University of North Carolina at Chapel Hill
Consent to Participate in a Research Study
Adult Participants
Consent Form Version Date: May 21, 2014
IRB Study # 13-1605
Title of Study: Effect of gamma tocopherol enriched supplementation on response to inhaled
LPS
Principal Investigator: David Peden
Principal Investigator Department: Pediatrics
Principal Investigator Phone number: (919) 966-0768
Principal Investigator Email Address: david_peden@med.unc.edu
Co-Investigators: William Bennett, Ph.D; Michelle Hernandez, MD; Neil Alexis, Ph.D.
Funding Source and/or Sponsor: National Institute of Environmental Health Sciences (NIEHS)
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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?
Asthma is the most commonly encountered breathing disease in children and adults in the United
States and is a leading cause of illness worldwide. Endotoxin is part of outdoor air pollution and
is found in a number of different workplaces. It is even found in homes, and it is in cigarette
smoke. Endotoxin is believed to be one of the triggers for asthma attacks. We plan to use
endotoxin in this study to see if a vitamin E supplement is useful in decreasing airway
inflammation caused by inhalation of endotoxin. The endotoxin used for this study is called
“Clinical Center Reference Endotoxin”, or CCRE. It was developed by a researcher at the
National Institutes of Health (NIH) and is obtained from a pharmacy at the NIH. Scientists have
found that while most people do not have a significant lung response to endotoxin at doses as
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high as 60,000 endotoxin units, (EU), a few respond to as little as 4500 EU. In our previous
studies, we have used a dose of 20,000 EUs of endotoxin in healthy individuals with no major
problems.
Scientists have shown a link between not having enough vitamin E (which is called mixed
tocopherols) and an increased risk of developing asthma and allergies. Vitamin E occurs
naturally in foods, like almonds, greens and avocados. These foods have more of a certain form
of vitamin E, called gamma tocopherol, than most over-the-counter supplements you can buy.
We will use a vitamin E supplement that is mostly gamma tocopherol.
The purpose of this study is to see if giving people the vitamin E taken in a capsule will affect
the lung response to the inhaled endotoxin. This study is considered a cross-over study, which
means that you will take the supplement with vitamin E for one session, and then take placebo
pill, which is sunflower oil, for another session. You, your personal doctor or the study doctor
will not know which one you are taking.
You are being asked to be in the study because you have mild asthma and allergies.
Are there any reasons you should not be in this study?
You should not be in this study if:
a) You have any chronic medical condition considered by the study doctor as a reason you
should not be in the study including, but not limited to, significant cardiovascular disease,
diabetes, kidney disease, thyroid disease, history of chronic infections/immunodeficiency, or a
bleeding disorder.
b) You have needed a physician to treat your asthma within the preceding 12 months as an
emergency.
c) You have asthma symptoms more than 2 times a week during the day, or 2 times month
during the night (except during exercise).
d) You take a daily medication to control your asthma.
e) You’ve had a recent upper respiratory tract infection, such as a cold.
f) You’ve had any infection that required antibiotics within the past 2 weeks,
g) You have severe asthma
h) You have any mental illness or history of drug or alcohol abuse that the study doctor feels
would keep you from following the study directions.
i) You use any medications regularly which may impact the results of the exposure, the study
staff will help determine this,
j) You smoke > 1 pack of cigarettes per month; or if you have a lifetime smoking history for
more than 10 years
k) You are allergic or sensitive to any of the study medications,
l) You have ever needed a breathing tube to treat you for your asthma
m) You have abnormal lab values at screening or during the treatment period.
n) Your exposure to x-rays and other radiation will be collected. If your exposure history within
the past twelve months would cause you to exceed the annual limit that is considered safe you
will not be able to complete the study. The study team will help you determine if you are within
the acceptable range.
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In addition, you must be willing to use reliable contraception if you are sexually active (IUD,
birth control pills/patch, condoms) throughout the study.
How many people will take part in this study?
There will be approximately 30 people in this research study.
How long will your part in this study last?
Prior to participating in this study you will have completed our Screening and Database Study,
IRB # 98-0799. Your participation in this study will last for 9 weeks. The visit schedule is as
follows:
Baseline visit (V0): 2.5 hours
Randomization (V1; V6) 30 minutes
Visit 2nd week of study medication (V2; V7): 30 minutes
Pre CCRE visit (V3; V8): 5 hours, with a 30 minute follow up the following day
CCRE visit (V4; V9): 9 hours
Follow up (V5; V10): 1 1/2 hours
You will receive a phone call from a study team member within 7 days of each CCRE visit to
check on how you are feeling.
