Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of Rural Residents of New Mexico Using Mixed Methods Research
Conditions: Activities, Mental Health Issue, Life Style
Sponsor: University of New Mexico

COVID 19 Effects on Quality of Life 
 
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PROTOCOL TITLE: 
Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of 
Rural Residents of New Mexico using Mixed Methods  
PRINCIPAL INVESTIGATOR(s): 
Carla S. Wilhite, DOT, OTR/L FAOTA 
Department of Pediatrics 
Co-Principal Investigators: 
Timothy Dionne, PhD, OTR/L 
Janet L. Poole, PhD, OTR/L FAOTA 
 
ADMINISTRATIVE CONTACT: 
Sylvia Nolasco, Division Administrator 
Department of Pediatrics-Division of Occupational Therapy 
VERSION NUMBER: 
v. 1.1  4/29/2020 
 
DATE: 
 
5/6/2020 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
 
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 
x 
Other: NIH 
 
FUNDING: 
National Center for Research Resources and the National Center for Advancing 
Translational Sciences of the National Institutes of Health through Grant Number 
UL1TR001449. UNM CTSC: CTSC034-10 
 

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CLINICAL TRIALS 
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:        
 
Does the study involve human participants? 
 Yes   
 No 
 
Are the participants prospectively assigned to an intervention? 
 Yes   
 No 
 
Is the study designed to evaluate the effect of the intervention on the participants? 
 Yes   
 No  
 
 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  
 

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Table of Contents 
1. 
Objectives .................................................................................................................... 5 
2. 
Background .................................................................................................................. 5 
3. 
Study Design................................................................................................................ 6 
4. 
Inclusion and Exclusion Criteria ................................................................................. 6 
5. 
Number of Subjects ..................................................................................................... 7 
6. 
Study Timelines ........................................................................................................... 7 
7. 
Study Endpoints ........................................................................................................... 7 
8. 
Research Setting .......................................................................................................... 7 
9. 
Resources Available .................................................................................................... 7 
10. 
Prior Approvals ........................................................................................................ 8 
11. 
Multi-Site Research ................................................................................................. 8 
12. 
Study Procedures ..................................................................................................... 8 
13. 
Data Analysis ........................................................................................................... 9 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 10 
15. 
Withdrawal of Subjects .......................................................................................... 10 
16. 
Data Management/Confidentiality ......................................................................... 10 
17. 
Data and Specimen Banking .................................................................................. 11 
18. 
Risks to Subjects .................................................................................................... 11 
19. 
Potential Benefits to Subjects ................................................................................ 11 
20. 
Recruitment Methods ............................................................................................. 11 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
22. 
Economic Burden to Subjects ................................................................................ 12 
23. 
Compensation ........................................................................................................ 12 
24. 
Compensation for Research-Related Injury ............ Error! Bookmark not defined. 
25. 
Consent Process ..................................................................................................... 12 
26. 
Documentation of Consent .................................................................................... 13 
27. 
Study Test Results/Incidental Findings ................................................................. 13 
28. 
Sharing Study Progress or Results with Subjects .................................................. 13 
29. 
Inclusion of Vulnerable Populations ...................................................................... 13 
30. 
Community-Based Participatory Research ............................................................ 13 
31. 
Research Involving American Indian/Native Populations ..................................... 13 
32. 
Transnational Research ........................................... Error! Bookmark not defined. 
33. 
Drugs or Devices..................................................... Error! Bookmark not defined. 
34. 
Principal Investigator’s Assurance ........................................................................ 13 
35. 
CHECKLIST SECTION ......................................... Error! Bookmark not defined. 
36. 
Partial Waiver of Consent for Screening/Recruitment ......... Error! Bookmark not 
defined. 
37. 
Partial Waiver of HIPAA Authorization for Screening/Recruitment ............. Error! 
Bookmark not defined. 
38. 
Waiver of Documentation of Consent .................... Error! Bookmark not defined. 
39. 
Alteration of Consent .............................................. Error! Bookmark not defined. 
40. 
Full Waiver of Consent/Parental Permission .......... Error! Bookmark not defined. 
41. 
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
 
Error! Bookmark not defined. 
42. 
Full Waiver of HIPAA Authorization (Checklist) .. Error! Bookmark not defined. 

