Severe Asthma Research Program (SARP)
A National Institutes of Health/ National Heart, Lung & Blood Institutes
sponsored network
CONSENT
TO ACT AS A PARTICIPANT IN A RESEARCH STUDY
STUDY
TITLE: A Phase II Study in
Patients with Asthma to Assess the Safety and Immunogenicity of an Unadjuvanted
Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels (Protocol No.
DAIT-AAIB-flu-001); Protocol Version 3.0, Consent Version 3A
PRINCIPAL INVESTIGATOR: Sally E. Wenzel, MD
Professor
of Medicine
University
of Pittsburgh
3459
Fifth Avenue; MUH 931 NW
Pittsburgh,
PA 15213
412-802-6859
412-958-7643
(pager)
SUB INVESTIGATORS: Fernando Holguin, MD Shean
Aujla, MD
University
of Pittsburgh Children’s
Hospital
412-692-2139 412-692-5630
Andrej
Petrov, MD Merritt
Fajt, MD Chetan
Naik, MD
412-648-6215 412-692-7279 412-692-2118
Danielle
Goetz, MD Allyson
Larkin, MD Chitra
Rao, MD
412-692-5630 412-692-2139 412-958-3813
(pager)
STUDY COORDINATORS: Cathy
Vitari, RN Scott
Simeone
412-692-4373 412-682-1769
Erin
Aiken Akilah
Scott Tracey
Dill
412-692-4747 412-692-2937 412-692-3154
Rebecca
Wade Lisa Lane
412-647-0776 412-692-2625
SOURCE OF SUPPORT: National
Institute of Allergy and Infectious Diseases
The National Institutes of Health (NIH)
Your
child is invited to participate in this study because your child has asthma and
this is a study of a “swine flu” vaccine in patients with asthma.
The
influenza virus (a germ) causes influenza or "flu", an infection of
your child’s breathing tubes and your child’s lungs. Flu is a disease caused by different types of
influenza viruses. Flu is spread from person-to-person mainly through coughing
and sneezing. When someone has the flu
usually it includes a runny nose, cough, sore throat, headache and fever. Each winter, the flu causes illness that often
feels just like the “common cold”. These
illnesses, known as “seasonal flu”, cause an average of 20,000-40,000 deaths
each year in the United States. Usually
the influenza viruses are similar from year-to-year.
When the flu virus
attacks your child’s body, the immune system in your child’s body makes
proteins called antibodies that help your child’s body fight the
infection. Later, if you child is
exposed to the flu, your child’s antibodies will help attack and kill the
virus. You child may not get sick at
all, or you child may have a much shorter or milder illness.
Three
times in the past 100 years a new strain of influenza virus has appeared. Because people had no protection to these new
strains, the illnesses were more severe, death rates were high even in healthy
young adults, and worldwide spread of infection occurred. This worldwide spread is called a
pandemic.
In
April 2009, a new type of flu was found to be spreading across North America
and into many parts of the world to the extent that it was called a pandemic (worldwide spread).
This new virus is called 2009 H1N1 flu, or “swine flu”. The vaccines for “seasonal flu” are not
expected to protect people from the “swine flu”. Therefore, a new vaccine specifically against
the “swine flu” is needed. Since
vaccines against the common “seasonal flu” work well, it is thought that an
effective vaccine against the 2009 H1N1 flu will help to control this pandemic.
Vaccines
can help prevent infection and/or disease. Vaccines work by causing the body to
make proteins called antibodies that fight infection. When your child receives the flu vaccine
(sometimes called the flu shot), your child’s immune system makes antibodies
against the flu virus.
Why is
this study being done?
The purpose of this study is to test a vaccine
against the 2009 H1N1 virus in people who have asthma. We would like to find out how safe the H1N1
flu shot is in people who have asthma and how well the body can react to the
vaccine and develop antibodies against the H1N1 flu virus. This study will also look at the differences
between people who have mild/moderate asthma and those who have severe asthma
after receiving the H1N1 flu shot.
