AFFILIATE SITE NAME AND IRB #
INFORMED CONSENT FORM TO PARTICIPATE IN RESEARCH
TITLE OF RESEARCH STUDY:
Serial Neurocognitive Screening of Children and Adolescents During Treatment For
Acute Lymphoblastic Leukemia (ALL) on the Dana Farber Cancer Institute ALL
Consortium Study 11-001 (K1363).
CONTACT:
Principal Investigator:
Insert Institutions’ PI Name
Site Address:
Phone Number:
Insert your Institution’s Address
Insert Contact Phone Number
If you are a parent or legal guardian of a child who may take part in this study,
permission from you is required. The assent (agreement) of your child may also be
required. When we say “you” in this consent form, we mean you or your child; “we”
means the doctors and other staff.
WHY AM I BEING INVITED TO TAKE PART IN THIS STUDY?
You are being asked to take part in this research study because you have been diagnosed
with cancer and because the cancer or the treatment that you are getting for that cancer
might affect the function of your central nervous system, including the brain. This is also
called neuropsychological function. For example, children treated for cancer can
sometimes develop learning, thinking, or behavioral problems. These problems can lead
to trouble remembering things, paying attention, planning ahead, and keeping up with
their classmates at school. The overall goal of this study is to identify subjects who are
more likely to develop problems with neuropsychological and behavioral function. This
information may help improve treatment planning for children with cancer in the future.
This study is in collaboration with the Dana Farber Cancer Institute (DFCI). DFCI is a
research group that conducts clinical trials for children and adults with cancer. Clinical
studies include only people who choose to take part. You have a choice about whether or
not you take part in this clinical study.
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Please take your time to make your decision. You may want to discuss it with your
friends and family. We encourage parents to include their child in the discussion and
decision to the extent that the child is able to understand and take part.
HOW LONG IS THE STUDY?
As part of this study, all subjects will be assessed at five (5) time points during therapy
and again 1-year post therapy for a total of six evaluations, each lasting about 25
minutes.
Your doctor or the study doctor may decide to take someone off this study under the
following circumstances:
•
if he believes that it is not in your best interest
•
if you are removed off the therapeutic study
WHY IS THIS STUDY BEING DONE?
The overall goal of this study is to assess neurocognitive functioning in children and
adolescents (5 to 18 years of age) diagnosed with Acute Lymphoblastic Leukemia
(ALL), in 5 domains (areas), (working memory, executive function, memory, processing
speed, and attention). You will be tested at 5 time points during the study and (1) one
year after you have completed the study.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
We anticipate enrolling approximately 100 subjects from all nine institutions
participating in the DFCI consortium who have enrolled in the DFCI protocol 11-001,
(CUMC K1363). Approximately fifteen (15) subjects will be enrolled at Columbia
University Medical Center.
WHAT WILL HAPPEN ON THIS STUDY THAT IS RESEARCH?
Data will be collected using an innovative computer based battery (CogState), with
which the relevant tasks can be administered in approximately 25 minutes by trained
staff members who are available at the time of a regularly scheduled medical visit (e.g.,
nurse, research assistant, study coordinator, psychologist, social worker). This battery is
available in English, Spanish and French Canadian. Participation thus would not require
a separate visit to a neuropsychologist. Use of this tool would minimize the burden for
families and greatly enhance the feasibility of collecting reliable data at multiple time
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points during therapy and 1 year after completion of therapy.
The design is longitudinal, with subjects being assessed at five (5) times during therapy
and again 1-year post therapy for a total of six evaluations
The neurocognitive assessment schedule is as follows:
•
Time I:
One practice administration and Baseline within two to
three weeks of start of protocol therapy
•
Time II:
During week three of Consolidation I
•
Time III:
During week three of CNS phase
•
Time IV:
After the intrathecal therapy in consolidation II,
During week three of that cycle (approximately 8 weeks after
the start of consolidation II).
•
Time V:
Fifteen months post-diagnosis (± 4 weeks), during week
three of a Continuation cycle.
•
Time VI:
One year after the completion of protocol therapy (± 8
weeks).
You can stop participating at any time. However, if you decide to stop participating
in the study, we encourage you to talk to the study doctor and your regular doctor
first.
