Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Emory University and Children’s Healthcare
Consent to be a Research Subject
Version 1.0 March 14, 2012
Title: AVICA – Acetaminophen versus ibuprofen in children with asthma
*This consent is to be completed after the INFANT consent
Principal Investigator: Anne M. Fitzpatrick, PhD
Sponsor: National Institutes of Health (NIH), National Heart, Lung and Blood Institute’s AsthmaNet
If you are the legal guardian of a child who is being asked to participate, the term “you” used in this consent refers to
your child
Introduction
You are being asked to be in a medical research study about how well acetaminophen and ibuprofen work in children
who have asthma. Your child is being invited to join this study because they are part of the INFANT study. Joining this
study is voluntary. However, in order to participate in INFANT, your child must be enrolled in AVICA. The INFANT and
AVICA studies go hand-in-hand.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site
will not include information that can identify you. At most the Web site will include a summary of the results. You may
search this Web site at any time.
Study Overview
The purpose of this study is to find out if acetaminophen or ibuprofen is the better analgesic-antipyretic for children
with asthma who are less than 5 years of age. An analgesic relieves aches and pains. An antipyretic brings down a fever.
It is possible that medications used to treat fever or body aches work differently in young children with asthma. This
difference might depend on their asthma controller treatment.
In the United States, acetaminophen is the most commonly used treatment for pain and fever in children. It is
considered safe when used in the recommended doses shown on medication labels. Recently, some scientists have
suggested that acetaminophen use may be related to asthma symptoms in children. However, there is no consensus,
and the American Academy of Pediatrics still recommends acetaminophen and ibuprofen as the best treatments for pain
and fever. This study will help to answer the question of whether acetaminophen or ibuprofen might be related to
asthma symptoms in young children.
This study is funded by the National Institutes of Health’s National Heart, Lung and Blood Institute. Emory University is
one of 9 clinical centers in the country doing this study. A total of approximately 900 children may need to be enrolled in
this study in order for approximately 300 children from across the nation to be randomized in this study. About 33
children will be randomized at Emory University.
What will my participation involve?
Page 1 of 6
IRB Form 02242012
Version Date: 03/12/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
RUN-IN PERIOD: The first 2-8 weeks of the study is called the run-in period. You may use whatever analgesic-antipyretic
medication that you want during the run-in. Please make sure that the study coordinator knows if you used any of these
medications.
TREATMENT PERIOD: At the end of the run-in period, your child will get assigned to the INFANT treatment order. At that
same time your child will be assigned to take either acetaminophen or ibuprofen to treat body aches and fever. Whether
your child is assigned to acetaminophen or ibuprofen will be decided randomly like the flip of a coin. It will be kept a
secret and will not change.
Acetaminophen and ibuprofen will be provided in liquid form, with identical flavoring, taste, and smell. Because the
medications will be identical, you and the study team will not know which medication has been assigned to your child.
The strength will be identical to the current over-the-counter formulations for “children’s” preparations of both
acetaminophen and ibuprofen. Your child’s dose will be based on their weight and may be adjusted if your child’s weight
changes during the study.
You will get written instructions for the proper use of these medications. The use of these medications is not necessary,
but might help relieve fever or pain. You should give this medication for pain and fever only. You may give a dose every 6
hours, as needed. Your child may have no more than 4 doses in 24 hours.
Please DO NOT use any other analgesic-antipyretic medication to treat your child’s body aches and fever. You will be
given a letter describing the AVICA study. You will be asked to share this letter with anyone who could treat your child’s
fever or pain such as babysitters, day care providers, or your child’s primary medical provider. Your child’s primary
medical provider may choose to not use AVICA medication. If that happens, follow their advice and please let the study
coordinators know.
PERSISTENT FEVER: If your child has a fever that lasts for 3 days, call your child’s primary care provider for guidance.
Follow their advice and inform the study coordinator. If your child has a fever related seizure, seek immediate medical
care.
PERSISTENT BODY ACHES AND PAINS: If you feel that your child’s pain is not adequately controlled by the AVICA
medication, call your child’s primary care provider for guidance. Follow their advice and inform the study coordinator.
Study medications should be stored at room temperature under dry conditions away from direct sunlight. The study
medications must be taken ONLY by the person for whom it has been prescribed. The study medications should only be
taken as directed and should be kept out of the reach of other children or people who cannot read or understand the
labels on the medications. AVICA study medications (used and unused) should be brought with you to every study visit.
Empties should not be thrown away.
There will be AVICA questionnaires for you to fill out during INFANT study visits and you will be asked to record AVICA
medication use in a diary.