Studies with this vaccine in people without asthma have already
begun.
The Food
and Drug Administration (FDA) has approved this vaccine to be used as a single
dose and a single strength. In this
study, subjects will be given two (2) doses of the vaccine either at the
approved dose or at double the approved dose. This is because of the
possibility that asthma patients on high dose inhaled or oral steroid medications may need higher doses of the vaccine
to get a good response. The results of this study will help researchers find
out if the different strengths of the H1N1 flu shot make your body produce H1N1
antibodies that are better at fighting H1N1 flu.
In this study, 2 strengths of the H1N1 flu shot
(given about 3 weeks apart) will be tested.
The results of this study will help researchers find out if the
different strengths of the H1N1 flu shot make your child’s body produce H1N1
antibodies that are better at fighting H1N1 flu.
Your child been asked to join this study because
they are at least 12 years old, male, or female who is not pregnant and have
asthma. Also, they are asked to join
because they are able to comply with the study procedures and able to give
informed consent. Women who are able to
get pregnant must agree to use an effective method of birth control from the
beginning of the study until 30 days after the second H1N1 flu shot.
Your child cannot take part in this study if they
are allergic to eggs or any of the ingredients in the vaccine. If your child has had any vaccines in the
last 2 to 4 weeks they may not able be a part of this study. If your child is pregnant or breastfeeding,
she cannot be part of this study.
If your
child has a history of Guillain Barre Syndrome or have some other chronic
diseases other than asthma they cannot participate in this study. Depending your child’s smoking history your
child may not be able to participate in this study. Also, your child may be
taking certain medications that may not allow them to be in this study. We will let you know.
Who is being asked to participate in
this research study?
About 350, and up to 400 asthmatic subjects will be asked
to take part in this study at up to 7 different study centers in the United
States. The University of Pittsburgh
will enroll approximately 80 subjects over a 4 week period.
What
procedures are being performed for research purposes?
Your
child will be in this study for about 7 months for a total of 10 study visits
(these include 5 phone calls and 5 clinic visits). During the first 1.5 months (6 weeks), your
child will have 5 study visits including 5 blood draws. Your child will receive both the first and
second H1N1 flu shots about 21 days (3 weeks) apart during 2 short clinic
visits. Your child will also have 2 follow-up clinic visits about a week after
each shot visit and 1 follow-up clinic visit about 3 weeks after the second
shot visit. Study personnel will also
call your child about 1 to 3 days after each shot visit to check on any
reactions or illnesses your child may have had since their last visit. After that, study personnel will call you
about 2, 4, and 6 months after the second H1N1 flu shot (3, 5, and 7 months
after the first H1N1 flu shot) to check on any reactions or illnesses your
child may have had since your child’s
last visit or telephone call. If your
child experienced any reactions or illnesses, the study doctor may ask that you
and your child come back to the study center.
If
your child agrees to take part in the study and qualifies, your child will be
assigned to one of two different vaccine strength groups. Your child cannot choose to which group they
will be assigned. Your child will have
an equal chance of being assigned randomly (like flipping a coin) to either
receive the 15 microgram (mcg) strength of the H1N1 vaccine or the 30 mcg
strength of the H1N1 vaccine. Half of
the people in this study will receive the 15 mcg strength of the H1N1 vaccine
and the other half the 30 mcg strength. Those people in the study who will be
in the 15 mcg group will get one injection of the vaccine at Visit 1 and one
injection at Visit 3 (about 3 weeks apart).
Those people who will be in the 30 mcg group will receive two 15 mcg
injections at Visit 1 and two injections at Visit 3.
The tests or procedures that are included in the
study are:
·
Medical
history.
·
Physical
examination- this will be performed by one of the study doctors including
height and weight.
·
Spirometry
– For this test, your child will blow
into a machine (spirometer) approximately 3 times in order to see how well they
are able to blow air out of his/her lungs.
