Boxing Training Effects on Cardiovascular Risk, Quality of Life, Endothelial Function, and Blood Flow Patterns in Individuals With Elevated Blood Pressure or Stage 1 Hypertension
Phase: NA
Conditions: Elevated Blood Pressure, Hypertension
Sponsor: University of Texas, El Paso

Cover Page for StudǇ ProtoĐol and StatistiĐal AnalǇsis Plan 
 
OffiĐial title 
CliŶiĐal EffeĐtiǀeŶess of BoǆiŶg TƌaiŶiŶg iŶ IŶdiǀiduals ǁith Eleǀated Blood 
Pƌessuƌe oƌ Stage ϭ HǇpeƌteŶsioŶ 
NCT Ŷuŵďeƌ  
N/A 
DoĐuŵeŶt 
Date 
ϭϭ DeĐeŵďeƌ ϮϬϮϯ 
 
 
 

StudǇ ProtoĐol 
PartiĐipants 
PaƌtiĐipaŶts ǁill ďe ƌeĐƌuited fƌoŵ the UŶiǀeƌsitǇ of Teǆas at El Paso aŶd its suƌƌouŶdiŶgs. TheǇ 
ǁill ďe ideŶtified ďǇ a pƌeliŵiŶaƌǇ ďlood pƌessuƌe sĐƌeeŶiŶg aŶd a health ƋuestioŶŶaiƌe. The 
iŶĐlusioŶ Đƌiteƌia ǁill ĐoŶsist of: ;ϭͿ шϭϴ Ǉeaƌs old, ;ϮͿ SBP ďetǁeeŶ ϭϮϬ-ϭϯϵ ŵŵHg oƌ DBP 
ďetǁeeŶ ϴϬ-ϴϵ ŵŵHg oďtaiŶed fƌoŵ Ϯ diffeƌeŶt daǇs, ;ϯͿ aŶ estiŵated ϭϬ-Ǉeaƌ ƌisk of 
CaƌdioǀasĐulaƌ Diseases чϭϬ%, ĐalĐulated ďǇ the AŵeƌiĐaŶ College of CaƌdiologǇ/AŵeƌiaŶ Heaƌt 
AssoĐiatioŶ Pooled Cohoƌt EƋuatioŶs, aŶd ;ϰͿ Ŷo ĐuƌƌeŶt paƌtiĐipatioŶ iŶ ϯ oƌ ŵoƌe daǇs peƌ 
ǁeek of eŶduƌaŶĐe oƌ ƌesistaŶĐe eǆeƌĐise tƌaiŶiŶg. EǆĐlusioŶ Đƌiteƌia ǁill iŶĐlude ŶoŶ-ĐoŶtƌolled 
ĐaƌdiaĐ, pulŵoŶaƌǇ, oƌ ŵetaďoliĐ diseases, sŵokiŶg, ĐoŶsuŵptioŶ of ŶutƌitioŶal suppleŵeŶts 
ĐoŶtaiŶiŶg aŶtioǆidaŶts, aŶd aŶǇ phǇsiĐal iŵpaiƌŵeŶt to eǆeƌĐise.  
ProtoĐol 
AŶ iŶitial ďƌaĐhial ďlood pƌessuƌe sĐƌeeŶiŶg ǁill ďe peƌfoƌŵed to ideŶtifǇ poteŶtial paƌtiĐipaŶts 
foƌ the pƌeseŶt studǇ. Those ǁith sǇstoliĐ ďlood pƌessuƌe ƌeadiŶgs ďetǁeeŶ ϭϮϬ-ϭϯϵ ŵŵHg oƌ 
diastoliĐ ďlood pƌessuƌe ďetǁeeŶ ϴϬ-ϴϵ ŵŵHg ǁill ďe iŶstƌuĐted to assist to the CliŶiĐal 
PhǇsiologǇ Laď at the UŶiǀeƌsitǇ of Teǆas at El Paso iŶ fastiŶg ĐoŶditioŶs foƌ a seĐoŶd ďlood 
pƌessuƌe assessŵeŶt to ĐoŶfiƌŵ the diagŶosis of eleǀated ďlood pƌessuƌe oƌ stage ϭ 
