Download P1111 Sample Informed Consent, English V1

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APPENDIX VI
IMPAACT SAMPLE INFORMED CONSENT TEMPLATE
________________________________________________________________________
DIVISION OF AIDS
INTERNATIONAL MATERNAL PEDIATRIC ADOLESCENT AIDS CLINICAL
TRIALS GROUP (IMPAACT)
SAMPLE INFORMED CONSENT
For protocol:
IMPAACT P1111: Phase I/II, Open-Label Trial to Evaluate Safety, Tolerability,
Pharmacokinetics and Antiviral Activity of Rilpivirine in Antiretroviral Naïve
HIV-1 Infected Children, < 12 Years of Age, Version X
SHORT TITLE FOR THE STUDY: P1111, Safety and PK of rilpivirine in HIV-1
Infected Children
INTRODUCTION
Your child is being asked to take part in this research study because your child has the
Human Immunodeficiency Virus (HIV), which is the virus that causes AIDS, and your
doctor has recommended that your child start on medications to treat HIV. This study is
sponsored by the National Institutes of Health (NIH). The doctor in charge of this study
at this site is: (insert name of Principal Investigator). Before you decide if you want your
child to be a part of this study, we want you to know about the study.
This is a consent form. It gives you information about this study. The study staff will talk
with you about this information. You are free to ask questions about this study at any
time. If you agree to allow your child to take part in this study, you will be asked to sign
this consent form. You will get a copy to keep.
WHY IS THIS STUDY BEING DONE?
This study is being done to learn about an antiretroviral HIV medication called
RILPIVIRINE. This drug is a type of medicine called a non-nucleoside reverse
transcriptase inhibitor (NNRTI). NNRTIs work by blocking reverse transcriptase, a
protein that HIV needs to infect human cells and make more copies of itself. The study
will help find the best amount or dose of RILPIVIRINE for children when it is taken with
two other antiretroviral medications. This study will also help find the safety of using this
medication in children and if there are any side effects from the medication.
RILPIVIRINE has been tested before in animals and in adults and adolescents but not in
children. The study drug (RILPIVIRINE) is experimental and is not approved by the
United States Food and Drug Administration (FDA) and/or local regulatory authorities
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for use in in children and adolescents. RILPIVIRINE is approved by the FDA and/or
local regulatory authorities for use in adults at a dose of 25 mg daily.
WHAT DOES MY CHILD HAVE TO DO IF HE/SHE IS IN THIS STUDY?
If you decide to allow your child to enroll in this study, you will be asked to bring your
child to the clinic at least 12 times over 48 weeks and then every 24 weeks until the end
of the study. Your child will be given RILPIVIRINE and your child will be asked to take
it once a day for the entire study, in addition to two other anti-HIV medicines. The other
two anti-HIV medications will be prescribed by your doctor and will not be given
through the study. RILPIVIRINE is available in tablet formulation and may not be
chewed, crushed or broken. RILPIVIRINE is also available in granule (powder)
formulation. RILPIVIRINE must be taken with a meal.
This study will be done in two parts – Stage one and Stage two. Stage one will enable the
doctors to find the right dose of study drug for your child and then will keep your child
on that dose to look for any side affects your child might experience as well as how well
the drug is controlling your child’s HIV infection. In Stage two the doctors will know the
right dose to put your child on and will look at any side effects that your child might
experience as well as how well the drug is controlling your child’s HIV infection. Your
child will be enrolled into either Stage one or Stage two, depending on when your child
enrolls in this study. This consent form is for Stage one and Stage two.
In this study there are 2 groups (cohorts) – Cohort 1 will enroll children 6 to less than 12
years of age and Cohort 2 will enroll children 2 to less than 6 years of age.
Screening:
If you are interested in allowing your child to enroll in this study, we will see if your
child is eligible for the study:
 You will be asked to give the study staff a telephone number or a method to
contact you during the study.
 The study staff will ask about your child’s medical history including questions
about your child’s health and what symptoms, medications, and illnesses your
child has had.
 We will also ask about the mother’s use of anti-HIV medicines during pregnancy.
 The study staff will do a special test called an electrocardiogram (ECG). Your
child will have special electrical wires placed on their chest and a machine will
read your child’s heart rhythm. This is a painless test.
 The study staff will do a physical exam that includes taking a height, weight, and
vital signs (pulse and blood pressure) and record your child’s age, gender, race,
and ethnicity.
 The study staff will also ask your child to provide a urine sample for a urine test.
