Research Study Title:
UVa IRB-HSR#
HIPAA Authorization:
Confidentiality, Use and Sharing of Health Information for Research Purposes
Participant’s Name ______________________________ Medical Record # _____________________
Your privacy is very important to us and the researchers will make every effort to protect it.
The UVa researchers are asking for your permission to gather, use and share information about you for this
cancer research study. You will also receive a copy of the consent form explaining this cancer research study.
If you decide to not give your permission, you cannot be in this study, but you can continue to receive regular
medical care at UVA.
For this study, we may collect any or all of the following information about you:
o Personal information such as name, address and date of birth.
o Your health information. If required for this study, this may include a review of your medical records and
test results from before, during and after the study from any of your doctors or health care providers. This
may include mental health care records, substance abuse records, and/or HIV/AIDS records.
o Tissue or blood samples, as described in the study consent form, if you agree to provide them for this study.
o Tissue or blood samples if you agree to provide them for genetic testing in this study.
Additional studies using saved tissue or blood samples and information
In the consent form, you may also be asked to choose whether to allow your tissue or blood samples and
information to be stored and used in future research studies. If you choose to agree, the UVA researchers will
send some of your tissue or blood samples and your information to a central database supported by the National
Cancer Institute, called the Biobank, to be saved and used in future research studies on cancers and other health
problems. The information that would be saved and used could include any of the information described above.
The consent form describes in greater detail how the collected information and samples will be stored in the
Biobank and released to researchers for future research studies. You do not have to agree to have your tissue or
blood samples and information saved in the Biobank and used in future research studies. If you do not agree,
you can still be in this cancer research study. You can also continue to receive regular medical care at UVA.
Who will see your private information in this study or in any future research study?
o The researchers to make sure they can conduct the study in the right way, to observe the effects of the study
and to understand its results.
o People that oversee the study to make sure it is conducted correctly.
o People who pay for the study including the National Cancer Institute and insurance companies.
o People who evaluate study results, which can include sponsors and other companies that make the drug or
device being studied, researchers at other sites doing the same study, and government agencies that provide
oversight such as the Food and Drug Administration (FDA) if the study is regulated by the FDA.
Some of the people who receive your information may not have to follow the federal Privacy Rule and may
share or release your information without your permission.
The information collected from you might be published in a medical journal. This would be done in a way that
protects your privacy. No one will be able to find out from the article that you were in the study.
Version Date: 03/22/13
Page 1 of 2
Research Study Title:
UVa IRB-HSR#
What if you sign the form but then decide you don't want to continue having your private
information collected for this study or for future research studies?
You can change your mind at any time. Your permission does not end unless you cancel it. To cancel it, please
follow the directions in the consent form. The researchers may still use information about you that was
collected before you changed your mind .
You will receive a copy of this signed form.
Adult Participant/ Parent/Guardian
___________________________________ _________________________________ ___________
PARTICIPANT /PARENT/GUARDIAN PARTICIPANT/PARENT/GUARDIAN DATE
(Signature)
(Print)
OR
Surrogate Consent
In the event the adult participant is unable to give consent:
__________________/_________________________
PERSON GIVING CONSENT FOR PARTICIPANT
(Signature/ Printed)
_______________
DATE
RELATIONSHIP TO PARTICIPANT: _________________________________________
Consent From Impartial Witness
If this form is read to the subject because the subject is blind or illiterate, an impartial witness not affiliated
with the research or study team must be present for the consenting process and sign the following statement.
The subject may place an X on the Participant Signature line above.
I agree the information in this form was presented orally in my presence and the person had the opportunity to
ask questions. I also agree that the person freely gave their informed consent to allow the release of their health
information.
_____________________________
________________________________
_____________
IMPARTIAL WITNESS
(Signature)
IMPARTIAL WITNESS
(Print)
DATE
Interpreter
This section must be completed if an interpreter is used during the consenting process because the subject does not speak
English.
By signing below you confirm that the information in this form has been fully explained to the potential
subject in a language they understand and all their questions have been answered.
If the interpreter speaks with the participant over the phone, write the interpreters ID # on the signature line below.
_________________________
___________________________________
______________
INTERPRETER
(Signature)
INTERPRETER
(Print)
DATE
Version Date: 03/22/13
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