Keeping Rural Minority 'Essential' Workplaces Open Safely During the COVID-19 Pandemic: The Role of Frequent Point-of-care Molecular Workplace Surveillance for Miners (Short Title: The Miners' Pandemic Project)
Phase: NA
Conditions: Covid19
Sponsor: University of New Mexico

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 1 of 32
PROTOCOL TITLE:
Keeping rural minority ‘essential’ workplaces open safely during the COVID-19 
pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners (Short title: The Miners’ Pandemic Project)
PRINCIPAL INVESTIGATOR:
Akshay Sood, MD (Contact P.I.) and Sara Assaf, MD (co-P.I.)
Department of Internal Medicine – Division of Pulmonary, Critical Care, and Sleep. 
(505) 272-4751
ADMINISTRATIVE CONTACT:
Vanessa Garcia
Department of Internal Medicine
(505) 272-5501
VERSION NUMBER:
11.2
DATE:
June 15, 2023
REGULATORY FRAMEWORK:
Please indicate all that apply (please note that the regulatory framework does not mean 
the funding source):
☐
DOD (Department of Defense)
☐
DOE (Department of Energy)
☐
DOJ (Department of Justice)
☐
ED (Department of Education)
☐
EPA (Environmental Protection Agency)
☐
FDA (Food and Drug Administration)
☒
HHS (Department of Health and Human Services)
☐
VA
☐
Other:      
FUNDING:
Sponsored by the National Institute of General Medicine Sciences (NIGMS) of the National 
Institutes of Health (NIH), Department of Health and Human Services (DHHS) (FP00009418)
CLINICAL TRIALS

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 2 of 32
Is this a clinical trial per the NIH definition of a Clinical Trial?   ☒ Yes   ☐ No
NIH Definition of a Clinical Trial: 
“A research study in which one or more human subjects are prospectively assigned to one or 
more interventions. An "intervention" is defined as a manipulation of the subject or subject’s 
environment for the purpose of modifying one or more health-related biomedical or behavioral 
processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; 
devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face 
interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, 
development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies 
(which may include placebo or other control) to evaluate the effects of those interventions on  
health-related biomedical or behavioral outcomes.” 
Use the following four questions to determine the difference between a clinical study and a 
clinical trial:       
1)
Does the study involve human participants? ☒ Yes   ☐ No
2)
Are the participants prospectively assigned to an intervention? ☒ Yes   ☐ No
3)
Is the study designed to evaluate the effect of the intervention on the participants? ☒ Yes  
☐ No 
4)
 Is the effect being evaluated a health-related biomedical or behavioral outcome? ☒ Yes   
☐ No
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a 
clinical trial, even if… 

You are studying healthy participants

Your study does not have a comparison group (e.g., placebo or control)

Your study is only designed to assess the pharmacokinetics, safety, and/or maximum 
tolerated dose of an investigational drug

Your study is utilizing a behavioral intervention
If yes to all 4 questions, please confirm that the research team is familiar with and agrees to 
comply with the investigator requirement to register the study on the ClinicalTrials.gov database. 
Additionally, the approved consent document(s) must be uploaded to the ClinicalTrials.gov 
database   ☒ Yes   ☐ No 
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu 

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
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Table of Contents
1.
Objectives.....................................................................................................................5
2.
Background ..................................................................................................................6
3.
Study Design ................................................................................................................8
4.
Inclusion and Exclusion Criteria ................................................................................11
5.
Number of Subjects....................................................................................................11
6.
Study Timelines..........................................................................................................11
7.
Study Endpoints: ........................................................................................................12
8.
Research Setting.........................................................................................................13
9.
Resources Available...................................................................................................14
10.
Prior Approvals.......................................................................................................14
11.
Multi-Site Research ................................................................................................14
12.
Study Procedures ....................................................................................................14
13.
Data Analysis..........................................................................................................16
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................18
15.
Withdrawal of Subjects...........................................................................................20
16.
Data Management/Confidentiality..........................................................................20
17.
Data and Specimen Banking...................................................................................20
18.
Risks to Subjects.....................................................................................................22
19.
Potential Benefits to Subjects .................................................................................22
20.
Recruitment Methods..............................................................................................23
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................23
22.
Economic Burden to Subjects.................................................................................23
23.
Compensation .........................................................................................................24
24.
Compensation for Research-Related Injury............................................................24
25.
Consent Process......................................................................................................24
26.
Documentation of Consent .....................................................................................25
27.
Study Test Results/Incidental Findings ..................................................................25
28.
Sharing Study Progress or Results with Subjects...................................................25
29.
Inclusion of Vulnerable Populations ......................................................................25
30.
Community-Based Participatory Research.............................................................25
31.
Research Involving American Indian/Native Populations .....................................26
32.
Transnational Research...........................................................................................26
33.
Drugs or Devices ....................................................................................................26
34.
Principal Investigator’s Assurance .........................................................................26
35.
CHECKLIST SECTION ........................................................................................30
36.
Partial Waiver of Consent for Screening/Recruitment ...........................................30
37.
Partial Waiver of HIPAA Authorization for Screening/Recruitment.....................31
38.
Waiver of Documentation of Consent ....................................................................31
39.
Alteration of Consent..............................................................................................32
40.
Full Waiver of Consent/Parental Permission..........................................................33
41.
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)34
42.
Full Waiver of HIPAA Authorization (Checklist)..................................................34
43.
Other Waiver Types (Checklist).............................................................................35
44.
Vulnerable Populations (Checklist)........................................................................35

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
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45.
Medical Devices (Checklist)...................................................................................41
46.
Export Control (Checklist) .....................................................................................42
47.
Data Transfer/Sharing (Checklist) (required –do not delete even if the answer is “No”)
42
48.
Specimen Transfer/Sharing (Checklist) (required –do not delete even if the answer is 
“No”) 43

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
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1. Objectives
The long-term goal of the study is to mitigate the spread of the pandemic in miners, a 
population of high-risk, rural essential workers who are susceptible and vulnerable to COVID-
19, partly based on exposure to particulate air pollution, and who are predominantly 
racial/ethnic minorities in New Mexico (NM) (3, 11). The study objective is to provide proof-
of-principle for frequent point-of-care molecular testing as a workplace surveillance tool to 
monitor and prevent the spread of SARS-CoV-2 infection in this unique population. The 
central hypothesis is that frequent workplace molecular surveillance is an effective method to 
reduce SARS-CoV-2 infection and discover novel host risk factors for the virus. The site of 
molecular surveillance (intervention site) will be a surface coal mine in McKinley County, 
NM, located just outside the Eastern Agency of the Navajo Nation, comprised of 66% minority 
miners. This site offers a unique opportunity for a community-based study of SARS–CoV-2 
infection in this population. Miners at the intervention site will provide nasal swabs before 
beginning their work shift on alternate days that will be analyzed with a ‘screening’ molecular 
test (12). This test is ideal because it is low cost, simple, portable, point-of-care, rapid, and can 
be performed by minimally trained professionals in low-infrastructure settings. The control 
site is a similar coal mine in Campbell County, Wyoming (WY). Both mines, operated by the 
same company, have similar engineering, administrative, and personal protective measures in 
place. The rationale for this study is to establish the suitability of longitudinal molecular 
surveillance to prevent and control SARS–CoV-2 infection in this unique population by 
completing the following specific aims.
Specific Aim 1: To determine the acceptance rate to frequent point-of-care molecular 
workplace surveillance among miners. Hypothesis 1: Miners will have a cumulative 
acceptance rate of frequent testing at ≥85%, with the added objective of exploring difference 
in acceptance by miner characteristics. 
Specific Aim 2: To determine the ability to detect the presence of SARS-CoV-2 by point-of-
care molecular workplace surveillance in a real-world setting of miners. 
Hypothesis 2: The sensitivity of the screening test in a real-world study setting is a) 
comparable to that described by others in controlled settings, and b) positively associated 
with viral load in upper respiratory specimens (latter measured in nose and nasopharynx 
using quantitative reverse transcriptase-polymerase chain reaction or RT-PCR). 
Specific Aim 3: To determine the effectiveness and implementation costs of frequent point-
of-care molecular workplace surveillance on reducing incident infection rates of SARS-CoV-
2.
Hypothesis 3A: Frequent point-of-care molecular testing over up to twelve months in the 
intervention mine will result in lower incident seropositivity rates compared to the control 
mine. Hypothesis 3B: Frequent point-of-care molecular surveillance in the intervention mine 
is cost-effective compared to the control mine.
Specific Aim 4: To determine novel predictive factors associated with incident 
SARS-CoV-2 infection, tests, and vaccination in miners. Hypothesis 4A: Miners with 
incident infection demonstrate less frequent use of cloth face-coverings outside the 
workplace, greater mine dust exposure intensity, presence of dust-related lung 