 The study staff will take about 3 teaspoons (14 to 16 mL) of blood, to check for
the following:
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o The amount of HIV in your child’s blood;
o How well your child’s immune system, liver, and kidneys are working and
the number of blood cells
o Whether your child is resistant to certain HIV medications (if your child is
resistant to the study drug, it will not work properly)
o To check for hepatitis B and C;
o If your child’s doctor is planning on including Abacavir (ABC, Ziagen®)
as one of the two other anti-HIV medicines, a test to find out if your child
may be allergic to Abacavir will be done;
You will be given the results of these tests. Girls who can have a baby will also be asked
to provide a urine sample to test for pregnancy. If your child is pregnant, your child
cannot be in the study. If your child is engaged in sexual activity that could lead to
pregnancy, your child will be asked to take birth control precautions (ways to prevent
pregnancy) throughout the study period.
On Study:
 Your study doctor will tell you whether your child is eligible for this study. If
your child is eligible for the study, your child will come to the clinic a total of at
least twelve (12) times, depending on the study Stage your child is in, for about
one year. Most of the visits will last about 1 to 2 hours. More visits will be needed
if the amount of study drug in your child’s blood is too low or too high and your
child’s dose needs to be adjusted. Your child will come to the clinic for the first
study visit within 30 days of the screening visit.

At each visit, a medical history will be taken and your child will have a physical
exam. At the enrollment visit and at Weeks 12, 24, 40, and 48, your child’s stage
of sexual development will be determined. For girls/women, this will be done by
looking at how developed the breasts are. For boys/men, this will be done by
measuring the size of the testes.

The study staff will draw blood at each visit. Depending on the specific study
visit, a little less than 1 teaspoon to a little less than 5 teaspoons (3-24 mLs) of
blood will be drawn at these visits; you will be informed of results of routine
blood tests. Some of the blood will be used to test the amount of HIV in your
child’s blood. Some of the blood drawn will be stored and used to test whether
your child is resistant to certain HIV medications. Some of your child’s blood
cells will also be stored to see if your child’s genes affect the amount of study
drug in his/her blood. This testing will be done after the study is over, and you
will not be given the results of these tests.

The study staff will also ask your child to provide a urine sample for a urine test
for routine testing.
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
Girls who can have a baby will also be asked to provide a urine sample to test for
pregnancy. If your child thinks she may be pregnant at any time during the study,
tell the study staff right away. The study staff will talk to your child about her
choices. If your child is pregnant, your child will not be allowed to continue on
the study drug, but will continue to come in for study visits until your child’s baby
is born.

The following information only applies if your child is in Stage 1 of the study:
o After your child has been taking the study medication for 12 to 16 days,
your child will be asked to come to the clinic to have blood drawn 8 times
over 24 hours during one visit to measure the amount of study drug in
your child’s blood (intensive pharmacokinetic [PK) visit).
 To prepare for this visit, your child will be asked not to take their
morning dose of rilpivirine but to bring it with them to the clinic.
Your child should not eat breakfast the morning of this visit, and a
breakfast meal will be provided at this visit after you arrive.
 What will happen at the intensive PK visit:
 Your child will be offered breakfast prior to taking their
morning dose of rilpivirine. Note: If your child vomits
within 30 minutes of taking his/her rilpivirine, he/she will
be asked to take another dose of rilpivirine. If your child
vomits more than 30 minutes after taking his/her
rilpivirine, another dose of rilpivirine will not be given to
your child and the visit will need to be rescheduled.
 A small plastic catheter (a needle that is used to place the
catheter in a vein for an extended period of time, so that
blood can be taken multiple times, without having to stick
your child with a needle several times) will be placed in
your child’s arm to draw blood samples. The plastic
catheter will stay in place until all of the blood samples are
taken.
 Blood samples will be obtained before your child takes
his/her study drug and 2,4,5,6,9,12, and 24 hours after
taking his/her study drug. You may be required to bring
your child back to clinic the next day for the 24 hour
sample. If so, we ask that you hold the next day’s study
drug dose until after the 24 hour blood sample has been
obtained.
 Up to 24 mL (a little more than 4 teaspoons) of blood will
be taken at this visit.
