Daily Stress Processes and Sympathetic Reactivity in Depression
Phase: NA
Conditions: Major Depressive Disorder
Sponsor: University of Delaware

Cover Page: Study Protocol 
 
Official Title of Study: Stress and the Sympathetic Nervous System in Adults with Depression 
 
NCT04838262 
 
Document Date: Study Protocol Document (PRS Review 05/22/2022); IRB Approval Letter + 
Protocol (05/23/2023) 

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ID: MH123928
    Stress and the Sympathetic Nervous System in Adults With Depression
   
NCT04838262
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Release:
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Last Update:
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PRS Review:
05/02/2022 07:07   Posted
Protocol Section
Study Identification
Unique Protocol ID: MH123928
Brief Title: Stress and the Sympathetic Nervous System in Adults With
Depression  
Official Title: Daily Stress Processes and Sympathetic Reactivity in Depression
 
Secondary IDs:
Study Status
Record Verification: April 2022  
Overall Status: Recruiting
Study Start: May 1, 2021   [Actual]
Primary Completion: March 2023   [Anticipated]
Study Completion: March 2023   [Anticipated]
Sponsor/Collaborators
Sponsor: The University of Texas at Arlington  
Responsible Party: Sponsor
Collaborators: Penn State University
Oversight
U.S. FDA-regulated Drug: No  
U.S. FDA-regulated Device: No  
U.S. FDA IND/IDE: No  
Human Subjects Review: Board Status: Approved     Approval Number: 2019-0266
Board Name: Institutional Review Board

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Board Affiliation: The University of Texas at Arlington
Phone: 817-272-1234   Email: kmorning@uta.edu
Address:
Center for Innovation, Suite 300, Box 19188
Arlington, TX 76010
Data Monitoring: No
FDA Regulated Intervention: No  
Study Description
Brief Summary:
To test our hypotheses, we will enroll healthy adults having no
history of mood disorders and adults with major depressive
disorder (MDD) having a broad range of depressive symptom
severity. After screening, subjects will meet with the research
coordinator or an investigator for a discussion, with opportunity
for questions, before applicable consent forms are obtained.
Daily stress processes will be assessed using an ecological
momentary assessment approach for 8 consecutive days. On
the last day of the daily stress assessment, we will directly
measure muscle sympathetic nerve activity, blood pressure,
and heart rate during acute laboratory-based cognitive,
emotional, and physiological interventions to induce a stress
response. A venous blood sample will be taken for
measurements of metabolic and renal health and systemic
inflammation.
Aim 1: To examine the effect of daily psychosocial stressor
exposure on acute sympathetic stress reactivity in MDD. Two
stressor exposure indicators will be calculated: stressor
frequency (i.e., percentage of interview days during which at
least one stressor occurred) and total stress (i.e., total number
of stressors reported across all interview days) and will be
related to the magnitude of responsiveness to the acute stress
interventions. We hypothesize that the slope of this relation will
be steeper in adults with MDD compared to healthy non-
depressed adults.
Aim 2: To determine the relation between negative affective
reactivity to daily psychosocial stressor exposure and acute
sympathetic stress reactivity in MDD. Negative affective
reactivity will be calculated as the change in affect on days
when stressors occurred compared to one's typical affect on
non-stressor days and will be related to the magnitude of
responsiveness to the acute stress interventions. We
hypothesize that the slope of this relation will be steeper in
adults with MDD compared to healthy non-depressed adults.
 
Detailed Description:  
Conditions

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Arms
Assigned Interventions
Experimental: Assessment of Daily
Stress Processes
Subjects will report cumulative
exposure, perceived severity,
and emotional responsiveness
to commonly occurring
everyday psychosocial
stressors utilizing an ecological
momentary assessment
approach for 8 consecutive
days.
Acute Stressors
Sympathetic nervous system activity
and blood pressure will be measured
before, during, and after several
acute laboratory-based cognitive
(Stroop Color Word Test), emotional
(International Affective Picture
System), and physiological (Cold
Pressor Test) stressors.
Conditions: Major Depressive Disorder  
Keywords:  
Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: N/A
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Arms and Interventions
 
Outcome Measures
  Primary Outcome Measure:
1. total number of daily stressors
[Time Frame: 8 days before intervention]
2. change in negative affect in response to daily stressors
[Time Frame: 8 days before intervention]
3. change in muscle sympathetic nerve activity in response to acute stress
(compared to resting baseline activity)
[Time Frame: during laboratory-based intervention (3 minutes)]
Eligibility
Minimum Age: 18 Years  
Maximum Age: 30 Years  
Sex: All  
Gender Based:  
Accepts Healthy Volunteers: Yes  

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Criteria:
Inclusion Criteria:
All participants will be 18-30 yrs.
Healthy non-depressed men and women will have no
history or evidence of psychiatric illness and will not
have a family history of MDD or major psychiatric
illness.
Men and women with MDD will have symptomatic
depression that meets diagnostic criteria and will be
non-medicated.
The capacity and willingness to provide written
informed consent, to attend all study related visits,
and to comply with the study protocol.
Exclusion Criteria:
Subjects will be excluded at the discretion of the
PI/collaborating clinician or for any of the following
reasons:
psychiatric illness aside from MDD (including current
or past psychotic disorders, bipolar disorder,
schizophrenia or schizoaffective disorder, panic
disorder, post-traumatic stress disorder, obsessive
compulsive disorder)
subthreshold depression
current use of psychotropic medications (including
major classes of antidepressants, anxiolytics,
antipsychotics, mood stabilizers)
active suicidal or homicidal ideation
active substance dependence or eating disorders
current use of any medications that could alter
sympathetic reactivity
diagnosed or suspected cardiovascular, renal, or
metabolic disease (hypertension, heart disease,
diabetes, hyperlipidemia)
autonomic disorders
tobacco use (including electronic cigarettes)
obesity (body mass index > 30 kg/m2)
breastfeeding or pregnancy
<18 or >30 yrs
Contacts/Locations
Central Contact Person: Jody Greaney, PhD
    Telephone:   817-272-7891
    Email:   jody.greaney@uta.edu  
Central Contact Backup:  
Study Officials:   

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Locations:
United States, Texas
The University of Texas at Arlington
     Recruiting
     Arlington, Texas, United States, 76010
 
     Contact: Jody Greaney, PhD    817-272-7891   
jody.greaney@uta.edu
     Principal Investigator: Jody Greaney, PhD
IPD Sharing Statement
Plan to Share IPD: Yes
Per the data sharing policy of the National Institute of Mental Health
(NIMH), we will deposit all phenotypic, psychosocial stress, and
sympathetic reactivity data from this study to the NIMH Data
Archive. We will use standard data dictionaries (NIH Toolbox
Cognition Battery, NIH Toolbox Emotion Battery, PHQ-9) and will
collect the data necessary to generate global unique identifiers for
each study subject.
Supporting Information:
Time Frame:
Access Criteria:
URL:
References
 
Citations:  
Links:  
Available IPD/Information:  
Document Section
[No PDF/A documents uploaded.]
U.S. National Library of Medicine  |  U.S. National Institutes of Health  |  U.S. Department of Health & Human Services  |  HHS Vulnerability Disclosure

  
 
 
 
 
 
O F F I C E  O F  R E S E A R C H  A D M I N I S T R A T I O N  
R E G U L A T O R Y  S E R V I C E S  
REGULATORY SERVICES 
The University of Texas at Arlington, Center for Innovation 
202 E. Border Street, Suite 300, Arlington, Texas 76010, Box #19188  
(Phone) 817-272-3723  (Email) regulatoryservices@uta.edu  (Web) www.uta.edu/rs 
 
5/12/2023 
 
IRB Approval of Full Board Continuing Review + Modification 
 
PI: Jody Greaney   
 
Department: Kinesiology 
 
                                                                               
IRB Protocol #: 2019-0266.13 
Study Title: Stress Reactivity in Human Depression 
 
  
       
 
Effective Approval: 5/12/2023 
 
Protocol Details  
 
• 
Original Protocol Approval Date: 6/28/2019 
• 
Protocol Expiration Date: 5/14/2024 
• 
Federally Funded: NIH, Mentis BlueSheet #2020-825 
o Subject to 45 CFR 46, Revised 2018 
• 
FDA Regulated: IND 
o Subject to FDA Regulations 21 CFR parts 5, 56, 312, and 812 
• 
Continuing Review required: Yes, standard  
 
This continuing review and modification was reviewed and approved with conditions at the convened 
IRB full board meeting on 05/09/2023; the status is continuing for one year. Conditions for approval 
were met on 05/11/2023. The approved modifications are limited to: 
• 
Add protocol personnel: Tracy Greer, Cassie Argenbright 
• 
Remove protocol personnel: Brandi Stephens, Ben Young, Damsara Nandadeva, Zachary Martin, 
Rachel Skow, Madeleine Harris, Jose Coello, and Aleema Haq. 
Principal Investigator and Faculty Advisor Responsibilities  
All personnel conducting human subject research must comply with UTA’s IRB Standard Operating 
Procedures and RA-PO4, Statement of Principles and Policies Regarding Human Subjects in Research.  
Important items for PIs and Faculty Advisors are as follows: 
 
• 
**Notify Regulatory Services of proposed, new, or changing funding source** 
• 
Fulfill research oversight responsibilities, IV.F and IV.G. 
• 
Obtain approval prior to initiating changes in research or personnel, IX.B. 
• 
Report Serious Adverse Events (SAEs) and Unanticipated Problems (UPs), IX.C. 
• 
Fulfill Continuing Review requirements, if applicable, IX.A. 
• 
Protect human subject data (XV.) and maintain records (XXI.C.). 
• 
Maintain HSP (3 years), GCP (3 years), and RCR (4 years) training as applicable. 

