Clinical trial NCT03479203
Conditions: Endothelial Dysfunction Biochemical Markers
Keywords: Inflammation
Sponsor: University of Pennsylvania
Start date: 2018-05-22; Completion date: 2022-08-31
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

Detailed description:
Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Arms: arm 1: Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)
Interventions: intervention 1: Electronic Cigarette Aerosol
Intervention descriptions: intervention 1: 16 two-second-long puffs from a non-nicotinized electronic cigarette.

Protocol documents:
Prot_SAP_000.pdf: 
MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers 
NCT 03479203 
September 15, 2017 


To determine the acute effects of e-cig aerosol inhalation we will quantify surrogate markers of EDF at the micro- 
and macro-vascular level before and after a nicotine-free e-cig aerosol in healthy subjects without history of 
cardiovascular disease.   
 
In order to isolate and assess the acute effects of inhaled aerosol on surrogate MRI markers of EDF (endothelial 
dysfunction), nicotine-naïve (i.e. non-smokers) will undergo an e-cig aerosol inhalation challenge using a com-
mercially available, disposable, non-flavored nicotine-free e-cig (ECO series, epuffer.com). 
 
All MR procedures will be performed on a 3T Siemens TIM Trio imager (Siemens Medical Solutions) 
using standard RF coils (8-channel extremity coil for cuff paradigm studies at the location of the femoro-popliteal 
artery and vein, and a combination of two body matrix and 12-channel head coils for PWV (pulse wave velocity) 
of the aorta and neurovascular reactivity in the superior sagittal sinus (SSS) in conjunction with the custom-
designed pulse sequences. Subjects will be asked to fast for eight hours, have abstained from taking vasoactive 
medications (including over-the-counter medications) as well as vigorous physical activity. Each visit will com-
prise two blood draws and two qMRI (quantitative magnetic resonance imaging) examinations, one before and 
one after an e-cig challenge to assess the changes in the functional and mechanical metrics described in the 
previous section. The e-cig challenge will consist of 16 two-second-long puffs (equivalent to smoking one con-
ventional cigarette). Smoking will be directly supervised to prevent superficial smoking or hyperventilation by the 
study subjects. The challenge will last approximately 20 minutes. A second blood draw will be taken six hours 
after the e-cig challenge. From the blood samples collected, inflammatory biomarkers will be assessed. 
 
Blood will be drawn from the antecubital vein of the subject’s left or right arm. At least 2 mL of plasma 
will be isolated and kept frozen after centrifuging blood for 15 min.  
 
The qMRI protocol will consist of three parts (cuff paradigm, PWV and breath-hold index). The patient 
set-up for PWV and breath-hold index (BHI) will be combined, i.e. the patient will enter the scanner head-first, 
supine, with head and body matrix coils in place. Vascular reactivity in the femoral artery and vein will be quan-
tified first. After the cuff-induced hyperemia portion of the protocol the patient will be prepared for the second 
part designed to measure aortic PWV and BHI.  
 
 
 
 
 
 
 
Data and Statistical Analysis 
The fractional changes in functional and mechanical qMRI parameters between pre- and post-nicotine challenge 
will be determined. For each parameter paired two-tailed t-tests will be performed with p<0.05 indicating statis-
tical significance. The data will allow us to determine which of the qMRI metrics (peripheral vascular reactivity, 
central arterial stiffness or neurovascular reactivity), are most sensitive to e-cig aerosol inhalation. We will also 
further conduct multivariate regression analysis on the within-subject changes controlling for other subject-spe-
cific covariates.   
 
To quantify the changes in the levels of inflammatory biomarkers in serum collected from study participants 
before and after e-cigarette aerosol exposure and compare these metrics with qMRI-derived biomarkers. 
 
Blood drawn from the antecubital vein by a phlebotomist from study participants in will be collected into tubes 
containing clot activator. Serum will be separated within 30 minutes by centrifugation and stored at −70°C prior 
to analysis. Inflammatory biomarkers will be detected via enzyme-linked immunosorbent assay (ELISA) tech-
niques from blood draws #1 and 2. MCP-1 and MIP-1 concentrations will be measured using commercially avail-
able ELISA kits (R&D Systems, Abingdon, UK); sICAM, sRAGE, IFN-g and TNF-α with RayBiotech kits 


(RayBiotech, Inc., Norcross, GA 30092); HMGB1 will be assayed by ELISA kits supplied by IBL International 
(IBL GmbH).   
Analyses 
Descriptive statistics will initially be performed to determine the characteristics of the various distributions and to 
identify outliers by displaying the data in the form of box and whisker plots and by computing means and standard 
deviations. Acute changes from baseline (blood draws pre- and post e-cig aerosol challenge) will be evaluated 
by paired t-tests for each of the variables listed above.  To compare the qMRI metrics with inflammatory indices, 
Spearman correlations will be performed.  We expect moderate inter-modality correlations (R2 ~ 0.5) for individ-
ual qMRI measures. We then use linear regression to create a classification model using the eight qMRI indices 
jointly. We expect R2 > 80%, substantially greater than each individual parameter alone, indicating that inhaled 
e-cig aerosol promotes systemic EDF. 
 

ICF_001.pdf: 
MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers 
NCT 03479203 
August 11, 2021 