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 6 of 32
disease, and racial/ethnic minority status than those not infected. Hypothesis 4B: Test 
and vaccine uptake by miners is predicted by specific barriers and facilitators.
Hypothesis 4B involves a separate but related study, titled “Facilitators and barriers for 
COVID-19 testing uptake and its impact on vaccine uptake in a rural diverse essential 
workplace (Assaf/Sood, Co-PIs; NIH 1U23MD016258-01 RADx-UP Central Data 
Coordination Center Rapid Research Pilot Project)”. The objective is to determine facilitators 
and barriers to COVID-19 test uptake, and the impact of the latter on vaccine uptake, at a 
surface coal mine. This study involves the administration of a questionnaire once between 6 
and 12 months time point.  
2. Background
Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome-
related coronavirus-2 (SARS–CoV-2) infection, is a novel disease, frequently transmitted at 
the workplace. Rural workers are increasingly affected, particularly racial/ethnic minorities (1-
3). In New Mexico (NM), a rural, minority-majority, and medically underserved state, the 
greatest impact from COVID-19 is seen in McKinley County, in and around the Navajo Nation. 
The high risk of infection in minority communities could be due to genetic factors, 
immunological differences, social determinants of health (4), comorbidities, and/or high 
prevalence of concomitant co-exposures (1, 5, 6), in alignment with COVID-19 known risk 
factors (7-10). Despite sentinel studies in health care workers, meatpackers, and cruise ship 
workers, there are limited studies on the spread of SARS–CoV-2 infection in rural essential 
workers with health disparities. This critical gap-in-knowledge must be addressed to develop 
and implement novel pandemic strategies to keep rural minority essential workplaces open, 
particularly in environments such as coal mines, which are unable to use physical distancing, 
flexible schedules, or telecommuting interventions (3).
Scientific Premise
Essential 
workers: 
An 
estimated 
15 
million 
US 
workers 
provide 
essential 
services during the pandemic. 
‘Essential’ 
services 
are 
deemed critical to societal 
infrastructure and are crucial 
for rural economies. Initial 
reports have highlighted the 
risk imposed on health care 
workers during the pandemic. 
However, 
essential 
work 
extends beyond health care. 
Despite being categorized as 
essential, many rural workers 
have not been adequately 
tested and studied for SARS-
CoV-2 infection (13). Miners 
are rural essential workers with 
Table 1: SARS-CoV-2 infection vulnerability and susceptibility 
factors in miners
Vulnerable workers: Workers at 
higher risk due to the greater 
likelihood of increased exposure
Susceptible workers: Workers at 
higher risk (or worse outcomes) at any 
level of exposure
Hazardous work characteristics: 

Exposure to infected aerosols 
amongst 
essential 
workers 
unable to work from home

Enclosed, or poorly ventilated 
workplaces; 
difficulty 
distancing 
from 
virus-laden 
aerosols

Prolonged and close face-to-
face or physical contact 

Lack of access to flexible work 
schedule
Demographic characteristics:
Male sex
Rural residence
American 
Indian 
& 
Hispanics 
(particularly in intervention mine)
Co-morbidities: 
Obesity, 
hypertension, 
diabetes 
mellitus, cardiovascular disease
Co-exposures: 
Smoking/environmental 
tobacco 
smoke 
Work in high particulate air pollutant 
environments
Cross-cutting factors for vulnerable and susceptible workers
Enhanced Exposure to SARS-CoV-2:
Residence in homes that are overcrowded or multigenerational or without 
access to running water use (particularly in intervention mine)
Predisposition to Poorer Health Outcomes:
Low socioeconomic status

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 7 of 32
multiple vulnerability and susceptibility factors, as noted in Table 1, making them a unique 
population to test and study. 
Community partners: Our engagement with key mining community 
stakeholders provides the foundation for the proposed project as well as 
sustainability for future partnerships. Our mobile screening program for 
NM and WY miners (14) was recognized as an innovation at the HRSA 
Rural Health Information Hub (Fig. 1). We have co-authored multiple 
research manuscripts with our partners (3, 15-20). Our Mining 
Advisory Council (MAC), chaired 
by a partner (Gore, LOS) allows 
stakeholders to review research 
materials and protocols. Our 
Miners’ Wellness TeleECHO 
Program helps telementor rural 
professionals caring for miners 
(21), details for which are 
available at 
http://echo.unm.edu/miners-
wellness/. The Advisory Council 
and the TeleECHO Program, 
recognized as rural COVID-19 
innovations by HRSA's Rural Health Information Hub, exemplify our 
partnerships that will be leveraged for future pandemic mitigation 
efforts. 
Based upon data shown in 
Table 2, we serve 37% 
Hispanic, 
and 
33% 
American Indian miners 
in NM, indicating robust 
participation 
from 
populations 
historically 
underrepresented 
in 
health research. NM data 
(19) indicate that minority 
miners are at greater risk for developing lung disease than non-Hispanic white miners (18, 22). 
The sex, race/ethnicity, and smoking distribution, and prevalence of lung and cardiovascular 
diseases, diabetes, and hypertension support our position that miners are a unique population for 
studying SARS-CoV-2. 
The literature indicates that American Indians are reticent towards participating in research due to 
historic mistrust, resulting in some of the poorest health outcomes of any racial/ethnic group (21). 
However, our data from town hall meetings (Table 3) indicate that American Indian miners 
welcome participation in research to the same degree as those of non-American Indian descent, 
but maybe less comfortable with sharing biological specimens. To address this challenge, we will 
not store biological specimens for future research without consent for the same. 
Table 2. Characteristics 
of NM miners (n=6685)
Characteristic
%
Male 
97
Race/ Ethnicity
 Non-Hispanic white
28
 Hispanic  
37
 American Indian
33
Age (years)
 < 40 
14
 40-59 
44
 ≥60  
42
Smoker
 Never 
47
 Former 
35
 Current 
19
Self-Reported 
Diseases (n=5281)
 Chronic bronchitis 
32
 Current asthma
5
 Dust-related 
lung 
disease
6
 Cardiovascular 
disease
18
 Diabetes mellitus
13
Table 3: Research attitudes in American Indian (n=112; Group 1) and non-
American Indian miners (n=47; Group 2). Data from town hall meetings.
Question: How would 
you feel about….
Gp.
Yes, %
Maybe, %
No, %
P 
value
1
48.2
41.1
10.7
Participate in a long-
term research study?
2
38.3
48.9
12.8
0.5
Gp.
Comfortable
No feeling
Un-comfortable
1
60.7
16.1
23.2
Provide blood samples 
for research?
2
63.8
29.8
6.4
0.14
1
47.3
21.4
31.3
Long-term storage of 
biospecimens?
2
63.8
23.4
12.8
0.02
Figure 1: HRSA-funded mobile screening 
clinic for NM & WY miners, operated by NM 
& WY Black Lung Programs.

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
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In a 2016 study at the intervention mine, we determined that 58% of miners used social media, 
91% reported Internet access over their telephone, and 92% used the phone for texting. Miners 
reported using social media for 51 (mean) ± 142 (SD) minutes daily for 6±5 years, indicating adept 
and frequent usage. 52% of those surveyed indicated an interest in using social media to receive 
information about miners’ projects from our group. The social media-savvy nature of rural NM 
miners, initially surprising to our group, is a novel way to reach out to the study population using 
phone/web apps, which will be developed by Ingenuity Software Labs, Albuquerque, New 
Mexico. Our mine safety officer partner, JC Williams, CMSP, helped establish our social media 
engagement and education plan, including a video tutorial. 
Our capacity for SARS-CoV-2 testing: Molecular tests 
help establish a diagnosis by detecting SARS–CoV-2 
nucleic acids using RT-PCR or nucleic acid amplification 
assays (23). Laboratory-based RT-PCR assays performed 
on nasopharyngeal (NP) swabs collected by trained 
professionals (i.e., diagnostic test) are the cornerstone of 
diagnostic testing. A recent study showed that 
unsupervised, self-collected, midnasal swabs for the 
detection of SARS-CoV-2 are comparable to clinician-collected nasopharyngeal swabs (Cohen K 
statistic = 0.81), offering a unique opportunity to scale-up workplace testing (24). The commercial 
choice of screening test for our study will be finalized, based on test availability, in collaboration 
with the NIH RADx-UP initiative, but will have the following characteristics (Regulatory status: 
All; Diagnostic target: Viral antigen; Analysis location: Self or Lab CLIA Waived; Platform: 
Lateral flow; Specimen collected: Nasal swab; Company: Any; Minutes to result: 30 minutes or 
less; Sensitivity and specificity: At least 80%)..
We have performed over 600 RT-qPCR measurements of patient samples for our ongoing projects 
using the CDC N1 and N2 assays and a published “Wuhan” spike protein (S) gene assay. The 
results showed that the CDC N1 assay is the most robust. As such, we present viral load dynamics 
(log10 copies/mL) for the N1 assay in non-severe (n=13) and severe (n=19) patients with COVID-
19. As shown in Fig. 2, patients with severe disease have a higher and more protracted viral load 
in the upper respiratory tract (NP, P<0.001, panel A) and peripheral whole blood (P<0.01, panel 
B) compared to non-severe patients. Also, to capture viral load during the time-course 
measurements, area-under-curve (AUC) was calculated for the two groups. Patients with severe 
disease had a higher AUC than those with non-severe disease for both NP and peripheral blood 
(Fig. 3C). There was a significant positive relationship between severe disease and viral loads 
measured from the NP swabs (P=1.2x10-4) and whole blood (P=4.9x10-3), and between the NP and 
peripheral blood viral loads (P=2.5x10-6). 
Table 4: List of study SARS-CoV-2 tests
SARS-CoV-2 test
FDA 
authorized
Screening test (molecular)
Yes
Diagnostic test (RT-PCR)
Yes
Serologic antibody test 
Yes
Viral burden (Quantitative RT-
PCR or RT-qPCR)
Research 
test

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 9 of 32
3. Study Design
3.1. Specific Aim 1:
Frequent testing (i.e. alternate work shifts) using less sensitive molecular tests is proposed 
to keep workplaces open safely during the pandemic (26, 27), but its feasibility has not 
been studied. Our objective is to perform an experimental feasibility study to determine the 
acceptance of frequent point-of-care screening testing in our unique population. Our 
working hypothesis is miners will have a cumulative acceptance rate of frequent screening 
testing at ≥85%, with the added objective of exploring difference in acceptance by miner 
characteristics. The rationale for the proposed work is to establish worker acceptability for 
the proposed workplace surveillance. We expect that our findings will help design novel 
primary SARS-CoV-2 prevention strategies at rural workplaces, including future 
vaccination studies of essential workers.
Research design: This is a longitudinal surveillance study over up to twelve months, 
starting January 2021. We will utilize a fixed cohort of less than 250 at-risk miners at the 
intervention site, a surface coal mine in McKinley County, NM, with a population 
comprised of 66% minorities (American Indian and Hispanic), in partnership with the 
mine leadership.
3.2. Specific Aim 2:
Effective molecular surveillance may be only marginally affected by a test’s lower 
analytical limits of detection (26). Although molecular tests may show false negatives (FN) 
early on or late in the infection cycle when viral load is increasing and decreasing, 
respectively, the viral burden corresponding to a positive screening test is not established 
(29). Interim results demonstrate that when compared to the diagnostic (laboratory-based 
qualitative RT-PCR), screening test in controlled settings (in urgent care clinic, 
hospitalized and nursing home patients) is ≥95% sensitive and ≥99% specific (30). In our 
study, the screening test utilizes samples collected: a) at the workplace, b) by the 
participant, c) using nasal swabs followed by point-of-care testing, d) in a low 
infrastructure community setting, e) by minimally trained professionals. The screening test 
was granted emergency use authorization without a detailed study on end-user needs in the 
real-world, but each of the above variables introduces a potential source of error in results. 