·
Vital
Signs (temperature, pulse, respiratory rate, blood pressure)
·
Urine
pregnancy test for females who are able to have children
·
Your child
will be asked to complete a questionnaire that will take approximately 15
minutes to complete.
·
Symptom
diary – to write down any symptoms your child may have after the vaccine. This may take 5-10 minutes to complete.
If your child decides to take part in this research study, your child
will undergo the following procedures that are not part of your child’s
standard medical care:
Screening
Procedures:
Procedures to determine if your child is eligible to take part in a
research study are called “screening procedures”. For this research study, the screening
procedures include:
If
the study doctor believes that your child is eligible to continue in this study
your child will continue and undergo the following experimental procedures:
·
We will
watch your child for 30 minutes for any reactions after the H1N1 vaccine
·
We will
check the site where your child received the first H1N1 flu shot
·
Repeat
Vital Signs
We
will give your child symptom diaries, a thermometer, and a ruler. We will ask your child to take his/her
temperature by mouth about the same time every day and write down the
temperature. We will ask your child to
use the ruler (provided by the study) to measure the size of any reaction at
the place of the shot (or shots). Your child will also need to write down any
symptoms your child has every day during the week after he/she receives the
first H1N1 flu shot or shots. Your child
should also write down any drugs or medicines (including over-the-counter
medications, vitamins, and herbal supplements) they take during this time. Your
child will collect the diary and thermometer information until the next study
center visit (Visit 2).
·
Your child will be asked to contact the study doctors
right away if your child has any unusual or severe reactions in the first week
after your child receives the first H1N1 flu shot (or shots).
Follow-up Phone Call
(1-3 days after Visit 1)
·
We will
call your child 1 to 3 days after the first H1N1 vaccine to check on any
reactions or illnesses your child may have had and any drugs or medicines
(including over-the-counter medications, vitamins, and herbal supplements) your
child has taken since your last visit.
·
We will
review the information in your child’s symptom diaries.
·
We will
also ask your child questions about your child’s asthma.
Visit 2 (8 -10 days after Visit 1)
The following will be done:
·
Review of
current health status and any reactions your child may have had since the
telephone call
· Medication review to include over the counter medications and
supplements
· Vital Signs
·
We will
check the site where your child received the first H1N1 vaccine.
·
A brief
physical examination may be done based on your child’s current health.
·
Spirometry
– to check how well your child is able to blow air out of their lungs.
· Questions about your child’s
asthma to see how well their asthma is controlled
· Blood draw – 25 milliliter (mL) (about 5 teaspoons)-to measure your child’s
antibody levels and for other substances that the immune system makes in
response to the vaccination.
· We will review the information in the symptom
diary with your child.
This visit is about 3 weeks after the first H1N1
flu shot.
The following will be done:
·
Review of
current health status and any reactions your child may have had since the last
visit.
· Vital Signs.
·
We will
check the area on your child’s arm or thigh where they received the first H1N1
vaccine.
·
We may do
a brief physical examination based on your child’s current health.
·
Spirometry
– to check how well your child is able to blow air out of their lungs.
· Questions about your child’s asthma.
·
Urine
pregnancy if your child is a female able to have children.
· Blood draw – 25 milliliter (mL) (about 5 teaspoons) -to measure your
child’s antibody levels and for other substances that the immune system makes
in response to the vaccination.
· Second H1N1 flu vaccination (1 or 2 shots depending what group your
child has been randomized to).
·
We will
watch your child for 30 minutes for any reactions after the H1N1 vaccine
·
We will
check the site where your child received the second H1N1 vaccine.
·
Repeat
vital signs.
