07_Attachment 4_Project Determination_Human Subject Research Determination_OneLab Network

Print Date: 10/24/23

Title:

CDC OneLab Network Data Collection

Project Id:

0900f3eb82188099

Accession #:

CLSR-DLS-6/12/23-88099

Project Contact:

Amber S Broughton

Organization:

CLSR/DLS

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

11/11/2023

Estimated Completion Date:

11/10/2026

CDC/ATSDR HRPO/IRB Protocol #:
0920-1154

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

6/14/23

Hummel_Kimberly B. (kbh2) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation

PRA:

PRA Applies

ICRO:
PRA Applies

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

6/14/23

Hummel_Kimberly B. (kbh2) OMB/PRA

9/6/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

06/26/2023

Determination Start Date:

06/14/23

Description:

The CDC OneLab Network is a collaborative network of public health and clinical laboratory professionals and CDC. OneLab
Network unites clinical and public health laboratory professionals and the testing community to improve training for public health
emergencies through meeting laboratory learners# most urgent training needs. The OneLab Network post-event survey and social
network survey will allow DLS to better address gaps in information shared through OneLab Network events, outreach efforts,
connections made and engagement to illuminate necessary programmatic improvements.

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

TWDB kicked off the OneLab Network in 2019, designed to strengthen interconnections between clinical laboratories, public health
laboratories, and CDC laboratory training subject matter experts to collectively support COVID-19 and other rapid, large-scale
responses. OneLab Network equips clinical and public health laboratory professionals with necessary tools, resources, and
networks to strengthen the US laboratory systems# ability to respond to public health emergencies rapidly and effectively.
Information gleaned from this network will provide crucial insight into needs of the laboratory workforce and gaps in existing CDC
training resources shared through OneLab Network. TWDB staff will also receive insights to better understand the effectiveness of
OneLab Network outreach efforts, engagement, and relationship development and strengthening among laboratory peers.
The objective of these materials is to gather information to help: Maintain a network that strengthens interconnections between

Objective:

training professionals within clinical laboratories, public health laboratories, and CDC in order to collectively support rapid, largescale emergency responses; Confirm that network events include representation from laboratories of various settings (e.g., hospital
labs, commercial labs, etc.); Engage OneLab Network members to identify their learners critical training needs; Improve the
strength of connections developed and maintained among OneLab Network peers; and Support a coordinated response to public
health emergencies like COVID-19 through the timely development and dissemination of training and education resources for
laboratory professionals.

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:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Laboratorians ; Laboratory Personnel ; Laboratory Professionals ; Laboratory Community

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

Method Categories:

Survey

Methods:

Respondent population and recruitment methods: The respondents to the OneLab Network post-event survey will include clinical
and public health professionals as well as representatives with responsibility for education and training within major laboratory
organizations (e.g., clinical and public health laboratories, large commercial laboratories, and manufacturers). OneLab Network
events will be conducted up to twelve times a year. The OneLab Network social network survey is a one-time survey in which
respondents include representatives of the Clinical Laboratory Partners Forum (CLPF) that are also OneLab Network members.
The anticipated number of respondents is maximum 5,400 for the OneLab Network post-event survey (up to 1,800 respondents per
year) and maximum 30 for the social network survey. Each survey will take respondents approximately 3 minutes to complete. The
estimated burden hours is 90 hours per year for the post-event survey and 1 and 30/60 hours for the social network survey. Data
Collection Methods: After each OneLab Network event, attendees will complete the post-event survey so that TWDB leadership
understands OneLab Network members# background characteristics (e.g., work setting), overall satisfaction with the event and any
ideas for future OneLab Network meetings. By Year 2 of the evaluation, TWDB leadership will identify up to 30 point of contacts
(POCs). Identified POCs will be OneLab Network members that are also members of organizations that are in the Clinical
Laboratory Partners Forum (CLPF). A link to a site-specific social network survey will be distributed to selected participants.
Participation in all data collection activities will be voluntary. Data in all surveys will be collected via Survey Monkey, aggregated and
de-identified.