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 10 of 32
Our objective is to determine the ability of the screening test to correctly detect the presence 
of the virus in upper respiratory specimens in the real-world setting. This will be 
accomplished by evaluating screening test performance at the workplace by quantifying 
viral loads from self-collected nasal swab and health personnel-collected nasopharyngeal 
(NP) swab specimens, using quantitative RT-PCR (RT-qPCR). Our working hypothesis is 
that the sensitivity of the screening test in a real-world study setting is a) comparable to 
that described by others in controlled settings, and b) positively associated with viral load 
in upper respiratory specimens. Successful completion of this study will help determine 
the real-world performance of less sensitive screening tests in disease settings of mild 
severity.
Research design: In this cross-sectional study, sensitivity, specificity and diagnostic 
accuracy (31) of the screening test on a self-collected nasal swab will be established by 
comparison with diagnostic test (qualitative RT-PCR), the latter conducted on an NP swab 
collected on the same day by trained health personnel, in a CLIA certified clinical 
laboratory (TriCore; Table 5). Also, since the diagnostic test is qualitative, we will also 
quantify viral load (log10 copies/mL) from repeat nasal (self-collected) and NP (collected 
by healthcare personnel) swab specimens using RT-qPCR established in the Perkins 
research laboratory (32). Viral load will be determined with primers and probes (N1 and 
RP) using the CDC 2019-nCoVEUA-01 diagnostic panel (33). Miners with any positive 
screening test (plus a sample of ~200 miners with a negative test) will undergo the above 
testing procedures. Database management and timelines will be similar to those described 
in Aim 1.
3.3. Specific Aim 3:
The role of frequent point-of-care molecular workplace surveillance to monitor and prevent 
the spread of SARS-CoV-2 is inadequately studied, particularly in rural essential 
workplaces. Our objective is to examine the effectiveness and costs of frequent point-of-
care molecular workplace surveillance in rural essential workers. Our working hypothesis 
3A is that frequent point-of-care molecular testing over up to twelve months in the 
intervention mine will result in lower incident seropositivity rates compared to the control 
mine. Hypothesis 3B is that frequent point-of-care molecular surveillance in the 
intervention mine is cost-effective compared to the control mine. The rationale for the 
Table 5: Test findings studied in Aim 2
Measurement
Biological specimen
N 
Purpose
Screening 
test 
(qualitative)
Self-collected 
nasal 
swab
less 
than 
250
Workplace surveillance
Diagnostic 
test 
(qualitative 
RT-
PCR)
Healthcare 
personnel 
collected NP swab
less 
than 
250
Establish sensitivity, specificity & diagnostic 
accuracy of screening test
Quantitative 
RT-
PCR
Self-collected 
nasal 
swab
less 
than 
250
Quantitate viral load vis-à-vis screening test
Quantitative 
RT-
PCR
Healthcare 
personnel 
collected NP swab
less 
than 
250
Quantitate viral load vis-à-vis screening test
Sputum biomarkers
Spontaneous 
home 
collected 
sputum 
samples
Less 
than 
250
Quantitate inflammation

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
miners
Page 11 of 32
proposed work is that by establishing its effectiveness, implementation costs, and cost-
effectiveness, our study will increase the real-world utility of workplace molecular testing, 
resulting in a novel primary prevention strategy targeted at rural essential workers.
Research design: We will conduct a up to twelve-month longitudinal surveillance study 
of miners at the intervention site (n=less than 250) in McKinley County, NM, and control 
site (n=less than 350) in Campbell County, WY. Both surface coal mines, operated by the 
same company, have similar engineering, administrative, and personal protective measures 
in place, including SARS-CoV-2 symptom & fever screening. While there will be frequent 
point-of-care molecular testing at the intervention site, seropositivity (baseline, 3, 6, and 
approximately12 m) will be measured at both sites.
3.4. Specific Aim 4:
Factors impacting SARS-CoV-2 spread is not well studied in rural essential workers 
outside healthcare. Our objective is to examine novel factors affecting the spread of 
infection in miners. A recent epidemiological study reported high COVID-19 mortality in 
communities exposed to ambient particulate air pollution (11). This novel risk factor is 
relevant for miners who are exposed to high levels of particulate air pollution at the 
workplace. Further, although the CDC encourages the public use of a cloth face-covering, 
its use by miners may vary, based upon individual and community factors (38), and has not 
been adequately studied. Our working hypothesis 4A is that miners with incident infection 
demonstrate less frequent use of cloth face-coverings outside the workplace, greater mine 
dust exposure intensity, presence of dust-related lung disease, and racial/ethnic minority 
status than those not infected. Hypothesis 4B: Test and vaccine uptake in miners is 
predicted by specific barriers and facilitators. The rationale for the proposed work is to 
prevent the spread of COVID-19 infection. We expect that our findings will result in novel 
primary prevention strategies for workers in dusty trades.
Research design: This is a up to twelve-month longitudinal surveillance study at the 
intervention (n=less than 250) and control (n=less than 350) mines. 
4. Inclusion and Exclusion Criteria
All miners will be recruited at the mine site with the support of mine leadership.
4.1. Inclusion Criteria

Male or Female Miner employed at the Peabody El Segundo mine in McKinley 
County, NM (i.e., intervention mine) or the Peabody Caballo and Rawhide mines at 
Campbell County, WY (i.e., control  mine).

> 18 years of age.

Willing and able to provide and sign Informed Consent Form. 

Willing and able to comply with study procedures.
4.2. Exclusion Criteria

Unable or unwilling to provide and sign Informed Consent Form

< 18 years of age.

PROTOCOL TITLE: Keeping rural minority ‘essential’ workplaces open safely during the 
COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
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We will not recruit or enroll pregnant women, incarcerated individuals, minors, or adults 
unable to consent.   
5. Number of Subjects
Less than 600 subjects will be recruited at all mine sites in this longitudinal study. Of these, 
less than 250 miners will be recruited from the Peabody El Segundo mine in McKinley County, 
NM at the edge of Navajo Nation (i.e., intervention mine). The remaining less than 350 miners 
will be recruited from the Peabody Caballo and Rawhide mines at Campbell County, WY (i.e., 
control mine). Both surface coal mines, operated by the same company, have similar 
engineering, administrative and personal protective measures in place, including SARS-CoV-
2 symptom & fever screening. While there will be frequent point-of-care molecular testing at 
the intervention site, seroprevalence (baseline, 3, 6, and 12 m) will be measured as an outcome 
at both sites.
6. Study Timelines
The duration of individual subject’s participation in this research is estimated to be 
approximately 12 months from the time they give and sign informed consent. We anticipate 
that all study participants will be enrolled in the first month of the recruitment and enrollment. 
Below are milestones with estimated dates of completion. The dates may be adjusted as 
necessary depending on the completion of previous milestones. 
Milestone 1: Completion of planning, contracts, purchase of tests and supplies, protocols and 
IRB approval: by January 2021. 
Milestone 2: Recruitment and collection of data: January 2021 through March 2022 
(anticipated). 
Milestone 3: Data analysis and dissemination: July 2021 through November 2022 
(anticipated).
7. Study Endpoints:
7.1. Specific Aim 1:
Predictor and Outcome variables: Screening test acceptance by miners is measured for 
each eligible work shift and cumulative acceptance rate (i.e., outcome) is calculated over 
the study timeframe (frequency of tests /number of eligible shifts worked, max=less than 
60). Characteristics predicting acceptance include self-reported educational and 
racial/ethnic minority status (from baseline questionnaire), self-reported prior SARS-CoV-
2 infection or vaccination (from app), evidence of prior infection (from a prior positive 
screening test), and daily county incidence and prevalence infection rates (from publicly 
available data). Focus group discussions and/or individual interviews will be performed in 
a sample of subjects at the intervention mine (in NM) to better understand ‘testing 
hesitancy’ towards the end of the study, using an interview script and trained interviewers. 
Only approved study members will be performing interviews. 
Expected outcomes: We anticipate a higher testing acceptance rate among non-Hispanic 
whites and those with higher self-reported educational status. Conversely, we expect lower 
acceptance rates among those with prior infection (or vaccination), and during time 

