App F2_NIOSH HSRB

Print Date: 6/1/21

Title:

A Longitudinal Examination of Mental and Physical Health among Police Associated with COVID-19

Project Id:

0900f3eb81b7c6f3

Accession #:

NIOSH-BB-6/25/20-7c6f3

Project Contact:

Erin Mccanlies

Organization:

NIOSH/HELD/BB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

08/01/2020

Estimated Completion Date:

07/31/2022

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

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Non-Exempt Human Subjects Research when CDC is not engaged

PRA:

Completed

Entered By & Role

6/29/20

Siegel_Paul D. (pds3) Division HSC

45 CFR 46.102(a) HHS/OHRP 2008 Engagement Guidance at III B(1-11)

Qualifies for a statutory waiver:

21st Century Cures Act - Sec. 3087 (Public Health
Emergency)

6/30/20

Sawyer Deloney_Tamela (tqs7) OMB /

PRA Applies

Justification: Data collection qualifies for
PHE waiver (COVID-19 related).

ICRO:
Returned with No Decision

PRA

6/30/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Urgent

Date Needed:

08/01/2020

Priority Justification:

In order to meet the aims of this project, it is imperative we start the project as soon as possible.

Determination Start Date:

06/26/20

Description:

The COVID-19 outbreak unmasks the inadequate preparation that society has for dealing with a pandemic, including limited
equipment and inadequately trained personnel. For police officers, an already highly stressed population, this quickly changing
landscape has likely resulted in even higher levels of mental and physical stress. Addressing police mental and physical health is
important for their wellbeing as well as that of the public they serve. Nonetheless, little research has been conducted to evaluate the
physical and mental health consequences of the COVID-19 pandemic on police officers. This project will be conducted in
collaboration with Dr John Violanti with whom we have previously conducted cross-sectional research projects to evaluate the
psychological, physiological, and subclinical measures of mental and physical health in Buffalo, NY police officers as part of the
Buffalo Cardio-Metabolic Occupational Police Stress (BCOPS) study. The BCOPs study itself includes a baseline examination and
follow-up examinations. Measures include the use of psychosocial stress surveys and stress biomarkers. Health outcomes include
changes in blood parameters and components of the metabolic syndrome. We will contract with the University of Buffalo, NY (John
Violanti) to recruit police officers for whom they have previously collected mental and physical health data. The contractor will
provide NIOSH with deidentified data that can be linked with previously collected data currently being held at NIOSH. This will allow
us to compare this mental and physical health data collected prior to the COVID-19 pandemic to data collected during the pandemic
and one year later. Given the high rates of mental and physical health issues in the policing population, this study could lead to new
knowledge about police specific occupational stressors during a pandemic and identify risk and protective factors that may be used
to mitigate these stressors. The objective of this study is to determine the longitudinal effects of the COVID-19 pandemic on the
mental and physical health of police officers. The projects specific aims are: 1. To evaluate the impact of COVID 19 on police
officers including the longitudinal psychological and biological measures of stress pre-pandemic to those collected during and after
the pandemic. 2. To examine personal and organizational resiliency and coping as it modifies stress. 3. To longitudinally examine
the impact of stress on cellular aging (telomere length) and stress associated with the COVID-19 pandemic. Frozen blood samples
are available prior to COVID-19 and will again be obtained from the same officers during the present proposed study to evaluate
longitudinal change in telomere length. 4. Evaluate mental health status one year later, post-COVID-19. 5. To disseminate results in
peer reviewed, stakeholder, and various media outlets. To meet the aims of this study, it is imperative that this study begin as soon
as possible.

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

Yes

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:

2019 Novel Corona Virus Response

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

This project is not duplicative. An environmental scan revealed no known projects with similar data collection activities in Erie
county, NY. Partners were contacted and no additional data collection activities are planned at this time in Erie county, NY.
Literature reviews also indicate that there are no other studies with similar data collection activities.

Objective:

The overarching objective of this proposed project is to determine the longitudinal consequences of the COVID-19 pandemic on the
mental and physical health of police officers.