hǇpeƌteŶsioŶ. TheŶ, theǇ ǁill Đoŵplete a health ƋuestioŶŶaiƌe to disƌegaƌd aŶǇ ĐaƌdiaĐ, 
pulŵoŶaƌǇ, oƌ ŵetaďoliĐ ĐoŶditioŶ. OŶĐe theǇ aƌe Đleaƌed to paƌtiĐipate, theǇ ǁill staƌt the 
iŶfoƌŵ ĐoŶseŶt pƌoĐess. Afteƌ oďtaiŶiŶg the ĐoŶseŶt, theiƌ height aŶd ǁeight ǁill ďe ŵeasuƌed 
usiŶg a stadioŵeteƌ ;SeĐa ϮϮϱ, SeĐa MediĐal MeasuƌiŶg SǇsteŵs aŶd SĐales, Haŵďuƌg, 
GeƌŵaŶǇͿ aŶd a digital sĐale ;TaŶita WB-ϭϭϬA, TaŶita CoƌpoƌatioŶ, TokǇo, JapaŶͿ, ƌespeĐtiǀelǇ. 
TheŶ, theǇ ǁill ƌeŵaiŶ seated foƌ ϱ ŵiŶutes folloǁed ďǇ aŶ assessŵeŶt of ĐeŶtƌal ďlood 
pƌessuƌe thƌough Pulse Waǀe AŶalǇsis ;SphǇgŵoĐoƌ, XĐel, West RǇde, AustƌaliaͿ. Theƌeafteƌ, 
paƌtiĐipaŶts ǁill ďe asked to laǇ doǁŶ iŶ supiŶe positioŶ oǀeƌ aŶ eǆaŵiŶatioŶ taďle foƌ ϭϬ 
ŵiŶutes ǁheƌe Pulse Waǀe VeloĐitǇ ;SphǇgŵoĐoƌ, XĐel, West RǇde, AustƌaliaͿ, ďƌaĐhial aŶd 
popliteal Floǁ Mediated DilatioŶ, aŶd stƌaiŶ gauge ǀeŶous oĐĐlusioŶ plethǇsŵogƌaphǇ ;AIϲ 
Aƌteƌial IŶfloǁ SǇsteŵ, D.E. HokaŶsoŶ IŶĐ., Belleǀue, WashiŶgtoŶͿ ǁill ďe peƌfoƌŵed. At the eŶd 
of the fiƌst laď ǀisit, theǇ ǁill Đoŵplete the SF-ϯϲ ƋuestioŶŶaiƌe aŶd theǇ ǁill ďe asked to ĐoŵplǇ 
ǁith a loǁ Ŷitƌate diet foƌ ϰϴ houƌs. IŶ a seĐoŶd ǀisit, a ďlood saŵples ǁill ďe ĐolleĐted fƌoŵ the  
aŶteĐuďital ǀeiŶ of the paƌtiĐipaŶts, folloǁed ďǇ a ďodǇ ĐoŵpositioŶ aŶalǇsis thƌough dual-
eŶeƌgǇ X-ƌaǇ aďsoƌptioŵetƌǇ ;DXAͿ ;LuŶaƌ PƌodigǇ, GE HealthĐaƌe, MadisoŶ, WIͿ aŶd 
ĐaƌdiopulŵoŶaƌǇ testiŶg usiŶg a ĐƌaŶk-aƌŵ eƌgoŵeteƌ ;AŶgio VϮ, Lode, GƌoŶiŶgeŶ, NetheƌlaŶdsͿ 
that ǁill deteƌŵiŶe theiƌ VOϮŵaǆ ;PaƌǀoŵediĐs IŶĐ., SaŶdǇ, UTͿ. TheŶ paƌtiĐipaŶts ǁill ďe 
ƌaŶdoŵlǇ assigŶed iŶto a ďoǆiŶg oƌ a ĐoŶtƌol gƌoup usiŶg aŶ oŶliŶe Ŷuŵďeƌ geŶeƌatoƌ 
;https://ǁǁǁ.gƌaphpad.Đoŵ/ƋuiĐkĐalĐs/ƌaŶdoŵizeϭ/Ϳ. FiŶallǇ, all the ŵeasuƌeŵeŶts that ǁeƌe 
takeŶ iŶ the fiƌst tǁo ǀisits ǁill ďe ƌepeated iŶ the saŵe oƌdeƌ afteƌ a ϲ-ǁeek iŶteƌǀeŶtioŶ.  
 