 You will be asked to complete a daily diary for your child, starting
on the day your child entered onto the study, up until and including
the intensive PK visit. You will bring the diary with you to the
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clinic on the Week 1 visit and the intensive PK visit. You will be
asked to record the following information in your child’s diary:
 How many scoops of rilpivirine your child took (applies
only if your child is taking the granule formulation)
 What time your child took his/her rilpivirine
 If your child ate his/her meal/food before taking the
rilpivirine
 What time your child stopped eating his/her meal/food
 A staff member from the clinic will call you every day for three
days before the intensive PK visit to make sure your child did not
miss any study medications. If your child has missed any doses in
the ten days before the intensive PK visit, the visit will need to be
rescheduled until your child has taken the medicines for 10 days
without missing any doses.
o After the intensive PK visit: If these tests show that the amount of study
drug in your child’s blood is not enough or is too high, your child may be
asked to take a different dose and return to the clinic within 12 to 16 days
for blood to be taken again 8 times over 24 hours. If there is concern that
the results may not be correct, for example, if your child had diarrhea, did
not take the rilpivirine dose with a meal/food, or something went wrong
when testing the blood samples, then a repeat intensive PK visit may need
to be scheduled in order to confirm the test results. It is also possible that
if the tests show that the amount of study drug in your child’s blood is not
enough or too high, then your child will be taken off the study drug and
referred to his/her regular doctor for standard HIV treatment.

Your child will have extra blood draws at two visits (Weeks 4 and 24). At these
visits your child will have blood taken two times about two hours apart to
measure the amount of rilpivirine in your child’s blood. The amount of blood
taken at the different study visits will be less than 1 teaspoon (4 mL).

The amount of study drug in your child’s blood will be measured at Weeks 8, 12,
and 48. If your child is in Cohort 1, the amount of blood taken will be a half of a
teaspoon (2 mL). If your child is in Cohort 2, the amount of blood taken will be a
quarter of a teaspoon (1 mL).

Your child will have an ECG done 12 to 16 days after your child started taking
the study medication (Stage 1 only), Weeks 12, 24 and 48.

At two of the study visits (entry and Week 48) an adrenocorticotropic hormone
(ACTH) stimulation test will be done. The adrenal glands produce the stress
hormone cortisol and are stimulated to produce cortisol by a small gland in the
brain named the pituitary gland. An ACTH stimulation test provides a maximum
stimulus to the adrenal glands, in addition to that usually produced by the pituitary
gland, to determine whether the adrenal glands are working. For this test, blood is
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taken to get a starting level of cortisol and other adrenal hormones. Then a dose of
ACTH is given by injection and blood is taken 60 minutes after the dose of
ACTH to measure the levels of cortisol and other adrenal hormones. To do this
test, a small plastic catheter (a needle that is placed in a vein for an extended
period of time, so that blood can be taken multiple times, without having to stick
your child with a needle several times) will be placed in your child’s arm to draw
the blood samples and inject the ACTH. The needle will stay in place until both
blood samples are taken. If the results of this test are abnormal, the test may need
to be repeated at the next scheduled visit. For this test your child will need to be in
the clinic in the morning between 7:30 and 9:30am.

At three of the study visits (Weeks 4, 12 and 24) your child will need to be in the
clinic in the morning to have blood taken between 7:30 and 9:30am in the
morning to measure the levels of cortisol (a hormone made by the adrenal gland)
and another adrenal hormone.

At two of the study visits (Entry and Week 48) your child will have blood taken to
measure the amount of hormones that are related to the development of puberty.
The amount of blood taken for these tests is less than a teaspoon (4 mL). The
blood that is taken during these visits will be tested at the end of the study.

You will also be asked if your child is taking his/her study medication at each
clinic visit.

If your child has a high level of virus in his/her blood at one of the study visits
he/she will be asked to come back to the clinic for a separate study visit in two to
four weeks. At this visit he study staff will take about 2½ teaspoons (12 to 14 mL)
of blood, to check for the following:
o The amount of HIV your child’s blood;
o How well your child’s immune system is working;
o Whether your child is resistant to certain HIV medications;
o The amount of study drug in your child’s blood.
Long Term Follow-Up
After your child has been on study drug for approximately 48 weeks, he/she will enter the
long term follow-up phase of the study. Your child will be asked to come back into clinic
every 24 weeks (every 6 months) for a minimum of 4 years (192 weeks). Most visits will
last about 30 minutes.
 At each visit, a medical history will be taken and your child will have a physical
exam. At each visit, your child’s stage of sexual development will be determined.
For girls/women, this will be done by looking at how developed the breasts are.
For boys/men, this will be done by measuring the size of the testes.
 The study staff will draw about 1 ½ teaspoon of blood (up to 8 mL) at each visit.
You will be informed of results of routine blood tests.
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Your child must continue to take his/her anti-HIV medications during the study as
prescribed by your child’s HIV care provider. If your child’s HIV care provider changes
your child’s anti-HIV medications during the study, your child can still take the study
drug. Your child will be asked questions about taking his/her anti-HIV medications and
the times he/she takes them and if he/she has missed any medications.