After visit 5 we will ask you to have “washout” period for 3 weeks, when you won’t be taking
any study medication. You will return for visit 6, and you will get the second series of study
medication.
There will be a final check out visit (V11) which will last for 30 minutes.
Here is a timeline for the study visits:
You arrive in the lab for study visit 0. You return the following week for study day 1, which is
also visit 1, when you begin taking the study medication.
Visit number
Study Day
V1
1
V2
7
V3
11
V3a
12
V4
14
V5
15
8
11
V9
12
V10
14
V11
15
Wait 3 weeks, then repeat the study days:
Visit number
Study Day
V6
1
V7
7
You will return the following week for V11, which is the final study visit.
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What will happen if you take part in the study?
The study design is summarized below. You and the study staff will be blinded to which
medication you are receiving each session. This means that neither you nor the study physician
or staff will know what you are receiving. The study physician can find out in case of
emergencies.
Study visit 0-Baseline Visit: This visit will last approximately 2 1/2 hours. We will ask you
to have a light breakfast without caffeine at least 2 hours before you arrive.
After you have read and signed your consent form, the following information and samples will
be collected:
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medical history, including any medication you use, will be reviewed
Vital sign measurements including temperature, pulse, breathing rate, blood pressure
A urine pregnancy test for all females with child-bearing potential, (meaning you could
possibly become pregnant). We will do this test even if you are using birth control
methods.
Symptom Scoring: Questions that ask you to rate the severity of any symptoms you
might have, such as “cough”, “fatigue” and “shortness of breath”.
Oxygen (O2) saturation level. Your O2 level will be measured using a plastic clip on
your finger that is like a clothespin.
Breathing test, also called spirometry or pulmonary function testing (PFT): This
measures how much air you can blow out and how quickly you blow it out. You will be
taught how to perform the test.
Blood draw: Approximately 3 tablespoons of blood will be drawn to measure your
blood cell count, to check your ability to clot blood, and for other scientific
measurements including immune levels, levels of vitamin E in your blood, and other
proteins and chemicals related to asthma and air pollution. At this visit we will also look
to see if you have a certain gene call GSTM1, which we think is important in asthma.
Physical exam of the ears, nose, throat and chest;
Induced sputum collection (inhalation of saline designed to produce cough) will be
performed as described on page 8 of this form. This will take about 30 minutes. Since
you have asthma, you will be asked to take 2-4 puffs of albuterol before the sputum
induction.
If you do not meet the criteria for being in the study (such as having slightly decreased lung
function or abnormal vital sign measurements), the visit may be stopped, and you may be asked
to return for a repeat baseline visit on another day. If on the repeat screening you meet all the
criteria to be in the study, we will repeat all testing for the baseline visit at that time. We will
refer you back to your primary physician if we identify and medical concerns that need attention
at any time during the screening.
Study Visit 1: (the following week after baseline)
At this visit we will do the following:
 Review any change in your medical status over past 24 hours
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Vital signs
O2 level
Asthma symptom score
Repeat the urine pregnancy test. We do these tests at least once per week at scheduled
visits to the research lab while you are taking study medication.
You will be given a container with the study medication for you to take each day. You may take
this with food. It is important that you take the medication in the morning, at the same time each
day, and take it exactly as directed. Do not share the medication with anyone else. Keep the
bottle even if it is empty, and return it and all unused study medication at the next visit. The
medication may be placebo (sunflower oil) or a mixed tocopherol (Vitamin E), enriched with
gamma tocopherol, supplement. The order you receive the study medication is determined by
chance like flipping a coin. You will take 2 capsules each day, in the morning. You will be given
a study medication diary to help you keep track of your doses and you will be asked to bring it
with you to the next visit. We will ask that you take the first dose while you are in the research
lab.
Study Visit 2: (7 days after Visit 1)
At this visit we will do the following:
 Review any change in your medical status over past 24 hours
 Vital signs
 O2 level
 Asthma symptom score
 Repeat urine pregnancy test.
We will collect your unused study medication, and give you a new supply to last till your next
visit. We will also look at your study medication diary and encourage you to use it through next
week.
Study Visit 3: (11 days after visit 1):
We will ask you to have a light breakfast without caffeine at least 2 hours before you arrive.
You will take the study medication today when you arrive in the research lab.
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medical history will be reviewed
Vital sign measurements including temperature, pulse, breathing rate, blood pressure
Symptom Scoring: Questions that ask you to rate the severity of any symptoms such as
“cough”, “fatigue” and “shortness of breath”.