 
Interventions 
Boǆing Training  
Fiƌst, iŶ a faŵiliaƌizatioŶ ǀisit, paƌtiĐipaŶts ǁill leaƌŶ hoǁ to ǁƌap theiƌ haŶds aŶd ďasiĐ ďoǆiŶg 
teĐhŶiƋues, suĐh as staŶĐe aŶd puŶĐhes, ǁhile ǁeaƌiŶg ϭϰ oz gloǀes. This ǀisit ǁill fiŶish ǁith aŶ 
iŶĐƌeŵeŶtal ďoǆiŶg test that ĐoŶsists of puŶĐhiŶg a ϭϬϬ lď heaǀǇ ďag ;RiŶgside soft filled leatheƌ, 
RiŶgside-CSI FitŶess ϭst, LeŶeǆa, KSͿ at a fiǆed foƌĐe that ǁill ďe tƌaĐked ǁith a seŶsoƌ attaĐhed to 
the ďottoŵ of the heaǀǇ ďag ;UFC FoƌĐe TƌaĐkeƌͿ aŶd ǁith iŶĐƌeŵeŶts oŶ the puŶĐhiŶg ĐadeŶĐe 
eǀeƌǇ ϯ ŵiŶutes. The test ǁill staƌt at a ĐadeŶĐe of ϲϬ puŶĐhes peƌ ŵiŶute ;ppŵͿ that is 
ĐoŶtƌolled ďǇ a ŵetƌoŶoŵe ;Pƌo MetƌoŶoŵe ďǇ EUMLaď, XaŶiŶ TeĐh. GŵďH.Ϳ, aŶd ǁill iŶĐƌease 
ϭϱ ppŵ eǀeƌǇ ϯ ŵiŶutes, uŶtil fatigue. As depiĐted iŶ Figuƌe Ϯ, at the eŶd of eaĐh ϯ-ŵiŶute 
ǁoƌkload, oǆǇgeŶ uptake, aŶd heaƌt ƌate ǁill ďe ŵeasuƌed.  
The ďoǆiŶg tƌaiŶiŶg iŶteƌǀeŶtioŶ ǁill ĐoŶsist of thƌee eǆeƌĐise sessioŶs peƌ ǁeek iŶ 
ŶoŶĐoŶseĐutiǀe daǇs foƌ siǆ ǁeeks. The ǁoƌkout ǁill ďegiŶ ǁith a ϯ-ŵiŶute ǁaƌŵ up peƌiod 
ǁheƌe paƌtiĐipaŶts ǁill aĐtiǀelǇ ŵoǀe theiƌ shouldeƌs, elďoǁs, ǁƌists, aŶd fiŶgeƌ joiŶts. TheŶ 
paƌtiĐipaŶts ǁill ďe iŶstƌuĐted to Đoŵplete ϭϬ ƌouŶds of thƌee ŵiŶutes ǁith oŶe-ŵiŶute ƌestiŶg 
peƌiod iŶteƌspeƌsed. Fouƌ ƌouŶds ǁill ĐoŶsist oŶ heaǀǇ ďag puŶĐhiŶg ;e.g. stƌaight, jaď, hookͿ at 
ϲϬ% VOϮŵaǆ aŶd thƌee ƌouŶds at ϵϬ-ϵϱ% VOϮŵaǆ, ǁhile the ƌeŵaiŶiŶg ϯ ƌouŶds ǁill ďe foĐus 
oŶ ŵitt ǁoƌk at ϲϬ% VOϮŵaǆ. Heaƌt ƌate ǁill ďe ĐoŶstaŶtlǇ ŵoŶitoƌed to eŶsuƌe that eaĐh 
paƌtiĐipaŶt ǁill ďe eǆeƌĐisiŶg at the desiƌe iŶteŶsitǇ. 
FleǆiďilitǇ and BalanĐe Training ;Đontrol interventionͿ 
The ĐoŶtƌol gƌoup ǁill peƌfoƌŵ thƌee daǇs peƌ ǁeek ϭϬ ŵiŶutes of dǇŶaŵiĐ aƌtiĐulaƌ ŵoǀeŵeŶt, 
fiǀe ŵiŶutes of uŶipedal staŶĐe, aŶd fiǀe ŵiŶutes of stƌetĐhiŶg of the uppeƌ liŵďs foƌ siǆ ǁeeks. 
 