INSTITUTIONAL REVIEW BOARD (IRB) FOR THE PROTECTION OF HUMAN SUBJECTS  
APPLICATION FOR RESEARCH INVOLVING HUMAN SUBJECTS 
 
Faculty, staff, or students who propose to engage in any research, research development, testing or evaluation 
with human subjects must have review and approval from the IRB prior to initiation.  Some activities involving 
humans are not considered human subject research requiring IRB review (i.e., class projects, program 
evaluation, oral histories, quality improvement).  Refer to the Research Project Chart for more information.   
 
**Utilize the IRB Submission Checklist to guide you through the full IRB application process.  NOTE: All study 
personnel must have completed Human Subjects Protection (HSP) Training prior to study approval.  HSP 
Training expires and must be retaken every 3 years.** 
 
If you require assistance to complete this form or need additional information, please contact Regulatory 
Services at 817-272-3723 or regulatoryservices@uta.edu.  Regulatory Services also has open office hours every 
Thursday from 9:00 – 11:00am.  The UTA IRB Website also has lots of helpful guidance– check it out! 
 
SECTION A: GENERAL INFORMATION 
 
1. Non-UTA Personnel: Enter all individuals that are NOT affiliated with UTA who will interact or intervene 
with human subjects for the research study OR who will access identifiable subject data.  UTA-affiliated 
personnel should be listed on the electronic portion of the protocol (#3) in the electronic submission system. 
 
*Note: In the electronic submission system, upload a completed Non-UTA Collaborator Form and Human 
Subject Protection training for each listed Non-UTA individual.   
 
Name: 
Organization: 
Bau Tran, PA-C, PharmD 
UT Southwestern Medical Center 
Jacqueline Mogle, PhD 
The Pennsylvania State University 
 
2. Expected Start Date and Completion Date: May 2019/Dec 2021  (You are not authorized to start any 
research on human subjects including subject recruitment until the IRB has approved the research 
protocol.) 
 
3. Funding: Indicate existing, potential, or pending sources of funding below (you may select more than one).          
*Note: If you do (or may) receive funding from NSF, NIH, CMMS, DOD, DOJ, DOE, DOEd, DOT, or any 
other federal agency, you MUST disclose this funding source below to ensure that your study is reviewed 
in accordance with the appropriate federal regulations for that specific federal funding source. 
 
External: 
    
 Federal (Sponsor:NIH)        
  State (Sponsor:     )        
  Industry (Specify Sponsor:      )     
 
Grants & Contracts Bluesheet Number from Mentis: 126602571 and 126602810 
 
Other: 
 
 UTA Department Account     
 Personal Funds       
 Other: start-up           
 None (No funding) 
 
SECTION B: RESEARCH CLASSIFICATION, RATIONALE, PROCEDURES, SITES, QUALIFICATIONS, OVERSIGHT 
 
4. Research Classification: Indicate if this study is categorized as Minimal Risk (MR) or Greater than Minimal 
Risk (GMR).  “Minimal Risk (MR)” means that the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in the 
subjects’ daily life or during the performance of routine physical or psychological examinations or tests.  
“Greater than Minimal Risk (GMR)” refers to research activities that do not meet the definition of “Minimal 

UTA IRB 
Proposal for Research Involving Human Subjects (Rev. February 2019) 
Page 2 of 19 
Risk.”  Throughout this application form, there are additional questions or information requested for 
studies categorized as GMR; these instructions will be presented in purple. 
 
 Minimal Risk (MR)              
 Greater than Minimal Risk (GMR) 
 
*Note: Studies that are federally funded and/or FDA regulated will be further classified into exempt, 
expedited, or full board in accordance with the Common Rule 45 CFR 46 and/or 21 CFR parts 50 and 56.  
See Flowchart. 
 
5. Rationale: List the primary research questions, hypotheses, and / or objectives guiding this study.  
 
Note:  This is a companion project to “Central mechanisms of neurovascular dysfunction in human depression” (IRB 
#2019-0127). The PI currently holds a FDA IND (125,994) for the procedures and drugs used in these studies; this 
IND is being modified for use in the current study. 
 
The proposed studies are complementary to those outlined in the PI’s funded NIH K99/R00 grant and, although not 
formally listed in the specific aims in the grant, these studies are described in the research strategy as alternative 
approaches to generate pilot data for future grant submissions. 
 
Rationale: 
Major Depressive Disorder (MDD) manifests in >15% of the population and is directly linked to the development of 
cardiovascular disease (CVD), independent of traditional cardiovascular risk factors. Importantly, CVD risk remains 
elevated even with the remission of depressive symptoms. Although multiple factors likely contribute, accumulating 
evidence indicates that vascular dysfunction plays a pathogenic role in depression-CVD comorbidity. 
 
Exposure to psychological stress plays a critical role in the etiology of MDD and is itself associated with endothelial 
dysfunction, accelerated atherosclerosis progression, and increased CVD risk. Despite this clear epidemiological 
association, no studies have examined the relation between everyday psychosocial stressors and direct measures of 
neurovascular reactivity to acute stress in adults with MDD. Exposure to acute stressors includes activation of the 
autonomic nervous system, which can induce transient vascular dysfunction and exaggerated increases in blood 
pressure. Collectively, chronic and repetitive exposure to psychosocial stress, or a maladaptive response to repeated 
stressors (i.e., exaggerated stress reactivity), may accelerate the atherosclerotic process and precipitate the 
development of CVD. 
 
In the laboratory, we propose to conduct a comprehensive examination of cardiovascular stress reactivity. We will 
then relate cardiovascular reactivity to daily psychosocial stressors in adults with MDD. Our central hypothesis is that 
adults with MDD will demonstrate altered sympathetic neural control of cardiovascular function and this impairment 
will be modulated by exposure to everyday psychosocial stressors; the resultant imbalance in vasodilator and 
vasoconstrictor regulation serves as a potential mechanistic link between daily stress and depression in increased 
CVD risk. Although the effects of daily stressors on activation of the hypothalamic-pituitary-adrenal axis are well-
established, particularly in MDD, our proposed series of studies will test the novel concept that naturally-occurring 
daily stressors also directly influence sympathetic neural reactivity of the cardiovascular system. 
 
Specific Aim 1: To examine microvascular stress reactivity in adults with MDD. 
Hyp 1: Microvascular adrenergic sensitivity will be greater in adults with MDD compared to healthy non-depressed 
adults, due to a reduction in the buffering capacity of β-adrenergic receptor-mediated vasodilation to offset ⍺-
adrenergic receptor-mediated vasoconstriction. 
Hyp 2: Adults with MDD exposed to everyday psychosocial stress will exhibit more severe alterations in the 
mechanistic control of microvascular adrenergic reactivity. 
 
Specific Aim 2: To examine cardiovascular stress reactivity in adults with MDD. 
Hyp 1: Blood pressure reactivity will be greater in adults with MDD compared to healthy non-depressed adults, due 
to exaggerated increases in sympathetic outflow and augmented vascular resistance. 
Hyp 2: Adults with MDD exposed to everyday psychosocial stress will exhibit more severe alterations in sympathetic 
control of blood pressure during acute cardiovascular stressors. 

UTA IRB 
Proposal for Research Involving Human Subjects (Rev. February 2019) 
Page 3 of 19 
 
Preliminary Results: 
The PI has extensive experience assessing the mechanisms and modifiers of cardiovascular function in a variety of 
pre-clinical populations (e.g., primary aging, hypertension, psoriasis, MDD). Specific to MDD, the PI recently 
demonstrated that acute exposure (within 1 day) to any naturally occurring everyday psychosocial stressor was 
associated with greater impairments in microvascular endothelial function in treatment-naïve young otherwise 
healthy adults with MDD (Greaney JL et al J Am Heart Assoc, 2019). Further, our exciting preliminary data suggests 
that psychosocial stress is related to greater norepinephrine-induced vasoconstriction, the mechanistic control of 
which appears to be altered in adults with MDD. 
 
Rationale for Addition of Accelerometry: 
 Indirect evidence suggests that habitual physical activity (PA) increases positive affect, decreases negative affect, 
and decreases overall perceived stress, all of which improve overall mood. Because PA is a powerful lifestyle 
intervention to reduce the psychobiological effects of stress, whether habitual PA also blunts NA-R to daily stress is a 
clinically relevant research question. Importantly, reducing NA-R has potential to reduce not only the psychological 
but also the cardiovascular consequences of daily stress. Also, increased sedentary time is now increasingly 
recognized for its negative implications for CVD risk, independent of habitual PA. Specifically, increased sedentary 
time is associated with greater 24-hour BP, vascular endothelial dysfunction, and CVD risk. Therefore, it is important 
to understand, separately, whether sedentary time sensitizes the relation between NA-R and BP reactivity. We do not 
have any specific aims/hypotheses related to sleep duration/heath, but these metrics are provided by the 
accelerometers. 
 
6. Procedures: Describe the procedures step-by-step, including details on all methods that will be used to 
collect human subject data from the beginning to the end of the study. Describe what data will be collected 
(and if it will be individually identifiable); when and where the data will be collected; and how it will be 
collected (instruments or other measures). Use clear, concise layman’s language that can be easily 
understood by persons outside your field and provide definitions for any technical terms. Add pictures if 
needed. *Note: Refer to the Types of Research guidance page for a list of specific information required 
for different types of research. For GMR research, it is also helpful to provide references or pilot data to 
support the proposed procedures. 
 