We
will give your child symptom diaries, a thermometer, and a ruler. We will ask you or your child to take your
child’s temperature by mouth about the same time every day and write down the
temperature. We will ask your child to
use the ruler to measure the size of any reaction at the place of the shot (or
shots).Your child will also need to write down any symptoms your child has
every day during the week after your child receives the second H1N1 flu shot or
shots. Your child should also write down
any drugs or medicines (including over-the-counter medications, vitamins, and
herbal supplements) your child takes during this time. Your child will collect
the diary and thermometer information until the next study center visit (Visit
4)
· Your child
will be asked to contact the study doctors right away if your child has any
unusual or severe reactions in the first week after your child receives the
second H1N1 flu shot (or shots).
Follow-up Phone Call (1-3 days after Visit 3)
·
We will
call your child 1 to 3 days after the second H1N1 flu shot or shots to check on
any reactions or illnesses your child may have had and any drugs or medicines
(including over-the-counter medications, vitamins, and herbal supplements) they
have taken since your child’s last visit.
·
We will
review the information in your child’s symptom diaries with your child.
·
We will
also ask your child some questions about their asthma.
Visit 4 – (8-10 days after Visit 3)
The
following will be done:
·
Review of
current health status and any reactions your child may have had since the
telephone call.
· Medication review to include over the counter medications and
supplements.
· Vital Signs.
·
We
will check the site (or sites) where your child received the second H1N1 flu
shot (or shots).
·
A brief
physical examination may be done based on your child’s current health.
·
Spirometry
– to check how well your child is able to blow air out of their lungs.
· Questions about your child’s asthma to see how well their asthma is
controlled.
· Blood draw – 25 milliliter (mL) (about 5 teaspoons) - to measure antibody
levels and for other substances that the immune system makes in response to the
vaccination.
· We will review the information in the symptom
diary with your child.
Follow up Procedures
Visit 5 – (18-24 days after Visit 3)
The
following will be done:
·
Review of
current health status and any reactions your child may have had since the
telephone call.
· Medication review to include over the counter medications and
supplements.
·
A brief
physical examination may be done based on your child’s current health.
·
Spirometry
– to check how well your child is able to blow air out of their lungs.
· Questions about your child’s asthma to see how well their asthma is
controlled.
· Blood draw – 25 milliliter (mL) (about 5 teaspoons)-to measure antibody
levels and for other substances that the immune system makes in response to the
vaccination.
· If your child has not received this year’s seasonal flu vaccine before
starting this study, this vaccine will be offered at this visit at no cost to
your child.
Follow-up Phone Call (2 months after the second
shot)
Follow-up Phone Call (4 months after the second
shot)
Early Withdrawal Visit
· If your child decides to leave the study early, or if we have to remove
your child from the study because your child is no longer eligible to continue,
we will ask your child to come back to the study center for a final visit
during which some of the same study procedures will be done.
Visits 1 and 3 will be
performed at the University of Pittsburgh Asthma Institute at UPMC; in while
some evening and Saturday appointments will be available. Visits 2, 4, and 5 will be performed in the
Children’s Hospital Pediatric Clinical Translational Research Center.
Clinic visits should
last approximately 1 ½ hours. The
telephone calls may take approximately 15 minutes of your child’s time.
What are the possible risks, side effects, and discomforts of this
research study?
The treatment and procedures involved in this
research project may have side effects that are not possible to predict. These unknown risks may affect your child’s participation in the study and/or at some point in
the future.
H1N1 Vaccine
Sometimes,
people who receive the flu shot may develop flu-like symptoms. These symptoms may be more likely if your
child receives the higher strength of the H1N1 flu shot in this study. These include fever, body aches, headache, or
nausea. These symptoms are usually the
worst in the first 24 hours after receiving the flu shot. They usually last only 1 or 2 days. Some people may develop reactions at the site
where they receive the flu shot (redness, swelling, pain, or tenderness).
Tylenol (acetaminophen) or ibuprofen (Motrin, Advil) or similar non-steroidal
anti-inflammatory drugs (NSAIDs) and rest will generally relieve or lessen
these symptoms. Usually, these reactions
go away in 1 to 4 days and do not need additional treatment.
