Informed Consent for Clinical and Tumor Molecular Profiling Data
Purpose
In its Treatment Education Program, Clearity provides
information about standard treatment options for your clinical situation as
well as the latest promising results from drugs in clinical development. A member of the Clearity scientific team will
review your clinical and tumor testing information with you and help you find
clinical trials for which you may be eligible, if/when appropriate.
Clearity does not provide medical advice about
which treatments you should receive. Instead, our staff explain tumor-testing
results and standard treatment options for your situation as well as provide
potential questions, and other information, that you can discuss with your physician.
Clinical Information and
Test Results
You have provided us with your clinical
information (e.g., clinical history) and will be having the results from the
testing of your tumor (or blood) sample sent to us. That
testing was performed to find out if
your cancer has certain molecular biomarkers. The biomarkers include chemical materials,
such as proteins and
RNA, which may cause cancer cells to grow out of control.
The biomarkers may also include changes in your DNA, called mutations. Biomarker test
results may help your doctor make
decisions about the best treatment
options for your ovarian cancer.
Storage of Your
Information in the Clearity Database
To help with your educational
discussions with Clearity staff, we will enter the clinical information that
you provide to us from your medical records (e.g., surgeries, chemotherapy
treatments) into The Clearity Foundation Database.
To enable our search of clinical trials
that match the biomarkers in your tumor, we also enter the chemical and
genetic
information about your tumor
samples
into the Database. Your personal
information (name, address, medical
record number, etc.) and clinical
information will be kept confidential in a privacy-protected, securely
encrypted place.
The Clearity
Foundation keeps your clinical
information and tumor molecular profiling results confidential and fully obeys
the Health Insurance Portability and Accountability Act (HIPAA). Your information will only
be released as directed by
you, which would include the healthcare provider (s) or his or her designee, as directed by you
(or a person legally authorized to act on your behalf) in writing, or as
required by federal and state laws.
Possible Risks
The Clearity Foundation takes all reasonable steps to protect
confidentiality, but confidentiality
cannot be guaranteed.
Possible Benefits
Understanding standard of care options, and
knowing the molecular profile of your
tumor may help you and
your doctor make more informed choices about your cancer treatment.
However, there is no guaranteed benefit to you from the educational and
clinical trial information provided by Clearity staff.
Consent