Parents of Minor
Subjects _____________________________________________________________________________
Consent
Form Version Date: January 30, 2003
Title
of Study: Characterization
of mucus and mucins in bronchoalveolar lavage fluids from infants with cystic
fibrosis
Principal
Investigator: Terry L.
Noah, MD
Co-Investigators:
Margaret W. Leigh, M.D.,
George Z. Retsch-Bogart, M.D., C. William Davis, Ph.D.
Sponsor: National Institutes of Health
_____________________________________________________________________________
You are being asked to allow your child
to take part in a research study. The investigators listed above are in charge
of the study; other professional persons may help them or act for them.
What
are some general things you should know about research studies?
Research studies are designed to gain
scientific knowledge that may help other people in the future. Your child may not receive any direct
benefit from participating. There may also be risks associated with
participating in research studies.
Your child’s participation is voluntary. You may refuse to allow this participation,
or may withdraw your permission at any time, and for any reason, without
jeopardizing your family’s future care at this institution or your relationship
with your doctor. If your child is a
patient with an illness, your child does not have to participate in research in
order to receive treatment.
Details
about this particular study are discussed below. It is important that you understand this information so that you
can decide in a free and informed manner whether you want your child to
participate. You will be given a copy
of this consent form. You are urged to
ask the investigators named above, or staff members who may assist them, any
questions you have about this study at any time.
What is the purpose of this
study?
The purpose of this research study is to
learn how much and what kind of mucus is present in the lungs of infants with
cystic fibrosis (CF), before they develop infections. This is important because currently CF physicians do not know whether
the excess sticky mucus causes, or results from, infection in the lungs of
young children with CF. Finding out the answer to this will help focus further
research into new strategies for prevention of early lung disease in CF.
How
many subjects will participate in this study?
Your child will be one of approximately
8-10 subjects in this research study.
How
long will your child’s participation last?
Your child’s participation in this study
will last for approximately 12 months, and you and your child will be asked to
visit UNC Hospitals 3 times during the 12 months. Each time you come, the tests will take about 4 hours.
What
will happen if your child takes part in the study?
You and your child will be asked to come to UNC Hospitals for 3 separate
visits, the first within the first 6 weeks of life, then repeat visits at about
6 months of age and 12 months of age.
At each of these 3 visits, the following will occur:
1. Bronchoscopy and bronchoalveolar
lavage (BAL)
You will be asked to bring your child to the anesthesia pre-care area so
an anesthesiologist can meet your child, examine him/her and review his/her
medical history. You and your child will remain together until it is time for
the bronchoscopy. Your child will undergo bronchoscopy either in the
Bronchoscopy Lab or the Operating Room. Your child will be given medicine to
make him/her sleepy. After your child
is sedated, a bronchoscopy will be done. You will be asked to wait in the
waiting area during this procedure. After
applying medicine to numb the nose and throat (XylocaineŇ), a thin tube is inserted through the nose and down into the
lower airways. A small amount of sterile salt water (2 teaspoonfuls), is placed
into the airways through the tube, and then suctioned out. This process, called
bronchoalveolar lavage or “BAL,” is done twice, in order to draw up a sample of
lung fluid. This procedure will also be repeated in another area of the lung.
The study team will videotape your child’s airways during the bronchoscopy so
the procedure may be viewed by your child’s doctor. The bronchoscopy and BAL
procedures take about ten minutes. The sample will be analyzed for types of
cells, the presence of inflammation or infection. Any specimens of BAL which
remain after the completion of the lab tests will be frozen and stored for
future research studies involving cystic fibrosis. After the bronchoscopy,
nurses will closely check your child until he/she is fully awake. Your child may then be sent home as directed
by the doctor.
2. Questionnaire
In
addition to your child having a bronchoscopy done, you will be asked to fill
out a questionnaire regarding the kinds of respiratory symptoms your child has
been having, and what medications he/she is taking.
3.
Storage of BAL fluid for
future research
Because
lung secretions from infants with CF are so valuable for research, if any of
the BAL fluid is left over after the research tests are done for this study, it
will be stored in a freezer for possible future use in other research studies.
Are
there any reasons your child should not participate?
Your child
should not participate in this study if any of the following apply to him/her:
1. History of reactions to or problems with
anesthesia or sedation.
2. History of hemoptysis (coughing up
blood).
3. History of anemia (low red blood cell
count) or thrombocytopenia ( low platelet count).
4. Acute respiratory infection or pulmonary
exacerbation within 14 days prior to bronchoscopy.
5. Administration of any investigational
drug within 30 days prior to today’s visit.
What
are the possible risks or discomforts?
This study might involve the following
risks and/or discomforts for your child:
·
Bronchoscopy
can cause some irritation of the walls of the nose, throat or bronchial
passage. If this occurs, it can cause
some bleeding, coughing, or wheezing (happens in 1-2% of patients). Leakage of air through the bronchial wall
and lung collapse can also occur but it is much rarer (less than 1%). These complications are minimized by using a
very small bronchoscope (1/8 inch wide) and having the procedure done only by
experienced bronchoscopists. The study
doctors are very experienced at doing this procedure.
·
The
bronchoscope will partially block the breathing passage while the procedure is
being done. In some cases this can make
breathing difficult, but your child’s breathing and oxygen level will be
constantly monitored during the procedure.