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE
STUDY?
While most children enjoy the one-to-one interactions during these evaluations, some
find the testing tiring or frustrating. Rarely the testing may remind you about other
problems. If the results of your testing show that you have problems that are concerning
to the study doctors, you may be given further assessments or referrals for other care. In
this case, you may be asked to participate in additional testing.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
We hope that you will get personal medical benefit from participation in this clinical
study, but we cannot be certain. The study evaluation may find thinking, learning,
remembering, or other problems that perhaps would otherwise not have been found.
We expect that the information learned from this study will benefit other subjects in the
future.
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WHAT OTHER OPTIONS ARE THERE?
Instead of being in this study, you have these options:
•
•
Choose not to take part in this study
Take part in another study
Please talk to your doctor about these and other options.
COSTS/REIMBURSEMENTS:
There will be no costs to you or your insurance company for participating in this trial.
COMPENSATION
You will not receive any payments for taking part in this study.
COMPENSATION/TREATMENT IN THE EVENT OF INJURY:
There are no physical risks, or research related injury associated with this study.
By signing this consent form, you are not waiving any of the legal rights, which you
otherwise would have as a subject in a research study.
H. CONFIDENTIALITY:
We will do our best to make sure that the personal information in your medical record
will be kept private. However, we cannot guarantee total privacy. Your personal
information may be given out if required by law. If information from this study is
published or presented at scientific meetings, your name and other personal information
will not be used.
Each subject will have a file that includes all the forms from the psychological testing.
The file will be stored according to the rules set by the American Psychological
Association, the group that publishes guidelines for psychologists to follow.
Organizations that may inspect and/or copy your research records for quality assurance
and data analysis include groups such as:
•
The investigator, study staff and other medical professionals who will be
evaluating the study
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



including the Institutional Review Board ('IRB')The Office for Human
Research Protections), or other domestic or foreign government bodies if
required by law and/or necessary for oversight purposes
Dana Farber Cancer Institute
Insert your IRB information .
Authorities from Columbia University Medical Center and New York Presbyterian
Hospital and the Columbia University Medical Center Institutional Review Board
The study data collected by a computer will be assigned a code number, and separated
from your name or any other information that could identify you. The research file that
links the subject name to the code number will be kept in a secure location on the 7th
floor of the Herbert Irving Pavilion and only the investigator and study staff will have
access to the file.
I hereby grant permission to access my childs’ basic medical and demographic
information that will be stored in a secured database for statistical purposes only.
Protected health Information will not be collected.
If the results of this research project are published or presented at a scientific or medical
meeting, you will not be identified. Otherwise, all results will be kept confidential and
will not be divulged (except as required by law) without permission.
You will be asked to review and sign a HIPAA Authorization form describing
confidentiality.
If you refuse to provide your authorization to disclose your protected health information,
you will not be able to participate in this study
L. WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
You can talk to your study doctor about any questions or concerns you have about this
study. Contact your study doctor, insert your study doctor information and telephone
number.
For questions about your rights while taking part in this study, call the
Institutional Review Board at your institution.
Insert your Institution IRB information and contact number.
An Institutional Review Board is a committee organized to protect the rights and welfare
of human subjects in research.
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WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose not to be in this study. If you
decide not to be in this study, you will not be penalized and you will not lose any benefits
to which you are entitled. You will still receive medical care.
During the testing, you may skip questions that are stressful and you may stop taking the
tests at any time.
You can decide to stop being in the study at any time. Leaving the study will not result in
any penalty or loss of benefits to which you are entitled. Your doctor will still take care
of you.
We will tell you about new information that may affect your health, welfare, or
willingness to stay in this study.
You may ask to be given a summary of the study results after they are written up. This
may be several years from now since all people on the study need have completed
assessment.
You will get a copy of this form. You may also ask for a copy of the protocol (full
study plan).
SIGNATURE
I have read this form and all of my questions have been answered. By signing below, I
acknowledge that I have read and accept all of the information above.
Signature of Research Participant
Date
Print Name of Research Participant
Signature of Person Obtaining Consent
Date
Print Name of Person Obtaining Consent
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