University of North Carolina at Chapel Hill
Consent to Participate in a Research Study
Consent Form Version Date: September 18, 2015
IRB Study # 13-3454
Title of Study: TCORS human sample acquisition protocol
Principal Investigator: Ilona Jaspers
Principal Investigator Department: Pediatrics
Principal Investigator Phone number: (919) 966-8657
Principal Investigator Email Address: ilona_jaspers@med.unc.edu
Co-Investigators: Robert Tarran, Ph.D; Neil Alexis, Ph.D; Raymond Coakley, MD; Terry
Noah, MD; Mehmet Kesimer, Ph.D; Charles Esther, MD, Ph.D
Funding Source and/or Sponsor: National Institutes of Health (NIH)
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What are some general things you should know about research studies?
You are being asked to take part in a research study. To join the study is voluntary.
You may refuse to join, or you may withdraw your consent to be in the study, for any reason,
without penalty.
Research studies are designed to obtain new knowledge. This new information may help people
in the future. You may not receive any direct benefit from being in the research study. There
also may be risks to being in research studies. Deciding not to be in the study or leaving the
study before it is done will not affect your relationship with the researcher, your health care
provider, or the University of North Carolina-Chapel Hill. If you are a patient with an illness,
you do not have to be in the research study in order to receive health care.
Details about this study are discussed below. It is important that you understand this information
so that you can make an informed choice about being in this research study.
You will be given a copy of this consent form. You should ask the researchers named above, or
staff members who may assist them, any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to examine cells from the nose and lungs, as well as from
blood, from healthy control volunteers who do not use tobacco products, and to compare them
with the cells of people who use inhaled tobacco. There is a good deal of scientific information
available on the effects of regular cigarette smoking, but very little on the effects of other inhaled
tobacco, such as E-cigarettes, hookahs and “little cigars”. We want to investigate the effects of
these products directly on cells in the airways of people who use them, and compare those cells
to people who don’t smoke anything and people who smoke regular cigarettes. We are also
investigating the differences in hormonal levels in woman that smoke.
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Are there any reasons you should not be in this study?
You should not be in this study if you have had recent nasal surgery, if you are have a bleeding
disorder, or if you have any significant health problems including asthma, chronic lung disease
or any immune deficiency problems. Women who are pregnant should not participate. If you
have hay fever or seasonal allergies, you will need to wait until you are not having any allergy
symptoms to participate.
How many people will take part in this study?
There will be approximately 140 people in this research study.
How long will your part in this study last?
All subjects will arrive for the initial visit, which will last for approximately an hour. For study
subjects who are non-smokers, the visit will continue for about another 2 hours, at that time your
participation will be complete. For study subjects who smoke any of the products we are
investigating, you will leave with a diary which will take no more than 2 minutes a day for up to
4 weeks. You will return after that time to complete the study, which will take up to 2 ½ hours.
Menstruating women will arrive for the initial visit, which will last for approximately 3 hours.
You will leave with a diary and will start recording 10 days after your menstrual cycle starts until
your next study visit. The diary will take no more than 2 minutes a day. You will return after
that time to complete the second study visit, which will take up to 2 ½ hours.
In addition, if you agree sputum, nasal cells and blood samples left over from this investigation
will be stored indefinitely to possibly be used in research studies not yet known, and they will be
stored only with your study number. Keeping these samples is done to make greatest use of the
information from studies involving people. We will keep any data we collect from this study for
at least 3 years after the entire study is stopped, but if you’ve given permission the samples will
remain stored indefinitely. You will be given a separate consent form to review for sample
storage, the UNC CEMALB Repository IRB # 05-2528. If you do not want to allow your
samples to be stored, that will not prevent you from participating in this study.
What will happen if you take part in the study?
