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FOR OFFICE
USE ONLY |
Parental Permission and Young Adult Assent for Participation
in Research
INTRODUCTION:
By signing
this form you have voluntarily agreed to participate in a research study Sleep
Mechanisms in Children: role of metabolism
to be carried out under the supervision of:
Principal
Investigator: Gabriel G. Haddad
Office
Address:
Office
Phone:
CONFIDENTIALITY: (Who May See Your
Records)
The study
research records will be kept confidential and you will not be identified in
any written or verbal reports. As part
of this study, the researchers will review your medical records and will keep
the information confidential. All laboratory specimens and reports will be identified
only by a coded number to maintain subject confidentiality. The research records will be kept in a
secured area and locked in a file cabinet in the research offices of the
Principal Investigator. Research
personnel authorized by the Principal Investigator will have access to these
records. All
laboratory specimens and reports will be identified only by a coded number to
maintain subject confidentiality. The research records will be kept in a secured
area and locked in a file cabinet in the Albert Einstein College of Medicine
Clinical Research Center (CRC). The
Clinical Research Center staff, as well as research personnel authorized by the
Principal Investigator will have access to these records.
Members
of the research team, the sponsors of this research and other institutions who
participate in this study may inspect your research records and medical
records. These include: The Albert
Einstein College of Medicine of Yeshiva University, Montefiore Medical Center,
Jacobi Medical Center, and North Central Bronx Hospital. These
include: The Albert Einstein College of Medicine, Yeshiva University,
Montefiore Medical Center, Yale University and the National Institute of
Health.
All of these groups have been requested to maintain confidentiality.
Your records
may also be inspected by the human research committee(s) of the Albert Einstein
College of Medicine Committee on Clinical Investigations (CCI), and the Montefiore Medical Center
Institutional Review Board (IRB).
WHOM TO CONTACT FOR QUESTIONS:
You can call
the supervisor of this study, named at the beginning of this consent document
in the INTRODUCTORY PARAGRAPH, either Dr. Hoby Hetherington, Dr. Jullie Pan or Dr. Lewis Kass for
Dr. Lewis Kass:
·
You have any questions related to this research project.
·
You have any questions about your rights as a research
participant.
·
You believe you have any injury related to this study.
You may also
call the Administrator of Committee on Clinical Investigations of Yeshiva
University, Monday through Friday between 9 AM and 5 PM, or the IRB Manager of
the Montefiore Medical Center Institutional Review Board, Monday through Friday
between 9 AM and 5 PM.
STUDY SPECIFICS
1. PURPOSE:
You and approximately 47 other young
adults are invited this year to participate in a study that will examine
the levels of certain chemicals in the brain when you are awake and sleep and
how the brain functions during sleep.
We are studying how acetate and glucose (blood sugar) in the brain
change or convert themselves to the chemicals glutamate and glutamine. You have
been asked to participate in this study because you are a normal healthy person
with no disease wand would therefore, represent who a healthy person responds.
2. PROCEDURES:
The study will involve 3 visits to the
Children’ Hospital/MR Center under the observation of Drs. Lewis Kass or
Haddad. Visit #1 is a screening Specialty Clinic visit during which a physical
exam, a history with blood tests will be performed. Visits #2 and 3 will be visits to the magnetic resonance (MR)
visits. Visits and procedures are as follows:
Screening Clinic Visit
(Visit #1):
Before you can be part of
the study, you will come to the Specialty Pediatric Clinic (4th floor of the Children’s
Hospital) for a screening visit of approximately 1 hour. During this visit, the procedures of the
study will be explained to you by a doctor who also will perform a physical
examination and ask about your medical history. During this visit a set of blood and urine tests will be done.
The amount of blood taken will be 1/2 ounce. One week later, after the results
of the first screening visit have been evaluated by the study investigators, Drs.
Kass, or Haddad will call you on the phone, to set up a date for the next
visits as described below. There are 4 groups of adolescent children
participating and you will be randomly assigned to one of these groups, as
described below.
Groups of children
participating (visits #2, 3):
There are 4 groups of children
in this study. Two groups will be studied with an infusion into a vein
containing 13C-acetate and the other two groups with an infusion
containing 13C-glucose. Carbon 13 (13C) is a stable
(non-radioactive) carbon that is present in nature. The 13C is part
of the glucose or acetate, and we use it to study metabolism. These infusions will allow us to monitor the
chemicals in your brain as we describe below.