E-CIG CONSENT SMOKERS
August 2, 2021 
 
1
UNIVERSITY OF PENNSYLVANIA 
RESEARCH SUBJECT 
COMBINED INFORMED CONSENT AND HIPPA AUTHORIZATION FORM 
Protocol Title: 
Acute and Long-Term Effects of E-Cigarette Aerosol Inhalation 
on Biomarkers of Endothelial Function and Vascular Reactivity 
Principal 
Investigator: 
Felix W. Wehrli, Ph.D. 
Department of Radiology 
University of Pennsylvania 
1 Founders Building 
3400 Spruce Street 
Philadelphia, PA 19104 
215-662-7951
Emergency Contact: Frank T. Leone, M.D., M.S. 
Office: (215) 662-8766  
Mobile: (215) 243-3265 
24-Hour Emergency Contact: 
Radiology Fellow on Call: 
215-662-6059
Research Study Summary 
You are being invited to participate in a research study. Your participation is voluntary. You should only 
participate if you completely understand what the study requires and what the risks of participation are. You 
should ask the study team any questions you have related to participating before agreeing to join the study. If 
you have any questions about your rights as a human research participant at any time before, during or after 
participation, please contact the Institutional Review Board (IRB) at 215-898-2614 for assistance. 
This research study is being conducted to test whether electronic cigarette aerosol has an effect on the 
endothelium, a layer of cells that act as a protective barrier and play an important part in controlling the flow of 
blood around the body. You are eligible for this study because you smoke electronic or conventional cigarettes, 
and you have no known health problems. 
If you agree to join the study, you will be asked to complete two magnetic resonance imaging (MRI) examinations. 
The second MRI examination will take place 12 months after the first MRI examination.  Your involvement in the 
study will end after both MRI examinations are complete.  
There is no direct benefit to you for participating in this study. 
The primary risk of participation is from the strong magnetic force emitted by the MRI magnet, which can disrupt 
or heat-up implanted medical devices or metallic foreign fragments in your body. The magnetic force can also 
cause metallic objects in the scanner room to become projectiles. There are many safety measures in place to 
reduce these risks. The alternative to participating in the study is to not participate. 
Please note that there are other factors to consider before agreeing to participate such as additional procedures, 
use of your personal information, possible costs, and other possible risks not discussed here. If you are interested 
in participating, a member of the study team will review the full information with you. You are free to decline or 
stop participation at any time during or after the initial consenting process. 
Why am I being asked to volunteer? 
You are being invited to participate in a research study because you are a conventional cigarette or electronic 
cigarette user between the ages of 18 and 45 years, with no symptomatic cardiovascular or pulmonary disorders, 
and a body mass index in the range 18.5 to 30. To participate, you must have smoked only conventional 
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 2
cigarettes or only electronic cigarettes for at least 6 months. Your participation is voluntary which means you can 
choose whether or not you want to participate. If you choose not to participate, there will be no loss of benefits 
to which you are otherwise entitled. Before you can make your decision, you will need to know what the study is 
about, the possible risks and benefits of being in the study, and what you will have to do in the study. The 
research team is going to talk to you about the research study, and they will give you this consent form to read. 
You may also decide to discuss it with your family, friends, or family doctor. You may find some of the medical 
language difficult to understand. Please ask the investigator and/or the research team about this form. If you 
decide to participate, you will be asked to sign this form. Your doctor may be an investigator in this research 
study. As an investigator, your doctor is interested both in your clinical welfare and in the conduct of this study. 
Before entering this study or at any time during the research, you may want to ask for a second opinion about 
your care from another doctor who is not an investigator in this study. You do not have to participate in any 
research study offered by your doctor. 
 
What is the purpose of this research study? 
The purpose of the study is to test whether electronic cigarette aerosol has an effect on the endothelium by 
comparing the effect that conventional cigarette smoke has on the endothelium. The endothelium is a layer of 
cells that acts like a protective barrier and plays an important part in controlling the flow of blood around the 
body. In this study we will test the effect conventional cigarette smoke or electronic cigarette aerosol has on the 
function of the endothelium using a blood pressure cuff and magnetic resonance imaging. Magnetic resonance 
imaging (MRI) is an exam that uses magnetic fields and radio waves to produce pictures of the inside of the 
body. We will be measuring changes in the endothelium by comparing magnetic resonance images at baseline 
and after 12 months. We will also take two blood samples to measure blood biomarkers. Biomarkers are 
biological indicators or molecules that can be measured to detect properties of health. In this study we will be 
measuring changes in blood biomarkers to detect inflammation by comparing a blood sample taken at baseline 
and taken again after 12 months. These tests will help us better understand the effects of electronic cigarette 
aerosol on the endothelium.  
 
How long will I be in the study?  
The study involves two visits to the Hospital of the University of Pennsylvania. The first visit, the baseline visit, 
will take about two hours. The second visit, the 12-month visit, will also take about two hours. Overall, you will 
participate in the study for 12 months. There will be a total of 45 conventional cigarette smokers and 45 electronic 
cigarette smokers participating in this portion of the study. You may be contacted after your completion in the 
study to collect more, necessary information for analysis. There will be a total of 129 people (smokers and non-
smokers) participating in the overall study. 
 
What am I being asked to do? 
The study involves two MRI exams and two blood samples. The first MRI exam and the first blood sample will 
be taken during your first visit. The second MRI exam and the second blood sample will be taken 12 months 
after your first visit.  
 
It is important that you do not do any vigorous physical activity or smoke any type of cigarette four hours before 
your study visit. You should not eat or drink anything except water for eight hours before your visit.  You should 
not take any medications the morning of your visit, but bring your morning medications with you.  
 
You will come to the Hospital of the University of Pennsylvania to meet with the research coordinator. You will 
read and sign this consent form after all of your questions and concerns have been addressed. You will complete 
a brief questionnaire about the MRI. Your weight, height, and blood pressure will be measured. A urine 
pregnancy test will be performed if you are female.   
 
You will go to the outpatient laboratory where a blood sample will be taken. You will then go to the MRI suite 
where you will change into a gown. You will lie on the MRI table and a standard FDA (Food and Drug 
Administration) approved device, called a radiofrequency coil, will be placed around your lower leg.  A blood 
pressure cuff will be placed on your upper thigh. Your whole body will go into the machine feet first. During the 
MRI exam the blood pressure cuff will be inflated to stop the circulation in your leg for five minutes. You will feel 
tightness or pressure around your thigh much like when a blood pressure cuff is inflated on your arm. This portion 
of the MRI exam will take about 20 minutes.  If you are too uncomfortable, you can stop the exam.  
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You will have a five-minute break while we set up the second part of the MRI exam. The second part of the exam 
will then take place, which will take about 15 minutes. You will be repositioned on the MRI table. Two 
radiofrequency coils, a head coil and a surface coil, will be used to examine blood flow in the major artery 
connected to your heart. Your head will rest inside the head coil and the surface coil will be placed on your chest. 
The head coil resembles a helmet and the surface coil resembles several flat plastic panels joined together. You 
will then complete only one of the two procedures below: 
 
1. A mask will be placed over your nose and mouth, which is connected to a piece of equipment called a 
RespirAct. The RespirAct delivers the air supply and measures the gases that you breathe in and out. 
You will be given a chance to practice breathing through the mask before you go into the machine. Your 
entire body, including your head, will go into the machine headfirst. After several short MRI scans lasting 
20 to 40 seconds, an exam lasting seven minutes will be performed. You will be breathing air through the 
mask that has a higher amount of carbon dioxide (hypercapnia). During this exam you will be asked to 
breathe normally. It will feel like you are inhaling from and exhaling into a large tube about three feet long. 
During the first minute you will breathe room air only. During the second minute you will breathe air with 
more carbon dioxide. During the third minute you will breathe room air only. During the fourth, fifth and 
sixth minute you will breathe air with different amounts of carbon dioxide. You will breathe room air only 
during the seventh and final minute. The MRI table will then move in further to scan your chest. This last 
exam will consist of several short scans lasting five to ten seconds. You will be breathing only room-air 
during this this last scan. 
 