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43. 
Other Waiver Types (Checklist) ............................. Error! Bookmark not defined. 
44. 
Vulnerable Populations (Checklist) ........................ Error! Bookmark not defined. 
45. 
Medical Devices (Checklist) ................................... Error! Bookmark not defined. 
46. 
Export Control (Checklist) ...................................... Error! Bookmark not defined. 
47. 
Data Transfer/Sharing (Checklist) .......................... Error! Bookmark not defined. 
48. 
Specimen Transfer/Sharing (Checklist) .................. Error! Bookmark not defined. 
 
 

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1. Objectives 
Purpose: The purpose of the research is to determine how people residing in New 
Mexico counties and cities are experiencing the phenomenology of the COVID-19 
pandemic and a rating of quality of life. The specific questions of interest are:  
1. How are rural-living vs. urban-living people responding physically and mentally to the 
crisis?  
2. What strategies of resilience are employed by people living in rural vs. urban counties? 
3. What are perceptions of access to critical supplies and services in urban vs. rural 
counties;  
4. How is the availability and use of technology used for news, reliable information, and 
communication? And;  
5. What alterations in daily life self-care, care of others, commerce, and valued routines 
in urban vs. rural counties are occurring?  
There is a critical need to determine the impact of the COVID-19 emergency on 
the comprehensive well-being of people as they are living through the emergency 
and the extended sequelae of the emergency period.  
Specific Aims: 
Aim 1: Extensively evaluate the perceived quality of life (QOL) of urban vs. rural living 
people during the COVID-19 emergency, thereby assessing similarities and differences in 
QOL impact during the national health emergency. 
 
Aim 2: Evaluate the daily lived experience of people living in rural and urban areas 
during the health emergency in regard to biopsychosocial factors impacting the well-
being of individuals and families, including access to services and resources for health, 
finances, technology, news and information use, use of time, and psychosocial support.  
 
Aim 3: Determining use of resilience strategies (protective factors) of urban vs. rural 
living people during the national health emergency.   
Hypothesis 
Rural-living people experience the health emergency with a significant impact to 
well-being (physical, psychological, and social) as compared to urban people. 
2. Background 
The state of New Mexico and the entire nation have entered an unprecedented health 
emergency created by the COVID-19 virus; affecting the lives of all people, many of 
whom were significantly unprepared for the disruptions the emergency created in daily 
life. Rural residents are at increased risk from effects of the emergency due to numerous 
disadvantages as compared to urban living people (i.e. critical care access, food 
insecurity, social isolation). Very little is known about how people are living through a 
national emergency event affecting all people of the nation. Therefore, a significant gap 
in knowledge exists: 
Preliminary research from China on mental health and quality of life during the COVID-
19 emergency (Zhang & Ma, 2020; Wang, et al. 2020) find mixed results. Zhang (2020) 
reports the pandemic as a mild stressful impact, although 52.1% (N=263) of respondents 