Note: This study does not meet the definition of a Clinical Trial, because no human subjects are “prospectively 
assigned to an intervention.” Rather, subjects are classified according to defined parameters based on their 
psychiatric profile and all subjects undergo the same experimental tests. Please see the confirmation email from the 
NIH Program Officer regarding its Clinical Trial designation. The PI currently holds a FDA IND (125,994) for the 
procedures and drugs used in these studies; this IND is being modified for use in the current study. 
 
This is a cross-sectional study. Two subject groups will be recruited: healthy control (HC) subjects will not have a 
family history of MDD or major psychiatric illness, and MDD patients will have clinically significant depression (non-
medicated). 
 
Please see below for a detailed description of all of the techniques and measurements to be utilized and/or obtained, 
as well as a complete description of the experimental protocol. Participants complete a screening/familiarization visit 
(~2 hours), an assessment of daily stress processes (~2 hours in total over the course of 8 consecutive days), and one 
experimental visit (~4 hours) to assess stress reactivity. 
 
Pre-Screening:  
Interested people may contact us. The script of the study information (see attached document labeled “stress 
recruitment script”) will be provided verbally (if initial contact is by phone) or in writing (if initial contact is by email). 
We conduct a basic telephone or electronic interview and health history [age, height/weight, medications taken 
regularly, health history (e.g., any known diseases), history of tobacco use, etc.] with the potential subjects and 
discuss the study with them (see attached document labeled “recruitment interview form”). The pre-screening 
information is provided by the subject either verbally over the phone or electronically via Qualtrics.  
 

UTA IRB 
Proposal for Research Involving Human Subjects (Rev. February 2019) 
Page 4 of 19 
In addition, during initial contact, subjects perform the PROMIS Emotional Distress-Depression Short Form (see 
attached document labeled “PROMIS”). This scale can be administered over the phone or electronically via Qualtrics. 
A raw PROMIS score > 18 is indicative of mild depressive symptoms. The PROMIS is used to “pre-screen” adults for 
depressive symptoms and thus limits the burden of scheduling and conducting screening visits in patients who are 
ultimately not likely to meet all eligibility criteria. Given the relative ease of recruiting young non-depressed adults 
into our research study, conducting the PROMIS prior to the on-site screening visit allows us to further target the 
patient population of interest. These pre-screening interviews and questions present no more than minimal risk of 
harm to subjects and involve no procedures for which written consent is normally required outside of the research 
context.  
 
If, after completion of this initial pre-screening interview, the subject meets study eligibility and is interested in 
enrolling, we will schedule a screening visit (see below for details). If enrolled, the PROMIS form will be coded with 
subject number. Pre-screening ‘failures’ will be tracked for date of contact and reason for ineligibility; however, if not 
enrolled, all pre-screening information is de-identified and destroyed. 
 
Screening/Familiarization Visit (see attached document labeled “screening protocol”): 
In the event that a subject does not meet the inclusion criteria following the screening visit, we suggest that the 
follow-up with a physician or mental healthcare provider (see attached document labeled “script study exclusion”). 
1. The participant signs the informed consent before screening procedures begin. After the participant signs the 
consent, we provide the participant a photocopy. 
2. Participants complete a standard health history form (see attached document labeled “medical history form”).  
3. The investigator measures height (stadiometer), weight (digital scale), waist circumference (tape measure), 
blood pressure (mercury sphygmomanometer), heart rate (Welch Allyn Connex), and temperature (Welch 
Allyn SureTemp Plus). 
4. Premenopausal women will provide a urine sample for a pregnancy test.  
5. Dr. Greaney or a trained investigator administers the Mini International Neuropsychiatric Interview (MINI) to 
determine depression status (see attached). The MINI has 16 sections and takes ~20 minutes to complete. 
• If a participant indicates an illness other depression, we give the participants a copy of the “Local Mental 
Health Providers” document (see attached document labeled “mental health providers”), strongly 
encourage them to follow-up with a clinician, and exclude the participant from the study. 
• If a participant indicates a “high” level of suicidality (coded as scoring ≥17 on the Suicidality Module) and 
immediate risk with intent to harm, MHMR Tarrant County Crisis Relief will be called for an external 
evaluation and study personnel will ensure the participant’s safe transfer to MHMR personnel or facility. 
6. Participants are familiarized with, and practice, the experimental measurements/procedures described in 
detail below. 
 
If, after completion of the Screening Visit, the subject meets study eligibility and is interested in continuing with 
enrollment, we will schedule the experimental visits (see below for details). Screening ‘failures’ will be tracked 
for date of screening and reason for ineligibility; however, if not enrolled in the experimental visits, all screening 
information, data, and blood samples are de-identified and destroyed. 
 
In order to provide the most flexibility to participants in terms of time constraints regarding scheduling, the following 
procedures may occur at either the screening visit or the experimental visits: 
1. An approved investigator or research nurse performs standard venipuncture to obtain a blood sample (100 
ml/~6.7 tbsp)  for complete blood count, chemistry analysis, lipid profile, and other substances of interest (NOx 
metabolites, inflammatory cytokines, indices of oxidative stress, peripheral blood mononuclear cells). The 
researchers do not perform genetic analyses on the blood nor do they look for the presence of disease (e.g., 
HIV). The blood draw may occur at either the screening visit or the experimental visit. 
• The lipid and basal metabolic panel will be analyzed by Labcorp Inc., the same facility that processes blood 
samples from Student Health Center at UTA. Each blood sample container is labeled with two identifiers, 
the subject initials+study number, and the subject's date of birth, as required by Labcorp (e.g., Subject: ABC 
01234, DOB 10/14/65) and placed in a locked drop-box. Labcorp is contacted and a courier retrieves the 
sample from the drop-box on the 1st floor of the Science and Engineering Innovation and Research building 
(SEIR) the same day. In case the subjects present any abnormal lab results from any of the bloodwork, we 
will inform them about their results and suggest to schedule an appointment with their primary-care 
physician. No medical diagnosis will be provided.  

UTA IRB 
Proposal for Research Involving Human Subjects (Rev. February 2019) 
Page 5 of 19 
• Blood will also be stored in a -80 degree freezer (in the corridor space designated for freezers and 
refrigerators) in the 1st floor clinical space of the Science and Engineering Innovation and Research building 
(SEIR) in order to allow samples for certain assays to be run all at one time and avoid variability. The code-
key will be kept in the PI’s lab in a locked cabinet. Only PI and study personnel on this IRB will have access 
to the files (via key). No other students or faculty will have access. All stored data will be de-identified using 
a coding system and frozen until analysis. After successful analysis, blood will be discarded into a container 
labelled with a biohazard sign and stored in secondary waste containers. 
2. An investigator administers a cognitive function assessment on an iPad using select measures of the Cambridge 
Neuropsychological Test Automated Battery (CANTAB). This assessment takes ~45 minutes. The CANTAB tests 
include: Rapid Visual Information Processing (RVP) to assess sustained attention; Delayed Matching to Sample 
(DMS) and Match to Sample Visual Search (MTS) to assess visual memory; Spatial Working Memory (SWM) to 
assess working memory; One Touch Stockings of Cambridge (OTS) to assess executive function; Emotion 
Recognition Task (ERT) and Emotion Bias Test (EBT) to assess emotion processing; and the Cambridge 
Gambling Task (CGT) to assess reward-based decision making. CANTAB is language-independent, culturally 
neutral, non-invasive and require no technical knowledge or prior familiarity with computers making them 
suitable for large, multi-site studies and diverse participant groups. This assessment may be administered at 
either the screening visit or the experimental visit. 
3. An investigator administers an emotional state assessment on an iPad using the NIH Toolbox Emotion 
Measures Battery. This assessment takes ~10 minutes. It entails survey-style questions for the assessment of 
positive affect, general life satisfaction, emotional support, friendship, loneliness, perceived rejection, 
perceived hostility, self-efficacy, sadness, perceived stress, fear, and anger. Participants are asked to evaluate 
each question along a continuum from “strongly disagree” to “strongly agree” or from “not at all” to “very 
much” or from “extremely untrue of me” to “extremely true of me” etc. This assessment may be administered 
at either the screening visit or the experimental visit. 
4. Participants undergo 24-hour ambulatory blood pressure monitoring (Oscar 2; SunTech Medical). We place a 
blood pressure cuff around the non-dominant upper arm. We plug the cuff into the control unit, which 
attaches to a strap placed around your waist or hung on your shoulder. The monitor makes a blood pressure 
measurement 3 times per hour while the participant is awake and 1 time per hour while he is asleep. To take a 
measurement, the cuff inflates, records blood pressure, and deflates, in the same manner as other automated 
brachial blood pressure devices used in this study. The subject will receive specific verbal and written 
instructions for the use of the ambulatory blood pressure monitor (see document labeled “ABPM 
instructions”). The participant will be instructed to return the unit to the investigators at the experimental 
visit. 
5. Flow-mediated dilation (FMD) to assess peripheral vascular function. During this procedure: 
• 
We place a small cuff around the forearm, just below the elbow. 
• 
Above the elbow, we use a Doppler ultrasound probe covered in ultrasound gel to image the brachial 
artery. The ultrasound measures blood vessel size and blood velocity. 
• 
After a 3-minute resting measurement, we tightly inflate the cuff for 5 minutes to occlude blood flow to 
the forearm. 
• 
After the cuff deflates, we continue to image the artery for ~5 minutes. We may repeat this measure 
several times. 
6. Pulse wave analysis (PWA) and pulse wave velocity (PWV) to assess arterial stiffness. To measure PWA, a 
standard blood pressure cuff is placed on the subject’s upper arm. The cuff will inflate/deflate to determine 
brachial artery blood pressure; after 5 seconds, the cuff will inflate again and automatically capture the PWA 
waveform. To measure PWV, a blood pressure cuff is placed on the subject’s upper leg. A pen-like probe 
(applanation tonometer) will be placed against the skin over the carotid artery to continuously measure the 
pulse wave while the blood pressure cuff on the upper leg is inflated and then deflated. 
 
