CDC Determination: IRB Approval is Not Required

Att 1-BEAM Eval Project Human Subjects Determination.pdf

[NCEZID] Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

CDC Determination: IRB Approval is Not Required

OMB: 0920-1071

Document [pdf]
Download: pdf | pdf
Print Date: 12/7/22

Title:

BEAM Dashboard User Feedback Survey

Project Id:

0900f3eb8205022e

Accession #:

NCEZID-DFWED-12/6/22-5022e

Project Contact:

Allison Miller

Organization:

NCEZID/DFWED

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

01/01/2023

Estimated Completion Date:

01/01/2025

CDC/ATSDR HRPO/IRB Protocol #:
0920-1050

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

12/7/22

Youngblood_Laura L. (zfk9) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement
Other - user feedback survey

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 6/28/22
OMB Expiration date: 6/30/25

12/7/22

Daymude_Thomas (qkh7) OMB / PRA

12/7/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

12/06/22

Description:

This project aims to collect user feedback for CDC NCEZID's BEAM (Bacteria, Enterics, Amoeba, and Mycotics) Dashboard.
BEAM Dashboard is an interactive tool to access and visualize data from the System for Enteric Disease Response, Investigation,
and Coordination (SEDRIC), which CDC uses to coordinate surveillance and response to disease outbreaks linked to food or animal
contact. BEAM Dashboard provides the public, academia, industry, public health partners and regulatory agencies with timely data
on pathogen trends and serotype details to inform work to prevent illnesses from food, water, the environment, and animal contact.
Launched in 2022, the first version of the dashboard focuses on data for Salmonella, E.coli and Shigella bacteria. As CDC aims to
expand data available in BEAM to include additional pathogens, antimicrobial resistance data, and epidemiologic data from
outbreak investigations, it is important to gather user feedback from versions 1 for consideration during future enhancements.

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

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

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

CDC has plans for future expansions of data available through BEAM Dashboard. We would like to provide BEAM Dashboard users
the ability to provide voluntary, anonymous feedback for consideration during future enhancements.

Objective:

We aim to better understand BEAM Dashboard user satisfaction and identify future needs for consideration during development of
future version enhancements. BEAM Dashboard aligns with Data Modernization Initiative (DMI) priorities by providing publicly
available, timely data on pathogen trends and serotype details to inform work to prevent illnesses from food, water, the environment,
and animal contact.

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Yes

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

No Human Population

Tags/Keywords:

Surveys and Questionnaires ; Foodborne Diseases ; Personal Satisfaction

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided ; CDC employees or agents will obtain or use anonymous or unlinked
data or biological specimens

Method Categories:

Survey

Methods:

CDC has developed an 11 question survey aimed to collect BEAM Dashboard user feedback. This survey will be administered via
EpiInfo.

Collection of Info, Data or Biospecimen:

CDC will utilize a EpiInfo survey to collect user satisfaction survey results. The survey will be available on the public website
(https://www.cdc.gov/ncezid/dfwed/BEAM-dashboard.html) where individuals can voluntarily choose to provide feedback on user
experience. Additionally, when the BEAM Dashboard is presented during webinars, conferences, and other forums CDC will provide
a QR code for users to access the feedback survey.

Expected Use of Findings/Results and their impact:

CDC intends to use the data collected from the satisfaction survey in the development of future versions of the BEAM dashboard.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

Other - user feedback survey

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

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 HIPPA 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

No Selection

future
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
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Allison
Miller

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

07/26
/2024

CoInvestigator

odh8@cdc.
gov

4047186309

DIVISION OF FOODBORNE, WATERBORNE,
AND ENVIRONMENTAL DISEASES

Hilary
Whitham

11/03
/2025

CoInvestigator

kqq7@cdc.
gov

4046398426

DIVISION OF FOODBORNE, WATERBORNE,
AND ENVIRONMENTAL DISEASES

Lyndsay
Bottichio

12/01
/2025

Principal
Investigator

xmm8@cdc.
gov

4046390570

DIVISION OF FOODBORNE, WATERBORNE,
AND ENVIRONMENTAL DISEASES

Data
DMP
Proposed Data Collection Start Date:

1/1/23

CITI Good Clinical
Practice Exp. Date

Proposed Data Collection End Date:

1/1/25

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Data intended for use by internal CDC program for product evaluation and improvement.

Public Access Justification:

The data collected will be user satisfaction survey data intended for internal CDC program use and evaluation.

How Access Will Be Provided for Data:

If requested or FOIA, access to the data can be made available.

Plans for Archival and Long Term Preservation:

Survey results within database will be maintained per CDC record management guidelines.

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

12/07/2022

NOA 0920-1050 (2022)

Notice of Action

NOA 0920-1050_2022.pdf

Youngblood_Laura
L. (zfk9)
CIO HSC

12/07/2022

NCEZID non-research
determination

HS Research Determination Memo

120722AM-NR-PE.pdf

Collection End
Date

Current

Miller_Allison
(odh8)
Project Contact

12/06/2022

Data collection form.

Data Collection Form

BEAM evaluation survey_clean.docx


File Typeapplication/pdf
File Modified2022-12-23
File Created2022-12-07

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