will participate; the data are solely being used to improve the next generation of a tool, and therefore would not be useful to the public
Public Access justification	For semi-structured interviews: the data will be used to inform new resource tool. Information will be limited to a small number of interview respondents, and we would not want individual interviewees to be identified. Findings from the interviews will be summarized and presented in aggregate. For the literature review, the content (e.g., report, spreadsheet of reviews) can be made available upon request. The tool will be shared broadly once designed.
How Access Will Be Provided for Data	N/A
Plans for archival and long-term preservation of the data	De-identified data will be saved and stored on the CDC share drive after data collection. No PII will be included, and the data will be used for the development of a new transportation safety tool.

Spatiality (Geographic Location)
Country	State/Province	County/Region
United States

Determinations
Determination	Justification	Completed	Entered By & Role
HSC: Does NOT Require HRPO Review	Not Research / Other 45 CFR 46.102(l) Other - formative evaluation data collection	10/22/24	Halstead_Mary (ygg9) CIO HSC
PRA: PRA Applies		10/22/24	Halstead_Mary (ygg9) OMB / PRA
ICRO: PRA Applies	OMB Approval date: 03/03/23 OMB Expiration date: 03/31/26	10/22/24	Zirger_Jeffrey (wtj5) ICRO Reviewer