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COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
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Page 13 of 32
intervals in which incidence of infection in the County is either trending down or at a low 
level.
7.2. Specific Aim 2:
Predictor and Outcome variables: Predictor variable is the sensitivity of the screening test 
in our study conditions. Outcomes are a) the sensitivity of the screening test reported by 
others in controlled settings, and b) viral load measurements in upper respiratory specimens 
(i.e., repeat nasal and NP swab). 
Expected outcomes: We anticipate that the screening test results can be confirmed by 
detecting the SARS-CoV-2 load, within the limit of RT-qPCR detection. Based on our 
preliminary data (Fig. 2), our detection limit is ≥100 viral copies per mL (32). This level 
of detection is contingent on obtaining enough sample material. It remains unclear if a self-
collected nasal swab collected in a real-world setting will consistently yield enough sample 
material to detect SARS-CoV-2. Since we will incorporate a primer and probe for the 
detection of the human ribonuclease P gene in our assay, we can directly determine if there 
is sufficient sample material on the screening test for the detection of SARS-CoV-2. The 
study design will also allow us to determine if the level of the virus on the nasal swab, self-
collected in a real-world setting, is comparable in its ability to detect SARS-CoV-2 as that 
of a health personnel-collected NP swab.
7.3. Specific Aim 3:
Predictor and Outcome variables: The predictor variable is the mine status (intervention 
vs. control). The primary outcome is any new seropositivity for SARS-CoV-2 IgM or IgG 
at 3, 6, or approximately 12 months relative to baseline. The serologic test (depending 
upon availability, finalized using NIH recommendation) allows for the qualitative 
detection of IgG or IgM antibodies (separately) against SARS-CoV-2, indicating recent 
(IgM: 3-5 days) or prior infection (currently unknown). We will also study the presence 
of symptoms or fever, irrespective of infection status, as an alternative study outcome for 
hypothesis 3A. Costs of the test-based surveillance program, employee absenteeism 
patterns, and mine coal production will contribute towards defining the outcome variables 
for hypothesis 3B. At a minimum, a valuable outcome is to determine surveillance 
program costs, which have not been previously established for this rural industry setting, 
organization size, or proposed surveillance frequency. Additionally, variance in outcome 
measures—defined as employee days lost due to incident infection, mine productivity, and 
reduction in worksite infection rate—across the two sites will be used to estimate the cost-
effectiveness of the intervention. Database management and timeline are similar to that 
for Aim 1.
Expected outcomes: We anticipate that as compared to the control mine, the intervention 
mine demonstrates lower incident seropositivity, and that workplace surveillance is cost-
effective over twelve months.
7.4. Specific Aim 4:
Predictor, and outcome variables: The outcome variable for hypothesis 4A of incident 
seropositivity, is defined as in Aim 3. Predictor variables include frequency of cloth face-
covering use outside the mine, occupational dust exposure intensity, presence of lung 

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COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
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disease (historically or measured by sputum inflammation), and race/ethnicity status. 
Additional predictor variables for hypothesis 4B are specific barriers and facilitators. 
Additional outcomes for hypothesis 4B are test and vaccine uptake.
Expected outcomes: We anticipate that low levels of use of cloth face-coverings in public 
settings outside the mine, high levels of occupational dust exposure intensity, baseline 
dust-related lung disease, and racial/ethnic minorities are each associated with a greater 
relative risk for incident seropositivity than those without these characteristics. We 
anticipate that additional predictor variables, as outlined in the previous paragraph, affect 
test and vaccine uptake.
8. Research Setting
Recruitment, enrollment, and data collection will be conducted at the Peabody El Segundo 
mine in McKinley County, NM (i.e., intervention mine) and the Peabody Caballo and Rawhide 
mines at Campbell County, WY (i.e., control mine). Both surface coal mines, operated by the 
same company, have similar engineering, administrative and personal protective measures in 
place, including SARS-CoV-2 symptom & fever screening.
Baseline survey will be collected from both intervention and control mine sites but the 
additional questionnaire (and sputum collection) will be limited to the NM mine site only.
Confirmatory diagnostic tests, which are standard of care RT-PCR tests, will be conducted at 
TriCore Reference Laboratories from samples collected at the Peabody El Segundo mine or at 
the Cibola General Hospital (where TriCore Reference Laboratories currently provide reference 
laboratory services). The results from the standard of care test will be provided by TriCore to 
the study investigators. This does not require a data user agreement.
Since the confirmatory diagnostic standard of care test is qualitative, we will also quantify viral 
load (log10 copies/mL) from nasal (self-collected) and NP (collected by healthcare personnel) 
swab specimens using research diagnostic RT-qPCR tests established in the research 
laboratory of Dr. Douglas J. Perkins at the Center of Global Health in the University of New 
Mexico’s Department of Internal Medicine. The specimens for the research diagnostic tests 
will be collected at the Peabody El Segundo mine or at the Cibola General Hospital. Any 
specimens collected will be transferred to the Perkins laboratory using a Materials Transfer Agreement 
(MTA) 
Statistical analysis will be completed at the University of New Mexico Health Sciences Center. 
We will engage and work with the Mining Advisory Council, chaired by a partner, Bobbi Gore. 
This council allows stakeholders to review research materials and protocols. 
9. Resources Available
This study is based on the collective experience, expertise and infrastructure put together by a 
respected team of researchers, and community and clinical experts from the University of New 
Mexico and the Peabody mine sites in the states of New Mexico and Wyoming. This 
collaborative team, from the University of New Mexico (UNM) Health Sciences Center 
(HSC), Miners Colfax Medical Center, the Peabody El Segundo Mine, and the Peabody 
Caballo and Rawhide Mine, combine expertise in miner epidemiology, infectious disease, 
clinical care, and community-based prevention and care. The team at UNM will include Dr. 

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COVID-19 pandemic: The role of frequent point-of-care molecular workplace surveillance for 
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Akshay Sood, MD (PI), Nicholas Edwardson, PhD (Co-I), Nestor Sosa, MD (Co-I), Douglas 
J. Perkins, PhD (Co-I), Linda S. Cook, PhD (Co-I), Orrin B. Myers PhD, (Co-I), Alisha Parada, 
MD (Co-I), Sara Assaf, MD (Co-I), and Shuguang Leng PhD, (Co-I). 
10.Prior Approvals
UNM HSC IRB approval will be obtained before beginning any study activities.
11.Multi-Site Research
This is a single site study (i.e., at UNM HSC), with recruitment at two mine sites. This does 
not qualify as multi-site search. This study will take place and recruit participants at the (1) 
Peabody El Segundo Mine in McKinley County, NM at the edge of Navajo Nation (i.e., 
intervention mine), and the (2) Peabody Caballo and Rawhide mines at Campbell County, WY 
(i.e., control  mine). Laboratory diagnostic testing will be conducted at TriCore Reference 
Laboratories. Since the diagnostic test is qualitative, we will also quantify viral load (log10 
copies/mL) from nasal (self-collected) and NP (collected by healthcare personnel) swab 
specimens using RT-qPCR established in the research laboratory of Dr. Douglas J. Perkins at 
the Center of Global Health in the University of New Mexico’s Department of Internal 
Medicine. Data storage and analysis will be conducted at the University of New Mexico Health 
Sciences Center. The PI will have regular communication with the locations to confirm all 
research staff are competent, properly trained; they will have the most current version of the 
protocol, consent documents, and HIPAA authorization; any modifications will be 
communicated to sites and implemented only after IRB approval; they will safeguard all 
research data; any non-compliance with the study protocol or applicable requirements will be 
reported immediately to the PI; all adverse events, interim results and study closure 
determinations will be communicated via email and/or teleconference between the PI and study 
staff.
12.Study Procedures 
During the baseline study visit, former miners and never-miners will complete a 
comprehensive baseline survey. Additional study procedures are outlined below
Overview of study procedures
Measurement
Intervention mine, NM, n=less 
than 250
Control mine. 
WY, n=less 
than 350
Baseline survey: Demographics (age or DOB, gender or sex, 
race and ethnicity, education, household income, insurance, 
height, weight, Mailing residential address and if PO Box, 
physical mailing address, phone number, medical history 
including 
hypertension, 
diabetes, 
COPD, 
asthma, 
pneumoconiosis, immunocompromised state, cardiovascular 
disease, smoking, environmental tobacco smoke exposure, 
home access to running water, use of household wood or coal 
smoke, d tobacco,  , current medications,  history of prior 
COVID hospitalization, shared transportation
At the time of study enrollment, using paper and/or 
REDCap
Additional questionnaire: Demographics (age or DOB, 
gender or sex, race and ethnicity, education, household 
income, insurance, Mailing residential address and if PO Box, 
physical mailing address, phone number, medical history, 
smoking,  history of prior COVID hospitalization, Testing 
and vaccination history
Once between 6 and 12 months, 
using paper,  or electronic (e.g. 
REDCap) 
None