Blood Samples
(Sites outside the U.S. only)
Some of your child’s blood samples will be shipped out of the country to the USA for
specialized tests. These tests will tell the doctors how much study drug is in your child’s
blood and if the study drug is causing any problems for your child.
FOR NICHD Sites:
Some of your child’s blood specimens collected as part of this study will be stored for
testing at a later date as part of this study. There is a separate consent form to explain this
and get your consent.
For NIAID Sites:
Storage of Blood
Some of your child’s blood will be stored (with usual protectors of identity) and used for
future IMPAACT-approved, HIV-related research. About a half a teaspoon (2 to 3 mL)
of blood will be taken for this purpose.
Your child’s samples will be stored at a special laboratory. Only approved researchers
will have access to them. People who work at the laboratory will also have access to your
child’s samples to keep track of them. These people won’t have information that directly
identifies your child. Your child’s samples will not be sold or directly used to produce
commercial products. All proposed research studies using your child’s samples will be
reviewed by the National Institutes of Health (NIH). There is no time limit on how long
your child’s samples will be stored.
The researchers do not plan to contact you or your child’s regular doctor with the results
of studies done using your child’s stored samples. This is because research studies are
often done with experimental procedures. The results of such studies should not be used
to make decisions about your child’s medical care. If the researchers decide that the result
of a certain study provides important information for your child’s medical care, your
child’s study doctor will be notified. If you would like to be contacted with this sort of
information, you must notify the study staff of any changes in your address or phone
number.
You may decide that you do not want your child’s samples stored for future research
studies. Your child can still participate in this study even if you make this decision.
You may withdraw your consent for the storage and use of your child’s samples at any
time. If you withdraw your consent, these stored samples will be destroyed.
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Please read the following statement carefully and then mark your initials in the
appropriate space provided.
I agree to allow my child’s blood samples to be stored for use in future IMPAACTapproved, HIV-related research studies.
__________ Yes
__________ No
__________ Date
OTHER INFORMATION
The information collected in this study may be used for other IMPAACT-approved HIVrelated research.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
About 60 children will take part in this study
HOW LONG WILL MY CHILD BE IN THIS STUDY?
Your child will be in the study for at least 48 weeks, depending on how long it takes to
find out the correct dose of study drug for children in your child’s age group.
After that time your child will enter the long term safety follow-up phase of the study.
During this time, your child will continue to take study-provided RILPIVIRINE and will
be asked to come to clinic every 24 weeks for the next 4 years.
WHY WOULD THE DOCTOR TAKE MY CHILD OFF THE STUDY DRUG / THIS
STUDY EARLY?
The study doctor may need to take your child off the study drug early, without your
permission, if:
 Continuing the study drug may be harmful to your child
 Your child becomes pregnant while on study
 Your child is not able to attend the study visits as required by the study
 Your child needs a treatment that your child may not take while on the study
 Your child is not able to take the study drug as required by the study
 If you elect not to attend repeat PK evaluations as part of the study
The study doctor may need to take your child off the study early, without your
permission, if:
 If you elect not to participate in the intensive PK evaluations as part of the study
 The study is cancelled by the U.S. Food and Drug Administration (FDA),
National Institutes of Health (NIH), the Office of Human Research Protections
(OHRP), IMPAACT, the drug company supporting this study (Janssen R&D), or
the site’s Institutional Review Board (IRB) or Ethics Committee (EC). An IRB or
EC is a committee that watches over the safety and rights of research subjects
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If your child’s doctor wants your child to stop taking the study drug, your child will be
asked to return to the clinic once more, four weeks after your child’s last dose of
RILPIVIRINE, to make sure you your child is continuing to do well. This visit will
include a history and physical exam, a blood draw and a review of your medical records.
If your child is having any side effects from the study drug your child will be asked to
return to the clinic until the side effects have resolved.
IF MY CHILD HAS TO PERMANENTLY STOP TAKING STUDY-PROVIDED
MEDICINE, OR ONCE HE/SHE LEAVES THE STUDY, HOW WOULD THE STUDY
MEDICINE BE PROVIDED?
During the study:
If your child must permanently stop taking study-provided RILPIVIRINE before your
child’s study participation is over, the study staff will discuss other options that may be of
benefit to your child.
After the study:
Once your child leaves the study, if he/she is gaining benefit from the study-provided
drug, this drug will continue to be provided until it is available to your child in your
country. Once this drug is available in your country, you will need to personally purchase
the medicine for your child.
WHAT ARE THE RISKS OF THE STUDY?