If he/she has difficulty breathing the procedure will be interrupted or
cancelled.
·
Insertion
of the bronchoscope causes a risk of infection in the lung. The risk of this is very small (less than
1%) because the bronchoscope is sterile, although the bronchoscope may transfer
infection from the nose to the lung.
·
Bronchoscopy
can cause a transient (temporary) slowing of the heart rate in 1-2% of
cases. This can occur even if the
child’s oxygen level is kept high.
·
Bronchoalveolar
lavage (BAL) can cause transient fever during the 24 hour period following the
procedure. This is seen more commonly
in young children only when there is a significant amount of inflammation
already present in the airways. Fever
after bronchoscopy (BAL) is treated with acetaminophen (Tylenolâ).
·
The
sedative medications given to make your child sleepy and comfortable during the
bronchoscopy can occasionally cause his/her breathing to become slow or
shallow. This will be monitored closely
throughout the procedure with both monitors and direct observation of your
child, in the same way as it is done routinely whenever bronchoscopy is done in
children for non-research purposes.
In addition, there may be uncommon or
previously unrecognized risks that might occur.
What
are the possible benefits?
As part of this
study, we will be obtaining cultures from your child’s lungs. Bronchoscopy (BAL) is the only procedure
available to obtain reliable cultures from the lower airway of young patients
with CF. If your child has an unsuspected pulmonary infection, these results
may be useful to your child’s doctor as they may assist him/her in choosing
appropriate antibiotic therapy. This
research is designed to gain knowledge that might help CF patients in the
future. We hope this study gives us new
information about lung mucus in CF, which would aid in the development of new
treatments for CF.
What
if we learn about new risks during the study?
You will be given any new information
gained during the course of the study that might affect your willingness to
continue your child’s participation.
How
will your family’s privacy be protected?
No subjects will
be identified in any report or publication about this study. Although every
effort will be made to keep research records private, there may be times when
federal or state law requires the disclosure of such records, including
personal information. This is very unlikely,
but if disclosure is ever required, UNC-CH will take all steps allowable by law
to protect the privacy of personal information.
Your privacy will be maintained by
assigning a code to your child’s BALF specimen and your questionnaire. Your child’s name will not appear in any
publication resulting from this research.
A copy of this consent form will be
placed in your child’s medical record.
This will allow the doctors caring for your child to obtain information
about what procedures he/she is receiving in the study and treat him/her
appropriately, if he/she has other health problems or needs during the study.
Will
you or your child be paid for participating?
Your child will receive $350 for
completing this study. If he/she does not complete the study,
his/her compensation will be prorated as follows: $100 for each bronchoscopy completed. (An additional $50 will be given upon completion of the entire
study)
You will receive $200 for completing this
study. If you do not complete the
study, your compensation will be prorated as follows: $50 for each questionnaire completed. (An additional $50 will be given upon completion of the entire
study). You will also be compensated
for travel at the rate of $0.33 per mile, and parking will be free in the
hospital parking deck.
Will
it cost you anything if your child participates?
The costs of this research will be paid
by the sponsor. There will be no costs
to you for participating.
Who is sponsoring this study?
This research is
funded by the National Institutes of Health.
This means that the research team is being compensated by the sponsor
for conducting the study. The
researchers do not, however, hold a direct financial interest in the sponsor or
the outcome of the study.
What
will happen if your child is injured by this research?
All types of research involve possible
risk, some including the risk of personal injury. In spite of all precautions,
your child might develop complications from participating in this study. If
such complications arise, the researchers will assist you in obtaining
appropriate medical treatment, but any costs associated with the treatment will
be billed to you and/or your insurance company. The University of North
Carolina at Chapel Hill has not set aside funds to compensate you for any such
complications or injuries, or for related medical care. You may contact the
principal investigator, Dr. Noah, at XXXXXXXXXX if you have any concerns related to possible bronchoscopy-related
complications for your child; if he is not available, you may contact the
Pediatric Pulmonologist on call at XXXXXXXXX. You do not waive any of your legal rights by signing this
form.
What
if you want to stop before your child’s part in the study is complete?
You can withdraw your child from this
study at any time, without penalty. The
investigators also have the right to stop your child’s participation at any
time. This could be because he/she has had an unexpected reaction, because you
have failed to follow instructions, or because the entire study has been
stopped.
What
if you have questions about this study?
You have the right to ask, and have
answered, any questions you may have about this research. If you have further
questions, or if a research-related injury occurs, you should call Dr. Terry L.
Noah, M.D. at XXXXXXXXXX .
What
if you have questions about your child’s rights as a subject?
This research has been reviewed and
approved by the Committee on the Protection of the Rights of Human Subjects
(Medical IRB) at the University of North Carolina at Chapel Hill. If you have any questions or concerns
regarding your child’s rights as a research subject, you may contact the
Chairman of the Committee at XXXXXXXXXX.
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Parent’s
Agreement:
I have read the information provided
above. I voluntarily agree to allow my child to participate in this study.
_________________________________________
Printed Name of Research Subject (Child)
_________________________________________
_________________
Signature of Parent Date
_________________________________________
Printed Name of Parent
_________________________________________
_________________
Signature of Parent Date
_________________________________________
Printed Name of Parent
_________________________________________ _________________
Signature of Person Obtaining Consent Date
_________________________________________
Printed Name of Person Obtaining Consent