A small
number of people (about 1 in 4 million people) have immediate allergic
reactions to vaccines. These can be
things like a skin rash, swelling of the throat,
difficulty breathing, or even fainting. If these reactions occur, they can
usually be stopped by the study personnel giving emergency medications. Your child will receive the vaccine in a
clinical setting with medical personnel observing your child after each shot or
shots for 30 minutes and who are able to treat your child if your child has a
reaction.
During the
“swine flu” vaccine drive of 1976, about 1 out of 100,000 people who got the
“swine flu” shot developed a serious illness.
This illness is called Guillain-Barré syndrome (GBS). The main symptom of this illness is muscle
weakness sometimes to the point where your child’s muscles cannot move
(paralysis) and you may need help breathing, but rarely causing death. Most patients who get Guillain-Barré syndrome
recover completely, although the recovery period may be as little as a few
weeks or as long as a few years. Some
persons may have a relapse of muscle weakness and tingling sensations many
years after the initial attack. This
illness has not been seen consistently with other flu vaccines. It is not known whether the cause was the
“swine flu” shot or the virus from which that shot was made or for some other
reason.
The
current 2009 H1N1 vaccine is different from the 1976 “swine flu” shot. It is unknown whether there will be as many
cases of GBS with the current 2009 H1N1 flu vaccine as were seen with the 1976
“swine flu” shot. Your child will not
receive the 1976 “swine flu” shot in this study.
Currently, the vaccine has only been
tested in healthy people. In these
people, side effects were similar to those seen with the seasonal flu vaccine
(described above). Blood tests showed a
good response to the vaccine in most people after just one shot. There is no data available on the safety and
effectiveness of the H1N1 flu shot in people with asthma. There may be risks that we do not know about
right now.
Studies of the seasonal flu vaccine in patients
with asthma indicate that there is no significant increase in asthma
exacerbations immediately after vaccination.
It is unknown, however, whether the vaccine for the H1N1 flu to be used
in this trial will have any bad side effects in the lungs in patients with
asthma.
Seasonal Flu Vaccine
At the last visit of this study, the seasonal flu
vaccine will be made available your child.
The risks of the seasonal flu vaccine are the same as those of the H1N1
vaccine.
Blood Draw
Some people get lightheaded, nauseated or
faint. If your child has a snack or
water before the blood draw they will be less likely to faint. The fainting feeling will pass if they lie
down. Taking blood can also cause
bruising. Bruising can be prevented or
reduced by putting pressure on the blood draw site for a few minutes after the
blood is taken.
It is possible to receive an infection
from having blood taken or receiving a vaccine like an injection. This is not very likely. To reduce the risk of infection, the area
where the blood will be drawn and where the H1N1 flu shot will be given will be
cleaned using aseptic technique. Sterile
equipment will be used.
Spirometry
Spirometry may cause coughing, chest
tightness, or lightheadedness that will go away shortly after the test is
finished.
Risks of becoming pregnant:
Your child cannot participate in this study if:
Treatments and procedures involved in this research project may involve
unexpected risks to your child’s unborn or nursing child.
If your child participates in this study, your child must agree to use
birth control during the study and for 30 days after receiving the second H1N1
vaccine. The acceptable birth control methods while your child is on this study
include the following: not having sex with a man (abstinence), oral
contraceptives ("the pill"), intrauterine devices (or IUDs),
contraceptive implants under the skin, contraceptive injections, and diaphragms
and condoms with foam. Your child should
not breastfeed her baby while on this study.
Your child may ask one of the study staff about counseling or for
information about preventing pregnancy.
If your
child should become pregnant while participating in this study, or if you
suspect that your child has become pregnant, your child must contact Dr. Wenzel
immediately.
What are possible benefits from taking part in this study?
The 2009 H1N1 strain of flu is
new but not completely different from flu strains in the seasonal flu vaccines.