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12.1. Specific Aim 1:
Miners work one of two twelve-hour shifts daily, in repeated patterns of 4 days on 
followed by 4 days off work. At the beginning of each alternate work shift, each miner, 
irrespective of symptom status, will provide supervised self-collected midnasal swabs to 
trained mine safety personnel at the mine entrance. The safety personnel will run the 
screening test on swabs at the mine site. Miners with a positive screening test will 
undergo a confirmatory diagnostic test, and will be: 1) referred to their healthcare 
provider; 2) offered telemedicine evaluation at UNM, for those interested, and 3) 
removed from the workplace per CDC guidance (28). The final assay for the screening 
test will be decided based on advice from the NIH RADx-UP Coordinating and Data 
Collection Center. Acceptance data will be entered at the mine site by the safety 
personnel into a Research Electronic Data Capture (REDCap) database. Focus group 
discussions and/or individual interviews will be performed in a sample of subjects at the 
intervention mine in NM to better understand ‘testing hesitancy’ towards the end of the 
study. 
12.2. Specific Aim 2:
Miners with any positive screening test (plus a sample of ~200 miners with a negative 
test) will undergo trained professional collected NP swab (for RT-PCR diagnostic 
testing), self-collected nasal swab (for RT-qPCR) and trained professional collected NP 
swab (for RT-qPCR). Database management and timelines will be similar to those 
described in Aim 1.
12.3. Specific Aim 3:
Web-based phone app questionnaire: Symptoms;  frequency 
of cloth face-covering use outside the mine ; vaccination 
history, infected contacts, & history of prior COVID infection 
Each work shift via the phone app
Measured fever screen
Each work shift measure, recorded via REDCap 
(normal vs. abnormal)
Nasal swab (self-collected) screening test 
Alternate shift collection plus test 
acceptance 
data 
entered 
into 
REDCap
None
Nasopharyngeal swab (trained professional or TP-collected) 
diagnostic test (RT-PCR, TriCore labs)
All 
abnormal 
screening 
tests 
(collected at TriCore Cibola) & 
sample (n=approximately 200) of 
normal screening tests (collected at 
mine site) plus test acceptance data 
entered into REDCap
None 
prescribed
Nasal (self-collected) and nasopharyngeal swab (TP-
collected) research test (RT-qPCR, Perkins labs)
All abnormal & sample of normal 
tests as above
None 
prescribed
Serology 
Blood sample at baseline, 3, 6, and approximately 
12 months plus test acceptance data entered into 
REDCap
Occupational dust exposure  intensity
Every work shift via job-exposure matrix created by 
occupational safety team via REDCap
Daily county incidence and prevalence data
Recorded daily by study coordinator from public 
health records entered into REDCap
Focus group discussions and/or individual interviews to study 
“testing hesitancy”
Yes
No
Spontaneous home collected sputum sample
Yes once at 
approximately 12 
months
No

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In brief, at the beginning of each work shift, trained mine safety personnel will obtain the 
following: 1) 24-hour history of SARS-CoV-2 symptoms, provider diagnosis of 
infection, close contact with any infected, vaccination, and use of cloth face-covering in 
public settings outside the mine, using a web-based phone app, also available using a 
computer connected to the Internet; and 2) body temperature measurement using a no-
touch forehead infrared thermometer. The web-based phone app, created by Ingenuity 
Software Inc., will be accessed by the subjects with password protection. The information 
will be encrypted during data transfer to a secure server that resides at the UNM HSC 
and will auto-populate the REDCap database.  The phone app has been approved by 
UNM HSC IT.
At the beginning of each alternate shift, the mine safety team will collect a supervised 
self-collected nasal swab from each worker for point-of-care screening testing, as 
described in Aim 1. Fingerstick or venipuncture blood samples will be obtained at the 
mine site from all study participants at the time of enrollment, and at 3, 6, and 
approximately 12 months (no more than 24 ml or 4.9 teaspoons each visit) to determine 
seropositivity, using the COVID-19 IgG/IgM antibody test. Employee absenteeism (both 
general and screen test results-driven) and coal production records will be analyzed.
12.4. Specific Aim 4:
Predictor variables are listed in Table titled Overview of Study Procedures. Database 
management and timeline will be similar to that for Aim 1.
13.Data Analysis
13.1. Specific Aim 1:
Predictor and Outcome variables: Test acceptance by miners is measured for 
each eligible work shift and cumulative acceptance rate (i.e., outcome) is 
calculated over the study timeframe (frequency of tests /number of eligible 
shifts worked, max number estimated at less than 120). Characteristics 
predicting acceptance include self-reported educational and racial/ethnic 
minority status (from baseline questionnaire), self-reported prior SARS-CoV-2 
infection or vaccination (from app), evidence of prior infection (from a prior 
positive screening test), and daily county incidence and prevalence infection 
rates (from publicly available data). 
Statistical approach: Cumulative acceptance rate will be compared between 
groups, defined by predictive characteristics. Poisson regression with indicator 
variables will be used to assess the effects of miner characteristics on 
cumulative acceptance rates. Analyses will use the number of shifts in which 
tests were available to miners for the rate denominator (offset) to account for 
absenteeism. Longitudinal analysis of shift-level acceptance by miners will be 
examined using mixed model regression for binary outcomes that account for 
repeated measures. Within-miner factors will include time-varying SARS-2-
COV-2 exposure (personal and community) and vaccination status, and linear 
and nonlinear time trends. 

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Power calculations: If we recruit less than 250 miners, we have the power to estimate 
85% acceptance rate ± 4.6%. For a comparison of acceptance rates between predictor 
groups, we assume, for example, non-Hispanic white and minority miners (1/3 and 2/3 
of the study population respectively) have 85% and 80% acceptance respectively. We 
used simulation to assess power for Poisson regression analyses where the rate 
denominator (offset) is the number of miner workdays, assumed to be 95% of possible 
days. For these conditions, power is 94% for a 5% lower acceptance rate for minority 
miners. We also used simulation to assess the planned longitudinal analysis of miner 
acceptance by assuming that miners attended work 95% of the shifts, that initial 
acceptance is 85% and that there is a linear decline in acceptance over the study to a 
final acceptance rate of 80%. For repeated measures on about 200 miners, the power to 
detect a linear decrease to 80% is 95%.
13.2. Specific Aim 2:
Statistical analysis: We will compare screening test performance measures 
between our real-world study setting and controlled settings (as published by 
others). We will use a one-sample Exact test for a binomial proportion to test 
whether sensitivity for the screening test is the same as that published. We will 
correlate screening test results with quantitative viral loads, and perform Bland-
Altman plots to reveal systematic differences between viral loads collected by 
the two sampling methods.
Power Calculations: If we conservatively estimate identifying 25 true positive miners, 
using a one-sample Exact test for a Binomial proportion equal to the comparison test, 
we have the power (>90%) to detect a difference between the screening and the 
comparison test if the screening test sensitivity is 90% or lower.
13.3. Specific Aim 3:
Predictor and Outcome variables: The predictor variable is the mine status. The 
primary outcome is any new seropositivity for SARS-CoV-2 IgM or IgG at 3, 6, 
or 12 months relative to baseline. The test allows for the qualitative detection of 
IgG and/or IgM antibodies (separately) against SARS-CoV-2, indicating recent 
(IgM: 3-5 days) or prior infection (currently unknown). The tests have positive 
percent agreements of 97% and 87% and negative percent agreements of 98% 
and 99% for IgG and IgM, respectively, compared to oropharyngeal swab RT-
PCR. We will also study the presence of symptoms or fever, irrespective of 
infection status, as an alternative study outcome for hypothesis 3A. Costs of the 
test-based surveillance program, employee absenteeism patterns, and mine coal 
production will contribute towards defining the outcome variables for 
hypothesis 3B. At a minimum, a valuable outcome is to determine surveillance 
program costs, which have not been previously established for this rural 
industry setting, organization size, or proposed surveillance frequency. 
Additionally, variance in outcome measures—defined as employee days lost 
due to incident infection, mine productivity, and reduction in worksite infection 
rate—across the two sites will be used to estimate the cost-effectiveness of the 
intervention. Database management and timeline are similar to that for Aim 1.

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Covariates: Baseline seropositivity, vaccination status, other host susceptibility 
and vulnerability factors outlined in Table 1, and daily community prevalence 
and incidence, will be studied as covariates in multivariable models (35). 
Statistical analysis: Chi-square tests will examine whether relative frequencies 
of incident seropositive miners are the same at 3-months, 6-months, and 12-
months for the two mine types, using α=0.025 to account for the two tests. 
Generalized linear models for repeated binary outcomes will be used to assess 
how covariates are associated with seropositive status over time. 
Power calculation: Based on representative seroprevalence/molecular prevalence rates 
for similar communities (36), we anticipate a 10% baseline seropositivity with incident 
seropositivity at 6 months at 5% for the intervention mine and a baseline seropositivity 
of 5% in the control mine. We anticipate similar power calculations to apply up to 12 
months. We explored a range of control miner incident seroprevalence values that 
would have 80% power when comparing frequencies at the two mines using chi-square 
tests. We expect 80% power if incident seropositivity at the control mine is ≥9% (α
=0.025).
13.4. Specific Aim 4:
Statistical analysis: Chi-square and logistic regression analyses will be used to 
explore how miner characteristics are associated with baseline seropositivity. 
Generalized linear models for repeated binary outcomes will be used to assess 
how predictor variables (noted in Table 7) and covariates (as noted in Aim 3) 
are associated with incident seropositivity at 3, 6, & approximately 12 months. 
Both analysis strategies will include mine type as a covariate and will add 
predictor and outcome variables noted in Table 7. 
Power calculation: We assessed power, using simulation for incident seropositivity at 6 
months with mine type as covariate and a predictor miner variable, such as high dust 
exposure. We anticipate similar power calculations up to 12 months. We assumed the 
miner variable, present in 1/3 sample, will increase the probability of incident 
seropositivity by 0.10. For a logistic regression analysis and this setup, power is >96%.
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
Data and Safety Monitoring Plan (DSMP) 
Overview: The proposed study is an NIH-designated clinical trial. The Mining Advisory 
Council (recognized in 2020 by HRSA as rural COVID-19 innovation) will serve as the 
Table 7: List of predictor and outcome variables for Aim 4
Predictor 
and 
outcome 
variables
Time of measurement
Procedure for ascertainment
Frequency of cloth face-
covering use outside the mine
On the day of the screening test; Mean summary 
variable over the one week before the test
Self-report, via the app, every 
work shift
Occupational dust exposure 
intensity
On the day of the screening test; Mean summary 
variable over the one week before the test
Mine safety team, via job-
exposure matrix, every shift 
Presence of lung disease
Baseline 
Baseline survey
Race/ethnicity status
Baseline (at study enrollment)
Self-report via questionnaire
Facilitators and barriers
Between 6 and 12 months
Self-report via questionnaire
Test and vaccine uptake
Between 6 and 12 months
Self-report via questionnaire

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“Human Subjects Unit” which will work to monitor ethical and social implications and 
human subjects concerns in testing implementation. This work is essential in monitoring 
implementation efforts are not exacerbating health disparities in our underserved and 
vulnerable populations. A data and safety monitoring board will not be needed for the study, 
since the intervention in the clinical trial is low-risk.
Purpose: to ensure the safety of research participants and protecting the validity and integrity 
of study data in the clinical trial.
The clinical trial will be monitored by the Principal Investigator (PI), Institutional Review 
Board (IRB), and members of the Mining Advisory Council. Monitoring of our clinical trial 
includes the following activities.