OR 
 
2. After several short MRI scans lasting 20 to 40 seconds, an exam lasting seven minutes will be performed. 
You will be coached to hold your breath for 30 seconds followed by 90 seconds of normal breathing. This 
sequence of a 30 second breath-hold and 90 seconds of normal breathing will be repeated three times. 
You will breathe normally during the seventh and final minute. The MRI table will then move in further to 
scan your chest. This last exam will consist of several short scans lasting five to ten seconds. You will be 
breathing normally during this last scan. 
 
This will be the end of your first MRI exam. You will then be asked to return after 12 months to repeat the above 
process.  
 
You may be contacted after your 12 month visit in order to collect more information for data analysis.  
 
What are the possible risks or discomforts?  
MRI Exam: The known risks associated with MRI are minimal. Some individuals may feel claustrophobic 
(uncomfortable in small spaces) during an MRI or be disturbed by the loud and repetitive sounds of the machine. 
The study staff will provide you with protective earplugs and make every attempt to ensure your comfort with 
blankets and pillows during your time in the scanner. The magnet is always on. Metal objects on or inside your 
body could heat up, move and/or not function properly within the MRI scanning room. Implanted medical devices 
and metallic foreign fragments inside your body could pose a risk if you were to enter the MRI scanning room. 
Pacemakers, internal cardiac defibrillators, insulin pumps, and other medical devices could also prevent you 
from safely having an MRI. Therefore, questions about your medical and work history will be asked prior to your 
exam. The magnet is very strong. Another risk is that from a metallic object flying through the air toward the 
magnet and hitting you. There are many safety measures in place to reduce this risk, including screening of all 
persons and materials entering the MRI scanning room. You will be asked to change into a standard hospital 
gown to further minimize this risk. The door to the room will be closed when the study starts to minimize the risk 
of someone accidentally walking into or bringing an object into the magnet room. Some of the pulse sequences 
(a series of radio wave signals) and/or radio frequency coils (device used to receive the radio wave signals) are 
not FDA approved but are considered to pose no more than minimal risk.  
It is possible that during the course of the research study the research staff may notice an unexpected finding. 
The appropriate personnel will consider the finding if this occurs and the principal investigator will inform you if 
necessary. Any possible findings may or may not be significant but may lead to anxiety about your condition and 
to further work-up by your physician.  
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Reproductive Risks: If you are pregnant, you should not take part in this study. Although there are no known 
risks of MRI on pregnant women or a fetus, there is a possibility of yet undiscovered pregnancy related risks. 
Since there is no direct benefit from participating in this protocol for a pregnant woman, we will exclude pregnant 
women. A negative urine pregnancy test will be required before a woman of childbearing potential can participate 
in this study. 
 
Blood Draw: There are minor risks that are associated with drawing blood, which include pain, a bruise at the 
point where the blood is taken, redness, swelling of the vein, infection, and a rare risk of fainting. 
 
Blood Pressure Cuff: There is a risk of discomfort during the blood pressure cuff inflation. You may feel an 
uncomfortable tingling or prickling similar to when a part of your body “falls asleep”.  
 
Hypercapnia: The symptoms of mild hypercapnia are generally mild or undetectable, but can include: flushed 
skin, faster heart rate, increased blood pressure, muscle twitches, hand flaps, exhaustion, anxiety, headache, 
and confusion. If this happens at any time, the emergency stop button on the RespirAct will be used. Mild to 
moderate hypercapnia induced by a gas mixture through a breathing mask is often used in scientific research to 
study the blood flow in the brain.  
 
Privacy and/or Confidentiality: Every effort will be made to protect your privacy and confidential information. 
However, this cannot be guaranteed.  
 
Unforeseen Risks: The long-term risks of electronic cigarette use are unknown at this time.  
 
Reproductive Risks: If you are pregnant, you should not take part in this study. Although there are no known 
risks of MRI on pregnant women or a fetus, there is a possibility of yet undiscovered pregnancy related risks. 
Since there is no direct benefit from participating in this protocol for a pregnant woman, we will exclude pregnant 
women. A negative urine pregnancy test will be required before a woman of childbearing potential can participate 
in this study. 
 
What if new information becomes available about the study? 
During the course of this study, we may find more information that could be important to you.  This includes 
information that, once learned, might cause you to change your mind about being in the study. We will notify you 
as soon as possible if such information becomes available. 
 
What are the possible benefits of the study?  
While there is no direct benefit to the individual subjects, this study has the potential to affect society as a whole.  
 
What other choices do I have if I do not participate?  
The alternative is not to participate in the study. 
 
Will I be paid for being in this study? 
You will be compensated for your time and travel after the study with $100 for each MRI test completed. If you 
complete one MRI scan you will receive $100. If you complete both MRI scans you will receive a total of $200. 
You will receive this money as a ClinCard, by Greenfield. The ClinCard will have the specified, loaded amount 
that you are owed at the time of the visit. For the baseline visit, the card will have $100. For the 12-month visit, 
the card will be re-loaded another $100. This is a total of $200 for both the MRI scans and completion of the 
study. It is important that you do not lose the University of Pennsylvania debit card (your ClinCard). Costs for 
replacing lost or stolen University of Pennsylvania debit cards will be your responsibility. The cost to replace the 
debit card is $3.00 and that amount will be deducted from your study visit payment.  To be compensated for your 
participation in this study, you must provide your social security number. The University of Pennsylvania is 
required to report to the IRS any cumulative payments for participation in research studies that exceed a total of 
$600 in a calendar year. 
 
Will I have to pay for anything? 
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All of the tests or procedures performed during this study will be free of charge to you and will not be billed to 
your insurance company. You are responsible for any deductibles or applicable co-pays for routine office visits, 
scans and blood work that are not related to this research study. 
 
What happens if I am injured from being in the study?  
We will offer you the care needed to treat injuries directly resulting from taking part in this research.  We may bill 
your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but 
you may also be responsible for some of them. 
 
There are no plans for the University of Pennsylvania to pay you or give you other compensation for the injury.  
You do not give up your legal rights by signing this form.   
 