Assessment of Daily Stressor Processes 
1. Participants will complete the Daily Inventory of Stressful Events (DISE; see attached document) survey once 
per day, for 8 consecutive days. The DISE survey will be completed using online software (Qualtrics; accessed 
via institutional contract), which significantly minimizes participant burden. The DISE survey can be 
completed on any device with internet connectivity (smartphone, tablet, laptop, desktop computer, etc.). 
2. This survey takes ~10-15 minutes to complete per day and consists of ~100 questions. The main types of 
information that will be obtained using the DISE include questions about the types of daily stressors (e.g., 
argument with a friend, work/school deadlines, malfunctioning computer), how the stressor made you feel 

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(e.g., angry, nervous), feelings of psychological distress (e.g., anxiety, irritability), and daily physical 
symptoms. Participants will also be asked questions about stress related to the COVID-19 pandemic. 
Participants are free to skip any questions that they prefer not to answer. 
3. Participants are familiarized with the organization, flow, and types of questions in the DISE prior to 
participation. 
4. A laboratory team member will send the participant both a text message and an email every day for the 8 
consecutive days of the assessment, and these reminder texts/emails will contain information on how to 
access the DISE survey. 
5. The DISE survey will be scheduled such that on Day 8 (i.e., the last day of the daily stressor assessment), the 
participant will return to the lab for one of the experimental visits (described below). The second 
experimental visit will be scheduled on Day 9 (i.e., one day after the last day of the daily stressor 
assessment). 
 
Assessment of Daily Physical Activity and Sleep 
1. 24-hour movement behaviors will be assessed using an accelerometer. This assessment will occur during the 
same sampling timeframe as the Assessment of Daily Stressor Processes described above. Participants will 
be asked to wear an accelerometer on the wrist of their non-dominant hand or hip for 24 hours a day except 
during aquatic activities, and to keep wearing it for 8 consecutive days. The accelerometer will be numbered 
to each participant with his/her age, gender, height, and weight information uploaded in advance. The 
participant will receive specific verbal and written instructions for the use of the accelerometer (See 
“Actigraph instructions”).  
2. Participants will return the accelerometer to the lab when they report for the Experimental Visit to Assess 
Cardiovascular Stress Reactivity (described below; this occurs on Day 8 of the DISE). The data captured by 
the accelerometer will be downloaded immediately on a password-secured computer in the Greaney lab. No 
GPS data can be collected in this assessment.  
3. The monitor will be cleaned between uses according to manufacturer recommendations. 
 
Experimental Visit to Assess Cardiovascular Stress Reactivity: 
1. Vital signs (oral temperature, heart rate, and blood pressure) are measure upon arrival to the lab. Women 
who are premenopausal submit urine for a pregnancy test if they have not been tested within 2 weeks prior 
to the experiment.  
2. Participants complete the Patient Health Questionnaire (PHQ9) to assess depressive symptom severity. The 
PHQ9 has 9 questions (see attached document labeled “PHQ-9”). 
3. Participants complete the International Physical Activity Questionnaire (IPAQ; see attached document 
labeled “IPAQ long-form”) to assess habitual physical activity. 
4. Participants complete the Daily Inventory of Stressful Events, an interview-based approach to the 
measurement of multiple aspects of daily stressors (see attached document labeled “daily stress survey”). 
5. Heart Rate (electrocardiogram, ECG): We tape 3-5 ECG leads to the chest to measure heart rate throughout 
the experiment (BioAmp, AD Instruments). 
6. Respiration: We place an elastic band (Pneumotrace II, UFI) around the abdomen to measure the rate and 
depth of breathing throughout the experiment. 
7. Blood Pressure: A blood pressure cuff will be wrapped around the upper arm to obtain blood pressure via a 
standard automated oscillometric device (BP Monitor, Welch-Allyn). In addition, beat-by-beat blood 
pressure will be obtained via finger photoplethysmography (Finger BP Monitor, Finapres). Blood pressure is 
measured continuously throughout the experiment. 
8. Sympathetic Nerve Activity (SNA): We measure SNA throughout the experiment using a technique called 
microneurography (Nerve Traffic Analyzer, University of Iowa/AD Instruments). 
• First, we apply a mild external electrical stimulus to the lower leg or upper arm using a pencil-like device 
to find the approximate location of the nerve beneath the skin. The nerve from which activity is recorded 
is located close to the skin’s surface on the lower leg just below the knee or on the upper arm near the 
elbow. When the nerve is stimulated, involuntary twitching and/or tingling sensations of the foot or hand 
will occur. The twitching or tingling will disappear when the stimulation is stopped. 
• After finding the general location of the nerve, two tiny, sterile, microelectrodes will be inserted through 
the skin. One is a reference electrode placed just above the nerve site (2 cm) and the other is the 
recording electrode. The recording electrode is advanced into the nerve. 

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• When the tip of the electrode enters the nerve, the subject may briefly notice either pressure or tingling 
sensations. At this point, minor adjustments in the position of the electrode will be made until an optimal 
nerve signal is obtained.  
• If necessary, SNA measurements conducted within 3 weeks of each other will be done on alternate legs 
or arms. This will in no way impact the subject, and there are no additional risks associated with 
alternating legs or arms. If the same leg or arm is used, experimental visits will be separated by at least 4 
weeks. 
9. Peripheral Blood Flow: Blood flow will be determined by using pulsed Doppler ultrasound to non-invasively 
measure mean arterial blood velocity and diameter. Peripheral blood flow (e.g., femoral artery, brachial 
artery) and central blood flow (e.g., carotid artery) can be obtained by placing a Doppler flow probe on the 
surface of skin over the respective artery. Ultrasound imaging of artery diameter will be performed at a site 
matching that at which velocity is measured. The following formula is used to calculate blood flow: blood 
flow = π * (radius^2) * velocity. For these measurements, when requested by the participants for "comfort" 
purposes, a lab member of their gender preference will be present to conduct these measurements during 
the protocol. 
10. Cardiovascular Reactivity is measured during a variety of perturbations that elicit transient increases in blood 
pressure and SNA. We continuously record blood pressure, heart rate, and muscle sympathetic nerve activity 
for each of the perturbations. Subjects may be asked to repeat a perturbation if necessary. 
• Isometric handgrip and post-exercise ischemia 
o Maximal voluntary contraction of the dominant hand will be measured. The subject will squeeze the 
device at maximal effort 3-5 times, and the highest value will be used as the maximum. This will be 
used to calculate relative work rates ranging from 20-40%.  
o An inflatable cuff will be place around the upper arm on the dominant side and connected to a rapid 
cuff inflator, which will be attached to an external air source. 
o After 5 minutes of baseline, subjects perform isometric handgrip when they squeeze the handgrip 
device at the target intensity for 2 minutes. At the completion of exercise, we ask the subject to rate 
the perceived difficulty of the exercise on a numerical scale ranging from 6-20. 
o During the last 5 seconds of handgrip, we rapidly inflate the outer cuff on the upper arm to supra-
systolic blood pressure for 3 minutes (post-exercise ischemia). At the completion of post-exercise 
ischemia, we ask the subject to rate the perceived discomfort of the ischemic period on a numerical 
scale ranging from 1-11. 
o Then we deflate the outer cuff and continue to collect data during a 2 minute recovery period. 
• Cold pressor test 
o After 5 minutes of baseline, the subject immerses one hand (up to the wrist) into an ice-water slurry 
(~4°C) for 2 minutes.  
o Data are recorded for an additional 2 minutes of recovery. 
o We ask the subject to rate the perceived discomfort of the cold pressor test on a numerical scale 
ranging from 1-11. 
• Mental arithmetic 
o After 5 minutes of baseline, subjects complete a series of simple arithmetic problems. Subjects are 
encouraged to respond as quickly and correctly as possible. Subjects perform the test for 2 minutes. 
o Data are recorded for an additional 2 minutes of recovery. 
o We ask the subject to rate the perceived difficulty of the mental arithmetic on a numerical scale 
ranging from 0-4. 
• Stroop color word test 
o After 5 minutes of baseline, subjects will be asked to name the ink color of a color word, a 
psychological task that is more difficult if there is a mismatch between the ink color and the word 
(e.g., the word ‘green’ printed in red ink). Subjects are encouraged to respond as quickly and correctly 
as possible. Subjects perform the test for 3 minutes. 
o Data are recorded for an additional 2 minutes of recovery. 
o We ask the subject to rate the perceived difficulty of the test on a numerical scale ranging from 0-4. 
• N-Back test 
o After 5 minutes of baseline, subjects will be shown a sequence of letters/geometric shapes one at a 
time. Subjects will be asked to state if the letter/geometric shape that they are currently viewing 
matches the letter/geometric shape shown 1 (“1-back”) or 2 screens previously (“2-back”). Subjects are 
encouraged to respond as quickly and correctly as possible. Subjects perform the test for 3 minutes. 

