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)
You are invited to participate
in this study because you have 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 breathing tubes and
your 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 body, the immune
system in your body makes proteins called antibodies that help your body fight
the infection. Later, if you are exposed
to the flu, your antibodies will help attack and kill the virus. You may not get sick at all, or you 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
you receive the flu vaccine (sometimes called the flu shot or shots), your
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 body produce H1N1 antibodies that are better at fighting H1N1
flu.
You
have been asked to join this study because you are at least 12 years old, male,
or female who is not pregnant and you have asthma. Also, you are asked to join because you 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.
You
cannot take part in this study if you are allergic to eggs or any of the ingredients
in the vaccine. If you have had any
vaccines in the last 2 to 4 weeks may not able be a part of this study. You may not participate in this research
study if you are pregnant or breastfeeding.
If
you have a history of Guillain Barre Syndrome or have some other chronic
diseases other than asthma you cannot participate in this study. Depending on your smoking history you may not
be able to participate in this study. Also, you may be taking certain
medications that may not allow you 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?
You 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), you will have 5 study visits including 5 blood draws. You will receive H1N1 flu shots about 21 days
(3 weeks) apart during 2 short clinic visits. You 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 you about 1 to 3 days after each shot visit to check
on any reactions or illnesses you may have had since your last visit. After that, study personnel will call you
about 2, 4, and 6 months after the second H1N1 flu shot visit (3, 5, and 7 months after the first
H1N1 flu shot visit) to check on any reactions or illnesses you may have had
since your last visit or telephone call.
If you experienced any reactions or illnesses, the study doctor may ask
that you come back to the study center.
If you agree to take part in the
study and qualify you will be assigned to one of two different vaccine strength
groups. You cannot choose to which group
you will be assigned. You 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 (including height and
weight) will be performed by one of the study doctors.
·
Spirometry – For this test, you will blow
into a machine (spirometer) approximately 3 times in order to see how well you
are able to blow air out of your lungs.
·
Vital Signs (temperature, pulse, respiratory
rate, blood pressure)
·
Urine pregnancy test for females who are
able to have children
·
You will be asked to complete a
questionnaire that will take approximately 15 minutes to complete.
·
Symptom diary – to write down any symptoms
you may have after the vaccine. This may
take 5-10 minutes to complete.
If you decide to
take part in this research study, you will undergo the following procedures
that are not part of your standard medical care:
Screening Procedures:
Procedures to
determine if you are 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 you
are eligible to continue in this study you will continue and undergo the
following experimental procedures:
·
We will watch you for 30 minutes for any
reactions after the H1N1 vaccine
·
We will check the site where you received
the first H1N1 flu shot
·
Repeat Vital Signs
We will give you symptom diaries, a
thermometer, and a ruler. We will ask
you to take your temperature by mouth about the same time every day and write
down the temperature. We will ask you to use the ruler (provided by the study)
to measure the size of any reaction at the place of the shot (or shots). You will also need to write down any symptoms
you have every day during the week after you receive the first H1N1 flu shot
(or shots). You should also write down
any drugs or medicines (including over-the-counter medications, vitamins, and
herbal supplements) you take during this time. You will collect the diary and
thermometer information until the next study center visit (Visit 2).
·
You will be
asked to contact the study doctors right away if you have any unusual or severe
reactions in the first week after you receive the first H1N1 flu shot (or
shots).
Follow-up Phone Call (1-3 days after Visit 1)
·
We will call you 1 to 3 days after the first
H1N1 vaccine to check on any reactions or illnesses you may have had and any
drugs or medicines (including over-the-counter medications, vitamins, and
herbal supplements) you have taken since your last visit.
·
We will review the information in your
symptom diaries.
·
We will also ask you questions about your
asthma.
Visit 2 (8
-10 days after Visit 1)
The
following will be done:
·
Review of current health status and any
reactions you 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 you
received the first H1N1flu shot or shots.
·
A brief physical examination may be done
based on your current health.
·
Spirometry – to check how well you are able
to blow air out of your lungs
· Questions about your
asthma to see how well your asthma is controlled
· Blood draw – 25
milliliter (mL) (about 5 teaspoons)-to measure your 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 you.
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 you may have had since the last visit
· Vital Signs
·
We will check the area or areas on your arm
or thigh where you received the first H1N1 vaccine.
·
We may do a brief physical examination based
on you current health.