Description of any specific events that would preclude a participant from 
continuing the intervention

Description of the potential risks and the measures in place to protect 
participants against foreseeable risks

Description of the consent procedures 

Description of the mechanisms in place to protect subject privacy 

Description of the trial stopping rules for the study

Description of the plan for management of incidental findings 

Description of the process for the disclosure of any conflicts of interest that 
may potentially challenge participant safety or bias the data and how the 
conflict will be managed

Description of the data security in place to protect the confidentiality of the 
data
The roles and responsibilities for the individuals participating in the DSMP are outlined 
below. No DSMB is needed since the intervention is low risk. 
Name of DSMP member
Qualification
Role
Akshay Sood (PI)
Physician
Plan for management of 
incidental findings & 
conflict of interest
Nour Assad
Physician
Adverse event monitoring
Kevin Vlahovich
Physician
Adverse event monitoring
 
Orrin Myers
Biostatistician
Trial stopping rules & data 
security
Xin Shore
Biostatistician
Trial stopping rules
William “Cotton” Jarrell
Mine safety officer
Consent and 
procedures/privacy
Bobbi Gore
Community manager
Community perspectives
Diane Gail Johnson
Community manager
Community perspectives

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Bruce Wissore
Miner lawyer
Legal perspective
Reportable Events: The team will follow the protocols and timelines laid down by the IRB 
(UNM HRPO) for collecting and reporting Adverse Events (AEs), Serious Adverse Events 
(SAEs), and Unanticipated Problems Involving Risks to Subjects or Others to appropriate 
monitoring and regulatory entities. The ITB also has rules regarding protocol violations, non-
compliance, suspensions, and terminations.
Data Management, Analysis, and Quality Assurance: The team will identify all data sources 
(e.g., questionnaires, biospecimen collections, app data, data entered by mine safety team 
into REDCap), outline the security measures to protect data sources including how the data 
will be labeled and stored, and determine quality assurance measures for subject recruitment, 
enrollment, enrollment targets, and for the validity and integrity of the data. 
15.Withdrawal of Subjects
Subjects are free to withdraw from study participation at any time during this clinical study. 
The Investigator may withdraw a subject if continued participation is not in the interest of the 
subject’s health and welfare, for noncompliance with protocol-specified procedures, or 
because of a protocol violation.  This will be evaluated on a case-by-case basis by the 
Investigator. Overall, because this is a study with a low risk to participants, no other stopping 
rules apply. Data collected from participants up to the point of withdrawal will not be 
destroyed, but no additional data will be collected.
The primary reason for discontinuation or withdrawal will be documented as one of the 
following:

AE

Noncompliance 

Protocol violation

Consent withdrawn
16. Data Management/Confidentiality
Data transfer between study personnel and for test results from TriCore Reference laboratory 
will use an HIPAA- compliant encrypted fax system managed by the HSC’s RightFax 
system. Data will be stored and managed on a REDCap database on a secure server at the 
UNM HSC. The database will be populated using both electronic and paper source systems. 
Once entered into REDCap, electronic and paper source documents will be destroyed. At the 
study site, password protected mobile and fixed computer devices will be utilized to collect 
study data utilizing the REDCap Mobile system. Data will be coded with a digital study 
number. Identifying information will be stored in a separate REDCap database. When off-site 
the database will be secured and accessed via secure https:// connection provided by UNM 
HSC. Control of users and privileges, as well as local and remote backup of the database will 
be in accordance with UNM HSC management procedures. All documents and paperwork 
will be stored in locked file cabinets at UNM and individual medical records will be 
electronically stored in HSC secure electronic drives. All personal data and identifiers will be 
maintained in accordance with HIPAA regulations. Study records and data will be kept for 6 
years at the local site after study closure per federal regulations. 

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De-identified data resulting from this study may also be presented at meetings, published in 
journals/books, used in classrooms for training/teaching purposes, and may be shared with 
other researchers including scientists at other universities and institutions.
Study information will be shared with: 1) local investigators at the CEAL-WEAVE study at 
the UNM HSC, PI Lisa Cacari-Stone (HRRC ID 21-371) of the data from the additional 
questionnaire administered between 6 and 12 months in a deidentified data format. The 
CEAL-WEAVE study has a similar objective related to vaccine uptake. 2) NIH (of the data 
from the additional questionnaire in a deidentified data format, by the CEAL-WEAVE study) 
and 3) the NIH-funded RADx-UP databases at the Duke Clinical Research Institute (DCRI). 
RADx-UP stands for Rapid Acceleration in Diagnostics (in) Underserved Populations. 
RADx-UP is a health research program to learn more about COVID-19 disease. DCRI is a 
research group chosen by the NIH to combine the data collected from everyone taking part in 
RADx-UP studies. The purpose of sharing of data with DCRI for future studies is to allow 
the medical community to learn more about COVID-19, in particular, and better health, in 
general. The data will be shared by secured internet connection and stored in secure 
electronic files. 
The DCRI will build two RADx-UP databases. The first database will only hold identifiable 
information. Examples are subject name, address, email, and gender.  

These data will be kept at the DCRI.  The DCRI will not share these data with the NIH.  

Subject information will be linked with information from other sources, such as the 
Centers for Medicare and Medicaid Services and subject’s electronic health record, among 
others.  

These data will stay in a password-protected secure electronic system and only staff 
responsible for maintaining the security of subject data at the DCRI will be able to see this 
information.
The second database will not hold information to identify the subject.  It will hold all the 
non-identifiable information the subject agrees to give.

The subject will be assigned a code and will only be identified in this database by this 
code.

It will not contain subject name or other information that could easily identify the subject. 

The DCRI plans to transfer and keep these non-identifiable data in a secure database for 
COVID-19 research at the NIH. Other researchers may use these data for studies, other than 
the ones stated in this consent form.

When using the data from this second database, researchers will only have access to 
subject non-identifiable data and cannot link the data back to the subject.  
For all data sets, preliminary analyses will include checking for missing values, range 
checking, and outlier checking. 
Only IRB approved study team members will be able to view and have access to research 
related data.
Please note that a DUA will be put into effect with Duke Clinical Research Institute (please 
see sections 47 and 48) and the SPO will be utilized for the same. Please note that a MTA 

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will be put into effect with any future researchers before material is transferred (please see 
sections 47 and 48).
DUA and MTA are part of the contract with Peabody mines. DUA is part of the contract with 
Ingenuity Software (for phone app creation).
17.Data and Specimen Banking
We will utilize the approved data and biological specimen repository study (HRRC ID 14-
058). Blood and respiratory specimens will be indefinitely banked in the approved tissue 
repository at UNM HSC for future studies, if allowed by the study subject. The specimens 
will be stored in the IRB and HTOC-approved MEL Repository with HRRC ID 17-422. The 
existing study 14-058, will be amended to account for samples from this study being added to 
it. 
18.Risks to Subjects
Potential Risks: The proposed protocol involves minimal risk only. However, we will 
continuously monitor the study related procedures and data collections. We have established 
mechanism to protect the confidentiality of participant information. Nevertheless, accidental 
disclosure of study data may occur.  There are no alternative treatments appropriate for this 
protocol and no circumstances for terminating the study other than declining to participate in 
the study. Only trained and certified staff will perform and administer the procedures to 
minimize the risk of following:
Loss of privacy: Participation in a research study may result in some loss of privacy. The risk 
of loss of privacy and confidentiality will be minimized. Information about a subject will be 
handled as confidentially as possible. Representatives from the University of New Mexico 
Health Sciences Center Human Research Review Committee that oversees human subject 
research and the National Institutes of Health will be permitted access to a subject’s records. 
Also, a subject’s participation in the study and information in a subject’s study records may be 
disclosed to a subject’s doctors and nurses, and may be disclosed as otherwise provided by 
law. However, a subject’s name will not be used in any published reports about this study. 
Please also see the section on data management.
Injury from fingerstick or venous blood draws: Temporary local discomfort accompanies 
virtually all needle sticks. Potential injury from venous blood draws includes occasional 
(<10%) bruising, sweating, dizziness and rarely (<1%) fainting and infection.
Nasopharyngeal (NP) and Nasal Swabs: Occasional and temporary mild discomfort and 
bleeding from repeated efforts of obtaining NP swabs.  Nasal swabs can be performed without 
discomfort or risk.
Precautions will be exercised in order to maintain the highest standard of anonymity. Each 
patient data/blood samples will be given a unique study number that will not be linked in any 
way to standard HIPAA identifiers, and importantly, the datasets we will work with are 
Limited Data Sets in accordance with HIPAA guidelines (stripped of standard identifiers). The 

