Download Southeast Cancer Control Consortium, Inc

CTSU/ACOSOG Z1031: Cohort A
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)
 American College of Surgeons Oncology Group (ACOSOG)
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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CTSU/ACOSOG Z1031: Cohort A
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).
10/1/09
Study Title and Purpose of Study:
A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25
mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with
Clinical Stage II and III Estrogen Receptor Positive Breast Cancer
Researchers have been studying breast cancer to learn the best way to treat the disease.
Chemotherapy (treatment with anticancer drugs) is commonly given before surgery to shrink
breast tumors. The therapy in this research study consists of one of 3 drugs of a type called
hormone therapy (a drug used to lower the level of the hormone estrogen). The hormone
therapies being tested in this study are exemestane, anastrozole, and letrozole. Research has
shown that reducing the amount of the hormone estrogen that gets to the cancer in
postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor
before surgery.
The purpose of this study is to find out whether it is better to receive exemestane, anastrozole, or
letrozole to improve the chance that the breast cancer will get smaller before surgery.
4. Who will be able to use my health information?
2/22/07
5/7/08
___________________________________________________________ (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
American College of Surgeons Oncology Group (ACOSOG)
The Quality Assurance Review Center (QARC), a central review center helping
with this ACOSOG research study
National Cancer Institute (NCI) and its representatives
National Human Genome Research Institute (NHGRI)
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
A qualified representative of applicable drug manufacturers and their authorized
Representatives
Possible other federal or state government agencies
Data Safety Monitoring Board (DSMB)
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CTSU/ACOSOG Z1031: Cohort A
Southeast Cancer Control Consortium Consent Form
Possible other federal or state government agencies
Central laboratories: Barnes-Jewish Hospital North in St.Louis, MO 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.
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: ____________________
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CTSU/ACOSOG Z1031: Cohort A
Southeast Cancer Control Consortium Consent Form
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.
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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