If you think you have been injured as a result of taking part in this research study, tell the person in charge of the 
research study as soon as possible.  The researcher’s name and phone number are listed in the consent form. 
 
When is the study over?  Can I leave the study before it ends? 
This study is expected to end after all participants have completed all visits, and all information has been 
collected.  This study may also be stopped at any time by your physician, the study Sponsor, or the FDA without 
your consent because: 
 
• 
The principal investigator feels it is necessary for your health or safety.  Such an action would not require 
your consent, but you will be informed if such a decision is made and the reason for this decision. 
• 
You have not followed study instructions.  
• 
The sponsor, the study principal investigator, or the FDA has decided to stop the study. 
 
If you decide to participate, you are free to leave the study at any time.  Withdrawal will not interfere with your 
future care.   
 
How will my personal information be protected during the study? 
We will do our best to make sure that the personal information obtained during the course of this research study 
will be kept private.  However, we cannot guarantee total privacy.  Your personal information may be given out 
if required by law. If information from this study is published or presented at scientific meetings, your name and 
other personal information will not be used. The Institutional Review Board (IRB) at the University of 
Pennsylvania will have access to your records. If this study is being overseen by the Food and Drug 
Administration (FDA), they may review your research records. Your study results will be filed using a unique 
subject identification number rather than your name. This identification number will be destroyed after all data 
from the study has been collected and analyzed. Research records and information from your examinations will 
be kept on a secure computer available only to the study investigators, and if necessary, for your medical 
management. You will have access to this information if you desire. Any paper files containing your information 
will be stored in a locked cabinet in the study coordinator's office during the study. Data from this study will be 
kept for at least six years per regulations set by the Department of Health and Human Services. Paper files from 
the study may be archived at the University of Pennsylvania Archives and Records Center following completion 
of the study.  
 
Will information about this study be available to the public?   
Information about the study will not be available to the public. 
 
What may happen to my information and samples collected in this study? 
Your information will be de-identified. This means that all identifiers have been removed. The information could 
be stored and shared for future research in this de-identified fashion. It would not be possible for future 
researchers to identify you as we would not share any identifiable information about you with future researchers. 
This can be done without again seeking your consent in the future, as permitted by law. The future use of your 
information only applies to the information collected on this study. 
 
Collection of Identifiable Specimens   
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Your samples may be used to create products, including some that may be sold and/or make money for others. 
If this happens, there are no plans to tell you, or to pay you, or to give any compensation to you or your family.  
 
Whole genome sequencing will not be conducted on your samples. Whole genome sequencing involves 
analyzing your entire personal genetic code. 
 
Future Use of Data and/or Specimens 
Specimens will not be stored or distributed for future research studies. Data from your imaging exam and blood 
serum analysis will be de-identified. De-identified means that all identifiers have been removed. This data could 
be stored and shared for future research in this de-identified fashion. It would not be possible for future 
researchers to identify you as we would not share any identifiable information about you with future researchers. 
This can be done without again seeking your consent in the future, as permitted by law. The future use of your 
information only applies to the information collected on this study. 
 
Electronic Medical Record and Release of Study Related Information  
 
What is an Electronic Medical Record?  
An Electronic Medical Record (EMR) is an electronic version of your medical chart within a health system. An 
EMR is simply a computerized version of a paper medical record.  
 
If you have never received care within Penn Medicine and are participating in a University of Pennsylvania 
research study that uses Penn Medicine healthcare related services, an EMR will be created for you for the 
purpose of maintaining any information produced from your participation. The creation of this EMR is a 
requirement of your participation in this study. In order to create your EMR, the study team will need to obtain 
basic information about you that would be similar to the information you would provide the first time you visit a 
hospital or medical facility. If you have been a patient at Penn Medicine in the past, information from your 
research participation will be added to your existing medical record.  
 
What may be placed in the EMR?  
Information related to your participation in the research (e.g., laboratory tests, imaging studies) will be placed in 
your EMR maintained by Penn Medicine.  
 
Once placed in your EMR your information may be accessible to appropriate Penn Medicine workforce members 
that are not part of the research team.  Information within your EMR may also be shared with others who are 
determined by Penn Medicine to be appropriate to have access to your EMR (e.g. health insurance company, 
disability provider, etc.).  
 
Penn Medicine also participates in automated information sharing through Health Information Exchanges (HIEs). 
HIEs securely share parts of your electronic health record, including research information, with other healthcare 
organizations involved in your care. This information is shared to improve the quality, safety, and efficiency of 
your healthcare. To request that your health information not be shared through HIEs, please call 215-662-4484.  
 
Will I, as a subject, have access to research related information within the EMR?  
The 21st Century Cures Act requires healthcare institutions to allow patients increased access to their electronic 
medical record. As part of your participation in this research, you will have access to research related information 
within your EMR through Penn Medicine’s patient portal – called MyPennMedicine (MPM).  
 
Will I receive the results of research testing that may be relevant to my health? 
Many of tests done in research studies are only for research and have no clear impact on your healthcare. 
Research results for this study will not be returned to you because they would not be relevant to your healthcare 
 
What information about me may be collected, used or shared with others?   
The following personal health information will be collected and may be disclosed for this research study:  
 
• 
Name, address, telephone number, email  
• 
Birthdate, medical record number, medical history, current and past medications or therapies  
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• 
MRI images 
• 
Social security number is required for payment only and is stored in a separate file  
 
Why is my information being used? 
Your information is used by the research team to contact you during the study. Your information and results of 
tests and procedures are used to: 
 
• 
do the research 
• 
oversee the research 
• 
to see if the research was done right 
• 
to evaluate and manage research functions   
 
Where may my information be stored?  
Information related to your participation in clinical research will be contained in a clinical trial management system 
(CTMS). A clinical trial management system (CTMS) is used to register your information as a participant in a 
study. This allows for your research data to be entered and stored for the purposes of study operational and 
financial applications and other activities required as part of the conduct of the research. Once placed in the 
CTMS your information may be accessible to other authorized personnel at Penn Medicine that support research 
operations. Your information may be held in other research databases.   
 
Who may use and share information about me?   
The following individuals may use or share your information for this research study: 
 
• 
The investigator for the study and the study team  
• 
Other authorized personnel at Penn Medicine and the University of Pennsylvania, including offices that 
support research operations 
• 
Other research personnel with access to the databases for research and/or study coordination and as 
otherwise approved by the IRB 
 
Who, outside of Penn Medicine, might receive my information?  
The following oversight organizations might receive your information: 
 
• 
The Food and Drug Administration 
• 
The National Institutes of Health 
• 
The Office of Human Research Protections 
 
Once your personal health information is disclosed to others outside the School of Medicine, it may no longer be 
covered by federal privacy protection regulations.   
 