You will arrive in the study lab, and we will explain the study to you, and allow you time to read
the consent form and to have your questions answered. Then we will collect your medical
history, including any smoking history, and we will ask you to complete a questionnaire. We
will check your vital signs, including your temperature, heart rate, respiratory rate, oxygen
saturation and blood pressure. We will also collect a urine sample from you to check for a
chemical called cotinine, which is a by-product of nicotine. We will do a pregnancy test for
women. If you are in any of the smokers groups, you will be given a diary to collect your
smoking activity for up to 4 weeks, when you will return to the research lab to complete the
study. If you are an e-cigarette smoker you will be given the option to use a “tally counter” to
help you record puffs per day in the diary. We ask that you return the tally counter at your last
visit. For study subjects who are non-smokers the study will continue at the initial visit. We will
ask you to undergo the following procedures:
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Your health history will be updated (if you are in the smokers group)
We will ask you about any and all medications, vitamins and supplements you use
Your height and weight will be measured.
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A blood draw from a vein, up to about 100ml, or about 7 tablespoons.
Exhaled Breath Condensate (EBC) Collection: You will breath passively into a plastic
tube which is covered with a frozen sleeve, covered with cloth. This takes about 10
minutes.
Epithelial Lining Fluid (ELF) Collection: Two small filter paper strips will be inserted
into the nostrils. Nose clips will then be placed on your nose and worn for two minutes.
Nasal lavage procedure: For this sample collection, we will have you spray a salt water
solution into your nose, and then blow the fluid into a cup. You will do this several times
in each nostril.
A nasal biopsy: One of the study researchers who is trained will perform a biopsy
procedure to retrieve a small cluster of cells from each of your nasal cavities. For the
biopsy procedure, you will be seated comfortably in a straight-backed chair or reclining
on an examination table with your head tilted as far back as possible while remaining
comfortable. A short, sterile plastic sampling device called a curette will be inserted into
one of your nasal cavities and the surface of your nasal cavity will be stroked several
times for approximately 5 seconds in order to obtain a small cluster of cells. This
maneuver will be repeated on the contra-lateral nasal cavity using a fresh curette.
Lung (pulmonary) function testing, called spirometry or PFT: This is a measure of how
much air you can blow out in one breath, and how fast you can blow it out. You will
breathe into a measuring device through a mouthpiece. We will ask you to do this
several times, and we will help you to be sure you are doing it correctly
Sputum Induction: Sputum induction is a method for obtaining lower airway secretions
(phlem) in a non-invasive way. These secretions can be tested to measure the degree of
airway inflammation and to look at chemicals the lung produces. We will ask you not to
eat for 2 hours prior to this test as food particles in your mouth may contaminate the
sample. You will breathe concentrated salt water from a nebulizer through a
mouthpiece. The nebulizer will change the salt water into a fine mist. After breathing
the salty mist, you will gargle, clear your throat and blow your nose. Then you will give
deep coughs and spit any sputum you cough up into a cup. We will do another lung
function test to check your breathing. These steps will be repeated 2 more times with
gradually increasing concentrations of salt water
Subjects will be offered to consent to the “Center for Environmental Medicine, Asthma,
and Lung Biology Repository for storage of coded samples” (05-PED-1073) to allow
storage and other use of excess samples. Subjects will not be required to participate in
the repository in order to participate in this study.
The menstruating cohort will repeat the following at the second visit: vitals, blood draw, EBC,
ELF, nasal lavage, nasal biopsy, PFTs, and sputum induction.
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. You will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved from being in this study?
Risk of nasal lavage: There are no risks associated with nasal lavage.
Exhaled Breath Condensate: There are no risks with EBC.
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Risk of Epithelial Lining Fluid (ELF) Collection: you may experience mild transient discomfort
on insertion of paper strips into the nostrils or agitation from having to breathe out of your mouth
for two minutes due to wearing the nose clips. If you are bothered by the nose clips we will
remove them.
Risk of nasal biopsy: This procedure can cause mild temporary bleeding from the nose. This
can be treated if it occurs by squeezing the tip of the nose for 5-10 minutes. Nasal biopsy also is
transiently painful. This procedure requires only a few seconds and you are free to excuse
yourself from the study at any time.
Risk of blood draw: A blood draw can cause some bruising and in some individuals fainting.
Bruising will be minimized by applying pressure after the blood draw. You will be able to lie
down while we draw the blood to reduce the risk of fainting.
Risk of Pulmonary Function Testing: Lung function testing may cause wheezing in susceptible
individuals. Lightheadedness with repeated efforts is slightly possible. You will be seated in a
non-rolling chair, but please let us know if you feel at all lightheaded during the breathing test,
and we will wait longer between each of your test breaths in order to prevent lightheadedness.
