Download Southeast Cancer Control Consortium, Inc

Alliance A221405
Southeast Clinical Oncology Research 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 Alliance is an organization that does research to learn about the causes of cancer, and how to
prevent and treat cancer. Researchers from the following group would like to use your health
information for research:
 Alliance for Clinical Trials in Oncology (Alliance)
 International Breast Cancer Study Group (IBCSG)
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 an Alliance coordinated research study, information that will be used
and/or released may include your complete medical record, and in particular, the following:
 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 Alliance data forms from __________________
________________________________ (SCOR 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 Alliance if you enter this Alliance research
study, or to evaluate your eligibility for a study. The Alliance researchers will use your
information for the following cancer research study.
10/15/15
Page 1 of 4
Alliance A221405
Southeast Clinical Oncology Research Consortium, Inc.
Study Title and Purpose of Study:
Study Title for Study Participants:
A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy
for young women with endocrine responsive breast cancer who desire pregnancy
Official Study Title for Internet Search on http://www.ClinicalTrials.gov:
Alliance A221405: Pregnancy Outcome and Safety of Interrupting Therapy for women
with endocrine responsIVE breast cancer
You are being asked to take part in this research study because you have been diagnosed with
and treated for hormone receptor-positive early breast cancer, you are currently taking endocrine
therapy, and you have expressed interest in getting pregnant. The best available evidence
suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a
recurrence from her breast cancer. The most recent data also suggest that this is true in women
with a hormone receptor-positive breast cancer. While delivery complications have been
reported, available information does not suggest an increased risk for delivery complications or
for newborns. This new study aims to clarify these results and to help determine how long a
woman should wait before trying to become pregnant after breast cancer diagnosis and treatment.
For women who want to become pregnant after a breast cancer diagnosis, taking five to ten years
of adjuvant endocrine therapy may greatly reduce the chance of a successful conception.
However, temporarily stopping endocrine therapy in these patients in order to try to achieve a
pregnancy earlier has not been studied.
The purpose of this study is to determine whether having a child after temporarily stopping
endocrine treatment is feasible and safe in patients with a hormone receptor-positive early breast
cancer. Specifically, the study will investigate whether a temporary interruption of endocrine
therapy, with the goal of permitting pregnancy and then resuming endocrine therapy to complete
a standard course, is associated with a higher risk of breast cancer recurrence. In addition, the
study aims to evaluate the success of pregnancy, the health of the newborn, and the patient’s
ability to breastfeed.
There will be about 500 women from about 12 countries taking part in this study.
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 Clinical Oncology Research Consortium, Inc. (SCOR) Administrative Office
Alliance for Clinical Trials in Oncology (Alliance)
The International Breast Cancer Study Group (sponsors of the study outside of the U.S.)
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at ____________ Hospital
10/15/15
Page 2 of 4
Alliance A221405
Southeast Clinical Oncology Research Consortium, Inc.
Possible other federal or state government agencies
Central laboratories: Alliance Biorepository at Mayo Clinic. Biospecimen Accessioning
Processing at Mayo Clinic in Rochester, MN and the IBCSG Central Pathology Office
at European Institute of Oncology in Milan, Italy where tissue samples (blood, bone
marrow etc.,) are reviewed.
5. How will information about me be kept private?
Alliance 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. Alliance 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: ____________________
10/15/15
Page 3 of 4
Alliance A221405
Southeast Clinical Oncology Research Consortium, Inc.
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 Alliance or
other researchers associated with the research study.
******************************************************************************
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: _____________________________________
10/15/15
Page 4 of 4