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PI will store the database linking the medical record and study numbers in a separate secure 
REDCap database. No reference to subject name or other personal identifiers that could 
jeopardize their privacy will appear in the main database, blood samples, in abstracts, scientific 
papers or other documents that emanate from this study. Importantly, random anonymous 
identifiers will be used to label blood samples.
Survey and Questionnaires: Answering some questions may cause stress and/or emotional 
discomfort.
Spontaneous home collected sputum: The risks related to spontaneous sputum 
expectoration are minimal and include cough, chest discomfort or shortness of breath but this 
is anticipated to be short lasting. At home, taking a shower before collecting the sample may 
help.
There may also be side effects or risks to study participation that are unforeseen and not 
known at this time.
19.Potential Benefits to Subjects
There will be no direct benefit to participants of this study. The risks involved do not pose a 
significant threat to the health of the participants. However, the prevalence of COVID-19 in 
rural essential workers and minorities can be very high. Thus, participants in the proposed 
study may benefit from early diagnosis and treatment of COVID-19.
20.Recruitment Methods
Less than 600 subjects will be recruited at all mine sites in this longitudinal study. Of 
these, less than 250 miners will be recruited from the Peabody El Segundo mine in 
McKinley County, NM at the edge of Navajo Nation (i.e., intervention mine). The 
remaining less than 350 miners will be recruited from the Peabody Caballo and 
Rawhide mines at Campbell County, WY (i.e., control mine). Both surface coal mines, 
operated by the same company, have similar engineering, administrative and personal 
protective measures in place, including SARS-CoV-2 symptom & fever screening. 
While there will be frequent point-of-care molecular testing at the intervention site, 
seroprevalence (baseline 3, 6 and approximately 12 m) will be measured as an outcome 
at both sites.
All miners will be recruited at the mine site with the support of mine leadership (see attached 
letters). Recruitment methods include 1) flyers and emails (attached) and 2) miner videos, 
placed on ‘theamericanminer.org’ website and played on mine TV monitors.
21.Provisions to Protect the Privacy Interests of Subjects
The research study will require IRB approval. 
The risk of loss of privacy and confidentiality will be minimized. Information about a 
subject will be handled as confidentially as possible. Representatives from the 
University of New Mexico Health Sciences Center Human Research Review 
Committee that oversees human subject research and the National Institutes of Health 
will be permitted access to a subject’s records. Also, a subject’s participation in the 

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study and information in a subject’s study records may be disclosed to a subject’s 
doctors and nurses, and may be disclosed as otherwise provided by law. However, a 
subject’s name will not be used in any published reports about this study. Please also 
see the section on data management.
The mines have walled-off sections that give privacy to study participants and for 
making them feel at ease and in control of with whom they interact and prevents 
‘eavesdropping’ or observation by non-study team members.  Privacy will be protected 
during recruitment, consent, and data collection.
Additionally, all tests will be similarly performed by qualified personnel using standard 
protocols and appropriate test settings to minimize the risks related to study procedures.
22.Economic Burden to Subjects
Subjects are not responsible for their participation in the research.  There are no costs to 
participants. If there are any adverse events or complications, the cost of treating those adverse 
events or complications will be borne by the participant and their insurance.
Responsible Party
Research Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Screening COVID-19 Testing
Multiple
☒
☐
COVID-19 qualitative RT-PCR and 
quantitative RT-PCR Testing
Multiple Possible
☒
☐
Phlebotomy/Serology IgG/IgM Test
4
☒
☐
Spontaneous home collected sputum
1
☒
☐
     
     
☐
☐
     
     
☐
☐
     
     
☐
☐
Responsible Party
Standard of Care Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
     
     
☐
☐
23.Compensation
There is a $10 reimbursement via a merchandise card (generic merchandise or CTSC-CLIN 
card) sent by email or by mobile phone text or by mail or hand delivered for providing each 
biological specimen (i.e., each nasal swab, each nasopharyngeal swab, each blood specimen, 
including fingersticks, and each spontaneous home collected sputum sample) while 
participating in the study, in addition to study tests being provided without charge. 
Eligible subjects will be provided telemedicine consultation upon request via UNM, which will 
be charged to their insurance.
Subjects will be provided an additional $5 reimbursement, using a merchandise card as 
described above, for completing the phone app survey every work shift, until the end of the 
project (estimated at  less than 120 work shifts). Since this information was not provided in the 

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consent, all participants will be informed by email (or phone text), using the message below 
(sent approximately every four days till the end of the project- estimated at approximately 26 
times). This message will also be 1) mailed to their mailing address once, with a phone app 
users guide; 2) placed at the worksite messages area (with copies of app users guides); 3) placed 
on the phoneapp in the Reminders section; and 4) placed in a flyer handed over to miners at 
the guard shack (at the mine entry) frequently.
Subjects will be provided a $100 reimbursement via a merchandise card as described above 
for completing the additional questionnaire once between 6 and 12 months.
Message to NM mine site: Please complete the Miners’ Pandemic Project Phone app 
survey (hyperlink leads to https://miners.health.unm.edu) before each work shift and 
receive a $5 merchandise card for each completed survey. For questions, please contact 
Cotton Jarrell.
Message to WY mine site: Please complete the Miners’ Pandemic Project Phone app 
survey (hyperlink leads to https://miners.health.unm.edu) before each work shift and 
receive a $5  merchandise card for each completed survey. For questions, please contact 
Kelly Zimmerscheid.
24.Compensation for Research-Related Injury
If a participant becomes sick or injured as a direct result from the study, they may receive 
emergency treatment, however, there is no commitment by the UNM HSC to cover the costs 
related to research related injuries. The subject and/or their third party payer will be charged 
in the usual way.
25.Consent Process
Consent will be obtained following local IRB SOP titled, “SOP: Informed Consent Process for 
Research (HRP-090).” Parts of the informed consent process may be conducted virtually, over 
the phone, or in person as allowed by the UNM Human Research Protection Office due to 
COVID-19 related restrictions. The in person consent process will take place in a private area at 
the mine site and be conducted by an IRB approved study team member. Participants will be 
given time, and encouraged, to discuss the study with friends and family before making an 
informed decision. Ongoing verbal consent will be obtained at each study visit. The protocol 
requests a waiver of written documentation of consent. This is reasonable since the research is no 
greater than minimal risk. However, signature will be obtained on the consent form within two 
weeks of the virtual consent. 
All participants will be reconsented for their continued study involvement between 6 months and 
up to 12 months. The reconsenting will occur at or after six months, using the approach outlined 
above. Participants who have or have not consented at baseline may consent at or after six 
months.
Participants not fluent in English

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Participants not fluent in English will not be consented or enrolled into the study. This 
is due to the questionnaires being only in English. Additionally, we may not have 
access to qualified interpreters. 
26.Documentation of Consent
To document our consenting process we will be following “SOP: Written Documentation of 
Consent (HRP-091).” The protocol requests a waiver of written documentation of consent. 
However, signature will be obtained on the consent form within two weeks of the virtual 
consent.
27.Study Test Results/Incidental Findings
Test results of clinical significance will be shared with the patients and they will be instructed 
to follow-up with their primary care physicians, as necessary.
We do not expect any incidental findings, as we are specifically testing for COVID-19 and 
IgG/IgM antibodies to COVID-19 only.  
28.Sharing Study Progress or Results with Subjects
Consented subjects will not be provided with a summary of the trial progress while the study 
remains underway nor will they be provided with study results. Results of positive screening 
test or positive RT-PCR diagnostic test will be shared with the study subject and occupational 
health and safety team. Results of the positive RT-PCR diagnostic test will be shared with 
public health authorities, as necessary. 
29.Inclusion of Vulnerable Populations
N/A – No vulnerable populations will be recruited for this study.
30.Community-Based Participatory Research
Community partners: Our engagement with key mining community stakeholders provides the 
foundation for the proposed project as well as sustainability for future partnerships. Our 
Mining Advisory Council (MAC), chaired by a partner (Gore, LOS) allows stakeholders to 
review research materials and protocols. Our Miners’ Wellness TeleECHO Program helps 
telementor rural professionals caring for miners (21), details for which are available at 
http://echo.unm.edu/miners-wellness/. The Advisory Council and the TeleECHO Program, 
recognized as rural COVID-19 innovations by HRSA's Rural Health Information Hub, 
exemplify our partnerships that will be leveraged for future pandemic mitigation efforts. 
Based upon data shown in 
Table 2, we serve 37% 
Hispanic, 
and 
33% 
American Indian miners 
in NM, indicating robust 
participation 
from 
populations 
historically 
underrepresented 
in 
health research. NM data 
(19) indicate that minority 
Table 3: Research attitudes in American Indian (n=112; Group 1) and non-
American Indian miners (n=47; Group 2). Data from town hall meetings.
Question: How would 
you feel about….
Gp.
Yes, %
Maybe, %
No, %
P 
value
1
48.2
41.1
10.7
Participate in a long-
term research study?
2
38.3
48.9
12.8
0.5
Gp.
Comfortable
No feeling
Un-comfortable
1
60.7
16.1
23.2
Provide blood samples 
for research?
2
63.8
29.8
6.4
0.14
1
47.3
21.4
31.3
Long-term storage of 
biospecimens?
2
63.8
23.4
12.8
0.02