Although it is not known if this study vaccine will offer protection against
infection and/or disease caused by the H1N1 strain of flu, and if it does, it
is not known how long that protection may last, there may be a potential for
benefit from the vaccine. The H1N1 flu shot is not expected however, to protect
your child against the “seasonal flu”.
What treatments or procedures are available if my child decides not to
take part in this research study?
Before your
child decides to take part in this study, the Study
doctor will talk with you and your child about
these and other options available to them.
The alternative is not to participate in the study.
If my child agrees to take part in this research study, will my child
be told of any new risks that may be found during the course of the study?
Will my insurance provider or I be charged for the costs of any
procedures performed as part of this research study?
Neither your child, nor your child’s insurance provider, will be
charged for the costs of any of the procedures performed for the purpose of
this research study (i.e., the Screening Procedures, Experimental Procedures,
or Monitoring/Follow-up Procedures described above). Your child will be charged, in the standard
manner, for any procedures performed for your child’s routine medical care.
Will my child be paid if he/she takes part in this research study?
Your child will be paid a total of $485 if they complete all parts of
this study, which will be given to them in two parts. Your child will receive $285 after completion
of Visit 3 and the remaining $200 after completion of Visit 5.
In addition, any parking fees and bus fares related to your child’s
participation in this study will be paid for by the study.
Who will pay if my child is injured as a result of taking part in this
study?
If your child believes that the research procedures have resulted in an
injury to your child, immediately contact the Principal Investigator who is
listed on the first page of this form. Emergency medical treatment for injuries
solely and directly related to your participation in this research study will
be provided to your child by the hospitals of UPMC. Your insurance provider may
be billed for the costs of this emergency treatment, but none of those costs
will be charged directly to your child. If your child’s research-related injury
requires medical care beyond this emergency treatment, you will be responsible
for the costs of this follow-up care. At this time, there is no plan for any
additional financial compensation.
This vaccine and the clinical trial are covered by the Public Readiness
and Emergency Preparedness (PREP) Act which limits your child’s ability to sue
if your child develops a reaction to the vaccine. A Federal program has been
created to help pay for medical care and other specific expenses of people who have
serious reactions that are caused by the vaccine. To be eligible for this
program, your child must file a claim within one year of the vaccination. The program is administrated by the Health
Resources and Services Administration.
An information sheet about the PREP Act, and the Federal program,
including how to file a claim will be provided to your child at the time your
child signs this consent.
Who will know about my child’s participation in this research study?
Any information about your child obtained from this research will be
kept as confidential (private) as possible.
All records related to your child’s involvement in this research study
will be stored in a locked file cabinet.
Your child’s identity on these records will be indicated by a case
number rather than by your child’s name, and the information linking these case
numbers with your child’s identity will be kept separate from the research
records. Your child will not be
identified by name in any publication of the research results unless your child
signs a separate consent form giving your permission (release).
Will this research study involve the use or disclosure of my
identifiable medical information?
This research study may involve the recording of current and/or future
identifiable medical information from your child’s hospital and/or other (e.g.,
any emergency room visit or physicians office visit) records. The information that will be recorded will be
limited to information concerning these types of visits during your child’s
time in this research study.
This research study will not result in identifiable information that
will be placed into your child’s medical records held at UPMC Presbyterian.
Who will have access to identifiable information related to my child’s
participation in this research study?
In addition to the investigators listed on the first page of this
authorization (consent) form and their research staff, the following
individuals will or may have access to identifiable information (which may
include your child’s identifiable medical information) related to your child’s
participation in this research study:
Authorized representatives of the University of Pittsburgh Research
Conduct and Compliance Office may review your child’s identifiable research
information (which may include your child’s identifiable medical information)
for the purpose of monitoring the appropriate conduct of this research study.
In unusual cases, the investigators may be required to release
identifiable information (which may include your child’s identifiable medical
information) related to your child’s participation in this research study in
response to an order from a court of law.
If the investigators learn that your child or someone with whom your
child is involved is in serious danger or potential harm, they will need to
inform, as required by Pennsylvania law, the appropriate agencies.