The principal investigator or study staff will inform you if there are any additions to the list above during your 
active participation in the trial. Any additions will be subject to University of Pennsylvania procedures developed 
to protect your privacy. 
 
How long may Penn Medicine use or disclose my personal health information?   
Your authorization for use of your personal health information for this specific study does not expire.  
 
However, Penn Medicine may not re-use or re-disclose information collected in this study for a purpose other 
than this study unless: 
 
• 
You have given written authorization  
• 
The University of Pennsylvania’s Institutional Review Board grants permission 
• 
As permitted by law  
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Can I change my mind about giving permission for use of my information? 
Yes. You may withdraw or take away your permission to use and disclose your health information at any time.  
You do this by sending written notice to the investigator for the study.  If you withdraw your permission, you will 
not be able to stay in this study. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
You will be given a copy of this Research Subject HIPAA Authorization describing your confidentiality and privacy 
rights for this study.  
 
By signing this document, you are permitting Penn Medicine to use and disclose personal health information 
collected about you for research purposes as described above. 
 
Who can I call with questions, complaints or if I’m concerned about my rights as a research subject? 
If you have questions, concerns, or complaints regarding your participation in this research study or if you have 
any questions about your rights as a research subject, you should speak with the principal investigator listed on 
page one of this form.  If a member of the research team cannot be reached or you want to talk to someone 
other than those working on the study, you may contact the IRB at the number on page one of this form. 
 
 
When you sign this form, you are agreeing to take part in this research study. This means that you have 
read the consent form, your questions have been answered, and you have decided to volunteer.  Your 
signature also means that you are permitting the University of Pennsylvania to use your personal health 
information collected about you for research purposes within our institution. You are also allowing the 
University of Pennsylvania to disclose that personal health information to outside organizations or people 
involved with the operations of this study. 
 
 
A copy of this consent form will be given to you.  
 
 
________________________ 
        
 
 
____________________________________ 
Name of Subject (Print)  
 
 
 
 
Signature 
 
             
Date 
 
 
 
 
________________________ 
 
 
 
_____________________________________ 
Name of Person Obtaining  
 
 
 
Signature                                  
Date 
Consent (Print)  
 
 
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 1 
 
UNIVERSITY OF PENNSYLVANIA 
RESEARCH SUBJECT 
COMBINED INFORMED CONSENT AND HIPPA AUTHORIZATION FORM 
 
Protocol Title:  
Acute and Long-term Effects of E-cigarette Aerosol Inhalation on 
Biomarkers of Endothelial Function and Vascular Reactivity 
Principal 
Investigator: 
Felix W. Wehrli, Ph.D. 
Department of Radiology 
University of Pennsylvania 
1 Founders Building 
3400 Spruce Street 
Philadelphia, PA 19104 
215-662-7951 
Emergency Contact: Frank T. Leone, M.D., M.S. 
Office: (215) 662-8766   
Mobile: (215) 243-3265  
 
24-Hour Emergency Contact:  
Radiology Fellow on Call: 
215-662-6059 
 
 
Research Study Summary  
You are being invited to participate in a research study. Your participation is voluntary. You should only 
participate if you completely understand what the study requires and what the risks of participation are. You 
should ask the study team any questions you have related to participating before agreeing to join the study. If 
you have any questions about your rights as a human research participant at any time before, during or after 
participation, please contact the Institutional Review Board (IRB) at 215-898-2614 for assistance. 
 
This research study is being conducted to test whether electronic cigarette aerosol has an effect on the 
endothelium, a layer of cells that act as a protective barrier and play an important part in controlling the flow of 
blood around the body. You are eligible for this study because you are a non-smoking healthy individual with no 
known health problems. 
 
If you agree to join the study, you will be asked to complete two magnetic resonance imaging examinations. Your 
participation will last four hours, including a waiting period of two hours between MRI examinations.   Your 
involvement in the study will end after the magnetic resonance examinations are completed.  
 
There is no direct benefit to you for participating in this study.  
 
The primary risk of participation is from the strong magnetic force emitted by the MRI magnet, which can disrupt 
or heat-up implanted medical devices or metallic foreign fragments in your body. The magnetic force can also 
cause metallic objects in the scanner room to become projectiles. There are many safety measures in place to 
reduce these risks. The alternative to participating in the study is to not participate. 
 
Please note that there are other factors to consider before agreeing to participate such as additional procedures, 
use of your personal information, possible costs, and other possible risks not discussed here. If you are interested 
in participating, a member of the study team will review the full information with you. You are free to decline or 
stop participation at any time during or after the initial consenting process. 
 
Why am I being asked to volunteer? 
You are being invited to participate in a research study because you are a non-smoking individual between the 
ages of 18 and 45 years, with no history of cardiovascular disease and a body mass index in the range of 18.5 
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 2 
to 30. Your participation is voluntary which means you can choose whether or not you want to participate. If you 
choose not to participate, there will be no loss of benefits to which you are otherwise entitled. Before you can 
make your decision, you will need to know what the study is about, the possible risks and benefits of being in 
the study, and what you will have to do in the study. The research team is going to talk to you about the research 
study, and they will give you this consent form to read. You may also decide to discuss it with your family, friends, 
or family doctor. You may find some of the medical language difficult to understand. Please ask the investigator 
and/or the research team about this form. If you decide to participate, you will be asked to sign this form. Your 
doctor may be an investigator in this research study. As an investigator, your doctor is interested both in your 
clinical welfare and in the conduct of this study. Before entering this study or at any time during the research, 
you may want to ask for a second opinion about your care from another doctor who is not an investigator in this 
study. You do not have to participate in any research study offered by your doctor. 
 
What is the purpose of this research study? 
The purpose of the study is to test whether electronic cigarette aerosol has an effect on the endothelium. The 
endothelium is a layer of cells that acts like a protective barrier and plays an important part in controlling the flow 
of blood around the body. In this study we will test the effect electronic cigarette aerosol has on the function of 
the endothelium using a blood pressure cuff and magnetic resonance imaging. Magnetic resonance imaging 
(MRI) is an exam that uses magnetic fields and radio waves to produce pictures of the inside of the body. We 
will also take two blood samples to measure blood biomarkers. Biomarkers are biological indicators or molecules 
that can be measured to detect properties of health. In this study we will be measuring changes in blood 
biomarkers to detect inflammation by comparing blood samples before and after an electronic cigarette 
challenge. These tests will help us better understand the effects of electronic cigarette aerosol on healthy, non-
smoking individuals.  
 
