Download RTOG 0915 HIPAA - Southeast Clinical Oncology Research

RTOG 0915
Southeast Cancer Control Consortium, Inc.
Authorization (Permission) to Use or Disclose (Release)
Identifiable Health Information For Research
Participant’s Name: ____________________________________________________________
Birth Date: ____________________
1. What is the purpose of this form?
The Radiation Therapy Oncology Group (RTOG) is an organization that does research to learn
about the causes of cancer, and how to prevent and treat cancer. Researchers would like to use
your health information for research. This information may include data that identifies you.
Please carefully review the information below. If you agree that researchers can use your
identifiable health information, you must sign and date this form to give them your permission.
2. What health information do the researchers want to use?
The researchers want to copy and use the portions of your medical record that they will need for
their research. If you enter a RTOG research study, information that will be used and/or released
may include your complete medical record, and in particular, the following:
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The history and diagnosis of your disease
Specific information about treatments you received
Information about other medical conditions that may affect your treatment
Medical data, including laboratory test results, tumor measurements, CT scans, MRIs,
X-rays, photographs of radiation therapy target areas, and pathology results
Information on side effects (adverse events) you may experience, and how these were
treated
Long-term information about your general health status and the status of your disease
Tissue and/or blood samples, associated data related to the analysis of the samples
Numbers or codes that may identify you, such as your Social Security Number and
medical record number.
You may request a blank copy of the RTOG data forms from __________________
________________________________ (SCCC Study Coordinator or Clinical Research
Professional) to learn what information will be shared.
3. Why do the researchers want my health information?
___________________________________________________________ (name of site) will
collect your health information and share it with RTOG if you enter a RTOG research study, or
to evaluate your eligibility for a study. The RTOG researchers will use your information for the
following cancer research study.
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Participant Initials _______
RTOG 0915
Southeast Cancer Control Consortium, Inc.
Study Title and Purpose of Study:
A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT)
Schedules for Medically Inoperable Patients with Stage I Peripheral
Non-Small Cell Lung Cancer
Early stage lung cancer is cancer that is limited to the lung and has not spread to the chest lymph
nodes or other parts of the body. Standard treatment for early stage lung cancer is surgery to
remove the cancer-bearing lung. Patients like you cannot have surgery because of other serious
health problems such as emphysema, diabetes, or heart disease. These patients often receive
radiation therapy.
Standard radiation therapy can involve daily treatment for several weeks and may not be as
effective as surgery at getting rid of the cancer. Standard radiation also may lead to a large
amount of scarring of the normal lung surrounding the tumor, which may make other serious
health problems worse.
A new radiation therapy called stereotactic body radiation therapy (SBRT) is now being offered
to patients with early stage lung cancer who cannot have surgery. The goal of SBRT is to get rid
of the lung tumor and spare the lung. SBRT gives fewer but higher doses of radiation than
standard radiation. It uses special equipment to position the patient and guide focused x-ray
beams toward the cancer and away from normal lung tissue. Research so far suggests that SBRT
can reduce the size or eventually eliminate lung tumors effectively and is relatively safe for
lungs.
There are a number of different approaches and timeframes used in giving SBRT for early stage
lung cancers. The purpose of this study is to compare two previously studied methods of
delivering high dose radiation to the lung to see if one treatment is better. In this study, you will
receive a single SBRT treatment OR 4 SBRT treatments over 4 days.
4. Who will be able to use my health information?
___________________________________________________________ (name of site) will use
your health information for research. As part of this research, they may give your information to
the following Groups taking part in the research. _____________________________________
(name of site) may also permit staff from these Groups to review your original records as
required by law for audit purposes.
Southeast Cancer Control Consortium (SCCC) Operations Office
Radiation Therapy Oncology Group (RTOG)
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
Possible other federal or state government agencies
Central laboratories: offices the RTOG has where tissue samples (blood, bone marrow,
etc.) are reviewed (if applicable).
9/3/09
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Participant Initials _______
RTOG 0915
Southeast Cancer Control Consortium, Inc.
5. How will information about me be kept private?
RTOG will keep all identifiable health information confidential to the extent possible, even
though they and other federal research groups are not subject to the same federal privacy laws
governing clinical centers. RTOG will not release identifiable health information about you to
others except as authorized by this form, or required by law.
However, once your information is given to other organizations that are not required to follow
federal privacy laws, we cannot assure that the information will remain protected.
6. What happens if I do not sign this authorization form?
If you do not sign this authorization form, you will not be able to take part in a research study for
which you are being considered.
7. If I sign this form, will I automatically be entered into the research study?
No, you cannot be entered into any research study without further discussion and separate
consent. After discussion, you may decide to take part in the research study. At that time, you
will be asked to sign a separate research consent form.
8. What happens if I want to withdraw my authorization?
You can change your mind at any time and withdraw this authorization. This request for
withdrawal must be made in writing. Beginning on the date you withdraw your authorization, no
new identifiable health information will be used for research. However, researchers may
continue to use the health information that was provided before you withdrew your permission.
If you sign this form and enter the research study, but later change your mind and withdraw your
authorization, you will be removed from the research study at that time.
To withdraw your authorization, please contact the person below. [He/she] will make sure your
written request to withdraw your authorization is processed correctly.
Contact Person: ________________________________________________________________
Title: _________________________________________________________________________
Address: ______________________________________________________________________
Phone: _________________________________ Fax: __________________________________
9. How long will this authorization last?
If you agree by signing this form that researchers can use your identifiable health information,
this authorization has no expiration date. However, as stated above, you can change your mind
and withdraw your permission at any time.
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Participant Initials _______
RTOG 0915
Southeast Cancer Control Consortium, Inc.
10. What are my rights regarding my identifiable health information?
You have the right to refuse to sign this authorization form. You have the right to review and/or
copy records of your health information kept by _____________________________________
(name of site). You do not have the right to review and/or copy records kept by RTOG or other
researchers associated with the research study.
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Signatures
You will be given a copy of this authorization upon request.
I agree that my identifiable health information may be used and disclosed for research purposes
described in this form.
Signature of Participant or Participant’s Legal Representative:
________________________________________________
Date: ___________________
Printed Name of Participant: ______________________________________________________
Printed Name of Legal Representative (if any): _______________________________________
Representative’s Authority to Act for Participant: _____________________________________
Signature of Person Obtaining Authorization: ___________________________ Date: ________
Printed Name of Person Obtaining Authorization: _____________________________________
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