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o Data are recorded for an additional 2 minutes of recovery. 
o We ask the subject to rate the perceived difficulty of the test on a numerical scale ranging from 0-4. 
• Operation span task 
o After 5 minutes of baseline, subjects will be shown a sequence of simple arithmetic problems followed 
by a word/letter one at a time. Subjects are encouraged to complete the arithmetic problems as 
quickly and correctly as possible. Subjects will be asked to state the order of words/letters shown to 
them at multiple time points throughout the task. This task is self-paced for a total of 75 math 
problems and 75 letters/words. 
o Data are recorded for an additional 2 minutes of recovery. 
o We ask the subject to rate the perceived difficulty of the test on a numerical scale ranging from 0-4. 
• Emotional stress 
o After 5 minutes of baseline, subjects will be shown a picture slide show, using pictures from the 
International Affective Picture System. The neutral (e.g., a table lamp) and negative (e.g., a wounded 
child) picture slide show each contains one blank slide and 59 pictures. Subjects will view each picture 
for 3 seconds (total viewing time of 3 minutes). 
o Data are recorded for an additional 2 minutes of recovery. 
o We ask the subject to rate the perceived stress of the picture viewing on a numerical scale ranging 
from 0-4. 
11. At the conclusion of the experiment, we de-instrument the subject. 
12. We measure blood pressure and heart rate before the subject departs the laboratory. 
 
Subject Participation: During the course of the study, a subject may decide not to participate in a particular 
experimental measurement or procedure; therefore, this portion of the protocol will not be completed. 
However, all other measurements and procedures will be performed. This will not affect the scientific value of 
the subject’s participation as each experimental measurement and procedure provides important and, in most 
cases, independent information. 
 
Subject Re-enrollment: The principal investigator may decide to re-enroll subjects in the study if previous testing 
was unsuccessful or certain experimental measurements and procedures were not initially performed. The re-
enrollment of subjects has no additional safety risks other than those inherent to the protocol and this will assist 
in the scientific merit of the project by providing additional information. 
 
Undergraduate Student Roles: All undergraduates involved in this project have completed all required EHS 
trainings for handling biological specimens for humans, and have been trained by the PI and graduate students 
for each specific procedure (eg, centrifugation, pipetting, storage). Invasive aspects of the study refers to those 
techniques that are invasive (eg, microneurography) or require a high degree of skill (eg, Doppler 
ultrasonography). They will have limited direct interaction with participants. They mostly function in a supporting 
role and assist all aspects of the study (eg, running the data acquisition computer -- this is a task that requires 
being present for the duration of the experiment (~4 hrs) but does not require undergraduate students (usually) 
to ever physically touch the participant or speak to them). 
 
7. Duration: Indicate how many participation sessions, interactions, or follow ups are expected for each 
subject participant, including the amount of time required for each visit and how long their total 
participation is expected to take (weeks, months, years, etc.) over the entire duration of the study. 
 
Screening Visit: no more than 2.5 hours 
Assessment of Daily Stressor Processes: no more than 3 hours per 8-day assessment (no more than 6 hours total) 
Experimental Visit to Assess Cardiovascular Reactivity: no more than 5 hours 
Total: no more than 13.5 hours 
 
 
8. Alternatives to Participation: Describe subjects’ available options if they choose not to participate in the 
research study and clarify whether individuals that decline participation will still be subjected to the 
intervention (even if their data will not be utilized for research purposes).  If research involves students, 

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describe their alternatives to obtain course / extra credit if applicable.  If research involves a health 
intervention, clarify whether individuals that decline will continue to receive standard care. 
 
The alternative to participation is choosing to decline participation. Participants may withdraw at any time. We may 
end the participant’s role in the study without her consent if we determine that her health or behavior adversely 
affects the study or increases the risks beyond those approved by the Institutional Review Board and agreed upon by 
her/him in the informed consent. Participants will be withdrawn if they cannot follow or understand the rules of the 
protocol. Participants will also be withdrawn if they cannot hold their appointments. 
 
9. Location(s) and Site(s): Specify all locations where research procedures are expected to take place and 
which study procedures will take place at each site. Studies that take place online should specify the 
websites where data will be collected.  Describe if any of the research will take place internationally. For 
multi-site research studies, review the web page for Collaborative Research. If any part of this study will be 
conducted in an institution or location administratively separate from UTA, indicate the institution(s) and 
upload a site permission letter. 
 
All studies will be performed in the clinical laboratories located on the 1st floor of the SEIR. These laboratories are 
BSL2 certified.  
 
10. Personnel Qualifications: Describe the relevant qualifications, special training, and experience of the 
research team/personnel as it pertains to the specific procedures or population of the study. If you (and 
your faculty advisor, if applicable) do not have any relevant qualifications or experience, please state that; 
the IRB will consider the risk level of the study and evaluate if additional oversight or input is necessary. 
 
Dr. Greaney, has extensive knowledge of and experience with human subjects research pertaining to neuro-
cardiovascular physiology in adults with pre-clinical cardiovascular disease (e.g., primary aging, hypertension, 
psoriasis, depression). Dr. Greaney has shadowed her collaborating psychiatrist, Erika Saunders, MD (co-mentor for 
her NIH-funded K99/R00), in outpatient psychiatry clinics to observe patients with psychiatric illness in the clinical 
setting, to learn the background of psychiatric diagnosis, and to receive psychiatric interview training. The training 
she received is fully adequate to ensure the accurate diagnosis of MDD.  
 
Dr. Greer will provide support and oversight for issues related to major depression and psychiatric illness. Dr. Greer is 
a Professor at UTA in the Dept of Psychology and has an appointment in the Dept of Psychiatry at UT Southwestern 
Medical Center. She has extensive experience conducting research and safety evaluations in vulnerable populations. 
 
Dr. Fadel is a Co-Investigator on this project. He too has extensive knowledge of and experience with human subjects 
research pertaining to neuro-cardiovascular physiology in adults with pre-clinical cardiovascular disease. He is an 
expert in human neural control of the cardiovascular system. 
 
Dr. Siddiqui is the Medical Director for Clinical Translational Science at UTA. He is a practicing surgeon with extensive 
expertise in neural cardiovascular physiology in health and disease and will provide medical input and oversight of 
our translational science team. He will assist in reviewing health history information of the participants. However, he 
will not be heavily involved in the administration of these studies. Carrie Arena-Marshall and Yaewon Seo will provide 
nursing support. 
 
These trainees have completed the required trainings, are familiar with the experimental measurements and 
procedures, and will assist with all phases of the research study: Ashley Darling, Jeremiah Joseph, Cynthia Dominguez, 
Cecilia Nguyen. 
 
These trainees have completed the required trainings, are familiar with the experimental measurements and 
procedures, and will primarily assist with the administration of the CANTAB cognitive function battery: Cassie 
Argenbright. 
 

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11. Study Oversight: The Principal Investigator has ultimate responsibility for the conduct of this research, 
protection of subjects, and supervision of all protocol personnel.  Describe your plan for oversight and 
communication to ensure that the entire research team: conducts the research ethically and in accordance 
with the approved protocol, creates/maintains appropriate study documentation and research records, and 
protects confidentiality of data.  
 
 
Dr. Greaney is responsible for conducting the study in compliance with this protocol, with institutional and IRB 
policies, with Good Clinical Practice guidelines and any other applicable regulatory requirements. She is assisted by 
members of her lab group. The monitoring is ongoing. Dr. Greaney and other investigators will hold regular lab 
meetings where relevant data safety and management procedures, interim data evaluation, untoward events (rare in 
this research), new developments in related research, and quality control issues are discussed. Regular bimonthly 
meetings and teleconference calls as deemed necessary will be scheduled with our collaborators. Collaborating 
investigator Dr. Mogle will assist with all phases of the implementation of the DISE survey (survey programming, data 
reduction/analysis), data interpretation, dissemination (abstracts/manuscripts), and the development of future grant 
proposals. 
 
SECTION C: POPULATION & ENROLLMENT 
 
12. Population(s):  Describe the target population(s) of the study, for example: UTA students, competent or 
healthy adults, children, prisoners, non-English speaking, pregnant women, individuals with impaired 
decision making capacity, other vulnerable populations.   
 
Competent adults; UTA students 
 
*Note: Additional forms may be required for your population. Obtain these from the Forms & Templates 
Page.  
 
For Individuals with Impaired Decision Making Capacity: Upload Form 2A. 
For Pregnant Women, Fetuses, Women Undergoing In-Vitro Fertilization, or newborns: Upload Form 2B. 
For Prisoners (Individuals involuntarily detained): Upload Form 2C. 
For Children (Under 18 or the local legal adult age): Upload Form 2D. 
 
13. Inclusion Criteria:  List all criteria for including subjects, and explain the methods you will use to determine 
whether a subject is eligible based on your criteria (i.e. pre-screen, medical chart review).  If your study 
is/will be funded, ensure that the inclusion criteria listed here match the details in your proposal. 
 
• Men and women 18 – 55  years,  
• Two subject groups will be recruited:  
1. Healthy control (HC) subjects will not have a history of MDD or other major psychiatric illness; PROMIS 
score < 18; and as confirmed by MINI 
2. MDD patients will have clinically significant depression (non-medicated); PROMIS score > 18; and as 
confirmed by the MINI 
 
14. Exclusion Criteria:  Explain any specific factors or contraindications that would make a subject  
ineligible to participate in this study, even if they would otherwise meet the inclusion criteria listed above.  
If your study is/will be funded, ensure that the exclusion criteria listed here match the details in your 
proposal. 
 
The exclusion criteria is applied to all groups. We will not enroll Non-English speaking individuals. This protocol 
involves the use of numerous questionnaires, including a detailed neuropsychiatric interview with the investigators. 
In addition, participants need to understand English in order to follow instructions and comply with procedures 
conducted during the screening and experimental visits. 
 