Risk of sputum induction: Collection of sputum may cause wheezing in sensitive individuals,
and coughing repeatedly may make your chest hurt. A physician is immediately available and
the rescue medication, inhaled albuterol will be available. You will be carefully monitored with
pulmonary function testing to ensure a return to baseline before you leave the CEMALB.
Confidentiality: All individuals who have been granted access to the data to perform their
research-related duties will be bound by an agreement of confidentiality. Your urine, nasal
biopsy and lavage samples and your blood cells will be stored until all measurements are made
for this study. If you signed the repository any samples that are left over will continue to be
stored.
There may be uncommon or previously unknown risks. You should report any problems to the
researcher.
What if we learn about new findings or information during the study?
You will be given any new information gained during the course of the study that might affect
your willingness to continue your participation.
How will information about you be protected?
All study data will be coded with your study number. Any item with any personal identifying
information, such as the study worksheets, will be secured in a locked office when not in use.
No one outside of the study staff will have access to these records. Samples collected as part of
the study will be identified only by your study number, and any electronic databases will only
have your study number. Participants will not be identified in any report or publication about this
study. Although every effort will be made to keep research records private, there may be times
when federal or state law requires the disclosure of such records, including personal
information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take
steps allowable by law to protect the privacy of personal information. In some cases, your
information in this research study could be reviewed by representatives of the University,
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research sponsors, or government agencies (for example, the FDA) for purposes such as quality
control or safety.
A Federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it
illegal for health insurance companies, group health plans, and most employers to discriminate
against you based on your genetic information. GINA does not protect you against genetic
discrimination by companies that sell life insurance, disability insurance, or long-term care
insurance. GINA also does not protect you against discrimination based on an already-diagnosed
genetic condition or disease
Will you receive results from research involving your specimens?
Most research with your specimens is not expected to yield new information that would be
meaningful to share with you personally. There are no plans to re-contact you or other subjects
with information about research results.
What will happen if you are injured by this research?
All research involves a chance that something bad might happen to you. This may include the
risk of personal injury. In spite of all safety measures, you might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help you get medical care,
but any costs for the medical care will be billed to you and/or your insurance company. The
University of North Carolina at Chapel Hill has not set aside funds to pay you for any such
reactions or injuries, or for the related medical care. You do not give up any of your legal rights
by signing this form.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, without penalty. The investigators also have the
right to stop your participation at any time. This could be because you have had an unexpected
reaction, or have failed to follow instructions, or because the entire study has been stopped.
Will you receive anything for being in this study?
You will be receiving $140 for taking part in this study. If you are a healthy control, you will
receive the entire amount at the completion of the first visit. If you are a smoker, you will
receive $30 at the completion of the first study visit, and then the remaining $110 when you
complete the study. In addition, smokers will receive $10/week for the diary completion, for a
total of $180.
If you are in the menstrual cycle cohort you will receive $125 for the first visit and $100 for the
second visit plus $20 for completing the diary, for a total of $245.
We will collect your social security number in order to pay you for participating in this study. If
you make more than $600 per year at UNC in study payments, this information is sent to the IRS
for tax purposes.
Will it cost you anything to be in this study?
It will not cost you anything to be in this study. We will provide parking coupons if you need to
park on campus.
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Who is sponsoring this study?
This research is funded by a grant from the National Institutes of Health. This means that the
research team is being paid by the sponsor for doing the study. The researchers do not, however,
have a direct financial interest with the sponsor or in the final results of the study.
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If
you have questions about the study (including payments), complaints, concerns, or if a researchrelated injury occurs, you should contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research participant?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject, or if you
would like to obtain information or offer input, you may contact the Institutional Review Board
at 919-966-3113 or by email to IRB_subjects@unc.edu.
Participant’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate in this research study.
______________________________________________________ ____________________
Signature of Research Participant
Date
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Printed Name of Research Participant
______________________________________________________ ____________________
Date
Signature of Research Team Member Obtaining Consent
______________________________________________________
Printed Name of Research Team Member Obtaining Consent
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