StatistiĐal AnalǇsis 
Data ǁill ďe aŶalǇzed ďǇ SPSS ǀeƌsioŶ Ϯϰ.Ϭ. Noƌŵal distƌiďutioŶ of the data ǁill ďe eǆaŵiŶed 
ǁith the Shapiƌo-Wilk test aŶd ǀisual iŶspeĐtioŶ. If the data is Ŷot ŶoƌŵallǇ distƌiďuted a 
tƌaŶsfoƌŵatioŶ ǁill ďe atteŵpted pƌioƌ the use of ŶoŶ-paƌaŵetƌiĐ statistiĐs. NoƌŵallǇ 
distƌiďuted data ǁill ďe pƌeseŶted as ŵeaŶ ;staŶdaƌd deǀiatioŶͿ ǁhile ŶoŶ-ŶoƌŵallǇ distƌiďuted 
ǁill ďe pƌeseŶted as ŵediaŶ ;iŶteƌƋuaƌtile ƌaŶgeͿ. Paiƌed t-tests ǁill ďe ĐoŶduĐted to Đoŵpaƌe 
pƌe- aŶd post-ǀaƌiaďles fƌoŵ ďoth gƌoups. The ŵagŶitude of the effeĐt ǁill ďe assessed thƌough 
Hedges's gs ĐoƌƌeĐted effeĐt size[Ϯϰϲ]. SigŶifiĐaŶĐe ǁill ďe estaďlished at α ч Ϭ.Ϭϱ.     
The saŵple size ǁill ďe deteƌŵiŶed usiŶg the softǁaƌe G*Poǁeƌ ϯ.ϭ. Based oŶ Izadi et al. ƌesults 
oŶ the effeĐts of siǆ ǁeeks of High IŶteŶsitǇ IŶteƌǀal TƌaiŶiŶg oŶ sǇstoliĐ ďlood pƌessuƌe ;effeĐt 
size = ϭ.ϳϯͿ, estaďlishiŶg α at Ϭ.Ϭϱ aŶd β at Ϭ.Ϯ, aŶd assuŵiŶg a ϯϬ% dƌop out ƌate, the 
estiŵated Ŷuŵďeƌ of paƌtiĐipaŶts peƌ gƌoup ǁill ďe ϭϮ. 

UTEPIRB 1.1(04/23/15) 
 
 
 
University of Texas at El Paso (UTEP) Institutional Review Board 
Informed Consent Form for Research Involving Human Subjects 
 
Protocol Title: Effects of Physical Activity on Cardiovascular Risk and Endothelial Function in 
Individuals with Elevated Blood Pressure or Stage 1 Hypertension 
Principal Investigator: Francisco Morales 
UTEP: Rehabilitation Sciences Department 
 
In this consent form, “you” always means the study subject. If you are a legally authorized 
representative (such as a parent or guardian), please remember that “you” refers to the study 
subject. 
 