We will also analyze some of your child’s blood (less than half a teaspoon – 1 to 2 mL) for glutathione and related
substances. Glutathione is a compound that protects the body against inflammation. Glutathione also assists with the
body’s breakdown of medicines such as acetaminophen and ibuprofen. This blood sample will be obtained at visit 2 at
the same time your child’s blood is drawn for the INFANT study.
What are the Risks?
Page 2 of 6
IRB Form 02242012
Version Date: 03/12/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Acetaminophen and ibuprofen are FDA-approved for this age group and are considered safe. Common side effects (39%) include: nausea, indigestion, constipation, headache, and dizziness. Less often (<1%): gastrointestinal
ulceration/bleeding raised liver enzymes, diarrhea, and nose bleeding.
The following symptoms are not expected but require immediate medical attention:
yellow skin or eyes, unexplained bruising, dark urine, pale stools, bleeding that will not clot.
Serious allergic reactions are uncommon. If your child develops hives, itching, difficulty breathing, or swelling, 1)
discontinue use immediately, 2) seek emergency medical care, and 3) contact the study coordinator at 404-712-1773.
Acetaminophen overdose can lead to liver failure. An overdose of ibuprofen may lead to abdominal pain, nausea,
vomiting, drowsiness, dizziness, headache, ringing in the ears, and vision changes. To prevent an overdose, your child
should not take more than 4 doses of AVICA medication in 24 hours.
There are many medicines that you can purchase over-the-counter or receive by a prescription that contain either
acetaminophen or ibuprofen as one ingredient such as Children's Tylenol Plus Multi-Symptom Cold, Triaminic Cough and
Sore Throat, and Pediacare Multi-Symptom Cold. Your child may not use any of these medications either during the
course of the study. We will provide you with a longer list of medicines which contain acetaminophen and ibuprofen for
you to refer to instructions on how to read medication labels to determine whether or not they contain acetaminophen
and ibuprofen.
The risks with taking blood include possible pain from the skin puncture, as well as bleeding or bruising of the skin. There
is a rare risk for infection at the place of puncture of the skin. Dizziness, lightheadedness, and fainting may occur.
There may be side effects from the study drug or procedures that are not known at this time.
New Information
It is possible that the researchers will learn something new during the study about the risks of being in it. If this
happens, they will tell you about it. Then you can decide if you want to continue to be in this study or not. You may be
asked to sign a new consent form that includes the new information if you decide to stay in the study.Taking part in this
research study is voluntary. You may choose not to have your child start the AVICA study but then they cannot take part
in the INFANT study. You may choose to stop the AVICA study at any time without penalty or loss of benefits that you
had prior to the study. At that time your child could continue to be enrolled in the INFANT study. You will be told of any
new and significant findings which may affect your willingness to continue. Your decision of whether or not to have your
child participate in this study will not affect the quality of their medical care at this institution. If you decide to quit the
study, you will be asked to return study related items to the study coordinators.
The study sponsor or study doctor may decide to stop your child’s participation without your permission. For example, if
your child drops out of the INFANT study, he/she will no longer be eligible to participate in the AVICA study. This could
also happen if the study doctor thinks that being in the study may cause your child harm or if the study outcome is found
out early.”
Benefits
You and your child are not expected to benefit in the long-run from being in this study. This study may help other young
children in the future because we will learn more about using acetaminophen and ibuprofen in toddlers who have
asthma.
Compensation
Page 3 of 6
IRB Form 02242012
Version Date: 03/12/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
You will be paid a total of $200 if your child completes the AVICA study. If you withdraw your child before the final visit,
your payment will be prorated for only study visits and phone calls that have been completed (see below). If you receive
more than the minimum reporting requirements as set by the Internal Revenue Service (>$599 in a calendar year) for
participating in the INFANT and AVICA studies, the Emory University must report this income to the IRS and will issue
you a 1099 form. We will ask that you provide your social security number for this purpose. You will be responsible for
reporting this compensation when you file your tax return. Non-monetary incentives such as small toys may be given to
children at each visit.
$25 for completion of the first visit
$25 each for completion of visits 2, 3, 4, 5, 6, 7, 8
Other Treatment Outside this Study
Your child does not have to take part in this study. However, if you choose to have your child take part in INFANT, they
must take part in AVICA.
Confidentiality
We will do everything we can to protect your and your child’s privacy. Records will be coded and stored in locked spaces
accessible only to research staff. The researchers might use information learned from this study in scientific journal
articles or in presentations. None of this information will indentify you or your child personally. 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.
