STATEMENT OF THE RESEARCH
It is a principle of medical practice that a subject who is to participate
in the clinical research investigation must give his or her and/or
parent or guardian's informed consent to such participation. Clinical
research studies include only patients who consent to take part.
This consent must be based on an understanding of the nature and
risks of the treatment, device or procedure. This document provides
information important for this understanding. If you have any questions,
please ask.
INTRODUCTION
Before agreeing that you/your child will take part in this project,
it is important that you read and understand the following explanation.
It describes purpose, benefits, risks and discomforts, and the safeguards
that will be taken. It also describes the other options available
and the right to withdraw from the study at any time.
BACKGROUND
Because you/your child has been diagnosed as having a Central Nervous
System Teratoid/Rhabdoid tumor, you are being asked to participate
in this study. You/your child's doctors would like to submit the
information about your child's tumor, it's treatment, and your child's
clinical course, to a central database that stores information about
patients with this tumor. Because this tumor is rare, this kind
of information is not available in medical literature.
PURPOSE
The purpose of this project is to collect information about the
clinical course and treatment of patients with Teratoid/Rhabdoid
tumor, so that in the future, the medical literature will include
information about the treatment of this tumor, and about outcomes.
PROJECT PLAN
When the diagnosis of Teratoid/Rhabdoid tumor is made, if you consent,
clinical information (such as age, sex, tumor size, X-ray reports,
surgical reports, type of treatment given) from your child's chart
will be sent to the tumor registry, using data capture forms. The
forms are filled out so that only your child's initials and date
of birth are used, so that your child cannot be identified. This
means that your privacy is protected, and the registry personnel
will not contact you. We will, however, respond to your questions
if you request contact. This study will take place in the hospitals
all across the United States of America as well as some international
hospitals.
BENEFITS
There is no immediate or direct benefit of this study for you. Indirectly,
your participation in this study will help us learn how best to
treat this rare tumor. This information will then be helpful in
the treatment of childhood Teratoid/Rhabdoid tumor in the future.
RISKS
There is no additional risk in participating in this study.
ALTERNATIVES
The alternative is not to participate in this study. Whether you
choose to participate or not will in no way affect you/your child's
medical care at Cleveland Clinic Foundation or with the Pediatric
Hematology/Oncology Department.
CONFIDENTIALITY
Records of patients are private, and any knowledge that is gained
that can be used to identify patients will not be given to anyone
other than your doctors and the staff at the tumor registry. Knowledge
that is gained from this study may be published in scientific journals,
but will not identify any patient.
COST
There is no cost to you if you participate.
OTHER INFORMATION
Taking part in this research study is completely voluntary. By signing
this Consent Form, you agree to take part in this research study.
If you have any questions at any time, they will be answered. If
you choose/your child/your ward chooses not to take part, you will
still be offered the best care for the patient's needs.
HOW TO GET ANSWERS TO YOUR
QUESTIONS
You are encouraged to ask questions both before you agree to be
in the study and also at any time you need information. If you have
any questions about this study please contact the researcher, Dr.
Joanne Hilden, at 216-444-8407. If you participate in the study
and have questions at a later date, please also feel free to ask.
If you have any questions about your rights as a research subject,
you should contact the Institutional Review Board (216/444-2924).
SIGNATURE
____________________ __________________________________
Date Subject Signature
____________________ ___________________________________
Date Witness/Person Obtaining Consent Signature
Permission of Parent/Legal
Guardian
You and your child have had the above research project explained
to you and your child, in a language that you and your child understand,
and you give permission for your child's participation.
_____ ____________________________ _________________________
Date Parent or Guardian's Printed Name Parent or Guardian's Signature
Child Assent Statement (Children Above
Age 7)
I have had the above research project explained to
me in language that I can understand and I agree to participate.
_______________ _____________________ ________________________________
Date Child (printed name) Signature of child