·
Spirometry – to check how well you are able
to blow air out of your lungs
· Questions about your
asthma
·
Urine pregnancy if you are a female able to
have children
· Blood draw – 25
milliliter (mL) (about 5 teaspoons) -to measure your 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 you have been assigned to).
·
We will watch you for 30 minutes for any
reactions after the H1N1 vaccine
·
We will check the site or sites where you
received the second H1N1 vaccine
·
Repeat vital signs
We will give you symptom diaries, a
thermometer, and a ruler. We will ask
you to take your temperature by mouth about the same time every day and write
down the temperature. We will ask you to use the ruler to measure the size of
any reaction at the place of the shot (or shots). You will also need to write down any symptoms
you have every day during the week after you receive the second H1N1 flu shot
or shots. You should also write down any
drugs or medicines (including over-the-counter medications, vitamins, and
herbal supplements) you take during this time. You will collect the diary and
thermometer information until the next study center visit (Visit 4)
· You will be asked to contact the study
doctors right away if you have any unusual or severe reactions in the first
week after you receive the second H1N1 flu shot (or shots).
Follow-up
Phone Call (1-3 days after Visit 3)
·
We will call you 1 to 3 days after the
second H1N1 flu shot to check on any reactions or illnesses you may have had
and any drugs or medicines (including over-the-counter medications, vitamins,
and herbal supplements) you have taken since your last visit.
·
We will review the information in your
symptom diaries with you.
·
We will also ask you some questions about
your asthma.
Visit
4 – (8-10 days after Visit 3)
The following will be done:
·
Review of current health status and any
reactions you 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 you
received the second H1N1 flu shot (or shots).
·
A brief physical examination may be done
based on your current health.
·
Spirometry – to check how well you are able
to blow air out of your lungs
· Questions about your
asthma to see how well your asthma is controlled
· Blood draw – 25
milliliter (mL) (about 5 teaspoons) - to measure your 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 you.
Follow
up Procedures
Visit
5 – (18-24 days after Visit 3)
The following will be done:
·
Review of current health status and any
reactions you 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 current health.
·
Spirometry – to check how well you are able
to blow air out of your lungs
· Questions about your
asthma to see how well your asthma is controlled
· Blood draw – 25
milliliter (mL) (about 5 teaspoons)-to measure your antibody levels and for
other substances that the immune system makes in response to the vaccination.
· If you have not
received this year’s seasonal flu vaccine before starting this study, this
vaccine will be offered at this visit at no cost to you.
Follow-up
Phone Call (2 months after the second shot or shots)
Follow-up
Phone Call (4 months after the second shot or shots)
Early
Withdrawal Visit
· If you decide to
leave the study early, or if we have to remove you from the study, or because
you are no longer eligible to continue, we will ask you to come back to the
study center for a final visit during which some of the same study procedures
will be done.
All clinic visits will take place in the Asthma
Institute located in Montefiore Hospital.
Clinic visits will take approximately 1 ½ hours to complete. The telephone calls may take approximately
15 minutes of your 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
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 you
receive 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.
You will receive the vaccine in a clinical setting with medical
personnel observing you after each shot (or shots) for 30 minutes and who are
able to treat you if you have 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
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. You 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
to you. The risks of this year’s
seasonal flu vaccine may be the same as those of the H1N1 vaccine.
Blood Draw
Some
people get lightheaded, nauseated or faint.
If you have a snack or water before the blood draw you are less likely
to faint. The fainting feeling will pass
if you 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
You cannot
participate in this study if:
Treatments
and procedures involved in this research project may involve unexpected risks
to your unborn or nursing child.
If you
participate in this study, you 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
you are 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. You should
not breastfeed your baby while on this study.
You may ask one of the study staff about counseling or for information
about preventing pregnancy.
If you should become pregnant while
participating in this study, or if you suspect that you have become pregnant,
you 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
you against the “seasonal flu”.
What
treatments or procedures are available if my I decide not to take part in this
research study?
Before you decide to take part in this study, the Study doctor
will talk with you about these and other options available to you. The alternative is not to participate in the
study.
If I agree to take
part in this research study, will I 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 you, nor
your 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). You will be charged,
in the standard manner, for any procedures performed for your routine medical
care.
Will I be paid if I
take part in this research study?