Certain offices and people other than the researchers may look at your medical charts and study records. Government
agencies and Emory employees overseeing proper study conduct may look at your study records. These offices include
[Food and Drug Administration, the Office for Human Research Protections, the Emory Institutional Review Board, the
Emory Office of Research Compliance, the Office for Clinical Research, the Clinical Trials Audit & Compliance Office, the
Radiation Safety Committee, etc.]. Study sponsors may also look at your study records. Emory will keep any research
records we create private to the extent we are required to do so by law. A study number rather than your name will be
used on study records wherever possible. Your name and other facts that might point to you will not appear when we
present this study or publish its results.
There is a Certificate of Confidentiality for this Study:
We will do everything we can to keep others from learning about your participation in the research. To further help
protect your privacy, the investigators have obtained a Confidentiality Certificate.
What the Certificate of Confidentiality protects:
The National Institutes of Health has given this study a Certificate of Confidentiality. Emory would rely on it to avoid
giving out study information that identifies you. For example, if Emory received a subpoena for study records that
identify you, we would say no. The Certificate gives Emory legal backup to say no. It covers information about you that
could harm your image or finances. It also covers information about you that could harm your chances at a job or
getting insurance.
What the Certificate of Confidentiality does not protect:
The Certificate does not prevent you or someone other than you from making disclosing your information. The
Certificate also does not prevent Emory from releasing information:
 to state public health offices about certain infectious diseases
Page 4 of 6
IRB Form 02242012
Version Date: 03/12/2012
Study No.: IRB00057906



Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
to law officials if child abuse has taken place
to prevent immediate harm to you or others
to the study sponsor as part of the research
Research Information Will Go Into the Medical Record:
If you are or have been an Emory Healthcare patient, you have an Emory Healthcare medical record. If you are not and
have never been an Emory Healthcare patient, you do not have one. Please note that an Emory Healthcare medical
record will be created if you have any services or procedures done by an Emory provider or facility for this study.
If you agree to be in this study, a copy of the consent form and HIPAA patient form that you sign will be placed in your
Emory Healthcare medical record. Emory Healthcare may create study information about you that can help Emory
Healthcare take care of you. For example, the results of study tests or procedures. These useful study results will/will
not be placed in your Emory Healthcare medical record. Anyone who has access to your medical record will be able to
have access to all the study information placed there. The confidentiality of the study information in your medical record
will be protected by laws like the HIPAA Privacy Rule. On the other hand, some state and federal laws and rules may not
protect the research information from disclosure.
Emory does not control results from tests and procedures done at other places, so these results would not be placed in
your Emory Healthcare medical record. They will not likely be available to Emory Healthcare to help take care of you.
Emory also does not have control over any other medical records that you may have with other healthcare providers.
Emory will not send any test or procedure results from the study to these providers. If you decide to be in this study, it
is up to you to let them know.
In Case of Injury
In the event that you or your child is physically injured as a result of participating in this research, emergency care will be
available. You will, however, be responsible for the charges for the emergency care. There is no commitment to provide
any compensation for research-related injury. You should realize that you have not released this institution from liability
for negligence. Please contact the investigator, Anne Fitzpatrick, PhD at 404-727-9112 if you are injured or for more
information.
Contact Information
Contact Anne Fitzpatrick, PhD. 404-727-9112:
 if you have any questions about this study or your part in it,
 if you feel you have had a research-related injury or a bad reaction to the study drug, or
 if you have questions, concerns or complaints about the research
Contact the Emory Institutional Review Board at 404-712-0720 or 877-503-9797 or irb@emory.edu:
 if you have questions about your rights as a research participant.
 if you have questions, concerns or complaints about the research.
 You may also let the IRB know about your experience as a research participant through our Research Participant
Survey at http://www.surveymonkey.com/s/6ZDMW75.

If you are a patient receiving care at Children’s Healthcare of Atlanta and have a question about your
rights, please contact Kristine Rogers, Director of Clinical Research at 404-785-1215.
Page 5 of 6
IRB Form 02242012
Version Date: 03/12/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Costs
There will be no costs to you for participating in this study, other than basic expenses like transportation. You will not be
charged for any of the research activities.
Consent
I am the parent/legal guardian of the child named below. I have read the information in this consent form, reviewed any
questions, and I voluntarily agree to have my child participate in this study. I have received a copy of this consent form.”
Please, print your name and sign below if you agree to be in this study. By signing this consent form, you will not give up
any of your legal rights.
Name of Subject
_______
Signature of Person Conducting Informed Consent Discussion
____________________________
Date
Time
__________________________________________________________
Name of Person Conducting Informed Consent Discussion
Signature of Legally Authorized Representative
Date
Time
Authority of Legally Authorized Representative or Relationship to Subject
Page 6 of 6
IRB Form 02242012
Version Date: 03/12/2012