The drugs used in this study may have side effects, some of which are listed below.
Please note that these lists do not include all the side effects seen with these drugs. These
lists include the more serious or common side effects with a known or possible
relationship. If you have questions concerning additional study drug side effects please
ask the medical staff at your site.
Use of Combination Antiretroviral Drugs
Immune Reconstitution Syndrome:
In some people with advanced HIV infection, symptoms from other infections or certain
diseases may occur soon after starting combination anti-HIV treatment but can also occur
later. Some of these symptoms may be life threatening. If you start having new
symptoms, or notice that existing symptoms are getting worse after starting your
antiretroviral therapy, tell your healthcare provider right away.
The use of potent antiretroviral drug combinations may be associated with an abnormal
placement of body fat and wasting. Some of the body changes include:
 Increase in fat around the waist and stomach area
 Increase in fat on the back of the neck
 Thinning of the face, legs and arms
 Breast enlargement
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Possible Risks Associated with RILPIVIRINE
RILPIVIRINE has been studied and approved for use in HIV-infected adults in other
completed and on-going studies. There is a chance that this drug may not keep viral load
low enough. If the viral load is not kept low enough, there is a risk that your child may
develop resistance to RPV and other antiretroviral medicines.
The following side effects have been seen with RILPIVIRINE:
 Very Common (could affect more than 1 in every 10 people)
o Nausea or feeling sick (mild to moderate)
o Headache (mild to moderate)
The following serious side effects have been associated with the use of RILPIVIRINE:
 Depression or mood changes.
Be sure to contact your health care provider immediately if you are feeling sad or
hopeless, feeling anxious or restless, or have thoughts of hurting yourself (suicide) or
have tried to hurt yourself.
Additional side effects associated with the use of RILPIVIRINE include:
 Liver problems can happen in people who take rilpivirine. People who have abnormal
liver tests before starting rilpivirine and people with liver diseases, like Hepatitis B or
C, have an increased risk of worsening liver disease. If you are developing liver
problems, you may have one or more of the following symptoms:
o Yellowing of the skin or whites of your eyes,
o Dark urine,
o Pain on the right side of your stomach,
o Loss of appetite,
o Upset stomach or
o Vomiting, pale colored stools,
o Itchy skin.
 Headache
 Trouble sleeping
 Rash
The following side effects have been seen, but it is not known yet if they were caused by
RILPIVIRINE:
 Very Common (could affect more than 1 in every 10 people)
o Diarrhea or loose stools
o Changes in pancreas blood tests
o Protein present in the urine
 Common (could affect more than 1 to 10 in every 100 people)
o Cold symptoms like runny nose and sore throat; cough; flu
o Dizziness or feeling light headed
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o
o
o
o
o
o
o
Trouble sleeping; abnormal dreams
Rash
Feeling tired
High temperature
Pain in the stomach; vomiting
Changes in kidney, liver and muscle blood tests
Ocular icterus (yellowing of the whites of the eyes)
In one animal study, gastric erosion (irritation of the stomach lining) was seen. This
finding has not been seen in adults in studies to date. However, if your child feels
heartburn or stomach pain or vomit, please contact your child’s study doctor.
Studies in dogs and monkeys showed abnormal changes in the adrenal glands and
changes in the blood cortisol levels (a stress hormone) and other hormones produced by
this gland. In clinical studies to date, rilpivirine does not appear to adversely affect this
stress hormone function in humans. In this study, cortisol stimulation tests will be
performed during the course of the study to monitor changes in hormones.
Other Risks
There is the risk of serious and/or life threatening side effects when non-study
medications are taken with study drugs. For your child’s safety, you must tell your child’s
HIV care provider and the study doctor or nurse about all medications your child takes
before the start of this study and also before starting any new medications while you your
child is on the study. In addition, you must tell the study doctor or nurse before enrolling
your child in any other clinical trials while on this study.
The use of highly active HIV medications may also be associated with altered fat
metabolism including increased triglycerides (fatty acid in the blood) and/or increased
cholesterol.
Other side effects besides those listed and side effects from taking these drugs together
may occur. If any unusual symptoms or changes happen, you should call your child’s
doctor immediately. It is also important that while participating in the study, your child
does not take any other prescription drugs or over-the-counter medications without first
talking to your child’s doctor or study nurse.
Blood Drawing and Heparin Lock Risks:
Blood drawing may cause some discomfort, bleeding or bruising where the needle enters
the body. A small blood clot may form where the needle enters the body or there may be
swelling in the area. There is a small risk of a minor infection at the blood draw site.
Lightheadedness and fainting can also occur when a needle enters the body.