You will be paid a
total of $485 if you complete all parts of this study, which will be given to
you in two parts. You 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 participation in this study will be
paid for by the study.
Who will pay if I am
injured as a result of taking part in this study?
If you believe that the research procedures
have resulted in an injury to you, 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 you 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 you. If your 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 ability to sue if you develop 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, you 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 you at
the time you sign this consent.
Who will know about
my participation in this research study?
Any information
about you obtained from this research will be kept as confidential (private) as
possible. All records related to your
involvement in this research study will be stored in a locked file
cabinet. Your identity on these records
will be indicated by a case number rather than by your name, and the
information linking these case numbers with your identity will be kept separate
from the research records. You will not
be identified by name in any publication of the research results unless you
sign 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 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 time in this research study.
This research study
will not result in identifiable information that will be placed into your medical
records held at UPMC Presbyterian.
Who will have access
to identifiable information related to my 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 identifiable medical
information) related to your participation in this research study:
Authorized
representatives of the University of Pittsburgh Research Conduct and Compliance
Office may review your identifiable research information (which may include
your 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 identifiable medical information) related to your
participation in this research study in response to an order from a court of
law. If the investigators learn that you
or someone with whom you are 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
identifiable medical information) related to your 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
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 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 identifiable medical
information) related to your 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
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
identifiable medical information) related to your 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 participation in this research study?
The investigators
may continue to use and disclose, for the purposes described above,
identifiable information (which may include your identifiable medical
information) related to your 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 blood as part
of this study, we would like your 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 samples. Your samples will be labeled only by a code - your study subject number
- and will not be labeled with your 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 you and your doctor. These coded samples may be shared with other
institutions and researchers.
May I have access to
my medical information that results from my participation in this research
study?
In accordance with
the UPMC Notices of Privacy Practices document that you have been provided, you
are permitted access to information (including information resulting from your
participation in this research study) contained within your medical records
filed with your health care provider.
Is my participation
in this research study voluntary?
You may decide not to take part
or leave the study at any time, even after signing the consent form. If you decide to leave the study, there is no
penalty or loss of benefits in your routine medical care or any other
benefit(s) that you would otherwise be entitled to receive. If you decide to leave the study you will be
asked to come back to the center for a final visit.
In addition, you should talk with the study doctor who will discuss
future treatment and procedures for your continued care when you are no longer
in this study.
May I withdraw, at a
future date, my consent for participation in this research study?
You may withdraw, at
any time, your consent for participation in this research study, to include the
use and disclosure of your identifiable information for the purposes described
above. (Note, however, that if you
withdraw your consent for the use and disclosure of your identifiable medical
record information for the purposes described above, you 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 participation in this
research study prior to the date that you formally withdrew your consent may continue
to be used and disclosed by the investigators for the purposes described above.
To formally withdraw
your consent for participation in this research study you 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 decision to
withdraw your consent for participation in this research study will have no
effect on your current or future relationship with the University of Pittsburgh. Your decision to withdraw your consent for
participation in this research study will have no effect on your current or
future medical care at a UPMC hospital or affiliated health care provider or
your current or future relationship with a health care insurance provider.
If you decide to
withdraw from study participation after you have received the study drug, you
should participate in described monitoring follow-up procedures directed at
evaluating the safety of the study drug.
If I agree to take part
in this research study, can I be removed from the study without my consent?
·
You
are diagnosed with an illness or other condition that may need treatments that
are not allowed in this study
If you are removed from the study, the study doctor will contact
you to discuss the procedures and appropriate future treatment for your
continued care.
In some cases, the study doctors may decide that you should not
receive the second vaccine, but may not take you off the study. This means we
would ask that you continue with the study visits and phone calls, but
we will not do blood drawing on Visits 4 and 5.
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.
You may store my
unused coded (identified as described on pages 13-14) samples for an indefinite
period of time for future research as described above]
Yes No _______________________
Initials
of Research Subject or Legal Guardian
You may store my 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 mine (labeling it only by study and dose
group).
Yes
No _______________________
Initials
of Research Subject or Legal Guardian
You may not use my samples for other future
research. Destroy my unused samples at
the end of this study.
Yes
No _______________________
Initials
of Research Subject or Legal Guardian
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 participation.
By signing this
form, I agree to participate in this research study. A copy of this consent form will be given to
me.
____________________________ ____________________________
Participant’s
Signature Printed
Name of Participant
________________
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