How long will I be in the study?  
This study involves one visit to the Hospital of the University of Pennsylvania. You will be in the study for 
approximately three hours. There will be a total of 39 non-smokers participating in this portion of study. There 
will be a total of 129 people (smokers and non-smokers) participating in the overall study.  
 
What am I being asked to do? 
The study involves two blood samples, smoking a non-nicotine electronic cigarette and two MRI exams. The first 
blood sample will be taken when you arrive and the second sample will be taken between 1-2 hours after smoking 
the electronic cigarette. The MRI exams will be taken before and after smoking the electronic cigarette. 
 
It is important that you do not do any vigorous physical activity four hours before your study visit. It is also 
important that you eat a light meal prior to your study visit.  
 
You will come to the Hospital of the University of Pennsylvania to meet with the research coordinator. You will 
read and sign this consent form after all your questions and concerns have been addressed.  You will complete 
a brief questionnaire about the MRI. Your weight, height, and blood pressure will be measured. A urine 
pregnancy test will be performed if you are female.   
 
You will go to the outpatient laboratory where a blood sample will be taken. You will then go to the MRI suite 
where you will change into a gown. You will lie on the MRI table and a standard FDA (Food and Drug 
Administration) approved device, called a radiofrequency coil, will be placed around your lower leg.  A blood 
pressure cuff will be placed on your upper thigh. Your whole body will go into the machine feet first. During the 
MRI exam the blood pressure cuff will be inflated to stop the circulation in your leg for five minutes. You will feel 
tightness or pressure around your thigh much like when a blood pressure cuff is inflated on your arm. This portion 
of the MRI exam will take about 20 minutes.  If you are too uncomfortable, you can stop the exam.  
 
You will have a five-minute break while we set up the second part of the MRI exam. The second part of the exam 
will then take place, which will take about 15 minutes. You will be repositioned on the MRI table. Two 
radiofrequency coils, a head coil and a surface coil, will be used to examine blood flow in the major artery 
connected to your heart. Your head will rest inside the head coil and the surface coil will be placed on your chest. 
The head coil resembles a helmet and the surface coil resembles several flat plastic panels joined together. You 
will then complete only one of the two procedures below: 
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 3 
 
1. A mask will be placed over your nose and mouth, which is connected to a piece of equipment called a 
RespirAct. The RespirAct delivers the air supply and measures the gases that you breathe in and out. 
You will be given a chance to practice breathing through the mask before you go into the machine. Your 
entire body, including your head, will go into the machine headfirst. After several short MRI scans lasting 
20 to 40 seconds, an exam lasting seven minutes will be performed. You will be breathing air through the 
mask that has a higher amount of carbon dioxide (hypercapnia). During this exam you will be asked to 
breathe normally. It will feel like you are inhaling from and exhaling into a large tube about three feet long. 
During the first minute you will breathe room air only. During the second minute you will breathe air with 
more carbon dioxide. During the third minute you will breathe room air only. During the fourth, fifth and 
sixth minute you will breathe air with different amounts of carbon dioxide. You will breathe room air only 
during the seventh and final minute. The MRI table will then move in further to scan your chest. This last 
exam will consist of several short scans lasting five to ten seconds. You will be breathing only room air 
during this this last scan. 
 
OR 
 
2. After several short MRI scans lasting 20 to 40 seconds, an exam lasting seven minutes will be performed. 
You will be coached to hold your breath for 30 seconds followed by 90 seconds of normal breathing. This 
sequence of a 30 second breath-hold and 90 seconds of normal breathing will be repeated three times. 
You will breathe normally during the seventh and final minute. The MRI table will then move in further to 
scan your chest. This last exam will consist of several short scans lasting five to ten seconds. You will be 
breathing normally during this last scan. 
 
You will then be taken out of the scanner to do the electronic cigarette challenge. Prior to the electronic cigarette 
challenge you will be shown a brief instructional video. You will be asked to take 16 puffs of an electronic cigarette 
that does not contain nicotine. Each puff will consist of a drag lasting two seconds, inhalation and exhalation of 
the electronic cigarette aerosol. After the electronic cigarette challenge you will have a second MRI exam. The 
second exam will be exactly the same as the first exam. That means there will be a coil placed around your lower 
leg and a blood pressure cuff placed around your upper thigh (where circulation will be cut off for five minutes 
and then released). You will have another five minute break and then be repositioned on the MRI table to perform 
the gas-breathing sequence OR the breath-hold sequence just as before. The MRI table will then move you 
inside the scanner again so we may scan your chest.  
 
About two hours after you have completed the electronic cigarette challenge, a second blood sample will then 
be taken in the outpatient laboratory. This will complete the study.   
 
You may have some free time after the second MRI test and your second visit to the outpatient laboratory for a 
blood sample. During this time please do not engage in any vigorous activity. Please also try to eat another light 
meal.  
 
It is possible that you may be asked to return for a repeat exam if the results from the MRI scans are not 
adequate. 
 
What are the possible risks or discomforts?  
Taking part in a research study involves risks or side effects. There may be side effects we do not know about 
yet. You should talk about these risks with the study staff.  
 
MRI Exam: The known risks associated with MRI are minimal. Some individuals may feel claustrophobic 
(uncomfortable in small spaces) during an MRI or be disturbed by the loud and repetitive sounds of the machine. 
The study staff will provide you with protective earplugs and make every attempt to ensure your comfort with 
blankets and pillows during your time in the scanner. The magnet is always on. Metal objects on or inside your 
body could heat up, move and/or not function properly within the MRI scanning room. Implanted medical devices 
and metallic foreign fragments inside your body could pose a risk if you were to enter the MRI scanning room. 
Pacemakers, internal cardiac defibrillators, insulin pumps, and other medical devices could also prevent you from 
safely having an MRI. Therefore, questions about your medical and work  
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 4 
history will be asked prior to your exam. The magnet is very strong. Another risk is that from a metallic object 
flying through the air toward the magnet and hitting you. There are many safety measures in place to reduce this 
risk, including screening of all persons and materials entering the MRI scanning room. You will be asked to change 
into a standard hospital gown to further minimize this risk. The door to the room will be closed when the study 
starts to minimize the risk of someone accidentally walking into or bringing an object into the magnet room. Some 
of the pulse sequences (a series of radio wave signals) and/or radio frequency coils (device used to receive the 
radio wave signals) are not FDA approved but are considered to pose no more than minimal risk.  
 