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in one city also felt “horrified and apprehensive” due to the pandemic; however Wang et 
al. (2020), found over 50% of respondents (N=1210) from 194 cities were experiencing 
moderate to severe psychological effects of the pandemic.  
Although there are no peer reviewed published studies in the United States at this time, 
the Henry J. Kaiser Family Foundation issued a briefing from a Kaiser poll indicating 
that 45% of adults in the U.S. have reported their mental health has been negatively 
impacted due to worry and stress over the virus, and noting those living in social isolation 
and low income may be disproportionately affected by the health emergency. One study 
on people living in the United States with rheumatic diseases (N=530) reported stresses 
and anxiety/fear/worry over access to medications, health care, sadness and loneliness 
with social distancing (Michaud, et al., 2020). Additionally, multiple mental health 
information links are now prominent on the Centers for Disease Control website, 
indicative of the severity of the mental health impact of the pandemic.   
Completion of the research acquires new knowledge in the field on how people have 
experienced a national emergency and thus, is innovative. As an outcome, the knowledge 
will be utilized by those who have roles in developing national and community responses 
to improve planning and preparation for future national health emergencies. As a result, 
rural and urban-living stakeholders and those in governance will be better informed when 
making decisions to ameliorate the risk-factors and disproportionate burden of national 
emergencies affecting access to critical supplies, services, and commerce. The research 
will be replicable in the region and nation.  
 
3. Study Design 
The exploratory research will be conducted using mixed methods: qualitative and 
quantitative approaches. The quantitative approach incorporates demographic 
information and a valid and reliable health quality of life measure from the World Health 
Organization (WHOQOL-BREF) used with permission. The WHOQOL-BREF is 26 
question instrument measuring perceptions of physical, psychological, social, and 
environmental health. Responses can be compared between subject cohorts for specific 
characteristics, correlations, and effects. The qualitative approach incorporates a 
researcher developed open-ended semi-structured interview instrument gauged to study 
the phenomenology of how people in urban vs. rural contexts are experiencing the 
COVID-19 pandemic.  
 
None of the investigators will be blinded during the investigation.  
 
4. Inclusion and Exclusion Criteria 
Inclusion Criteria: Adult residents of New Mexico of any gender, gender identity, and 
ethnic origin speaking the English language, living in rural or urban/suburban locations, 
ages 18-85, will be eligible to participate in the study. Screening for eligibility will occur 
at time of making contact. Pregnant women are not excluded from participation because 
this special status is not relevant, the research poses less than minimal risk, and 
pregnancy is not the focus of the study.  
 

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Exclusion: Incarcerated individuals, children, and those with inability to give consent will 
be excluded from the study. Assessing the capacity of consent of the person is limited due 
to the method of surveying by telephone or internet. The investigators will endeavor to 
ensure ability to consent by questioning the potential subject about their understanding of 
the research, their understanding of the right to consent or withdraw (i.e. understanding 
choice), their ability to reason, clarity in decision-making, and noticing confusion by the 
potential participant, or noticing cues of impairment (i.e. difficulty with orienting to 
temporal events, days, months). Investigators will be familiar with principles of 
competency for consent including items from the MacArthur Competency Assessment 
Tool for Clinical Research (MacCAT-CR). 
Residents of New Mexico may be excluded if they are unable to speak English since the 
WHOQOL-BREF may not be available in other languages of the resident. The 
researchers will be preparing for future research using Spanish translations, but will not 
be modifying the protocol at this time in order to be timely in gathering the urgent data.  
 
Number of Subjects 
Up to 300 participants (150 in each group: urban or rural) will be recruited to take the 
WHOQOL-BREF. The qualitative interview will continue until saturation is reached, not 
to exceed 300 interviews. The sample is adequate to power the study to reach a power of 
0.8.  
 
5. Study Timelines 
Consented participants will be enrolled in the study until April 30, 2021 at which 
time the study will be closed to enrollment. Participants will be given a WHOQOL-
BREF survey twice during the health emergency, anticipating timing to be once 
during the emergency and once post-emergency. Analysis of de-identified collected 
data will continue after April 30, 2021 to complete statistical operations and 
preparation of manuscripts.   
6. Study Endpoints 
 
The primary study endpoint will occur by April 30, 2021 at the end of the grant funding.  
 