Authorized
representatives of the sponsor of this research study or their affiliates,
(National Institutes of Health, Novartis, and Rho Federal Systems, Inc.), will review and/or obtain identifiable information (which may include
your child’s identifiable medical information) related to your child’s
participation in this research study for the purpose of monitoring the accuracy
and completeness of the research data and for performing required scientific
analyses of the research data. While the
study sponsor understands the importance of maintaining the confidentiality of
your child’s identifiable research and medical information, the UPMC and University
of Pittsburgh cannot guarantee the confidentiality of this information after it
has been obtained by the study sponsor.
The investigators involved in the conduct of this research study may
receive funding from the sponsor to perform the research procedures and to
provide the sponsor with identifiable research and medical information related
to your child’s participation in the study.
Authorized representatives of the U.S. Food and Drug Administration may
review and/or obtain identifiable information (which may include your child’s
identifiable medical information) related to your child’s participation in this
research study for the purpose of monitoring the accuracy of the research
data. While the U.S. Food and Drug
Administration understands the importance of maintaining the confidentiality of
your child’s identifiable research and medical information, the University of
Pittsburgh and UPMC cannot guarantee the confidentiality of this information
after it has been obtained by the U.S. Food and Drug Administration.
Authorized representatives of the UPMC hospitals or other affiliated
health care providers may have access to identifiable information (which may
include your child’s identifiable medical information) related to your child’s
participation in this research study for the purpose of (1) fulfilling orders,
made by the investigators, for hospital and health care services (e.g.,
laboratory tests, diagnostic procedures) associated with research study
participation; (2) addressing correct payment for tests and procedures ordered
by the investigators; and/or (3) for internal hospital operations (i.e. quality
assurance).
For how long will the investigators be permitted to use and disclose
identifiable information related to my child’s participation in this research
study?
The investigators may continue to use and disclose, for the purposes
described above, identifiable information (which may include your child’s
identifiable medical information) related to your child’s participation in this
research study for a minimum of seven years after final reporting or
publication of a project.
After
tests are done on your child’s blood as part of this study, we would like your
child’s permission to keep any remaining blood to use in possible future
research studies. These studies may test
for antibodies that the body produces against the flu as well as to test for
the substances that the immune system produces in response to vaccination. No human genetic tests will be performed on
your child’s samples. Your child’s samples will be labeled only by a code - your child’s study subject number - and will not be
labeled with your child’s name or
initials.
These
samples may be shared with other investigators at other institutions for
studies that are first approved by a scientific and ethical review group at the
institution. If these stored samples are
tested in the future, no identifying information will be used in the reporting
or publication of any results. Results
from this future research would not be reported to your child or your child’s doctor. These coded samples may be shared with other
institutions and researchers.
May I have access to my child’s medical information that results from
my child’s participation in this research study?
In accordance with the UPMC Notices of Privacy Practices document that
your child has been provided, you and your child are permitted access to information
(including information resulting from your child’s participation in this
research study) contained within your child’s medical records filed with your
child’s health care provider.
Is my child’s participation in this research study voluntary?
Your child may decide not to take part or leave the study at any time,
even after signing the consent form. If
you or your child decides to leave the study,
there is no penalty or loss of benefits in your child’s routine medical care or any other benefit(s) that your
child would otherwise be entitled to receive. If your child
decides to leave the study your child will be
asked to come back to the center for a final visit.
In
addition, your child should talk with
the study doctor who will discuss future treatment and procedures for your child’s continued care when they are no
longer in this study.
May I withdraw, at a future date, my consent for my child’s
participation in this research study?
Your child may withdraw, at any time, consent for your child’s
participation in this research study, to include the use and disclosure of your
child’s identifiable information for the purposes described above. (Note, however, that if your child withdraws
consent for the use and disclosure of your child’s identifiable medical record
information for the purposes described above, your child will also be
withdrawn, in general, from further participation in this research study.) Any identifiable research or medical
information recorded for, or resulting from, your child’s participation in this
research study prior to the date that your child formally withdrew consent may
continue to be used and disclosed by the investigators for the purposes
described above.