1. Introduction 
You are being asked to take part voluntarily in the research project described below. Please take 
your time making a decision and feel free to discuss it with your friends and family. Before 
agreeing to take part in this research study, it is important that you read the consent form that 
describes the study. Please ask the study researcher or the study staff to explain any words or 
information that you do not clearly understand. 
 
2. Why is this study being done? 
You have been asked to take part in a research study to determine the effects of physical 
activity on cardiovascular risk and endothelial function in individuals with elevated blood 
pressure or stage 1 hypertension. 
 
A total of 24 participants will be recruited from the University of Texas at El Paso and its 
surroundings. They will be identified by a preliminary blood pressure screening and a health 
questionnaire. The inclusion criteria will consist on: (1) 18-40 years old, (2) Systolic Blood 
Pressure between 120-139 mmHg or Diastolic Blood Pressure between 80-89 mmHg obtained 
from 2 different days, (3) an estimated 10-year risk of CVD ≤10%, calculated by the ACC/AHA 
Pooled Cohort Equations, and (4) no current participation in 3 or more days per week of 
endurance or resistance exercise training. Exclusion criteria will include non-controlled cardiac, 
pulmonary, or metabolic diseases, smoking, consumption of nutritional supplements containing 
antioxidants, and any physical impairment to exercise. If you decide to enroll in this study, your 
involvement will last about 8 weeks. The first and last weeks, you will be asked to come to the 
 
 
Approved:             02/22/19 
Expires:                  01/30/20   
 Study Number:   1364179-3 
                                                     
 

UTEPIRB 1.1(04/23/15) 
 
 
 
laboratory for testing 2 times per week for around 1 hour each time.  The other 6 weeks, you will 
be asked to exercise three days per week (e.g. Monday, Wednesday, and Friday) for a 
maximum of 1 hour each time. 
 
3. What is involved in the study? 
If you volunteer to participate in this study, you will be asked to do the following things:  
You will attend some testing and training sessions for 8 weeks to Room 454, located at the 4th 
floor of the Health Science Building of UTEP. During these visits, you will need to wear loose 
shorts or pants and short sleeve t-shirt. 
 
During your first visit, you will discuss your participation with the investigator. Then, if you agree 
to participate, you will sign this informed consent form. Afterwards, you will answer some 
questions about you (like your date of birth) and your height and weight will be measured. Then, 
you will remain seated for 5 minutes followed by an assessment of blood pressure with an 
automatic cuff. Thereafter, you will be asked to lay down on an examination table for 10 
minutes. Next, we will attach some electrodes on your chest and your baseline blood pressure 
will be taken. After resting on the table for 15 minutes, your blood pressure will be taken again. 
Then, a transducer holder, which is a plastic structure attached to the arm to keep the position 
of the ultrasound wand, will be attached to your arm and ultrasound pictures will be recorded of 
the large artery of your upper arm. A blood pressure cuff will be placed below your elbow and 
will be inflated at 200 mmHg; as it is inflated at the doctor office, for 15 - 20 seconds and then 
deflated. The Ultrasound pictures will be repeated immediately following deflation of the cuff for 
the next 3 minutes. Then, the same procedure will be repeated, but this time the ultrasound 
wand will be placed behind your knee and the cuff will be placed below the knee. Additionally, 
we will place a tonometer (pen-like device) on your neck to measure the velocity of propagation 
of the blood pressure wave. At the end of the first lab visit, you will perform an exercise test 
using a crank-arm ergometer that will determine their maximum oxygen uptake (VO2max). For 
this last test, we will put a mouth piece connected via a long tube to a metabolic cart, and a 
nose-clip to prevent air leakage. Immediately before starting their exercise tests, your earlobe 
will be poked with a micro-lancet (similarly as blood glucose sampling from the finger) and the 
 
 
Approved:             02/22/19 
Expires:                  01/30/20   
 Study Number:   1364179-3 
                                                     
 

UTEPIRB 1.1(04/23/15) 
 
 
 
baseline blood micro-sample will be draw with a micro-hematocrit capillary (i.e. very small glass 
straw). Additionally, you will be asked to comply with a low nitrate diet for 48 hours. 
 