Research Setting 
This is a prospective study. Research will be conducted via telephonic or wireless 
technologies enabling individual contact with prospective participants. Researchers will 
be based in HSC offices or, from work at home locations as determined by the HSC as 
necessary due to the pandemic. Prospective participants will be reached via public 
directories available across every New Mexico county. 
7. Resources Available 
Dr. Janet Poole is well qualified to direct the study as a principal investigator. She has 
been a principal investigator on collaborative multi-center, multi-state federal grants 

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including those from the Patient Centered-Outcome Research Institute. She has 
significant experience in conducting UNM approved and indigenous IRB approved 
research on the Navajo Nation regarding impact of arthritis.  
Co-Investigator Dr. Carla Wilhite has previous IRB approved research experience on 
disability in agriculture and quality of life of farmers and ranchers with health conditions. 
She is very knowledgeable about rural health issues of New Mexico communities.  
Co-Investigator Dr. Timothy Dionne, has previous IRB approved research experience in 
rehabilitation and interventional technologies.  
To Be Determined: Research Coordinator: The team will hire a research coordinator to 
assist with adhering to timeline, facilitating filing of interim and final reports, monitoring 
budget with the assistance of the OT Division Administrative Manager, and other 
administrative responsibilities. The Research Coordinator will not be handling 
identifiable information of participants 
Four Occupational Therapy Graduate Students who have completed HIPAA & CITI 
training will assist with collection of data. They will be trained in the appropriate use of 
screenings, eligibility criteria, and collection tools. 
The research team anticipates a 20 hour a week effort (all team members combined) to 
contact potential research participants for up to 48 weeks. Approximately300 participants 
are needed to achieve sufficient power for the study.  
No dedicated offices or laboratories will be necessary to complete the research.  
8. Prior Approvals 
 
This study is registered with the National Institutes Clinical Trials registry.  
 
No radiation will be used in the study, no animals will be used in the study, and no 
biological specimens are being collected.  
 
9. Multi-Site Research 
N/A 
 
10. Study Procedures  
 
Contact information for accessible prospective participants will be derived from publicly 
available directories for the 33 counties of New Mexico. The research team will be 
attempting to obtain a representative sample of all New Mexico residents using 
proportional systematic sampling with a random start point, and a sampling interval of 
10, to make contact via telephonic or internet technologies. The goal is to obtain a 
probability sample for residents by age, gender, ethnicity, and geographic distribution 
into two cohorts: urban and rural residents. It is desirable to generate a sample that 
closely mirrors the population of New Mexico.  
 
Researchers making contact will use a contact script to introduce themselves, the purpose 
of the research, and determine the interest of the person in participating. If a person is 

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interested in participating a screening for eligibility will be conducted. Once the 
screening is complete and eligibility is determined, an informed consent process will 
follow. The consent process will describe the research and the rights of the participant to 
participate or withdraw from the study. The prospect will be advised the interview will be 
recorded using a hand-held digital recorder with a phone audio pickup. If consent is 
obtained verbally, the collection of data will commence. A copy of the consent will be 
delivered to the participant via U.S. post, facsimile, or electronically.  
 
Demographic data: name, address, county, preferred contact phone and/or email, age, 
gender/gender identity, education level, socio-economic status, and ethnicity. (see 
demographic data intake form). 
 
Assessments: WHOQOL-BREF (see attached) 27 item survey questions will be read to 
the subject and response recorded. The WHOQOL-BREF measures the biopsychosocial 
perceptions of individuals about quality of life. A semi-structured interview will follow 
that will ask questions about the emergency experience of the COVID-19 health 
emergency regarding perceptions of daily life routines, availability of needed resources, 
and preferred sources of information regarding COVID-19. (See semi-structured 
interview form). 
 
Once the assessment data is obtained, the subject will be thanked and then invited to 
participate in a post-event data collection using the WHOQOL-BREF and interest in 
participating in a focus group at a future time.  
 
Post-event assessment: WHOQOL-BREF. Prior to the conclusion of the study, 
participants will be asked to perform a post-event assessment of quality of life.  
 