Collection of Info, Data or Biospecimen:

Attendees in OneLab Network events will receive a link to a post-event survey. CLPF POCs identified by TWDB leadership will
receive a site-specific social network survey link. A follow-up email reminder to complete the survey will be sent.
This information can be used to support the ongoing improvement of OneLab Network events. Collecting this information will enable

Expected Use of Findings/Results and their impact:

Could Individuals potentially be identified based on
Information Collected?

DLS/TWDB to better understand the representation of members comprising OneLab Network, how effective outreach efforts are in
engaging target audiences as well as determining the development and richness of connections between OneLab Network
members. These data will enable DLS/TWDB to sustain and disseminate timely education and training resources, such as job aids,
webinars, interviews with subject-matter experts, videos, and other microlearning resources that meet the target audience#s most
pressing needs in responding to public health emergencies. The approach outlined in this project aims to equip the clinical and
public health laboratory workforce with necessary tools, resources, and networks to strengthen the US laboratory system#s ability to
rapidly and effectively respond to public health emergencies, such as COVID-19.
No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Other Federal Funding

OneLab Laboratory Capacity-Building Community

BAC C6M1161101

2021

5

HSC Review

HSC Attributes
Program Evaluation

Yes

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Budget Amount

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
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
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

Amber
Broughton

Breyanna

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

09/18
/2026

CoInvestigator

oev8@cdc.
gov

4044985815

TRAINING AND WORKFORCE
DEVELOPMENT BRANCH

08/31

Co-

qpq5@cdc.

404498-

TRAINING AND WORKFORCE

Mikel

/2026

Investigator

gov

4095

DEVELOPMENT BRANCH

Meron
Asfaha

03/02
/2026

CoInvestigator

oyi3@cdc.
gov

--

DIVISION OF LABORATORY
SYSTEMS

Data
DMP
Proposed Data Collection Start Date:

11/11/23

Proposed Data Collection End Date:

11/10/26

Proposed Public Access Level:

Public

Public Access Justification:

Project results will be reported publicly in anonymized, aggregated summary form to inform CDC and other public health and clinical
laboratory partners of OneLab Network performance. Identifying information for responding laboratories and organizations will not
be released to the public.

How Access Will Be Provided for Data:

Data collected and generated by this project will be transferred and stored to CDC internal servers. All data will be deidentified.
Access to survey data will be limited to authorized users and will be password protected in order to promote data security and
compliance. Supporting documentation will include a data dictionary.

Plans for Archival and Long Term Preservation:

Both the anonymous OneLab Network post-event survey and OneLab Network social network survey data will be initially retained
on DLS/TWDB#s password protected SurveyMonkey account. The data will be downloaded onto CDC internal servers and deleted
from SurveyMonkey at least every two months throughout One Lab Network#s existence. The data will be stored with adequate
security measures in adherence to federal records requirements.

Spatiality
Country

State/Province

County/Region

United States

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

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and
Role
Zirger_Jeffrey
(wtj5)
ICRO Reviewer

Current

Asfaha_Meron
(oyi3)
Project Contact

Current

Asfaha_Meron
(oyi3)
Project Contact

Current

Asfaha_Meron
(oyi3)
Project Contact

Date Added

Description

Supporting Info Type

Supporting Info

09/06/2023

NOA 0920-1154 (2023)

Notice of Action

NOA 0920-1154_2023.pdf

06/12/2023

In the attachment is the OneLab
Network Social Network survey
tool, including introductory
language when participants open
the survey links.

Other-Enter new type

FINAL OneLab Network Social Network Survey.docx

06/12/2023

In the attachment is the language
sent to OneLab Network event
attendees to complete the OneLab
Network post-event survey, as well
as language for selected
participants to complete the
OneLab Network Social Network
survey.

Other-Enter new type

Emails_OneLab Network Surveys.docx

06/12/2023

In the attachment is the OneLab
Network post-event survey tool,
including introductory language
when participants open the survey
links.

Other-Enter new type

FINAL OneLab Network Post Event Survey.docx