Download Southeast Cancer Control Consortium, Inc

CTSU/GOG - 0198
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?
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The Cancer Trials Support Unit (CTSU) is an organization that does research 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:
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• Cancer and Leukemia Group B (CALGB)
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• National Surgical Adjuvant Breast and Bowel Project (NSABP)
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• Radiation Therapy Oncology Group (RTOG)
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• Southwest Oncology Group (SWOG)
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• 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 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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Participant Initials _______
CTSU/GOG - 0198
Southeast Cancer Control Consortium, Inc.
3. Why do the researchers want my health information?
___________________________________________________________ (name of site) will
collect your health information and share it with GOG Statistical and Data Center and the GOG
Administrative Office if you enter a 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 Randomized Study of Tamoxifen Versus Thalidomide (NSC #66847) in Patients with
Biochemical Recurrence only Epithelial Ovarian Cancer, Cancer of the Fallopian Tube,
and Primary Peritoneal Carcinoma after First Line Chemotherapy
You have been asked to participate in a clinical research study. You have been told also that you
have the option not to participate. This study is being carried out under the sponsorship of the
Gynecologic Oncology Group (GOG); an organization dedicated to clinical research in the field
of gynecologic (female organs) cancer. The GOG is funded by the Federal Government through
the National Cancer Institute (NCI). In general, the research carried out compares the
effectiveness of different methods of treating cancer of the female genital organs.
You will be entered onto this study as part of the Cancer Trials Support Unit (CTSU), a pilot
project run by the National Cancer Institute (NCI) to provide physicians with greater access to
NCI-sponsored Phase III clinical trials.
You have been diagnosed with cancer of the ovary, fallopian tube, or peritoneum (the membrane
lining the walls of the abdominal cavity). You have received initial chemotherapy and your
doctor can find no evidence of cancer at the present time except a blood test that suggests it may
have come back. You have been told that advanced ovarian cancer is considered a chronic
disease and that in most patients, the cancer is likely to return at some point in time.
A drug called thalidomide has been shown to be effective in stopping or slowing tumor growth in
the laboratory and in animals. Thalidomide appears to work by interrupting the growth of new
blood vessels to the tumor. Thalidomide has also stabilized tumor growth in patients with a
variety of cancers other than ovarian, fallopian tube or peritoneal cancer. Thalidomide is
considered research in the treatment of ovarian, fallopian tube and peritoneal cancers. One
purpose of this study is to determine the side-effects of thalidomide given for up to one year in
patients with your type of cancer. The main purpose of this study is to determine which of the
drugs, thalidomide or tamoxifen, may prevent your cancer from returning for the longest time.
Tamoxifen is a hormone that is currently being used in breast cancer patients to prevent
recurrences (return of the tumor). It has been shown to stop or slow growth in patients with
ovarian cancer. If you agree to go on this study, you will be randomized (similar to flipping a
coin) to receive thalidomide or tamoxifen. Neither you nor your doctor will have control over
which of the treatments you receive.
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Participant Initials _______
CTSU/GOG - 0198
Southeast Cancer Control Consortium, Inc.
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.
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 Southeast Cancer Control Consortium (SCCC) Operations Office
• Cancer Trials Support Unit (CTSU) a clinical trials mechanism sponsored by the NCI to
provide greater access to Phase III Trials
• 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) Administrative Office, and Statistical and Data
Center, and members of review groups established by GOG
 Food and Drug Administration (FDA)
 Institutional Review Board (IRB) at your hospital
 National Cancer Institute (NCI)
 Office for Human Research Protections (OHRP)
• Study Sponsor – Celegene, the provider of thalidomide
 Possible other federal or state government agencies
• Central laboratories: GOG Tissue Bank Children’s Hospital in Columbus, OH where
tissue samples (blood, bone marrow, etc.) are reviewed.
• Department of Health and Human Services (DHHS)
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.
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.
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Participant Initials _______
CTSU/GOG - 0198
Southeast Cancer Control Consortium, Inc.
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 or other
researchers associated with the research study.
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Participant Initials _______
CTSU/GOG - 0198
Southeast Cancer Control Consortium, Inc.
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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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