Focus group: Prior to conclusion of the study, a facilitated focus group comprised of two 
groups (urban or rural) will be assembled to present the qualitative themes gained from 
the semi-structured interview. Subjects selected for the focus group will be representative 
of the state’s population by age, gender, socio-economic, geography, and ethnicity. Some 
individuals may represent more than one characteristic.  
 
11. Data Analysis 
 
Qualitative Analysis: Data for qualitative analysis will come from the semi-structured 
interviews. Each interview will be anonymized using an identification number. The key 
between subject and identification number will be held on a secure encryption device 
held in a secure location of the primary investigator’s office. The interview will be 
transcribed verbatim using a transcription application from Olympus. Investigators will 
examine the transcripts to ensure accuracy, resolve misspellings, or resolve missing 
sections due to poor sound reproduction. The transcriptions will be sent to the 
participant via U.S. post, facsimile, or email in order to check for accuracy (member 
checking). Transcripts will be analyzed using resources from the CTSC utilizing 
qualitative analysis software to help with organizing, sorting, and arranging the 

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materials for analysis. Codes will be generated via the software and used to assist 
investigators in developing thematic material. Team members will confer and reach 
consensus on the results (peer debriefing). Iteratively, the meaning of the content will 
be derived and prepared for reporting. The de-identified transcripts and data will be 
subjected to auditing by an outside auditor with expertise in qualitative research 
methods. All media: paper and electronic will be held in secure offices within locked 
metal filing cabinets. Electronic media will have further security using devices meeting 
federal standards for encryption and password protection.  
Quantitative analysis will be analyzed by Dr. Dionne with assistance from a graduate 
student employee using SPSS.  
 
12. Provisions to Monitor the Data to Ensure the Safety of Subjects 
The study is not expected to involve more than minimal risk to participants. Some people 
may experience sadness depending on the effect of COVID on their lives and changes or 
losses encountered.  
  
13. Withdrawal of Subjects 
Participants will be free to withdraw from the study at any point. However, any 
previously collected data will remain for use in the study up to the point of 
termination from the study. Withdrawal should be in writing, although it may be 
anticipated that some participants may terminate orally. Investigators will respect the 
autonomy of participants and record the oral termination. Reasons for participants to 
terminate from the study could include several precipitating events: change in 
residence, change in health status, inconvenience, timing, or other subjective or 
objective factors. Reasons for investigators terminating participants from the study 
might include abusive behavior of participants, unable to contact the participant for 
follow-up, or potential cognitive change of participant that might impair ability to 
consent. The ability and conditions of withdrawal will be stated clearly in the consent 
document.  
14. Data Management/Confidentiality 
 
The members of the research team having access to the data include the investigators (PI, 
Co-PIs, graduate student investigators added to the project who have completed HIPAA 
and CITI training). Once all data collection is completed, the only team member 
requiring access to the identifiable data will be the PI and Co-PIs. The research will not 
require disclosing any protected information. The research team does not anticipate 
receiving any information that requires additional protections (i.e. HIV status, etc.). 
Because the research is being conducted using NIH funding and is registered in 
clinicaltrials.gov, a Certificate of Confidentiality will be used to protect the data from 
forced release. Although the risk of exposure of identifiable information is remote, a 
participants identify might be deduced depending on the nature of disclosures they make 
during the interview and the geographic region they reside.   

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Extreme care will be taken to protect the data using UNM HSC IT recommended 
technology for encryption and password protection. The team will purchase a portable 
storage device (jump drive) for that purpose. Only the PI and Co-PIs will have physical 
control of storage devices. Identifiers will be held separately from the storage device, in 
the PIs secure office, in a secure and locked metal filing cabinet. Each participant will be 
given a unique code for data analysis purposes. In every instance, identifiable information 
is secured separately from the data and participant code. Identifying data will be held for 
three years, per IRB recommendation, and thereafter destroyed using a secure shredding 
bin. The identifying data includes the audio recordings of participants. De-identified data 
will be kept indefinitely for manuscript purposes. Data will not be transferred 
electronically and work with the data will occur on non-networked computers owned by 
the division. No identifiable health information is being collected.  
15. Data and Specimen Banking 
 