ARE THERE RISKS RELATED TO PREGNANCY?
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It is not known if the drug or drug combinations in this study harm fetuses. Tests in
pregnant animals do show some risk to the mother. If your child is having sex that could
lead to pregnancy, your child must agree not to become pregnant.
Because of the risk involved, your child and their partner must use two methods of birth
control that you discuss with the study staff. Your child must continue to use both
methods until four weeks after stopping study drug. Your child may choose two of the
birth control methods listed below:




Birth control drugs that prevent pregnancy given by pills, shots, placed on the
skin (e.g. Patch) or placed under the skin
Male or female condoms with or without a cream or gel that kills sperm
Diaphragm or cervical cap with a cream or gel that kills sperm
Intrauterine device (IUD)
All birth control methods listed above except condoms do not reduce the risk of giving
HIV to someone else. HIV-infected individuals should use a birth control method that
includes condoms to keep from giving HIV to someone else.
If your child can become pregnant, she must have a pregnancy test before entering this
study and will have a pregnancy test obtained at each visit except the Week 1 visit. If
your child is pregnant, she cannot be in the study. If you think your child may be
pregnant at any time during the study, tell the study staff right away. The study staff will
talk to you about your child’s choices.
If your child becomes pregnant while on study, she will not be allowed to continue on the
study drug but will be asked to remain on study and come in for study visits as planned in
case of safety concerns and so that the doctors can follow her pregnancy until your
child’s baby is born.
(For US/International Sites)
US/International clinical sites may register the subject’s pregnancy in the Antiretroviral
Pregnancy Registry. http://www.apregistry.com/reg.htm (In US: 1-800-258-4263).
ARE THERE BENEFITS TO TAKING PART IN THIS STUDY?
If your child takes part in this study, the amount of HIV in your child’s body may go
down and your child’s immune system may become stronger, but no guarantee can be
made. Your child may receive no benefit from being in this study. Information learned
from this study may help others who have HIV.
WHAT OTHER CHOICES DOES MY CHILD HAVE BESIDES THIS STUDY?
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There are other medicines approved to treat children with HIV. Rilpivirine is being
studies because it may be safe and easier for children to take than some of the other
medicines that are available.
Instead of being in this study your child has the choice of:
 treatment with prescription drugs approved for treatment of HIV which are
available to your child
 treatment with other experimental drugs, if your child qualifies
 no treatment (NOT recommended)
Please talk to your doctor about these and other choices available to your child. Your
child’s doctor will explain the risks and benefits of these choices.
WHAT ABOUT CONFIDENTIALITY?
(For US Sites Only)
To help us protect your privacy, we have obtained a Certificate of Confidentiality from
the National Institutes of Health. With this Certificate, the researchers cannot be forced to
disclose information that may identify you, even by a court subpoena, in any federal,
state, or local civil, criminal, administrative, legislative, or other proceedings. The
researchers will use the Certificate to resist any demands for information that would
identify you, except as explained below. The Certificate cannot be used to resist a
demand for information from personnel of the United States Government that is used for
auditing or evaluation of federally funded projects or for information that must be
disclosed in order to meet the requirements of the federal Food and Drug Administration
(FDA).
People who may review your child’s records include the U.S. Food and Drug
Administration, the Office of Human Research Protections (OHRP), the site IRB /EC
(insert name of site IRB/EC), the National Institutes of Health, study staff, study
monitors, drug companies supporting the study, and their designees.
You should understand that a Certificate of Confidentiality does not prevent you or a
member of your family from voluntarily releasing information about your child’s
participation in this research. If an insurer, employer, or other person obtains your written
consent to receive research information, then the researchers may not use the Certificate
of Confidentiality to withhold that information.
(For sites outside the U.S.)
Efforts will be made to keep your child’s personal information confidential. We cannot
guarantee absolute confidentiality. Your child’s personal information may be disclosed if
required by law. Any publication of this study will not use your child’s name of identify
your child personally.
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Your child’s records may be reviewed by the Ministry of Public Health in your country,
the FDA, the Office of Human Research Protections (OHRP), the NIH, (insert name of
site) IRB/EC, study staff, study monitors and the drug companies supporting this study.
WHAT ARE THE COSTS TO MY CHILD?
There are no costs to your child for study drugs, study visits or study procedures.
However, taking part in this study may lead to added costs to you and your insurance
company if medical complications arise or if your child’s doctor decides extra tests are
needed. In some cases it is possible that your insurance company will not pay for these
costs because your child is taking part in a research study.
WILL MY CHILD RECEIVE ANY PAYMENT?
