Research determination

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Print Date: 12/11/20

Title:

Restaurant Employee Health Policy Study

Project Id:

0900f3eb81a574d9

Accession #:

NCEH-FT-11/1/19-574d9

Project Contact:

Kramer_Adam (ank5)

Organization:

NCEH/ATSDR/DEHSP/WFEHSB/FT

Status:

Pending Clearance : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

12/02/2019

Estimated Completion Date:

09/29/2020

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

0920-1227

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Research Not Involving Human Subjects

Entered By & Role

12/11/20

Davis_Stephanie I. (sgd8) CIO HSC

12/11/20

Davis_Stephanie I. (sgd8) CIO OMB / PRA

10/17/20

Vann_Jerrell A. (jiv4) HRPO Reviewer

9/30/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

45 CFR 46.102(e)

PRA:
PRA Applies

HRPO:
HRPO/IRB Approves

Completed

HRPO/IRB decision date: 10/7/20
IRB Expiration date: 12/31/30

ICRO:
Returned with No
Decision

Description & Funding
Description
Priority:

Standard

Date Needed:

12/02/2019

Determination Start Date:

11/18/20

Description:

This study will be conducted by the Environmental Health Specialists Network (EHS-Net) program, a collaborative
project of the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the
U.S. Department of Agriculture (USDA), and eight local and state public health departments (Franklin County
[Ohio], New York, New York City [New York], Minnesota, Rhode Island, Tennessee, Southern Nevada Health District
[Nevada], and Harris County [Texas]). This is an EHS-Net intervention study designed to assess whether an
educational intervention will result in restaurants either developing or modifying their sick worker management
plans. The study will occur in randomly selected restaurants in the EHS-Net sites. The study will use a quasiexperimental pre- and post-test design. The study will include two randomly assigned groups (intervention and
control). Each of the eight EHS-Net sites will collect data in twenty restaurants in each group for a total of 320
restaurants. In both the intervention and the control groups, data collectors will conduct an initial site visit in which
they will interview the manager and observe food safety practices within the restaurant. Then, on this same visit,
the restaurants in the intervention group will receive an educational intervention comprised of an explanation of the
need to develop sick worker management plans and a toolkit (with sample policies). The restaurants in the control
group will not receive this intervention at this time. Three to six months later, the intervention and control
restaurants will be visited again, and a similar data collection will occur. At this second visit, the intervention will be
provided to control restaurants. If the intervention is successful, based on either the development or modification
of restaurant sick worker policies, a telephonic follow up interview will occur with previous control restaurants to
see if their policies have changed.

IMS/CIO/Epi-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

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CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

Examine whether an educational intervention will result in restaurants either creating or modifying their sick worker
management plans. Sick food workers are the leading source of norovirus outbreaks attributed to restaurants.
These plans can help restaurants prevent sick workers from working and consequently reduce outbreaks.

Objective:

The objective of the study is to determine if an educational intervention leads restaurants to create or improve their
sick worker management plans.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be
Included/Represented:

Other

Tags/Keywords:

Food Services, Sick food worker

CDC's Role:

CDC employees will participate as co-authors in presentation(s) or publication(s), CDC employees will provide
substantial technical assistance or oversight, CDC is providing funding

Method Categories:

Individual Interviews (Qualitative); Observation

Methods:

Data collectors (EHS-Net site staff which are experienced food safety professionals) will interview restaurant
managers about: restaurant policies around sick food workers and preventing illness transmission; their
demographics; and their beliefs about sick food workers. Data collectors will also collect observation data in the
restaurant kitchen on implementation of practices designed to prevent illness transmission from a sick food worker.

Collection of Info, Data or Biospecimen:

Information will be obtained through interview and observation.

Expected Use of Findings/Results:

The findings will be used to inform public health practice in developing interventions to keep sick food workers from
working.

Could Individuals potentially be identified
based on Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

Environmental Health Specialists Network

EH20-001

2020

5

HSC Review
Suggested level of IRB review
Expedited review is suggested

Yes

1a - Study of drugs not requiring
Investigational New Drug exemption from
FDA

No Selection

1b - Study of medical devices not requiring
Investigational Device Exemption from FDA

No Selection

2a - Collection of blood from healthy, nonpregnant adults; below volume and
frequency limits, minimally invasive

No Selection

2b - Collection of blood from other adults
and children; below volume and frequency
limits, minimally invasive

No Selection

3 - Prospective noninvasive collection of
biological specimens for research purposes

No Selection

4 - Collection of data through routine,
noninvasive procedures, involving no
general anesthesia, sedation, x-rays, or
microwaves

No Selection

5 - Research that uses previously collected
materials

No Selection

6 - Collection of data from voice, video,
digital, or image recordings made for
research purposes

No Selection

7 - Research that uses interview, program
evaluation, human factors, or quality
assurance methods

Yes

HSC Attributes
Non-Human/Non-Animal Material

Yes

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Other - This is a research study about
Yes
restaurant food safety policies and practices
and not human subjects.

Additional Ethical
Considerations
This is a re-determination of research study
previously reviewed and approved as CDC
Protocol 7261 (Restaurant Employee Health Policy
Study). The PI is Dr. Adam Kramer (ank5). After
careful deliberation of the research aims, it has
been determined that this protocol is "research
not involving identifiable human subjects" and
will not require IRB review. This is a research
study about restaurant food safety policies and
practices and not about human subjects.

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

No

Estimated number of study participants

Population - Children

N/A

Population - Minors

N/A

Population - Prisoners

N/A

Population - Pregnant Women

N/A

Population - Emancipated Minors

N/A

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
No Selection

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Exception is requested to PHS informing
those bested about HIV serostatus
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
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Franklin County Public Health

Funding #
EH20-001

Centers for Disease Control & Prevention

FWA00001413

10/31/24

Harris County Public Hlth & Environmental Services

FWA00009349

12/11/19

EH20-001

Minnesota Department of Health

FWA00000072

03/24/22

EH20-001

New York City Dept of Hlth & Mental Hygiene

FWA00009459

08/06/25

EH20-001

New York State Dept of Hlth

FWA00003700

10/01/25

EH20-001

Rhode Island Department of Health

FWA00006141

09/09/25

Southern Nevada Health District

FWA00023704

10/23/24

EH20-001

Tennessee Department of Health

FWA00000379

02/07/22

EH20-001

RHODE ISLAND STE DEPT HLTH IRB #1

04/03/22

EH20-001

Staff
Staff
Member

SIQT Exp.
Date

Adam
Kramer

05/31/2022

Laura
Brown

12/20/2021

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good
Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

12/31/2022

Principal
Investigator

[email protected]

4044981228

FOOD

12/20/2021

CoInvestigator

[email protected]

770488-2

WATER FOOD AND
ENVIRONMENTAL HEALTH
SERVICES BRANCH

Data
DMP
Proposed Data Collection Start Date:

12/2/19

Proposed Data Collection End Date:

9/29/20

Proposed Public Access Level:

Public

Public Access Justification:

The dataset may have identifying information if combined with other data that could lead to the identification of the
restaurant and potentially to the person responding to the survey. Specific fields would not be allowed to be
released to protect the privacy of the respondents.

How Access Will Be Provided for Data:

Data will be released in aggregate format. Any non-aggregated data will have EHS-Net site identifiers and any
other potential identifiers omitted from release.

Plans for Archival and Long Term
Preservation:

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

Data
Publisher/Owner

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection
End Date

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Public
Access
Level
Dataset yet to be added...

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