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Subjects will be excluded at the discretion of PI/collaborating psychiatrist/examining clinician or for any of the 
following reasons: 
• Psychiatric illness aside from MDD (including bipolar disorder, panic disorder, schizophrenia) 
• Psychiatric treatment with medication  
• Active suicidal/homicidal ideation 
• Active substance dependence 
• Eating disorders 
• Medications that could conceivably alter neurovascular function 
• Changes or alterations in medication status (starting a new, additional, or different medication) 
• Cardiovascular, renal, or metabolic disease (hypertension, heart disease, diabetes, hyperlipidemia) 
• Tobacco use 
• Pregnancy 
• Latex allergy 
• G6PDSickle cell anemia 
• Lack of access to a device with internet connectivity 
 
15. Number of Subjects:  Provide the number of subjects (or subject records/data sets) you intend to enroll 
over the course of the study. This information will be utilized by the IRB to understand the scope and 
logistics of the study; you may provide a projected range.  
 
Based on power calculations and previous experience using these techniques, up to 100 subjects per group (total 
n=200) will be included. This estimate will permit appropriate statistical comparisons and accounts for the technical 
difficulties of obtaining high-quality experiment measurements in all subjects and accounts for technical failure and 
subject dropout. 
 
 
 
*Note: For MR research, there is no cap on enrollment (enrollment can exceed the number provided here 
when needed for the study).  
  
For GMR research, the proposed number of subjects must be supported by statistical justification and/or 
references; please provide that information here.  Enrollment for GMR research is capped (IRB will approve 
a specific range or maximum number of participants and enrollment must not exceed that approved 
number unless the IRB approves a modification request). 
 
16. Recruitment Strategies:  Describe how you will identify and contact potential participants, and how you 
will obtain their contact information. Upload permission letters/emails as needed from individuals or 
organizations providing access to private contact information. Upload a copy of all planned recruitment 
materials (i.e. letters/emails; website/social media posts; printed flyers; telephone scripts; subject pool 
posts (SONA, Mechanical Turk, Research Match); scripts for recruitment in-person).  
 
Subjects will be recruited primarily from the University of Texas at Arlington and the greater Dallas-Fort Worth area. 
We use recruiting methods that will reach a large percent of the general population. We advertise for subjects and 
interested persons contact us. We post recruitment flyers in various campus (e.g., student union, classroom building 
bulletin boards, dormitory bulletin boards, campus eateries, etc) and community (e.g., coffee shops, bookstores, local 
businesses, etc) locations. We will obtain permission to provide recruitment flyers to local physicians’ offices (family 
physicians, mental healthcare providers/specialists) and other locations specifically targeted to recruit patients with 
depression (Counseling and Psychological Services). Additionally, the text from the fliers may be utilized in “word of 
mouth” recruiting if the opportunity presents itself (see attached document labeled “stress recruitment ad”). 
Recruitment may also occur via ResearchMatch.com and other online resources such as Craig’s List and Facebook. If 
we recruit by Research Match, we will not do so until we receive approval from all parties involved. 
 
We also avail ourselves of lists of potential subjects maintained by other labs conducting human subjects research at 
University of Texas Arlington. The people on these lists have consented for other IRB-approved studies and indicated 
that they wished to be maintained on a list of potential subjects to be contacted in the event that they may qualify 

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for additional studies. Also, other researchers may agree to send an email (provided by us; see attached document 
labeled “neural recruitment email”) to their research subjects who have indicated a willingness to be contacted for 
future studies for which they may qualify.  
 
SECTION D: COMPENSATION AND COSTS 
 
*Note: You are responsible for maintaining accurate and confidential records regarding payment of your 
subjects.  Per Accounting Services procedures, compensation must be documented for tax purposes using a W-9 
form unless an exception is granted by the Accounting department.  Obtaining an exception should be 
considered for cases of sensitive research or when disclosure of a subject’s identity would expose them to high 
risk.  Exception requests are submitted through the Business Affairs Exceptions Tracker (BAET) in SharePoint.  
Refer to knowledge base article KB0010632 for guidance. Contact Business Technology Services at 817-272-
2155 or submit a ServiceNow ticket at https://uta.service-now.com/selfservice/ for assistance. 
 
17. Compensation:  Describe any compensation to subjects for participation, including monetary payments, 
gift cards, course/extra credit, raffle prizes, goods or services, donations to charity, etc.  Describe how and 
when you will provide the payment to the subjects, and how confidentiality will be maintained (for 
example, use of coding in payment log books/receipts).  If you intend to hold a raffle, explain when you 
expect that the raffle will be drawn, and how participants will be contacted if they win the drawing.  For 
course / extra credit, alternative non-research assignments must be offered for an equal amount of credit. 
 
Participants will be compensated at the completion of the study or after the final visit to the lab. 
 
For the screening visit, subjects will be compensated $30. This compensation will only be provided to participants 
who qualify. That is, if the MINI or medical health history indicate an exclusion criterion and the subject is not 
enrolled in the study, he will not be compensated. 
 
For the experimental visit, subjects are compensated $75. Additional compensation is not provided if the participant 
is asked to repeat a trial within the same experimental visit. However, if a participant is asked to repeat the 
experimental visit, they will be compensated for the completion of the second visit as described above.  
 
For the assessment of daily stressors, there is a base compensation of $15, with a $5 bonus for the completion of the 
DISE survey on all 8 days. Thus, participants who complete the entire 8-consecutive day DISE assessment will be 
compensated $20. Participants who do not complete the DISE survey on all 8 days will receive the base compensation 
of $15. This compensation scheme will also be followed for participants who may complete each of two 8-day 
assessments. Participants will be compensated in the form of an electronic gift card for completion of the DISE 
surveys. This compensation scheme will significantly reduce participant burden and, given the ongoing COVID-19 
pandemic, will help to limit the number of times they are asked to come to campus and to the lab. 
 
If a participant is asked to repeat certain experimental measurements or procedures that were not initially 
performed, they will be compensated $15/hour. 
 
18. Costs:  Describe any costs or expenses (monetary or non-monetary) subjects will incur as a result of 
participation.   
 
N/A 
 
SECTION E: INFORMED CONSENT 
 
*Note: The ethical foundation of human subject research is informed consent. It is important to ensure that 
subjects are provided with sufficient information to understand the requirements of their participation and the 
use/purpose of their data. You also cannot obtain information about a person through another individual (such 
as a family member) unless that person has undergone the informed consent process themselves. Use the 

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Office of Human Research Protection (OHRP) informed consent checklist 
(http://www.hhs.gov/ohrp/policy/consentckls.html) and the IRB’s Templates as guidance.  
 
19. Informed Consent, Broad Consent, & Assent: Describe the informed consent process, including when, 
where, and how subjects will be consented. If children or mentally disabled or incapacitated persons will be 
subjects, explain the assent process. If broad consent (consent to use data for future studies) will be 
requested, describe the scope and the process for tracking subjects’ accept/decline responses.  Upload 
finalized copies of all consent, assent, and / or verbal consent script documents in the electronic system. 
There are several consent form templates available for your use on the Forms & Templates Page. 
 
Informed consent will be obtained at the screening/familiarization visit in the laboratory where the experimental 
visits will occur. These rooms are private. Access to these rooms is restricted. An investigator will review each section 
of the consent form with the participant. The participant will then be asked if they have questions. They will be 
explicitly given the option of taking the consent home for additional consideration and providing consent at a later 
date. Prior to any screening/testing, all subjects will provide written, informed consent.  
 
19a. Requesting a Waiver of Consent or Waiver of Written Documentation: If you wish to waive some 
or all of the requirements of informed consent, or the requirement for written/signed informed consent, 
please describe (if your study is federally funded or FDA-regulated, also upload Form 3 from the Forms 
Page).   
 
Please see Form 3. 
 
20. Incomplete Disclosure / Deception:  Describe if your study will withhold information from subjects 
regarding the purpose of the research or the nature of the intervention, interaction, or procedures.  Provide 
scientific justification for utilizing deception (if your study is federally funded, also upload Form 3). 
 
N/A 
 
SECTION F: RISKS & BENEFITS 
 
21. Risks to Subjects: Explain any potential risks to subjects that could result from the research 
intervention/procedures, including physical risks (i.e. fainting, falls, infections, muscle soreness, pain, 
broken bones, physical fatigue, headache, burns, medication side effects); psychological risks (i.e. 
depression, anger, stress, guilt, embarrassment, damage to self-esteem); social risks (i.e. potential damage 
to financial standing, reputation, or employability); risks to privacy or confidentiality (i.e. exposing 
someone as a research subject, release or breach of sensitive data); and/or risk of perceived 
coercion/undue influence (i.e. if investigator could have influence by nature of their relationship or status, 
such as a teacher & student, manager & employee, doctor & patient).  
 
There is risk that the illness (MDD) will worsen during participation. All participants will be given materials on local 
resources for psychiatric care and suicide hotline information. During the interview process, subjects will be advised 
that they are able to stop the interview at any time or not answer questions if preferred. If during the course of the 
study, at any time, the participant experiences suicidal or homicidal ideation with intent to harm, MHMR Tarrant 
County Crisis Relief will be called for an external evaluation and transfer. Failing all of the above options, 911 will be 
called for immediate assistance. If a participant has significant worsening of MDD but no immediate safety concern, 
we will recommend that the patient seek psychiatric consultation. 
 
Availability of Medical or Psychological Resources: Subjects will be free to contact the PI regarding any concerns or 
emergency during the study. The investigators also will provide the subjects with a detailed explanation of the 
neurovascular physiology of MDD. If participants have questions regarding clinical care, they will be referred to a 
psychiatric or medical provider. All participants are provided with a copy of the “Local Mental Health Providers” 
document. All subjects with MDD are highly encouraged to seek follow-up with a health care provider. If a subject 

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with MDD does not have a health care provider, the investigators will help them to identify local resources. 
Furthermore, the investigators will provide subjects with their screening data so that they may forward this 
information to a health care provider. 
 