Oxygen (O2) saturation level. Your O2 level will be measured using a plastic clip on
your finger that is like a clothespin.
Repeat the urine pregnancy test.
Breathing test, also called spirometry or pulmonary function testing (PFT): This
measures how much air you can blow out and how quickly you blow it out. You will be
taught how to perform the test.
Blood draw: Approximately 3 tablespoons of blood will be drawn to measure your
blood cell count and also for the scientific measurements.
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Physical exam of the ears, nose, throat and chest;
Lung transmission scan: We will place a source of Tc99m, which is radiation, in front
of your chest for up to 5 minutes to obtain a transmission scan of your lungs. These
scans are used to visualize an outline of your lungs. Additional information is on page 8
of this form.
Evaluation of mucociliary clearance (MCC). The MCC scan measures how quickly
mucus clears from your airways. Additional information is on page 8;
Induced sputum collection (inhalation of saline designed to produce cough) will be
performed as described on page 6 of this form. This will take about 30 minutes. Since
you have asthma, you will be asked to take 2-4 puffs of albuterol (which we provide)
before the sputum induction. After the sputum induction is complete you will undergo a
brief (<10 minute) repeat MCC scan.
Study Visit 3a: (24 hours after V3)
 Follow up MCC scan: This scan will indicate the change in mucus clearance from your
airways compared to the day before.
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Study Visit 4: On the last day of study medication, or day 14 of the study.
We will ask you to have a light breakfast without caffeine before you arrive. You will take the
study medication today when you arrive in the research lab.
You will undergo the following:
 Review any change in your medical status
 Vital signs
 O2 level
 Asthma symptom score
 Breathing test
 Physical exam of the ears, nose, throat and chest
 If above measures are acceptable, the Endotoxin challenge will be performed. You will
be asked to breathe 20,000 endotoxin units. The endotoxin used will be Clinical Center
Reference Endotoxin (CCRE), prepared from the E. coli bacteria and supplied by the
National Institutes of Health pharmacy. You will inhale this using a nebulizer until the
solution is used up. This will take approximately 10 to 15 minutes to complete.
 Post-challenge monitoring including breathing tests, vital signs, O2 level, and symptom
score at the following intervals: 30 and 60 minutes and then hourly for 3 more hours.
 Blood draw: Approximately 3 tablespoons of blood will be drawn
 Approximately 4 hours after the endotoxin challenge, you will have an MCC scan.
 After MCC scan, sputum induction will be performed. After the sputum induction is
complete you will undergo a brief (<10 minute) repeat MCC scan.
Study Visit 5: 24 hours later
At this visit we will:
 Review any change in your medical status
 Vital signs
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
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oxygen saturation
Asthma symptom score
You will then have:
 Follow-up MCC scan
After the follow up scan, you will undergo a sputum induction. You will be discharged from the
study for 3 weeks to allow all of the study medication to “wash out” of your system. We will
send you home with a diary to complete each day for 4 days. You will return for Study visit 6 in
3 weeks, and you will repeat the above procedures. You will get the study other medication
(tocopherol or placebo) for this session
Final study visit the following week -This visit will last approximately ½ hour.
You will return with your completed symptom scoring sheets
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Vital signs
O2 level
Asthma symptom score
Breathing test
If any findings are abnormal, medical evaluation as directed by the study physician will
be undertaken
The table below summarizes the procedures at each visit:
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Assessment/
Procedure
Baseline
visit
V0
V1
V2
V3
V3a V4
V5
V6
V7
V8
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
V8a
V9
V10
V11
X
X
X
Informed
consent
Review
history/AE’s
Urine
pregnancy test
Vital signs
X
X
X
X
X
X
X
X
X
X
X
X
X
Breathing test
X
X
X
X
X
X
X
X
X
X
X
X
Physical exam
X
Blood draw
X
Symptom score
X
Sputum
Induction
Study drug and
medication
diary dispensed/
collected
MCC and Lung
Transmission
scan
Endotoxin
challenge
X
Follow-up scan
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
x
X
X
x
Symptom
scoring
diary
given
The sputum and blood samples that are collected during the study will be stored until this study
is complete, so that we may do analysis relating to the study. In addition, if you will allow us to
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X
store any leftover sample in the CEMALB repository (IRB # 05-2528), these samples will
remain stored indefinitely. This repository part is completely voluntary and will not affect your
participation in this study. You will be given a separate consent form for sample storage which
includes additional details,
Information regarding procedures and measurements to be performed:
Breathing test (Spirometry or Pulmonary Function Testing): This test measures the amount and
how fast you when breathe out after a full inhalation. You will inhale as deeply as possible, then
exhale as rapidly and completely as possible into the spirometer. We will be using the American
Thoracic Society guidelines for spirometry during this study.