In a second visit, 21 ml of blood will be collected from your antecubital vein followed by a body 
composition analysis through dual-energy X-ray absorptiometry (DXA), an echocardiographic 
assessment to determine cardiac dimensions and function, and you will complete a 
questionnaire of 36 questions related to quality of life. Then participants will be randomly assign 
to a 6-week intervention of physical activity and you will need to come 3 times per week for 6 
weeks for the training sessions. Finally, all the measurements that were taken in the first two 
visits will be repeated in the same order after the intervention. 
 
4. What are the risks and discomforts of the study? 
Exercise stress tests have inherent risks involved. The risk is about 1 nonfatal event in 10,000 
maximal cycle tests.1 In fact, the risk of dying during a supervised exercise test, as the ones you 
will be performing, is lower than dying from being bitten by a Dog (i.e. 1 in ~100,000 sub-
maximal exercise tests). Your risk will be kept as low as possible because all personnel involved 
are experienced with exercise testing, and emergency treatment is readily available. Your 
exercise test will be supervised by a licensed physical therapist. Shortness of breath or fatigue 
is common during testing. Muscle soreness may follow testing but is normal and should not 
interfere with other activities. Finally, there is a small chance of falling off the bicycle; however, 
at least two people will be overseeing your exercise test to prevent that from happening.  
 
Your electric heart activity will be continuously monitored during exercise and we will stop the 
test if your heart shows any abnormal rhythm (e.g. ST segment depression, multiple premature 
ventricular contractions (PVCs), or atrial fibrillation). We will also stop the test if you have a 
sudden drop in blood pressure, chest pain, significant leg pain, or significant shortness of breath 
(dyspnea). All these signs can be related to a cardiac problem.  
 
In the event that you suffer a decompensation of your heart condition (e.g. an acute cardiac 
event or myocardial infarction), the lab is equipped with an external automatic defibrillator, all 
personnel are CPR-certified, and we will immediately call 911. Any hospital expenses due to a 
decompensation will be billed to you or your insurance provider. You will be responsible for any 
deductible, co-insurance, or co-payments.  
 
 
 
Approved:             02/22/19 
Expires:                  01/30/20   
 Study Number:   1364179-3 
                                                     
 

UTEPIRB 1.1(04/23/15) 
 
 
 
There is minimal risk associated with drawing blood from an earlobe. The risks include 
discomfort and possible bruising or swelling around the drawing site; rarely an infection; and, 
uncommonly, faintness from the procedure. This risk will be minimized by the use of sterile tips 
and alcohol pads. In addition, we ask you to put some ice on it when you get back home. If you 
request to stop the procedure because it is painful or highly uncomfortable, blood draws will be 
stopped immediately.  
 
There is no risk when using ultrasound imaging techniques. Ultrasound does not produce any 
radiation and it is extremely safe. However, if you experience any discomfort for having your 
arm straight for 10-20 minutes, images acquisition will be stopped immediately. 
 
DXA scanning radiation is considered minimal. For example, the total radiation of a 7-hour flight 
is 0.04 mSv and for a chest x ray is 0.04 mSv, meanwhile, for a single DXA evaluation the 
exposure is 0.002 mSV.2 
 
There is a slight risk that information given by you could be revealed inappropriately or 
accidentally. However, every effort will be made to protect the information attained from 
subjects. 
 
1. 
Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, et al. Exercise standards for testing and 
training: a scientific statement from the American Heart Association. Circulation 2013; 128 (8):873-934. 
2. 
Australian Radiation Protection and Nuclear Safety Agency. https://www.arpansa.gov.au/search/DEXA. 
 