[Note to sites: Insert site-specific information on compensation to study participants].
WHAT HAPPENS IF MY CHILD IS INJURED?
If your child is injured as a result of being in this study, your child will be given
immediate treatment for his/her injuries. The cost for this treatment will be charged to
you or your insurance company. There is no program for compensation either through
this institution or the National Institutes of Health (NIH). You will not be giving up any
of your/your child’s legal rights by signing this consent form.
WHAT ARE MY CHILD’S RIGHTS AS A RESEARCH SUBJECT?
Taking part in this study is completely voluntary. You may choose not to take part/not to
allow your child to take part in this study or leave this study/take your child out of the
study at any time. Your decision will not have any impact on your participation in other
studies conducted by the NIH and will not result in any penalty or loss of benefits to
which you are otherwise entitled.
The study staff will tell you about new information from this or other studies that may
affect your health, welfare or willingness to stay in this study. If you want the results of
the study, let the study staff know.
WHAT DO I DO IF I HAVE QUESTIONS OR PROBLEMS?
For questions about this study or a research-related injury, contact:
 name of the investigator or other study staff
 telephone number of above
For questions about your child’s rights as a research subject, contact:
 name or title of person on the Institutional Review Board (IRB), Ethics
Committee (EC) or other organization appropriate for the site
 telephone number of above
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SIGNATURE PAGE
If you have read this consent form (or had it explained to you), all your questions have
been answered and you agree to allow your child to take part in this study, please sign
your name below.
___________________________
Participant’s Name (print)
____________________________
Participant’s Mother (print)
____________________________________
Mother’s Signature and Date
__________________________
Father’s Name
(If father’s consent is required)
__________________________________
Father’s Signature and Date
(If father’s consent is required)
____________________________
Participant’s Legal Guardian (print)
(As appropriate)
____________________________________
Legal Guardian’s Signature and Date
________________________
Study Staff Conducting
Consent Discussion (print)
____________________________________
Study Staff Signature and Date
________________________
Witness’ Name (print)
(As appropriate)
____________________________________
Witness’s Signature and Date
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APPENDIX VII
FACT SHEET and TEMPLATE CONSENT FORM for
Specimen Storage at the Repository of the National Institute of Child Health and Human
Development (NICHD)
When your child joins this NICHD sponsored Study, you will be asked to consent to
having some specimens that the doctor or nurse will take from your child’s body saved in
a repository. (A repository is a special laboratory with freezers where specimens like
blood or tissue cells and body fluids that are taken from you during the study are kept.
Your child’s name will not be on these specimens, only a special study number. The
people who run the repository laboratory will not know your child’s name.)
Why have a repository?
Researchers can learn a lot from a study but as time goes by the tests that they used get
better or brand new tests are developed, and more can be learned with these better or new
tests. When study volunteers consent to put specimens in the repository and consent to
the researchers doing new tests on the specimens at some time in the future after their
time in the study is ended, researchers can learn new information by being able to use the
specimens. Your child’s rights and your privacy will be protected in any of these new
studies.
How will my child’s privacy be protected?
The only record that your child participated in this NICHD sponsored study is at the
clinic where it is kept separate from your child’s health records and locked away.
Your child’s specimens in the repository will not have your child’s name on them, only a
special study code. It will be the same code that is on your child’s information in the
NICHD sponsored Study from your interviews and examinations. Again, none of this
information will have your child’s name on it.
How would a researcher get to use the specimens in the repository?
If a researcher wants to do a test on specimens from the NICHD repository in the future,
he or she will write up the idea and it will have to be approved by a committee to make
sure the research is worthwhile. If the idea is approved, then coded specimens and coded
information will be given to the researcher. The researcher will not know the names,
addresses, or phone numbers of the people who gave the specimens to the repository.
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Why wouldn’t I find out the results of the research using my child’s specimens?
You will not receive the results of research done with your child’s specimens. This is
because research can take a long time and must use specimens from many people before
results are known. Results from research using your child’s specimens may not be ready
for many years. Often when studies are first done, it is not always clear how to use the
information from the study to change the health care that people receive. So none of these
study results is likely to affect your child’s care right now, but they may be helpful to
people like your child in the future. Your child’s specimens can last in the freezer for
many years and there is no time limit to when studies could be done in the future.
Would I ever be contacted in the future about research using my child’s specimens?
All of the studies to be done in the future on your child’s specimens in the repository will
be for the particular reasons that you agreed to. Every study that is planned to use
specimens from your child and others from this NICHD Study has to be reviewed to
make sure that what is planned is the same kind of study that you agreed to. If it is, then
the research will go ahead since you would have agreed that these particular tests could
be done without anyone contacting you to get your permission in the future.