Does this project include interventions, services, or Not Selected
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:

Not Selected

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 ; Research with Humans

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

novel coronavirus-COVID19 ; police officers

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 ; CDC employees will participate as co-authors in presentation(s) or publication(s)

Method Categories:

Prospective Cohort Study

Methods:

The overarching objective of this proposed project is to determine the longitudinal effects of the COVID-19 pandemic on the mental
and physical health of police officers. Because this is a longitudinal study, the sample size is set at 240, because that is the number
of participants for whom we have previously collected mental and physical health data. We anticipate that approximately 10% of the
240 might not participate in the first round and 10% might not participate in the second round, leaving a sample size of 194. A
longitudinal analysis strategy will be used to address or answer the aims of this project. A statistician was consulted to determine if

we have sufficient power to address the aims of this project. Power calculations showed the minimum detectable effects that would
be detected at 80% power given a sample size of n=194, indicating that this is reasonable or sufficient to address the aims of this
study.

Collection of Info, Data or Biospecimen:

A sample size of 240 participants with questionnaire, salivary cortisol, and serologic sample collection is required. The
questionnaires, salivary cortisol, and serological sample collections will be administered within the first 6 months of the study then
one year later the questionnaire data alone will be collected again. We anticipate that approximately 10% of the participants will not
present for testing during the first round and another 10% may not respond to the second round of questionnaires. We expect all the
participants who complete the questionnaires to provide a blood sample, but it is possible that some of the participants will not
return the cortisol collection kit (~1%). The estimated is appropriate. The estimated burden time is: Questionnaire round 1: 216 * 1.0
hours = 216 hours Serological sample collection: 216 * 1.0 = 216 hours Salivary cortisol collection: 216 * 0.5 hours = 108 hours
Questionnaire round 2: 194 * 1 = 194 hours Total burden for project: 734 hours The project has sufficiently addressed potential
privacy concerns, including a formal agreement to prohibit the release of identifiers.

Expected Use of Findings/Results:

Given the high rates of mental and physical health issues in the policing population this study could lead to new knowledge about
police specific occupational stressors during a pandemic and identify risk and protective factors that may be used to mitigate these
stressors. Study findings will be disseminated through peer reviewed publications, presentations at scientific conferences, and also
directly to police officers through workshops and publications in trade journals.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

CDC Funding Intramural

9390EX3

HSC Review

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

No

Funding #

Original Budget Yr

# Years Award

2019

2

Budget Amount

Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

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
Name

FWA #

FWA Exp Date

IRB Title

University at Buffalo - State University of New York

FWA00008824

02/03/25

Select one

IRB Exp Date

Funding #

Staff
Staff Member

Anna
Mnatsakanova

SIQT Exp.
Date

CITI Biomedical
Exp. Date

12/04/2021

10/21/2021

CITI Social & Behavioral
Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Co-Investigator

[email protected]

304-2854

BIOANALYTICS
BRANCH

Claudia Ma

04/08/2023

Desta
Fekedulegn

12/10/2021

Erin Mccanlies

12/06/2021

John Violanti

12/04/2021

Michael
Andrew

12/06/2021

Oliver Wirth

12/21/2021

Co-Investigator

[email protected]

304-2856280

BIOANALYTICS
BRANCH

Co-Investigator

[email protected]

304-2858

BIOANALYTICS
BRANCH

Principal Investigator

[email protected]

304-2856132

BIOANALYTICS
BRANCH

10/21/2021

Principal Investigator

violanti@buffalo.
edu

716-8295481

University at
Buffalo, NY

10/31/2021

Co-Investigator

[email protected]

304-2856189

BIOANALYTICS
BRANCH

Contract Officer
Representative

[email protected]

304-2856323

BIOANALYTICS
BRANCH

12/21/2021

12/31/2022

11/01/2021

Data
DMP
Proposed Data Collection Start Date:

8/1/20

Proposed Data Collection End Date:

7/31/22

Proposed Public Access Level:

Restricted

Restricted Details:
Data Use Type:

Data Sharing Agreement

Data Use Type URL:
Data Use Contact:

Dr Erin McCanlies

Public Access Justification:

To protect the privacy of the study participants.

How Access Will Be Provided for Data:

Individuals interested in using this data must contact the PI, who will determine if the use is for research purposes only. After a data
use agreement has been signed, delinked, deidentified data will be provided, or alternatively we will offer to conduct the statistical
analysis, so that only aggregate and statistical results are sent rather than raw data.

Plans for Archival and Long Term Preservation:

The data will be held in NIOSH/HELD/BB secure LAN file. Only NIOSH study staff will have access to this data. All laws,
regulations, and rights regarding the data have been compiled.

Spatiality
Country

State/Province

County/Region

United States

New York

Erie

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date