MINI/PROMIS/PHQ9: For the purposes of this study, we use these tests to identify potential subjects who have 
clinical depression and to identify for exclusion those who have psychiatric illness other than depression. Subjects 
answer 8 questions (PROMIS), 9 questions (PHQ9), and 16 sections (MINI) (see uploaded documents). A score of 18 or 
more on the PROMIS test is considered depressed. A score of 5-9 on the PHQ9 is indicative of mild depressive 
symptoms. The MINI has 16 sections with multiple questions per section and provides a more in depth examination. 
Dr. Greaney has learned to conduct the PROMIS, PHQ9, and MINI through extensive instruction and training by Dr. 
Saunders. Subjects may feel uncomfortable about answering the questions. They are reminded that they may decline 
to answer the questions and leave the study at any time. Some subjects may be disturbed if the test recommends 
their inclusion in the depression group. We remind them that the test is not intended to be a diagnosis or healthcare 
recommendation but is used as a tool to identify people who may have particular experiences or forms of 
psychological distress useful for the purposes of this study. If the subject has concerns about the results of the test, 
we suggest that she/he seeks follow-up with a healthcare or mental healthcare provider. If she/he does not have 
access to one or the other, we can provide her/him with contact information. 
 
Flow Mediated Vasodilation (FMD) / Doppler Ultrasound: There is a small chance the probe could irritate the skin. 
Placing the probe on the arm’s skin may cause temporary minor redness. The inflated cuffs may cause the 
participant’s arms and feet to feel numb or tingly, and the skin’s color to change slightly. The cuffs could cause mild 
bruising. The gel is the same as that used with medical ultrasound tests. The gel may feel cool or cold on the skin. A 
bad reaction to the gel is highly unlikely. The cuffs inflate for a minimal amount of time. The temporary redness from 
the probe is unlikely to have lasting ill effects. The participant may decline the test. 
 
Microneurography: The technique of microneurography is an accepted and safe research technique. With regard to 
the assessment of nervous system activity, the use of the pencil-like device for external electrical stimulation may 
cause minor discomfort. There may also be mild discomfort when the fine wire needle is inserted through the skin; 
however, this needle is very small. Brief sensations of pins and needles and/or cramping are likely to be felt during 
the nerve search. This fine wire needle will be left in place for the duration of the experimental visit (approximately 3-
4 hours). It is also possible that feelings of muscle weakness and/or pins and needles sensations can be felt after 
completion of the procedure. There is no specific treatment for these sensations, and in the small number of 
volunteers that have experienced them, they have disappeared spontaneously. As with venipuncture or any event 
that breaks the skin, there is also a small risk of infection at the site where the fine wire needle is inserted. The 
microneurographer (Jody Greaney, PhD) is proficient in this technique, using it in research for >7 years, and no 
subjects have previously reported any long-term adverse effects (>265 microneurography experiments performed). 
 
Handgrip Exercise and Post-Exercise Ischemia: The muscles are likely to experience temporary fatigue and soreness 
during exercise. During and after cuff inflation, the arm may feel uncomfortable, numb, or tingly. These sensations 
cease rapidly, and there are no long-lasting adverse effects from these tests. 
 
Cold Pressor Test: The subject’s hand is likely to feel very cold. Subjects may stop the test at any time. They are 
unlikely to experience long-lasting adverse effects from this test. 
 
ECG: The researchers attach 3-5 electrodes to the participant’s chest and then attach the electrode wires to a ECG 
machine. The machine records the electrical activity of the heart. There are no adverse effects from this measure. A 
participant may be shy about electrodes applied to the chest. The staff carefully remove the tape afterward. They 
conduct the test professionally and privately. 
 
PWA/PWV: A cuff inflates tightly on the upper arm and lower leg. Automated measurement technique minimizes the 
duration of cuff inflation. 
 
Blood pressure: A cuff inflates on the upper arm. The inflated cuff may make the arm feel tingly and numb, and the 
cuff may temporarily bruise the arm. Efficient and competent measurement technique minimizes the duration of cuff 
inflation. The finger cuff (Finapres) may make the finger feel tingly and numb. The finger may be switched to a 

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different finger when necessary. These techniques to measure blood pressure are unlikely to produce lasting ill 
effects. 
 
Blood draw: Blood draws can cause anxiety (with increased heart rate and blood pressure), mild pain, swelling, 
nausea, lightheadedness, fainting, or bleeding. There is a slight chance of infection or small blood clot. A competent 
nurse performs blood draws using standard venipuncture-procedure and techniques that minimize the chance of 
infection. Participants may recline for the procedure. 
 
Cognitive Function Assessment: This test helps us to interpret the physiological data we record during the 
experiment. Subjects may feel shy or disturbed by the questions. They may choose not to answer the questions and 
decline to be in the study. We do not use the tools to decide a recommendation for healthcare. We keep the 
completed forms confidential and secure. Only approved staff may access the results. 
 
Emotional State Assessment: This test helps us to interpret the physiological data we record during the experiment. 
Subjects may feel shy or disturbed by the questions. They may choose not to answer the questions and decline to be 
in the study. We do not use the tools to decide a recommendation for healthcare. We keep the completed forms 
confidential and secure. Only approved staff may access the results. 
 
Surveys (Physical Activity Questionnaire, DISE): These surveys help us learn of a subject’s experiences that are useful 
for the purposes of this study. The surveys help us to interpret the physiological data we record during the 
experiments. Subjects may feel shy or disturbed by the questions. They may choose not to answer the questions and 
decline to be in the study. We do not use the tools to decide a recommendation for healthcare. We keep the 
completed forms confidential and secure. Only approved staff may access the results. 
 
Screening: The screening includes blood sample, height, waist circumference, weight, heart rate, blood pressure, 
pregnancy test, and history performed by the competent research staff. Participants may be uncomfortable giving 
medical information or being measured. The participants may decline to answer questions or participate in 
measurements. The researchers conduct screenings professionally and privately. 
 
Latex: Some gloves and medical materials are made of latex rubber. Some people may be sensitive to latex. Screening 
identifies and excludes candidates having a known latex allergy. 
 
Confidentiality: There is a risk of loss of confidentiality. 
 
22. Strategies to Minimize Risks: Explain the strategies that the research team will use to minimize the 
potential risks listed above.   
 
General Procedures 
The research group’s members are trained and competent in their duties. The group, led by Dr. Greaney, evaluates 
the effectiveness and safety of protocols and procedures in an ongoing fashion. They discuss the protocol with 
candidates, invite questions, and offer tours of the laboratory. Prior to medical screening, candidates read and sign 
informed consent forms detailing protocols, procedures, risks, sensations, compensation, etc. The researchers give 
candidates witnessed copies of the signed consent forms. After accepting participants into the study, the researchers 
discuss and review the procedures and protocols with them generally and at each step throughout the project. They 
frequently remind participants of the option to withdraw from the study at any time. Restricting access to 
experiments, data, and coding to authorized personnel maintains confidentiality. Lists of emergency numbers remain 
by lab telephones. At least one cell phone is present at each experiment. A hospital and emergency medical services 
are within 1-2 miles of the lab. An AED hangs nearby in the hallway. 
 
The PI has obtained an IND number from the FDA for the pharmacological agents used with this protocol (IND 
125,994). We are in complete compliance with FDA regulations. The agents are individually logged in a log book 
(quantity of agent, date of arrival and lot number). The date of use is then logged into the log book. 
 
Availability of Medical or Psychological Resources: Subjects will be free to contact the PI regarding any concerns or 
emergency during the study. The investigators also will provide the subjects with a detailed explanation of the 
neurovascular physiology of MDD. If participants have questions regarding clinical care, they will be referred to a 

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psychiatric or medical provider. All participants are provided with a copy of the “Local Mental Health Providers” 
document. All subjects with MDD are highly encouraged to seek follow-up with a health care provider. If a subject 
with MDD does not have a health care provider, the investigators will help them to identify local resources. 
Furthermore, the investigators will provide subjects with their screening data so that they may forward this 
information to a health care provider. If a participant indicates a “high” level of suicidality (coded as scoring ≥17 on 
the Suicidality Module) and immediate risk with intent to harm, MHMR Tarrant County Crisis Relief will be called for 
an external evaluation. 
 
Screening: Guided by the inclusion and exclusionary criteria approved by the IRB for the study, the investigators and 
clinical staff screen subjects before participation to insure that the subjects meet the study’s requirements. 
 
Stoppage Criteria: Although such events are extremely unlikely to occur, the investigators are prepared to 
immediately stop experiments and seek medical assistance if the subjects should experience the more serious 
reactions described in the informed consents and IRB applications such as signs and symptoms of an allergic reaction, 
anaphylactic shock, and fainting. In the case of a medical emergency, campus police will be contacted. The 
investigators end the experiments if the subject’s blood pressure is greater than 220/110 mmHg or less than 90/60 
mmHg, if heart rate is >120 bpm or <40 bpm, or the presence of symptoms. The investigators will stop the 
experiments at any time should a subject wish it. Also, the investigators will exercise the discretion to end a subject’s 
participation if the subject should engage in behavior that could jeopardize his/her own health and well-being or that 
of others. 
 
Previously Unknown Medical Conditions: It is possible that the investigators will discover a participant’s previously 
unknown medical condition as a result of the screening. At the time of screening, the investigators inform subjects of 
any condition identified that might require further treatment, and will suggest follow-up with a healthcare provider. 
The investigators make the results from laboratory studies available to the subject as soon as possible. 
 
Specific Procedures 
Psychiatric Screening Instruments [MINI, PROMIS, PHQ9]: Subjects are reminded that they may decline to answer the 
questions and leave the study at any time. Some subjects may be disturbed if the test recommends their inclusion in 
the depression group. We remind them that the test is not intended to be a diagnosis or healthcare 
recommendation, but is used as a tool to identify people who may have particular experiences or forms of 
psychological distress useful for the purposes of this study. 
 