Sputum collection ( induction): Induced sputum is a method for obtaining lower airway
secretions, which are the fluids from deeper in the lungs. This procedure provides a noninvasive measurement of airway inflammation. We will ask you not to eat for 2 hours prior to
this test as food particles in your mouth may contaminate the sample. If you have asthma, you
will receive 2 to 4 puffs of inhaled albuterol before the sputum induction to prevent narrowing of
your airways (bronchospasm). You will breathe concentrated salt water from a nebulizer
through a mouthpiece. The nebulizer will convert 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 breathing test to check
your breathing. These steps will be repeated 2 more times with gradually increasing
concentrations of salt water. If the breathing test drops from the beginning of the test we will
stop the sputum procedure.
Lung transmission scan: We will tape two small, radioactive discs (Americium 241) to your upper
and lower back in order to determine your position in front of the gamma camera. The
Americium 241 discs are the same sources found in household smoke detectors and will expose
you to a very tiny radiation dose (which is included in the total dose of radiation you are exposed
to in the study). You will then be seated in front of a gamma camera, which is a device for
measuring radioactivity. After measuring background radioactivity for 15 minutes, we will place
a plate that contains a small amount of Cobalt 57 (a radioactive material) in front of your chest to
create a picture of the shape of your lungs, similar to a weak chest X-ray.
Mucociliary Clearance Scan: For the MCC scan, you will inhale radiolabeled particles and sit in front of
the gamma camera to track the movement of the particles out of your lungs for 2 hours. You will have
intermittent rest breaks during this period. You will need to return the day after this test for approximately
1/2 hour for a repeat scan.
Blood draw: Blood will be drawn to look at different cells in your blood that are produced when you are
exposed to things that might cause your asthma to flare up, like the as endotoxin, and also to determine
what genes may play a role in a person’s response to endotoxin. Using a small needle, blood will be
drawn from a vein in your arm or hand. At each blood draw up to 50cc (3 1/2 tablespoons) will be drawn.
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The total for the entire study will about 350 cc. In comparison, at the time of a Red Cross blood donation,
approximately 500 cc’s are drawn.
Symptom scoring: You will be asked to rate the severity of your symptoms on a scale of 0 to 3. A
score of 0 will be equal to “none”, and a score of 3 will be equal to “severe”. The symptoms
you will be asked to rate include: malaise (a vague sense feeling bad); fatigue; shortness of
breath; cough; myalgia (muscle aches); chills; fever; and headache.
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?
There may be uncommon or previously unknown risks. You should report any problems to the
researcher. In the past, we used this same vitamin E supplement with an inhaled endotoxin
challenge without any major problems in healthy people who don’t have asthma.
Pregnancy tests will be done on all females who might be able to get pregnant at the start of the
study; the study will pay for the test.
Potential risks of Vitamin E:
There is a rare (less than 1%) chance that higher doses of vitamin E may affect your ability to
clot blood. We will monitor your clotting levels throughout the study.
Endotoxin Challenge:
The amount of Endotoxin (CCRE) used in this study is based on that which has been previously
used for studies of the effect of inhaled endotoxin in healthy subjects. 20,000 units of endotoxin
is approximately equal to the amount a person would inhale over an eight hour period in many
job settings, such as working on an industrial pig farm. Study volunteers sometimes have a brief,
intermittent cough (usually < a few seconds) during CCRE inhalation. We see this less than 50%
of the time when people inhale the CCRE. It stops after just a couple of minutes. Immediate
adverse effects of endotoxin might include shortness of breath, continuing cough, wheeze,
headache and flu-like symptoms, but we see this in our studies very rarely (less than 1% of the
time). Such problems are observed at doses of inhaled endotoxin of approximately 60,000 EU.
Doses of endotoxin of 15,000 EU or less rarely cause noticeable side effects, as determined from
studies in this lab as well as others. Nonetheless, there can be no guarantee that a given person
may not be unusually sensitive to the effect of endotoxin.
Breathing Test (Spirometry or Pulmonary Function Testing):
Lung function testing may cause wheezing (less than 1% of the time) in susceptible individuals.
Lightheadedness with repeated efforts is possible in anyone; we will make sure you are not
lightheaded before we continue. 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.