It is possible that during the course of the research study the research staff may notice an unexpected finding. 
The appropriate personnel will consider the finding if this occurs and the principal investigator will inform you if 
necessary. Any possible findings may or may not be significant but may lead to anxiety about your condition and 
to further work-up by your physician.  
 
Reproductive Risks: If you are pregnant, you should not take part in this study. Although there are no known risks 
of MRI on pregnant women or a fetus, there is a possibility of yet undiscovered pregnancy related risks. Since 
there is no direct benefit from participating in this protocol for a pregnant woman, we will exclude pregnant women. 
A negative urine pregnancy test will be required before a woman of childbearing potential can participate in this 
study. 
 
Blood Draw: There are minor risks that are associated with drawing blood, which include pain, a bruise at the 
point where the blood is taken, redness, swelling of the vein, infection, and a rare risk of fainting. 
 
Blood Pressure Cuff: There is a risk of discomfort during the blood pressure cuff inflation. You may feel an 
uncomfortable tingling or prickling similar to when a part of your body “falls asleep”.  
 
Aerosol Inhalation: There are also some minimal risks associated with aerosol inhalation. These risks include dry 
mouth, cough, sore throat, eye irritation, taste differences, dizziness and an increase in heart rate heart rate.  
 
Hypercapnia: The symptoms of mild hypercapnia are generally mild or undetectable, but can include: flushed 
skin, faster heart rate, increased blood pressure, muscle twitches, hand flaps, exhaustion, anxiety, headache, 
and confusion. If this happens at any time, the emergency stop button on the RespirAct will be used. Mild to 
moderate hypercapnia induced by a gas mixture through a breathing mask is often used in scientific research to 
study the blood flow in the brain. 
 
Privacy and/or Confidentiality: Every effort will be made to protect your privacy and confidential information. 
However, this cannot be guaranteed.  
 
Unforeseen Risks: The long-term risks of electronic cigarette use are unknown at this time.  
 
What if new information becomes available about the study? 
During the course of this study, we may find more information that could be important to you.  This includes 
information that, once learned, might cause you to change your mind about being in the study. We will notify you 
as soon as possible if such information becomes available. 
 
What are the possible benefits of the study?  
While there is no direct benefit to an individual participant, this study has the potential to affect society as a whole.  
 
What other choices do I have if I do not participate?  
The alternative is not to participate in the study. 
 
Will I be paid for being in this study? 
You will be compensated for your time and travel after you have completed the entire study with $200, via ClinCard 
by Greenfield. It is important that you do not lose the University of Pennsylvania debit card (your ClinCard). Costs 
for replacing lost or stolen University of Pennsylvania debit cards will be your responsibility. The cost to replace 
the debit card is $3.00 and that amount will be deducted from your study visit payment. To be compensated for 
your participation in this study, you must provide your social security number. The University of Pennsylvania is 
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 5 
required to report to the IRS any cumulative payments for participation in research studies that exceed a total of 
$600 in a calendar year. 
 
Will I have to pay for anything? 
All of the tests or procedures performed during this study will be free of charge to you and will not be billed to your 
insurance company. You are responsible for any deductibles or applicable co-pays for routine office visits, scans 
and blood work that are not related to this research study. 
 
What happens if I am injured from being in the study?  
We will offer you the care needed to treat injuries directly resulting from taking part in this research. We may bill 
your insurance company or other third parties, if appropriate, for the costs of the care you get for the injury, but 
you may also be responsible for some of them. 
 
There are no plans for the University of Pennsylvania to pay you or give you other compensation for the injury.  
You do not give up your legal rights by signing this form.  
  
If you think you have been injured as a result of taking part in this research study, tell the person in charge of the 
research study as soon as possible.  The researcher’s name and phone number are listed in the consent form. 
 
When is the study over?  Can I leave the study before it ends? 
This study is expected to end after all participants have completed all visits, and all information has been collected.  
This study may also be stopped at any time by your physician, the study sponsor, or the FDA without your consent 
because: 
 
• 
The principal investigator feels it is necessary for your health or safety.  Such an action would not require 
your consent, but you will be informed if such a decision is made and the reason for this decision. 
• 
You have not followed study instructions.  
• 
The sponsor, the study principal investigator, or the Food and Drug Administration has decided to stop 
the study. 
 
If you decide to participate, you are free to leave the study at any time.  Withdrawal will not interfere with your 
future care.   
 
How will my personal information be protected during the study? 
We will do our best to make sure that the personal information obtained during the course of this research study 
will be kept private.  However, we cannot guarantee total privacy.  Your personal information may be given out if 
required by law. If information from this study is published or presented at scientific meetings, your name and 
other personal information will not be used. The Institutional Review Board (IRB) at the University of Pennsylvania 
will have access to your records. If this study is being overseen by the Food and Drug Administration (FDA), they 
may review your research records. Your study results will be filed using a unique subject identification number 
rather than your name. This identification number will be destroyed after all data from the study has been collected 
and analyzed. Research records and information from your examinations will be kept on a secure computer 
available only to the study investigators, and if necessary, for your medical management. You will have access 
to this information if you desire. Any paper files containing your information will be stored in a locked cabinet in 
the study coordinator's office during the study. Data from this study will be kept for at least six years per regulations 
set by the Department of Health and Human Services. Paper files from the study may be archived at the University 
of Pennsylvania Archives and Records Center following completion of the study.  
 
Will information about this study be available to the public?   
A description of this clinical trial will be available on wwww.clinicaltrials.gov, as required by U.S. law. This website 
will not include information that can identify you.  
 
What may happen to my information and samples collected in this study? 
Your information will be de-identified. This means that all identifiers have been removed. The information could 
be stored and shared for future research in this de-identified fashion. It would not be possible for future 
researchers to identify you as we would not share any identifiable information about you with future researchers. 
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 6 
This can be done without again seeking your consent in the future, as permitted by law. The future use of your 
information only applies to the information collected on this study. 
 
Collection of Identifiable Specimens   
Your samples may be used to create products, including some that may be sold and/or make money for others. 
If this happens, there are no plans to tell you, or to pay you, or to give any compensation to you or your family.  
 
