Human Subjects Determination

Print Date: 12/12/23

Title:

Project Firstline Continuing Ed 3-week Follow-up Amendment 1

Project Id:

0900f3eb82275f1d

Accession #:

CSELS-ODSIO-11/9/20-2d49d

Project Contact:

Jessica M Waechter

Organization:

NCEZID/DHQP

Status:

Pending Regulatory Clearance : Amendment

Intended Use:

Project Determination

Estimated Start Date:

11/23/2020

Estimated Completion Date:

05/31/2026

CDC/ATSDR HRPO/IRB Protocol #:
0920-1071

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

11/24/23

Peterson_James M. (iyr1) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:

PRA Applies

11/27/23

Vice_Rudith (nhr9) OMB / PRA

HRPO:
Concur

11/12/20

Cope_James R. (voz4) HRPO Reviewer

11/28/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

ICRO:
PRA Applies

OMB Approval date: 5/10/21
OMB Expiration date: 5/31/24

Description & Funding
Description
Priority:

Standard

Date Needed:

11/12/2020

Determination Start Date:

11/16/23

Description:

Project Firstline#s goal is to provide necessary infection prevention and control (IPC) knowledge to prevent transmission of COVID19 in healthcare settings and thereby ensure the safety of frontline healthcare personnel and patients. Through partnership between
Project Firstline and CDC#s Education & Training Services Branch (ETSB), Project Firstline videos are available for both formal
training for continuing education (CE) credit and informal viewing (not for CE). Anyone viewing these videos are provided an
opportunity to complete a post-training evaluation, but only those pursuing CEs are required to complete a survey. Those obtaining
CE#s are also offered an opportunity to complete a follow-up survey 3 weeks after receipt of CEs, but this is voluntary. These
trainings are slated to launch by the end of November.

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

Yes

IMS Activation Name:

2019 Novel Coronavirus Response

Primary Priority of the Project:

Protection of healthcare personnel and patients

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
TCEO currently administers a standard twenty-one question post-training survey as a required step for receiving CE credit as well
as a six-question follow-up survey to all CE recipients 3 weeks after receiving CE credit. We propose adding five brief questions to
the post-training survey and three brief questions to the standard survey instrument, to understand better (1) the outcomes of the
training and (2) ongoing awareness of Project Firstline as a program, (3) demographic characteristics of participants, and (4)

Goals/Purpose

Objective:

perceived value and improved understanding of participants. The standard follow-up survey will remain unchanged for non-Project
Firstline trainees. Those who view the Project Firstline videos informally (not for CE credit) are provided an opportunity to complete
a post-survey that consists of the same 5 add-on questions used in the TCEO survey described in paragraph above. TCEO#s
standard 21 question survey is not included (only applies to those pursuing CEs). This information will inform programmatic
decisions to improve this and future Project Firstline activities. Describe efforts to minimize duplication across CDC and other U.S.
government agencies: This data collection is specific to experiences with the implementation of Project Firstline. Since Project
Firstline is a new initiative and these are brand new trainings developed in response to COVID-19, information on trainee
impressions do not exist elsewhere at CDC or within other U.S. government agencies and will not be collected by others.
The purpose of this specific data collection is to understand who attended the training (professional role/setting, geographic
location), whether they found the information to be of value, whether their understanding of the topic improved, and how trainees
have used what they learned from the training and if they have pursued additional information about infection control. This
information will be used by the program to identify areas for improvement, such as modifying training content or informing
subsequent Project Firstline activities, to better provide infection control training to frontline healthcare personnel during the COVID
response.

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?:

Yes

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Healthcare Provider

Tags/Keywords:

Infection Control ; Infection control and prevention ; Training Support ; Program Evaluation ; IMS Task Force

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:

To ensure quality of the project, the proposed data collection efforts will be led by CDC. CDC is developing the questions to use in
data collection and will be responsible for analyzing data. CDC is also responsible for using the findings to inform training
development in the midst of the COVID-19 response. Statistical methods have not been reviewed. The data will be analyzed using
basic descriptive statistics. There is no plan to generalize findings. Findings will be used for program reporting and to inform
ongoing internal CDC decisions on training content and delivery.
Data will be collected via CDC#s TRAIN and TCEO systems.CDC#s TCEO system currently administers a standard twenty-one
question post-training survey as a required step for receiving CE credit as well as a six-question follow-up survey to all CE
recipients 3 weeks after receiving CE credit. We propose adding five brief questions to the post-training survey and three brief
questions to the standard survey instrument, to understand better specific aspects of Project Firstline that are not captured in the
standard follow-up survey. The standard follow-up survey will remain unchanged for non-Project Firstline trainees. Participation is

Collection of Info, Data or Biospecimen:

voluntary. CDC will receive and analyze the data, using basic descriptive statistics. Findings will be used for monitoring and
improvement purposes. No PII will be collected for this specific data collection. TCEO might capture and house PII for training and
registration purposes, but, again, PII is not part of this specific data collection and will not be used for analyses described here. The
exact burden estimate will depend on the number of trainees viewing Project Firstline videos (either formally for CE credit or
informally). We estimate 3,000 survey completions annually for those viewing for CE and a survey completion time of 5 minutes,
resulting in 250 burden hours annually. We estimate 25,000 participants will view PFL videos informally and choose to complete an
evaluation, and a survey completion time of 2 minutes, resulting in 833 burden hours annually.

Expected Use of Findings/Results and their impact:

Findings will be used for program reporting and to inform ongoing internal CDC decisions on training content and delivery.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Quality Assurance / Improvement

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 #:

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

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

Staff
Staff
Member

SIQT Exp.
Date

Margaret
Paek

08/31/2026

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

09/07/2021

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

kvz3@cdc.
gov

404-7186423

OD Science/Informatics
Office

Data
DMP
Proposed Data Collection Start Date:

11/23/20

Proposed Data Collection End Date:

5/31/26

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - This information is intended to inform project implementation and is not intended for public distribution.

Public Access Justification:

This information is intended to inform project implementation and is not intended for public distribution.

How Access Will Be Provided for Data:

CDC's TCEO system will provide the project team with the data. We do not intend to collect or store PII.

Plans for Archival and Long Term Preservation:

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Dataset yet to be added...

Supporting Info
No Supporting Info

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date