One group receiving the acetate infusion will be studied during
wakefulness or sleep after a normal daily activities and the other group will
be studied after sleep deprivation of one whole night. That is, you will be studied during the
following day or night after you have not slept one whole night prior to the
study day or night. Similarly, each of the two groups receiving the glucose
infusion will be studied in the same way as for the groups receiving acetate,
that is one group will be studied after normal activities during the previous
day and the other after one night without any sleep.
The studies will be done in a large magnet whether you will be
studied awake or asleep. The study in
the magnet will make us able to look at how your brain functions during sleep
or when you are awake.
PAYMENTS TO
SUBJECTS:
In order to help defray the
costs you have incurred in each visit, we will compensate your family as follows:
$50 for the clinic visit (screen), $100 for the sleep visit and $150 for each
of the 2 NMR studies. If you finish 1-2
phases, you will be
compensated for your time.
3. RISKS:
The risks of this study are
minimal. Intravenous catheters used during the glucose or acetate infusion are
associated with a mild pain upon insertion, and a small risk of localized
bruise, hematoma and/or infection. Other than the needle stick for the local
numbing (anesthesia) of the skin before the infusion is started, this is a
painless procedure. Hence the risks in this whole study are minimal.
If there is a physical injury as a result of this
research, only immediate, essential, short-term medical treatment as determined
by the participating hospital, will be available for the injury without charge
to you personally.
The amount of hemoglobin in your
blood will be tested prior to the study and if it is low you will be excluded
from the study. The total blood loss
for the study will not exceed 1.5 ounces, a volume which is safe to take and
which is only a small fraction of the amount of blood taken during a normal
blood donation
Glucose and acetate are
naturally occurring substances in your body. Carbon 13 is an isotope of carbon,
it is not radioactive and has no known harmful effects. It exists in nature and
it is the form of carbon that can be measured with the magnet.
While high field (4Tesla) magnets of the type
used for this study are still considered experimental, they are well within the
safe limits of magnetic field exposure as currently set by the Food and Drug
Administration and are not considered to have any additional risk. The large magnet and
magnetism will give us chemical information from your body. If you have a pacemaker or some type of
metallic implant, you will be excluded from this study due to possible effects
of magnetic fields on the pacemaker or implant. Be sure to tell us if you know or think you have a pacemaker or a
metallic implant in your body. When you
fill out the attached safety questionnaire make sure that there is no hazard to
you from one of the devices mentioned on the form. There are no known side effects associated with these
procedures. A few people become anxious
when they are in the magnet. If you
think or know that you feel that way, let us know.
PROTOCOLS WITH RESULTING DATA THAT HAVE
THE POTENTIAL TO AFFECT SUBJECT INSURABILITY:
Some tests
reveal information that may not affect a person’s insurability.
4. BENEFITS:
This study offers no direct
benefits to you. However, it is hoped
that the results of this study will give more insight into how the brain uses
glucose (sugar) and acetate in healthy individuals during wakefulness, during
sleep and after people are deprived of sleep. This will not help you but will
help, possibly other children.
5. ALTERNATIVES:
You may choose
not to participate in this study.
COSTS TO SUBJECTS:
These studies
are performed free of charge.
WITHDRAWAL:
Your
participation in this study is voluntary. You may be a participant in it only
if you wish, and you may withdraw from the study at any time. Your treatment by doctors and staff at the
institution(s) involved in this study, now and in the future, will not be
affected in any way if you refuse to participate or if you enter the program
and withdraw later.
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The
information in this Informed Consent Document has been explained and
discussed with you. You have also
been given the opportunity to ask questions about this research and have your
questions answered. A copy of this
consent document has been given to you, whether or not you have agreed to
participate in this study.
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________________________ Signature of
Participant Date _________________________ Signature of
person obtaining consent Date |
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PARENTAL PERMISSION: I
voluntarily give permission for my child to participate in the research
protocol. Signature of
Parent or Guardian Date |
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FOR OFFICE
USE ONLY |
[Help Text1] this paragraph is REQUIRED and should be included on the LAST PAGE of the consent form PRECEDING the Signature Lines.