Project Determination (25AB)

Print Date: 10/1/24

Title:

Foundational User Interviews with the public

Project Id:

0900f3eb8240a46a

Accession #:

OPHDST-IDD-8/7/24-0a46a

Project Contact:

Alante D Fields

Organization:

OPHDST/IDD

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

09/30/2024

Estimated Completion Date:

02/14/2025

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations

0920-1154

Determination

Justification

Completed

Entered By & Role

9/30/24

Gadsden-Knowles_Kim (klg6) Human Subjects Coordinator

PRA Applies

9/30/24

Gadsden-Knowles_Kim (klg6) OMB/PRA Coordinator

HRPO:
Concur

9/30/24

Chirila_Robert (uno4) HRPO Reviewer

9/30/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:

ICRO:
PRA Applies

OMB Approval date: 3/3/23
OMB Expiration date: 3/31/26

Description & Funding
Description
Priority:

Standard

Date Needed:

09/30/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

09/11/24

Description:

As part of CDC#s focus on Human Centered Design, OPHDST#s Inform and Disseminate Division (IDD) would like to collect
information from the public monthly, with approximately 12-15 interviews per month within the next 5 months, for a total of 60
participants to inform the improvement and development of dashboards and other tools for data dissemination. CDC offers these
dashboards and other tools as a service to the public, the end user. Information collection will be in the form of monthly rounds of
semi-structured interviews using a virtual meeting platform.

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

To ensure that Data Channel and SAPHIRE content is useful, actionable, and accessible to the public, the design team within the
IDD will conduct foundational interviews for data collection from users to understand the full-spectrum experience of accessing,
reviewing, and interpreting public health content with a focus on discovering the components of trust and experiences that lead to
action.

Objective:

Data Channels and SAPHIRE connects to the Public Health Data Strategy Milestone 3.1 by enabling external users, such as State,
Tribal, Local, and Territorial Health Departments (STLTs) and the public, to have expanded access to data and visualizations for
four CDC data assets, including emergency department, mortality, and case data, to support public health decision-making. Some
of the top priority questions that we need to explore are around the audiences and their needs. By initiating data collection from
users, the team building Data Channel and SAPHIRE capabilities will be able to answer these questions and deliver what is needed
to achieve the milestone.

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
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?:

No

Activities or Tasks:

Programmatic Work

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Access to Information ; Information Dissemination ; Information Literacy ; Information Seeking Behavior

CDC's Role:

CDC is the sole institution conducting activity

Method Categories:

Individual Interviews (Qualitative)
Facilitate semi-structured interviews by asking the interviewee open-ended questions to understand their experiences and unmet
needs. Respondents will be members of the general public focusing on approximately 60 individuals, or 6 studies of 10 individuals
each over the course of 5 months (~12-15 interviews/month), will be interviewed across multiple categories and demographics. Four
studies will be focused on the general public: data enthusiasts/ appreciators (individuals with positive beliefs in the role of data and
seek data to inform decision making) data ambivalent (individuals who do not have strong beliefs around the role of data and rarely

Methods:

seek data to inform decision making), caretakers/adult children of older adults, and parents of young children. People who identify
as immunocompromised will be an alternate participant category. There will also be two studies on accessibility focused on people
with disabilities.

Collection of Info, Data or Biospecimen:

Qualitative interviews will be conducted using a virtual in-depth, potentially activity-based format. Qualitative data collected will be
coded and anonymized to remove any potential PII to protect participants# privacy. Online collaboration tools including Excel and
Miro will be used to analyze scrubbed data. Based on previous experience, a single interview results in approximately 3-4 hours of
prepping, cleaning, and multiple rounds of analysis and synthesis using the data collected.

Expected Use of Findings/Results and their impact:

Data collected from these interviews will inform future development of OPHDST services like CDC Wonder and Data Channels on
cdc.gov.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

CDC Contract
CDC Contract

Funding #

Original Budget Yr

# Years Award

Budget Amount

Data Modernization Accelerator at CDC IDD Data Visualization and Design

2024

1

3120000.00

Leverage Contractor for User Research with General Public

2024

1

77188.00

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will require review by

No

a CDC IRB or HRPO?
Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPAA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions

Will you be working with an outside Organization or Institution? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Alante
Fields

10/23
/2026

Matthew
Ritchey

07/01
/2026

Raina Russ

10/23
/2026

Rebecca
Rubenstein

07/01
/2026

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

10/15/2025

10/15/2025

Staff Role

Email

Phone

Organization

Program
Lead

lzm1@cdc.
gov

--

INFORM AND
DISSEMINATE
DIVISION

Program
Official

hha7@cdc.
gov

7704887232

INFORM AND
DISSEMINATE
DIVISION

CoInvestigator

zus8@cdc.
gov

CoInvestigator

zvh5@cdc.
gov

Data
DMP
Proposed Data Collection Start Date:

10/7/24

Proposed Data Collection End Date:

2/14/25

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Data collected is not of value to the public.

Public Access Justification:

Qualitative data will be stored on project SharePoint--which is not accessible to the public.

How Access Will Be Provided for Data:

Data will be stored on a project SharePoint. Any potential PII will be removed before saving to the project SharePoint.

Plans for Archival and Long Term Preservation:

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

09/30/2024

NOA 0920-1154 (2023)

Notice of Action

NOA 0920-1154_2023.pdf

Gindi_Renee
(iuz2)
Project Contact

09/24/2024

Revised document

Other

Foundation Interviews Revised_Clean.docx

Gindi_Renee
(iuz2)
Project Contact

09/24/2024

Revised document

Other

Foundation Interviews Revised.docx

Current

Fields_Alante
(lzm1)
Project Contact

09/11/2024

0920-1050 Customer Service
GenIC Template

Other-Enter new type

0920-1050 Customer Service foundational-interviews.docx

Current

Fields_Alante
(lzm1)
Project Contact

09/11/2024

SSA-0920-1050

Other-Enter new type

SSA_0920-1050_foundational-interviews-24.docx

Current

Fields_Alante
(lzm1)
Project Contact

09/11/2024

Part II Worksheet

Other-Enter new type

Part II Worksheet_0920-1050_foundational-interviews.pdf

09/11/2024

Interview Guide

Other-Enter new type

FINAL_Foundation Interview Script-OMB.docx

Fields_Alante
Current

(lzm1)
Project Contact

Current

Fields_Alante
(lzm1)
Project Contact

09/11/2024

Data Collection Plan

Other-Enter new type

CDC Data Collection Plan-final.docx

Current

Fields_Alante
(lzm1)
Project Contact

09/11/2024

Invitation email that vendor will
send to their customer list

Other-

Email Template for Participants.docx