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miners are at greater risk for developing lung disease than non-Hispanic white miners (18, 22). 
The sex, race/ethnicity, and smoking distribution, and prevalence of lung and cardiovascular 
diseases, diabetes, and hypertension support our position that miners are a unique population 
for studying SARS-CoV-2. 
The literature indicates that American Indians are reticent towards participating in research due 
to historic mistrust, resulting in some of the poorest health outcomes of any racial/ethnic group 
(21). However, our data from town hall meetings (Table 3) indicate that American Indian 
miners welcome participation in research to the same degree as those of non-American Indian 
descent, but maybe less comfortable with sharing biological specimens. To address this 
challenge, we will not store biological specimens for future research for participants who do 
not provide consent for the same.
31.Research Involving American Indian/Native Populations
We anticipate enrolling approximately 66% racial/ethnic minorities, including approximately 
33% American Indians, at the NM-based intervention mine. Since we will not collect tribe-
specific data on American Indian subjects and since the intervention mine is located outside 
the Navajo nation and University IRB rules apply, we do not need tribal IRB permissions. We 
anticipate enrolling 5% racial/ethnic minorities in the WY-based control mine, reflecting the 
demographic population of that mining community.
32.Transnational Research
N/A 
33.Drugs or Devices
Diagnostic device studies (i.e., screening test in this study) are exempt from the IDE 
requirements  as long as the sponsor complies with the requirements of 21 CFR 809.10(c) for 
labeling, and if the testing: (1) is noninvasive; (2) does not require an invasive sampling 
procedure that presents significant risk; (3) does not by design or intention introduce energy 
into a participant; and (4) is not used as a diagnostic procedure without confirmation of the 
diagnosis by another, medically established diagnostic product or procedure.
34.Principal Investigator’s Assurance
By submitting this study in the Huron IRB system, the principal investigator of this study confirms 
that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance with these 
requirements. 
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security Best 
Practices, including:
1. Best Practice for data collection is for it to be directly entered onto a data collection form 
that is in a secured access folder on an HS drive behind a firewall, or in a secure UNM 
Data Security approved system such as REDCap.

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2. Data collection of de-identified data, if done in a clinical setting or other setting that does 
not allow direct entry into a secured system, may be done temporarily using a personal or 
university owned electronic storage device or hard copy document. The important 
security safeguard is that no identifiers be include if the data is entered or stored using 
an untrusted device or storage.
3. Permanent (during data analysis, after study closure) storage must reside on HSC 
central IT managed storage. Processing of data (aggregation, etc.) are to be carried out in 
such a way as to avoid creating/retaining files on untrusted storage devices/computers. 
Trusted devices are HSC managed and provide one or more of following safeguards: access 
logs, encryption keys, backups, business continuity and disaster recovery capabilities.
Alternate storage media must be approved by HSC IT Security as meeting or exceeding HSC 
central IT provided security safeguards.
47. Data Transfer/Sharing (Checklist) (required –do not delete even if the 
answer is “No”)
Provide all information requested if the research involves transferring/sharing of data with an 
external entity (institution, company, etc.).
A. Will data be transferred/shared with an external entity (institution, company, etc.)?  
☒Yes
☐No. The remainder of this section does not apply. 
B. Indicate if the data is incoming and/or outgoing: Outgoing 
C. Provide the name of the entity that data will be transferred/shared with: Outgoing Data: 
Duke Clinical Research Institute (DCRI), Duke University, NC, USA, which serves as the 
Coordination and Data Collection Center (CDCC) for the NIH-funded program entitled: 
“Rapid Acceleration of Diagnostics for Underserved Populations Coordination and Data 
Collection Center” also referred to as “RADx-UP CDCC”, under the direction of Duke’s 
investigator, Michael Cohen-Wolkowiez, MD. 
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with: Outgoing Data: Michael Cohen-Wolkowiez, MD, 300 West 
Morgan Street, Box 3850, Durham, NC 27701, phone: (919) 668-8812, email: 
michael.cohenwolkowiez@duke.edu 
E. Who is responsible for transmission of the data? Outgoing Data: Akshay Sood, MD at 
UNM HSC
      
F. Who is responsible for receiving the data? Outgoing Data: Alka Srivastava, J.D.
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC Central IT 
Transfer is detailed on the Sponsored Projects website:  Outgoing Data: All data will 

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be transferred from our secure REDCap databases to the secure Duke Network using 
Duke approved secure remote access via Duke provided solutions. All transfer activities 
during remote access may be monitored by Duke and UNM HSC IT, as necessary. At the 
time of data transfer, the UNM HSC project team will download the CSV file of the 
project data from the UNM HSC project database in REDCap. This file will then be 
uploaded by a designated project team member into the secure RADxUP CDCC data 
portal by logging in to the CDCC system through a web browser (portal to be created – 
the link will be shared with HSC IT when available for further approval).  The secure, 
cloud-based portal will require individual credentials and log-in to access to data upload 
feature. Credentials will be assigned by the CDCC, or if the institution has federated 
credentials via In Common, their access will be granted via that method. No external 
users will have access to the UNMHSC REDCap database. 
H. For data being transferred/shared with outside locations or entities, describe the 
following:

Where is data storage and how will it be maintained in a secure manner (i.e. 
encryption, password protection, use of Qualtrics or REDCap, etc)?  Outgoing 
Data: Data will be stored on protected, secure computer systems with approved 
secure password.
    

What is method in which data will be collected and stored (i.e. electronic, hard 
copy, etc)?  Outgoing Data: Data will be stored on protected, secure computer 
systems. DCRI will limit and keep track of who can see these data. Anyone who 
can see these data will have to use a password. DCRI will take steps to protect the 
information from others that should not be able to see it. When data are shared 
with other researchers, they will not have information that can identify 
participants. This project has a Certificate of Confidentiality from the United 
States government. 
  

How long will the data be stored? Outgoing Data: The data will be stored 
indefinitely.     

Who will have access to data? Outgoing Data: The staff at DCRI and researchers 
approved by DCRI will have access to data, as described below in subsection I.
  
I.
 Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that identifiers 
that MUST be removed to make health information de-identified are as follows: Names, 
All geographic subdivision smaller than a State, All elements of year (except year), 
Telephone, Fax numbers, E-mail addresses, Social Security, Medical record number, 
Health plan beneficiary, Account numbers, Certificate/license numbers, Vehicle 
identifiers and serial numbers, Device identifiers and serial numbers, Web URLs, IP 
address numbers, Biometric identifiers, full face photographic images, and Any other 

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unique identifying number, characteristic or code.)   Outgoing Data: The DCRI will build 
two RADx-UP databases. The first database will only hold identifiable information, 
which include participant name, address, county, date of birth, telephone, email, and 
gender but will not include any medical information.  These data will be kept at the 
DCRI.  The DCRI will not share these data with the NIH. Participant information will be 
linked with information from other sources, such as the Centers for Medicare and 
Medicaid Services and participant electronic health record, among others. Only if 
participant agrees, as per the consent form, the DCRI will keep information that can 
identify participants in order to contact them for future research studies. These data will 
stay in a password-protected secure electronic system and only staff responsible for 
maintaining the security of your data at the DCRI will be able to see this information. 
The second database will not hold identifiable information. It will hold all the non-
identifiable information the participant agrees to give. This information will include 
COVID test results as well as the results of all surveys and questionnaires completed by 
the participant.  Participants will be assigned a code and will only be identified in this 
database by this code. It will not contain participant name or other information that could 
easily identify him or her. The DCRI plans to transfer and keep these non-identifiable 
data in a secure database for COVID-19 research at the NIH. Other researchers may use 
these data for studies, other than the ones stated in the consent form. When using the data 
from this second database, researchers will only have access to non-identifiable data and 
cannot link the data back to study participants. Because the data cannot be linked back to 
participants, DCRI will not contact the participants to inform them or ask their 
permission before sharing the data with researchers.
J.
If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to identify, 
contact, or locate a person (e.g., name, medical record number, etc.), are the subjects 
going to consent to or authorize the disclosure of their individually identifiable health 
information?  The research requires the access, use, or disclosure of one or more of the 
18 individually identifiable protected health information (PHI) identifiers, as noted in 47I 
and the subjects will consent to or authorize the disclosure of their individually 
identifiable health information.
a.
Or is HIPAA authorization altered or waived? No. HIPAA authorization is not 
altered or waived.    
K. What is the classification of the data (de-identified, limited data set, protected health 
information, other). protected health and identifiable information 
L. Does the request to transfer/share data include clinical data that belongs to the UNM 
Health Systems? Yes
M. Does the data to be transferred/shared include information about patients seen at external 
health system or at a third party medical provider? No
N. Is the external entity a “covered entity”?   Yes
O. Is the data that is going to be transferred/shared owned or partially owned by another 
party or have any type of restrictions including regulatory restrictions (i.e. HIPAA, 
FERPA, etc.)? No

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P. Is the data publically available? If yes, please provide details: No
Q. Does the data include information about substance abuse treatment, sexually transmitted 
diseases, genetic testing results, HIV/AIDS testing results, and/or mental health?  No 
48.Specimen Transfer/Sharing (Checklist) (required –do not delete even if the 
answer is “No”)
Provide all requested information if the research involves transferring/sharing of specimens with 
an external entity (institution, company, etc.). 
A. Will specimens be transferred/shared with an external entity (institution, company, etc.)? 
      ☐ Yes
☒No. The remainder of this section does not apply. 
B. Indicate if the specimens are incoming and/or outgoing: NA
C. Provide the name of the entity that specimens will be being transferred/shared with: NA
D. Provide the contact name, email and phone number with whom specimens are being 
transferred/shared with: NA
E. Who is responsible for sending out the specimens? Please note specimens cannot be sent 
out without a fully executed material transfer agreement. 
NA
F. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement. 
NA    
G. For specimens being transferred/shared with outside locations or entities, describe the 
following:
Where is specimen storage and how will it be maintained in a secure manner? NA  

What is method in which specimens will be collected and stored? NA

How long will the specimens be stored? NA
Who will have access to the specimens? NA