IRB No. #5181 Study Title: A Registry for Central
Nervous System Atypical Teratoid/Rhabdoid Tumor
This additional form provides you with specific information
about the use and disclosures that the Cleveland Clinic may make
of your private identifiable health information. This Addendum has
been approved by the Cleveland Clinic Institutional Review Board
and should be used in combination with the IRB-approved consent
form for the above-listed study that you are being asked to participate
in.
The medical and research information recorded about
you will be used within the Cleveland Clinic and/or disclosed outside
the Cleveland Clinic as part of this research. Some of the tests
and procedures done solely for this research study also may be placed
in your medical record so your other doctors know you are in this
study. Upon completion of the study, you may have access to the
research information that is contained in the medical chart.
Your access to research information about you will
be limited while the study is in progress. Preventing this access
during the study keeps the knowledge of study results from affecting
the reliability of the study. This information will be available
should an emergency arise that would require your treating physician
to know this information to treat you best.
Your research information may be disclosed to Joanne
M. Hilden, M.D., the study's principal investigator, and her agents,
the Cleveland Clinic research review staff, the U.S. Food and Drug
Administration, and other outside collaborators or laboratories
that are participating in this study, if any, that are listed as
follows:. (none). The Cleveland Clinic also may use and disclose
this information for treatment and payment reasons. The Cleveland
Clinic must comply with legal requirements that mandate disclosure
in unusual situations. Otherwise, the information recorded about
you as part of this research will be maintained in a confidential
manner. It is possible that information disclosed about you outside
the Cleveland Clinic could be redisclosed and no longer protected
by federal privacy laws.
Your research information may be used and disclosed
indefinitely, but you may stop these uses and disclosures at any
time by writing to Joanne M. Hilden, M.D., Department Chair, Pediatric
Hematology-Oncology, Desk S20, at The Cleveland Clinic Foundation,
9500 Euclid Avenue, Cleveland, Ohio 44195. If you do so, any information
previously disclosed cannot be with-drawn. The Cleveland Clinic
will not use or disclose the information collected in this study
for another research purpose without your written permission, unless
the Cleveland Clinic Institu-tional Review Board gives permission
after ensuring that appropriate privacy safeguards are in place.
The Institutional Review Board is a committee whose job is to protect
the safety and privacy of research subjects.
If you choose not to sign this consent form, you will
not be permitted to participate in this research study.