If the study to be done is not like the kind of tests you agreed could be done, then the
committee will decide if you need to be contacted to give permission for the new study.
I gave my consent to testing my child’s specimens in the repository, but what if I change
my mind?
People always have the right to stop participating in research. So if you decide that you
do not want researchers to be able to use the specimens from your child in the repository,
you can contact the clinic staff. They will tell the repository that the specimens with the
study code number linked to your child’s name in the clinic should not be studied. These
specimens can be removed from the repository and destroyed if you tell us to do that.
What type of research will be done with my child’s specimens?
Many different kinds of studies use specimens. Some researchers may develop new tests
to find diseases. Others may develop new ways to treat or even cure diseases. In the
future, some of the research may help to develop new products, such as tests or drugs. If
this would happen and these tests or drugs make money, there are no plans to share that
money with the people who gave the specimens.
As part of this study (Phase I/II, Open-Label Trial to Evaluate Safety, Tolerability,
Pharmacokinetics and Antiviral Activity of Rilpivirine in Antiretroviral Naïve
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HIV-1 Infected Children, < 12 Years of Age), your child is being asked to have some
blood taken. These specimens will go into the NICHD repository for research to be done
at some time in the future so that more information can come from your child’s time in
this NICHD sponsored Study.
You do not have to agree to store your child’s specimens for future tests to take part in
this study. Your child will not lose any benefits to which your child is entitled if you
decide against storing your child’s specimens.
TEMPLATE CONSENT/ASSENT FORM
What are the general HIV-related studies that can be done with the repository specimens?
Researchers would like to store your child’s specimens to understand how HIV causes
disease and complications, and how best to treat or prevent HIV infection and its
complications. They need specimens from people who have HIV and from those who do
not. Sometimes, too, the specimens can be used to learn something about new problems
that people with HIV have like liver disease, diabetes, and heart disease. These general
studies would not include any genetic testing (looking at your child’s DNA).
Benefits: There are no direct benefits to your child. You will be helping
researchers learn more about how to help people with HIV or at risk of HIV
infection.
Risks: The specimens would be collected as part of your child’s study visits.
(Insert text about collection procedures.) Once in the repository, there are few
risks. Your child’s name will not be available to the repository or to the scientists
who may be doing any future test.
I consent to the use of my child’s stored specimens for the purposes stated in the
preceding section (general HIV-related tests).
_________________________
_________________
Parent or Legal Guardian Signature Witness Signature
Date
_________
I give my assent to the use of my stored specimens for the purposes stated in the
preceding section (general HIV-related tests).
__________________________
__________________
_______
Participant Signature
Witness Signature
Date
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What are the special HIV-related studies that can be done with the repository specimens?
Researchers in this study would also like to store your child’s specimens to understand
how HIV causes disease and complications, and how best to treat or prevent HIV
infection and its complications through looking at how each person’s genetic makeup
(your child’s DNA) either protects them or puts them at greater risk. It may be that
researchers use some of your child’s blood to make a “cell line”. That means the blood
cells can keep dividing and give an endless supply of your child’s DNA for tests to be
done in the future. This kind of information will be particularly important as scientists
work toward a vaccine that could protect people from AIDS. They need specimens from
people who have HIV and from those who do not.
Benefits: There are no direct benefits to your child. Your child will be helping
researchers learn more about how to help people with HIV or at risk of HIV
infection.
Risks: The specimens would be collected as part of your study visits. (Insert text
about collection procedures.) Once in the repository, there are few risks. Your
child’s name will not be available to the repository or to the scientists who may be
doing any future test. Since there are no plans to give subjects the results of the
tests performed on their stored specimens, you will not receive any information
on your child’s genetic makeup.
I consent to the use of my child’s stored specimens for the purposes stated in the
preceding section (special HIV-related tests).
___________________________
Parent or Legal Guardian Signature
___________________________ _______
Witness Signature
Date
I give my assent to the use of my stored specimens for the purposes stated in the
preceding section (special HIV-related tests).
__________________
Participant Signature
___________________________ _______
Witness Signature
Date
What if I have more questions?
If you have any questions about the repository, about storage, or the use of your samples,
contact (Study personnel) at (phone).
If you have questions about giving consent or your rights as a research volunteer, contact
the (Name of Institution) Institutional Review Board at (phone).
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I refuse to have any specimens collected from my child for storage in the repository.
_______________________
_______________________
Parent or Legal Guardian Signature Witness Signature
Date
_____