N/A 
 
16. Risks to Subjects 
The investigators anticipate minimal risk to subjects being surveyed and interviewed 
for the study. However, due to the severity and extent of the COVID-19 health 
emergency, they do anticipate some participants may express extreme stress, 
depression, or anxiety. The investigators will have a readily available and sharable list 
of mental health resources, financial resources, and food bank resources to mitigate 
distress caused by the emergency. Reversibility of risks depends on the length of the 
health emergency and improvement in socio-economic status for some participants. 
These may be outside the direct influence of investigators, but efforts to mitigate will 
be offered through providing reliable information and referral. Through careful 
handling of data, as described above, investigators will minimize the risk of breach of 
confidentiality and/or privacy. The risks will be described in the consent.   
Since participants will be giving individual interviews, it is not likely the procedures 
will put non-participants at risk. However, if participants disclose being victims of 
domestic violence or perpetrating domestic violence or performing acts of abuse or 
neglect of children or elderly co-habitants, it is necessary in the consent to give 
warning that as health professionals, the investigators would be bound to report such 
disclosures per state law.  
17. Potential Benefits to Subjects 
No direct benefits are expected to accrue to research participants. 
. 
18. Recruitment Methods Where I left off:  
 
All recruitment material(s) (e.g., advertisement, flyer, e-mail, letter, phone script, etc.) to 
be used in the study must be submitted with this exemption request. 
 

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This is a prospective study. Research will be conducted via telephonic or wireless 
technologies enabling individual contact with prospective participants. Researchers will 
be based in HSC offices or, from work at home locations as determined by the HSC as 
necessary due to the pandemic. Prospective participants will be reached via public 
directories available across every New Mexico county and a random pattern will be used 
to systematically use the directory listings. There will also be opportunities for 
participants to elect to contact the researchers in order to be surveyed, by placing print 
notifications via public service announcements to rural and urban news organizations or 
via advertisement. Respondents will also have the option of writing their responses and 
returning by mail.  
 
19. Provisions to Protect the Privacy Interests of Subjects 
 
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. 
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 included 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. 
4. Alternate storage media must be approved by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards. 
 
Our process is to immediately de-identify data collected so that privacy is maintained.  
 
20. Economic Burden to Subjects 
 
N/A 
 
21. Compensation 
 
NONE 
 
22. Consent Process 

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23. Documentation of Consent 
 
There will be an IRB approved consent process. Participants MUST be provided study 
information to include a disclosure that the activities involve research, a description of the 
research procedures, a disclosure that participation is voluntary and the name and contact of 
information of the PI. This can be in the form of a letter, email, verbal script or information 
sheet. Consenting will take place with members of the approved research team: Dr. Wilhite, 
Poole, and Dionne, and graduate student researcher Grit Ramuschat. 
 
24. Study Test Results/Incidental Findings 
 
Study results will be aggregated data and thematic data.  
 
25. Sharing Study Progress or Results with Subjects 
 
The researchers intend to share the findings by submitting to journals. Participants can 
elect to opt in to receive research results.  
 
26. Inclusion of Vulnerable Populations 
Screening for eligibility will occur at time of making contact. Pregnant women are not 
excluded from participation because this special status is not relevant, the research poses 
less than minimal risk, and pregnancy is not the focus of the study. Exclusion: 
Incarcerated individuals, children, and those with inability to give consent will be 
excluded from the study.  
 
 
27. Community-Based Participatory Research 
 
N/A 
 
28. Research Involving American Indian/Native Populations 
Native American/American Indian subjects are not the key focus of this research, and 
recruitment will not occur on any tribal nations, but American Indian/Native Population 
individuals may elect to participate in the research.  
29. Principal Investigator’s Assurance 
By submitting this study in the Click 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: 

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