To formally withdraw your child’s consent for your child’s
participation in this research study you child should provide a written and
dated notice of this decision to the principal investigator of this research
study at the address listed on the first page of this form.
Your child’s decision to withdraw consent for your child’s
participation in this research study will have no effect on your child’s
current or future relationship with the University of Pittsburgh. Your child’s decision to withdraw consent for
your child’s participation in this research study will have no effect on your
child’s current or future medical care at a UPMC hospital or affiliated health
care provider or your child’s current or future relationship with a health care
insurance provider.
If you child decides to withdraw from study participation after your
child has received the study vaccine, your child should participate in
described monitoring follow-up procedures directed at evaluating the safety of
the study vaccine..
If my child agrees to take part in this research study, can my child be
removed from the study without my consent?
·
Your child is diagnosed with an illness or
other condition that may need treatments that are not allowed in this study
If your child
is removed from the study, the study doctor will
contact your child to discuss the procedures and appropriate future treatment
for your child’s continued care.
In some cases, the study doctors may
decide that your child should not
receive the second vaccine, but may not take your child off the study. This
means we would ask that your child continue with the study visits and phone
calls but we will not do blood drawing on Visits 4 and 5
You may store my
child’s unused coded (identified as described on pages 13 and 14) for an
indefinite period of time for future research as described above.
Yes No _______________________
Initials
of Research Subject or Legal Guardian
You may store child’s
unused samples for an indefinite period of time for future research as
described above, but you must remove any information that could identify it as
my child’s (labeling it only by study and dose group).
Yes
No _______________________
Initials
of Research Subject or Legal Guardian
You may not use my
child’s samples for other future research.
Destroy my child’s unused samples at the end of this study.
Yes
No _______________________
Initials
of Research Subject or Legal Guardian
VOLUNTARY CONSENT
The above information has been explained to me and all of my current
questions have been answered. I
understand that I am encouraged to ask questions about any aspect of this
research study during the course of this study, and that such future questions
will be answered by a qualified individual or by the investigator(s) listed on
the first page of this consent document at the telephone number(s) given. I
understand that I may always request that my questions, concerns or complaints
be addressed by a listed investigator.
I understand that I may contact the Human
Subjects Protection Advocate of the IRB Office, University of Pittsburgh
(1-866-212-2668) to discuss problems, concerns, and questions;
obtain information; offer input; or discuss situations that have occurred
during my child’s participation.
______________________________
Child’s Name
I understand that, as a minor (age less than 18
years), the above-named child is not permitted to participate in this research
study without my consent. Therefore, by signing this form, I give my consent
for his/her participation in this research study.
______________________________
Parent’s Name (Print)
______________________________
Relationship to Participant (Child)
______________________________ _______________
Parent’s Signature Date
Assent
This research has been explained to me, and I
agree to participate.
______________________________ _______________
Signature of Child-Subject Date
______________________________
Printed Name of Child-Subject
Verification of Explanation:
I certify that I have carefully explained the
purpose and nature of this research to (name of child) in age appropriate
language. He/she has had an opportunity to discuss it with me in detail. I have
answered all his/her questions and he/she provided affirmative agreement (i.e.,
assent) to participate in this research.
______________________________ _______________
Principal/Co-Investigator Signature Date
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and
purpose of this research study to the above-named individual(s), and I have
discussed the potential benefits and possible risks of study
participation. Any questions the
individual(s) have about this study have been answered, and we will always be
available to address future questions as they arise. I further certify that no
research component of this protocol was begun until after this consent form was
signed.
___________________________________ ________________________
Printed Name of Person Obtaining Consent Role in Research Study
_________________________________ ____________
Signature of Person Obtaining Consent Date
_________________________________ _____________
Signature of Investigator Date