Microneurography: The microneurography procedure will be immediately discontinued if the subject experiences any 
excessive discomforts. According to the Eckberg et. al (Eckberg DL et al. Prospective study of symptoms after human 
microneurography. Acta Physiol Scand. 137(4):567-9, 1989), the risk of symptoms during or after microneurography 
are minimized when no more than 60 minutes are used for the nerve search; we generally avoid searing for more 
than 45 minutes—and consistent with Eckberg’s recommendation, we never search for more than 60 minutes. 
 
ECG: We carefully remove the tape afterward. We conduct the test professionally and privately. The subjects may 
request that a person of the same gender perform the test. 
 
PWA/PWV: During the short time the cuff is inflated, the subject’s arm may feel numb. The measure will be taken 
efficiently to minimize the amount of time the cuff is inflated. The investigator can manually deflate the cuff at any 
time during the procedure, if necessary. 
 
Brachial blood pressure: During the short time the cuff is inflated, the subject’s arm may feel numb. The measure will 
be taken efficiently to minimize the amount of time the cuff is inflated on the arm. 
 
Finger blood pressure: The researcher will move the cuff to a different finger if the subject needs to give the first 
finger a rest. 
 
Blood draw: Subjects may decline. Experienced personnel draw the blood. Sterile supplies are used. Subjects will only 
be subjected to a maximum of two attempts per arm by one person. 
 

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Surveys/Cognitive Function Assessment/Emotional State Assessment: The subjects may decline to answer questions 
or participate in measurements. We do not use the tools to decide a recommendation for healthcare. We keep the 
completed forms confidential and secure. Only approved staff may access the results. 
 
Medical screening: The subjects may decline to answer questions or participate in measurements. Screenings are 
conducted privately. The subjects have the option of having a person of the same gender perform the measurements. 
 
Tape and adhesive disks: The researchers remove the tape and adhesive disks carefully. Ointment is available, if 
needed.  
 
Latex: Screening identifies and excludes candidates having a known latex allergy. 
 
Confidentiality: Qualtrics is a secure website and survey application designed to support data capture for research 
studies. All data is encrypted. Data are deleted from Qualtrics’ servers within 24 hours. The data files are downloaded 
and stored on an external password-protected hard-drive. Only authorized members of the lab have access to these 
files. 
 
23. Health & Safety Considerations: Specify whether the study involves any hazardous materials, locations, or 
equipment that is relevant to the health and safety of either the subjects or the protocol personnel (i.e. 
handling of human blood/body fluid/tissue, chemical or biological hazards, radiation/X-rays, lasers, or 
carcinogens). List any related authorizations/approvals from the Environmental Health & Safety Office. 
 
The laboratory space is designated as BSL-2 and approved for the collection and processing of blood samples.   
 
24. Benefits: List potential benefits that may accrue directly to the study subjects as a result of their 
participation, if any (other than compensation).  Also describe the expected or potential benefits of this 
study to the field or society at large. 
 
There is no direct benefit to participation; however, there are several possible benefits to the subjects. Subjects 
receive a medical screening that could inform them about their health. They learn their blood pressure and blood 
cholesterol levels. We advise those with depression, high blood pressure, or blood cholesterol to follow-up with a 
health care provider.  
 
Participants learn of the possible connection between depression and cardiovascular disease. Because impaired 
vascular function is an important contributor to the elevated cardiovascular risk, knowledge of the mechanisms 
underlying vascular dysfunction in adults with depression can be used to develop treatment plans to help decrease 
the incidence of disease in these individuals. 
 
SECTION G: PRIVACY & CONFIDENTIALITY  
 
25. Privacy: How will the privacy of subjects be protected during the course of the study (privacy refers to 
controlling the environment and circumstances of interactions with subjects to prevent situations where 
they might be embarrassed, exposed, or stigmatized)? 
 
Subjects will be enrolled and tested individually in a private setting.  Subjects may request an individual of the same 
sex to perform certain experimental measures and procedures.  We tell participants that they may decline to answer 
questions and decline to participate in the study. Only authorized personnel are present during screening and 
experiments. On occasion (e.g. educational visit, visiting colleague, site visit) participants may give permission for 
visitors to observe a procedure or experiment. 
 
26. Confidentiality & Data Security: Explain if the data collected (including biospecimens) will be anonymous, 
identifiable/coded, or de-identified*.  Explain the precautions that will be taken to protect confidentiality of 
subject data and information, and how these precautions will be communicated to subjects (during 
informed consent or another process).  Security should be considered for each phase of data’s life cycle, 

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including: collection, transmission, accessing, collaboration, storage, analysis, reporting, and disposition.  
Consider the tools and resources that will be utilized for data collection, how access to identifiable data will 
be limited only to authorized research personnel, and who will be responsible for storage and disposition.  
Recordkeeping: UTA and the IRB must be able to access research records and consent forms at any time; 
therefore, all paper documents in their original form must be stored on the UTA campus unless the IRB 
grants an exception.  All electronic data must be maintained on UTA servers utilizing sanctioned storage 
tools unless the Office of Information Security grants an exception.  Record Retention Period: All records 
(paper or electronic) must be maintained and kept secure for at least 3 years after the closure of the 
protocol or in accordance with funding agency requirements (whichever is longer).  Student PIs should 
address long-term storage arrangements if planning to leave UTA prior to the end of the retention period. 
Visit the UTA IRB’s Web Page on Human Subjects Data Security for allowable data storage options and 
more helpful information about DO’s and DON’Ts with human subject data! 
 
All files will be coded with a unique code for each subject. Hard copies of all data entered for a given subject and 
informed consent form originals will be stored in a locked file cabinet in the laboratory. The computerized data files 
are password protected and automatically backed-up. All of the electronic data are coded and do not contain 
personal identifying information. These data are stored using UTA-sanctioned storage tools. Only the PI and study 
personnel on this IRB will have access to the files. No other students or faculty will have access. 
 
Qualtrics is a secure website and survey application designed to support data capture for research studies.   The 
participant may be concerned about data’s security. All web traffic to and from the Qualtrics application website is 
done via a Secure Socket Layer (SSL) that encrypts the data in transmission. The questionnaire contains statements 
advising of the limitations of technology and that there is no confidentiality guarantee. Data is deleted from the 
Qualtric’s servers within 24 hours after the user deletes it from the website.   
 
Documents allowing identification of participants do not leave the investigator’s labs and are only available to 
authorized persons. The investigators store any list linking the code to participants’ identity in locked cabinets and on 
password-protected computers maintained in a locked room. Data forms containing identifiable information are 
shredded when no longer needed (3 years after publication of results). Screening data from subjects who are not 
accepted into the study are shredded immediately. 
 
Subjects may give permission to have their contact information retained in the investigator’s secured files if they wish 
to be considered for participation in future studies. After the investigators complete the study, they remove all 
identifiers from the data and store the data indefinitely. Individual data may be used without identifying the subject 
to illustrate representative response. 
 
*Note: “Anonymous” means that the data is unidentifiable (personally identifiable information will not be 
collected or accessed).  “Identifiable” means that data obtained will be recorded in such a manner that 
subjects’ identity can be readily ascertained, either directly or indirectly through identifiers linked to the 
subjects (research involving a coding mechanism that links to identifiable data is considered identifiable, 
but it is a helpful measure to protect confidentiality).  “De-identified” means that all direct personal 
identifiers are permanently removed, no code or key exists to link the data to its original source, and the 
remaining information cannot reasonably be used by anyone to identify the source. 
 
26a. Legal Limits to Confidentiality:  If any part of this study could result in the potential 
identification of child abuse, elderly abuse, communicable diseases, or criminal activities that 
would / could not have been otherwise identified, explain this possibility and estimate the 
likelihood of disclosure.  Describe the plan of action that you will take if this occurs. In rare 
circumstances when research reveals these issues, confidentiality should be maintained to the 
extent that the law allows. 
 

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In accordance with UTA policy, if an incidence of abuse is reported or suspected, mandatory reporting will 
take place.   
 
27. Data Sharing:  If you intend to share, release, or present any identifiable subject data from this study, 
explain where, when, and to whom the identifiable information will be shared, presented or released, and 
how this will be communicated to the subjects beforehand. 
 
N/A 
 
SECTION H: CONFLICT OF INTEREST 
 
28. Conflicts of Interest (COI): Does the Investigator or any protocol personnel have an affiliation, 
arrangement, or financial interest that could be perceived as a conflict of interest?  If yes, please describe.  
 
There are no Conflicts of Interest to report. 
 
*Note: All Covered Individuals in GMR research are required to have a current COI disclosure on file in Mentis 
(this must be complete prior to approval of the protocol).  Covered Individuals are those with responsibilities for 
the conduct, design, or reporting of this research study. 
 
SECTION I: REQUIRED ADDITIONAL ATTACHMENTS 
 
29. Upload finalized versions of the following documents as applicable to your study in the electronic 
submission system: 
 
• 
Survey instruments / questionnaires (and any versions translated into other languages) 
• 
Demographics surveys 
• 
Interview questions / prompts 
• 
Focus group instructions / questions / prompts 
• 
Observation data collection sheets 
• 
Psychological & educational tests 
• 
Educational materials 
• 
All recruitment materials including flyers, ads, scripts, emails, social media posts, etc. 
• 
Informed Consent Documents / cover letters and translated versions (See Forms Page for 
Templates) 
• 
Permission letters from non-UTA study sites / collaborating organizations  
• 
Signed Non-UTA Collaborator Forms & HSP Training (Collaborative Research Page)