5. What will happen if I am injured in this study? 
The University of Texas at El Paso and its affiliates do not offer to pay for or cover the cost of 
medical treatment for research related illness or injury. No funds have been set aside to pay or 
reimburse you in the event of such injury or illness. You will not give up any of your legal rights 
by signing this consent form. You should report any such injury to Dr. Alvaro Gurovich at (915) 
747-7248 and to the UTEP Institutional Review Board (IRB) at (915) 747-7693 or 
irb.orsp@utep.edu.  
 
6. Are there benefits to taking part in this study? 
Physical activity has shown to be beneficial for cardiovascular health. Being involved in this 
study will improve your health. This research could improve the treatment and prevention of 
cardiovascular diseases, such as high blood pressure. 
 
 
Approved:             02/22/19 
Expires:                  01/30/20   
 Study Number:   1364179-3 
                                                     
 

UTEPIRB 1.1(04/23/15) 
 
 
 
 
7. What other options are there? 
You have the option not to take part in this study. There will be no penalties involved if you 
choose not to take part in this study. 
 
8. What are my costs? 
There are no direct costs. You will be responsible for travel to and from the research site and 
any other incidental expenses. 
 
9. Will I be paid to participate in this study? 
You will not be compensated for taking part in this research study. 
 
10. What if I want to withdraw, or am asked to withdraw from this study? 
Taking part in this study is voluntary. You have the right to choose not to take part in this 
study. If you do not take part in the study, there will be no penalty or loss of benefit. 
 
If you choose to take part, you have the right to skip any questions or stop at any time. 
However, we encourage you to talk to a member of the research group so that they know 
why you are leaving the study. If there are any new findings during the study that may affect 
whether you want to continue to take part, you will be told about them.  
 
The researcher may decide to stop your participation without your permission, if he or she 
thinks that being in the study may cause you harm. 
 
11. Who do I call if I have questions or problems? 
You may ask any questions you have now. If you have questions later, you may contact Dr. 
Alvaro Gurovich at (915) 747-7248, agurovich@utep.edu or Francisco Morales at (812) 917-
8661, fmoralesac@miners.utep.edu. 
 
If you have questions or concerns about your participation as a research subject, please 
contact the UTEP Institutional Review Board (IRB) at (915-747-7693) or irb.orsp@utep.edu. 
 
12. What about confidentiality? 
Any information that is obtained in connection with this study and that can be identified with 
you will remain confidential and will be disclosed only with your permission or as required by 
 
 
Approved:             02/22/19 
Expires:                  01/30/20   
 Study Number:   1364179-3 
                                                     
 

UTEPIRB 1.1(04/23/15) 
 
 
 
law. Confidentiality will be maintained through 3 methods: 1) coding, 2) data storage, and 3) 
confidentiality training. 
1) Coding: after signing this informed consent, a study code will be assigned to your name. 
Your name and code will be together only on one form. All other forms will use only your 
code. 
2) Data storage: this informed consent, the preliminary screening questionnaire and the form 
with your name and code will be kept in a locked cabinet on Dr. Gurovich office. Only Dr. 
Gurovich will have access to all study forms. 
3) Training: all the researchers, including principal investigators and research assistants, are 
trained on health information privacy guidelines. 
These measures will minimize the risk of any confidentiality break. 
 
13. Authorization Statement 
I have read each page of this paper about the study (or it was read to me). I know that being 
in this study is voluntary and I choose to be in this study. I know I can stop being in this 
study without penalty. I will get a copy of this consent form now and can get information on 
results of the study later if I wish. 
 
 
Participant Name:  
 
 
 
 
 
 
Date:  
 
 
Participant Signature:  
 
 
 
 
 
 
Time: 
 
 
14. Voluntary Follow-Up 
Can we contact you if there are other studies that you might qualify? 
 
Yes         No  
 
 
 
 
 
  
  
 
Participant Signature:  
 
 
 
 
 
 
Date: 
 
 
 
 
Approved:             02/22/19 
Expires:                  01/30/20   
 Study Number:   1364179-3