Whole genome sequencing will not be conducted on your samples. Whole genome sequencing involves analyzing 
your entire personal genetic code. 
 
Future Use of Data and/or Specimens 
Specimens will not be stored or distributed for future research studies. Data from your imaging exam and blood 
serum analysis will be de-identified. De-identified means that all identifiers have been removed. This data could 
be stored and shared for future research in this de-identified fashion. It would not be possible for future 
researchers to identify you as we would not share any identifiable information about you with future researchers. 
This can be done without again seeking your consent in the future, as permitted by law. The future use of your 
information only applies to the information collected on this study. 
 
Electronic Medical Record and Release of Study Related Information  
 
What is an Electronic Medical Record?  
An Electronic Medical Record (EMR) is an electronic version of your medical chart within a health system. An 
EMR is simply a computerized version of a paper medical record.  
 
If you have never received care within Penn Medicine and are participating in a University of Pennsylvania 
research study that uses Penn Medicine healthcare related services, an EMR will be created for you for the 
purpose of maintaining any information produced from your participation. The creation of this EMR is a 
requirement of your participation in this study. In order to create your EMR, the study team will need to obtain 
basic information about you that would be similar to the information you would provide the first time you visit a 
hospital or medical facility. If you have been a patient at Penn Medicine in the past, information from your research 
participation will be added to your existing medical record.  
 
What may be placed in the EMR?  
Information related to your participation in the research (e.g., laboratory tests, imaging studies) will be placed in 
your EMR maintained by Penn Medicine.  
 
Once placed in your EMR your information may be accessible to appropriate Penn Medicine workforce members 
that are not part of the research team.  Information within your EMR may also be shared with others who are 
determined by Penn Medicine to be appropriate to have access to your EMR (e.g. health insurance company, 
disability provider, etc.).  
 
Penn Medicine also participates in automated information sharing through Health Information Exchanges (HIEs). 
HIEs securely share parts of your electronic health record, including research information, with other healthcare 
organizations involved in your care. This information is shared to improve the quality, safety, and efficiency of 
your healthcare. To request that your health information not be shared through HIEs, please call 215-662-4484.  
 
Will I, as a subject, have access to research related information within the EMR?  
The 21st Century Cures Act requires healthcare institutions to allow patients increased access to their electronic 
medical record. As part of your participation in this research, you will have access to research related information 
within your EMR through Penn Medicine’s patient portal – called MyPennMedicine (MPM).  
 
Will I receive the results of research testing that may be relevant to my health? 
Many of tests done in research studies are only for research and have no clear impact on your healthcare. 
Research results for this study will not be returned to you because they would not be relevant to your healthcare. 
 
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What information about me may be collected, used or shared with others?   
The following personal health information will be collected and may be disclosed for this research study:  
 
• 
Name, address, telephone number, email  
• 
Birthdate, medical record number, medical history, current and past medications or therapies  
• 
MRI images 
• 
Social security number is required for payment only and is stored in a separate file  
 
Why is my information being used? 
Your information is used by the research team to contact you during the study. Your information and results of 
tests and procedures are used to: 
 
• 
do the research 
• 
oversee the research 
• 
to see if the research was done right 
• 
to evaluate and manage research functions.   
 
Where may my information be stored?  
Information related to your participation in clinical research will be contained in a clinical trial management system 
(CTMS). A clinical trial management system (CTMS) is used to register your information as a participant in a 
study. This allows for your research data to be entered and stored for the purposes of study operational and 
financial applications and other activities required as part of the conduct of the research. Once placed in the 
CTMS your information may be accessible to other authorized personnel at Penn Medicine that support research 
operations. Your information may be held in other research databases.   
 
Who may use and share information about me?   
The following individuals may use or share your information for this research study: 
 
• 
The investigator for the study and the study team  
• 
Other authorized personnel at Penn Medicine and the University of Pennsylvania, including offices that 
support research operations 
• 
Other research personnel with access to the databases for research and/or study coordination and as 
otherwise approved by the IRB 
 
Who, outside of Penn Medicine, might receive my information?  
The following oversight organizations might receive your information: 
 
• 
The Food and Drug Administration 
• 
The National Institutes of Health 
• 
The Office of Human Research Protections 
 
Once your personal health information is disclosed to others outside the School of Medicine, it may no longer be 
covered by federal privacy protection regulations.   
 
The principal investigator or study staff will inform you if there are any additions to the list above during your active 
participation in the trial. Any additions will be subject to University of Pennsylvania procedures developed to 
protect your privacy. 
 
How long may Penn Medicine use or disclose my personal health information?   
Your authorization for use of your personal health information for this specific study does not expire.  
 
However, Penn Medicine may not re-use or re-disclose information collected in this study for a purpose other 
than this study unless: 
 
• 
You have given written authorization  
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 8 
• 
The University of Pennsylvania’s Institutional Review Board grants permission 
• 
As permitted by law  
 
Can I change my mind about giving permission for use of my information? 
Yes. You may withdraw or take away your permission to use and disclose your health information at any time.  
You do this by sending written notice to the investigator for the study.  If you withdraw your permission, you will 
not be able to stay in this study. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
You will be given a copy of this Research Subject HIPAA Authorization describing your confidentiality and privacy 
rights for this study.  
 
By signing this document, you are permitting Penn Medicine to use and disclose personal health information 
collected about you for research purposes as described above. 
 
Who can I call with questions, complaints or if I’m concerned about my rights as a research subject? 
If you have questions, concerns, or complaints regarding your participation in this research study or if you have 
any questions about your rights as a research subject, you should speak with the principal investigator listed on 
page one of this form.  If a member of the research team cannot be reached or you want to talk to someone other 
than those working on the study, you may contact the IRB at the number on page one of this form. 
 
 
When you sign this form, you are agreeing to take part in this research study. This means that you have read 
the consent form, your questions have been answered, and you have decided to volunteer.  Your signature also 
means that you are permitting the University of Pennsylvania to use the personal health information collected 
about you for research purposes within our Institution. You are also allowing the University of Pennsylvania to 
disclose that personal health information to outside organizations or people involved with the operations of this 
study. 
 
A copy of this consent form will be given to you.  
 
 
________________________         
 
 
____________________________________ 
Name of Subject (Print)  
 
 
 
 
Signature 
 
             
Date 
 
 
 
 
________________________ 
 
 
 
_____________________________________ 
Name of Person Obtaining  
 
 
 
Signature                                  
Date 
Consent (Print)  
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