Download CTSU 0218 HIPAA auth - Southeast Clinical Oncology

CTSU/GOG 0218
Southeast Cancer Control Consortium Consent Form
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 Cancer Trials Support Unit (CTSU) is an organization that coordinates research for many
National Cancer Institute (NCI) sponsored national cooperative groups to learn about the causes
of cancer, and how to prevent and treat cancer. Researchers from one of these groups would like
to use your health information for research:
 Cancer and Leukemia Group B (CALGB)
 National Surgical Adjuvant Breast and Bowel Project (NSABP)
 Radiation Therapy Oncology Group (RTOG)
 Southwest Oncology Group (SWOG)
 Gynecologic Oncology Group (GOG)
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 CTSU coordinated 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 CTSU data forms from __________________
________________________________ (SCCC Study Coordinator or Clinical Research
Professional) to learn what information will be shared.
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Southeast Cancer Control Consortium Consent Form
3. Why do the researchers want my health information?
___________________________________________________________ (name of site) will
collect your health information and share it with CTSU and ___________ if you enter this CTSU
research study, or to evaluate your eligibility for a study. The CTSU researchers will use your
information for the following cancer research study(ies).
Study Title and Purpose of Study:
A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus
Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND
#7921) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent
and Extended Bevacizumab, in Women with Newly Diagnosed, Previously
Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal
Cancer
You are being asked to take part in this study because you have ovarian or peritoneal
primary cancer. Standard chemotherapy for your type of cancer usually consists of two
drugs called carboplatin and paclitaxel, which are given every three weeks for a total of
six treatments. Chemotherapy is given to control the growth of your cancer and to lower
the chance of it coming back. This treatment has been found to be effective, but longterm cure is uncommon. Many patients will eventually develop recurrent cancer and
need additional treatment.
1/16/06
A newer drug, called Bevacizumab, has recently been approved by the U.S. Food and
Drug Administration (FDA) for use in combination with chemotherapy in patients with
colon cancer that has spread to distant sites in the body. The Bevacizumab being
provided in this study is for investigational use only and is not the commercially
marketed product. The commercially available Bevacizumab is marketed under the
name of Avastin. Investigational Bevacizumab and commercially available Avastin may
be produced at separate facilities. Although investigational bevacizumab and Avastin
are expected to be very similar, it is possible that some differences may exist.
Bevacizumab is thought to work by blocking the effect of Vascular Endothelial Growth
Factor, (VEGF) a protein made by tumors which can stimulate growth of tumor cells as
well as blood vessels in and around tumors in some patients. Bevacizumab has been
given alone on a clinical trial for patients with ovarian and primary peritoneal cancer
whose tumors have recurred (come back). Approximately 18% of the 62 patients’
tumors have shrunk, and 39% have not grown in at least six months.
The purpose of this study is to compare the combination of carboplatin, paclitaxel and
Bevacizumab to the standard combination of carboplatin and paclitaxel alone.
Effectiveness of treatment will be measured in terms of survival, time without evidence
of cancer growth and quality of life (wellness and physical functioning).
In this study, you will receive treatment with either: 1) the combination of carboplatin,
paclitaxel and Bevacizumab; 2) the combination of carboplatin, paclitaxel and
Bevacizumab followed by extended Bevacizumab treatment for 15 months of total
treatment; or 2) the combination of carboplatin and paclitaxel alone. Researchers in the
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Southeast Cancer Control Consortium Consent Form
Gynecologic Oncology Group and the National Cancer Institute have determined that
the only way to compare the effectiveness and side effects of these three treatments is
to substitute a placebo (fluid without Bevacizumab) for Bevacizumab when
Bevacizumab is not given. The treatment assigned will be based on a process called
randomization, which is explained below.
In addition to the treatment part of this study the researchers plan to create a bank to
store tumor tissue and serum (blood) samples from patients who go on this study. This
will be done in order to perform laboratory studies that will provide important data on
how patients’ cancer responds to treatment and how it relates to survival. You will be
asked to sign a separate section of the Informed Consent if you agree to participate.
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
 Cancer Trials Support Unit (CTSU) and its representatives
 National Surgical Adjuvant Breast and Bowel Project (NSABP)
 Gynecologic Oncology Group (GOG) and its representatives
 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
 A qualified representative of Genetech, Inc.
 Possible other federal or state government agencies
 Central laboratories:______________________where tissue samples (blood, bone
marrow etc.,) are reviewed.
5. How will information about me be kept private?
CTSU 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. CTSU 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.
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Southeast Cancer Control Consortium Consent Form
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.
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 CTSU and
_________ 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.
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Southeast Cancer Control Consortium Consent 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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