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Sputum Collection (induction):
Collection of sputum may cause wheezing (less than 1% of the time) in sensitive individuals,
and coughing repeatedly may make your chest hurt. A physician is immediately available and
rescue albuterol is on hand. You will be carefully monitored with pulmonary function testing to
ensure a return to baseline before you leave the CEMALB or prior to CCRE challenge.
Lung transmission scan and Mucociliary Clearance (MCC) scans:
The lung transmission and MCC scans entail exposure to some radiation. Since radiation can be
especially harmful to a developing fetus, it is important that pregnancy be avoided during this
study by using effective birth control measures (either hormonal contraceptives, like birth control
pills; or a barrier method, like condoms). Pregnancy tests will be done on all females who might
be able to get pregnant at the start of the study and before each mucus clearance measurement;
these tests will be paid for by the study site. If you become pregnant during the study you should
notify the researcher right away.
The radiation dose you will receive in this study is 177 mRem, which is equal to the radiation
exposure everyone receives from natural background sources in 145 days.. The risk from the
radiation dose received from this procedure is too small to be detected. You must inform one of
the investigators if you have had any x-rays or other radiation exposure within the past year so
that we do not exceed the yearly dose limits. If you wish, Dr. Peden will provide you with
additional information and answer any questions you may have. If desired, additional
information can be obtained from Marija Ivanovic, Ph.D, Chairman of the Radiation Safety
Subcommittee of UNC Hospitals at 919-843-0717. Although it is best to avoid radiation
exposure, this is a small amount of radiation and is considered acceptable to experience on a
limited basis. You should take this information into consideration when agreeing to participate in
this study and any future studies.
Blood sampling:
Risks with having your blood drawn include mild discomfort or bruising at the site. A small risk
of infection also exists. Your blood will be drawn by well-trained staff.
Confidentiality:
All individuals who have access to the data to perform their research-related duties are bound by
an agreement of confidentiality. Your blood goes to an outside lab and the sample will have
your study number but no personal identifying information.
In this study, several measures have been taken to minimize risk to you. First, you will not
receive a challenge if you are having difficulty breathing due to your asthma or any other lung
disease; or because you are recovering from an upper respiratory infection (a cold). Second, all
CCRE challenges will take place in the Center for Environmental Medicine, Asthma and Lung
Biology. This facility is staffed with personnel who are experienced in administering these
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challenges and is equipped with emergency equipment. The professional skills and facilities of
the UNC Medical Center will also be available for consultation, emergency or follow-up
treatment.
In addition, there may be uncommon or previously unknown risks that might occur. You should
report any problems to the researchers.
What are the risks to a pregnancy or to a nursing child?
We do not know the effect of the study drug on babies before they are born, or on nursing
children. Many drugs can get into the mother's milk. You should not breast feed your child
while taking the study drug.
If you are a woman and you are planning to get pregnant, you should not be in the study. If you
are a man, you should not father children while in the study. If you or your partner becomes
pregnant during the study you should notify the researcher right away.
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. All data will be entered into a
database with only your study number, not your name. We will need to use your date of birth for
the lung function program.
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, 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.
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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 $1290 for taking part in this study, if you complete all parts of the study.
The payment is broken down as follows:
Baseline (V0): $80
V1:
$20
V2:
$20
V3 and 3a:
$165+ $15
V4:
$250
V5:
$75
V6:
$20
V7:
$20
V8 and 8a:
$165 + $15
V9:
$250
V10:
$75
V 11:
$50
Bonus:
$50
Medication
Diary:
$20
$1290
Payment will be prorated for completed visits if you withdraw or if the study physician
withdraws you for medical reasons. If you arrive at the study site for any scheduled session that
is subsequently canceled, but can be rescheduled, such as for weather, equipment or staffing
problems, you will be compensated for the visit or $50.00, whichever is lower. Snacks (juice
and crackers or granola bars) will be provided for you after sputum inductions. Parking vouchers
will also be provided.
Will it cost you anything to be in this study?
All study procedures will be paid for by the study. We will give you parking coupons to cover
the cost of parking.
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Who is sponsoring this study?
This research is funded by the National Institute of Environmental Health Sciences, or the
NIEHS.
This means that the research team is supported by a federally-funded grant.
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.
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S.
Law. This website will not include information that can identify you. At most, the website will
include a summary of the results. You can search this website at any time.
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
______________________________________________________
Printed Name of Research Participant
______________________________________________________ ____________________
Signature of Research Team Member Obtaining Consent
Date
______________________________________________________
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Printed Name of Research Team Member Obtaining Consent
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