Authorization to Use and Disclose Protected Health Information
for Research Purposes
Study Title:
Principal Investigator:
If you are a parent, guardian or other authorized representative, as you read the information in this form, the word “you” refers to your child or other research participant for whom you are granting permission.
What is the purpose of this authorization form?
The "Health Insurance Portability and Accountability Act (HIPAA)"contains federal privacy laws that protect the confidentiality of your protected (identifiable) health information (PHI). PHI is personal information that can identify you or can be linked to you. Examples of PHI include information such as your name, date of birth, address or medical record number. UCSF Benioff Children's Hospital Oakland (CHO) or your health care provider (e.g., physician office) cannot release your PHI to the research team unless you give your permission. The research team includes the researchers and people hired by the researchers or the sponsor to do the research. This form describes the different ways that your PHI can be used and released for the above-referenced research study.
Do I have to give my permission for the use and release of my PHI?
No, your permission to use and release your PHI is completely voluntary. Whether or not you give permission will have no effect on your current or future medical care at CHO, or your future relationship with CHO. However, if you do not give your written permission you will not be allowed to participate in the research study. If you decide to give your permission and to participate in the research study, you must sign this form as well as the consent form.*
*Under no circumstances are you required to authorize the
release of psychotherapy notes which must be specifically
authorized in a separate consent form.
How will my PHI be used?
Your PHI may be used to fill out a research report (sometimes called a "case report"). The research report may include your date of birth, initials, dates you received medical care, a unique code number and information the research team collects in the study. Reports will not include your name, address, telephone number, social security number, or any other direct personal identifier in study records released outside of CHO. If you give your permission and sign this authorization form we may use or disclose (release), as applicable, medical history, outpatient reports, progress and consultation reports, results of physical exams and lab tests, diagnostic test reports, operative reports, pathology reports, or other health information and medical records indicating or relating to the research study.
Your PHI may be used and shared with others as described in the consent form for this research study.
Who may use and receive my PHI?
In addition to this study's research team, your PHI may be shared with representatives of the CHO Institutional Review Board for the purpose of monitoring the appropriate conduct of this research study. Other individuals who are required by law to review the quality and safety of the research may review your PHI including regulatory and governmental agencies such as the U.S. Food and Drug Administration (FDA) and European Medical Agency (EMEA), the research sponsor or the sponsor's authorized representatives. These organizations and their representatives may see your PHI. They may not copy or take it from your medical records unless permitted or required by law.
Once your health information is released it may not be protected by HIPAA privacy lawsand might be shared with others. However, other laws protecting your confidentiality may still apply. If you have questions, please ask a member of the research team.
Can I cancel my permission?
Yes, you can cancel your permission at any time. However, if you cancel your permission you will no longer be in the research study. Any PHI that was already collected or released in this research study before the date that you formally cancelled your permission may continue to be used and released by the investigators as necessary to maintain the integrity of the research as described above. No information will be collected after you cancel your permission.
Your request to cancel permission must be made in writing to the investigator responsible for the study, as stated in the research consent form. Your decision to cancel will have no effect on your current or future medical care at CHO, your future relationship with CHO, or your current or future relationship with a health care insurance provider.
How long will the investigators be permitted to use my PHI?
Your PHI will be kept in your research record until the year 20 or until after the study is completed, whichever is longer. At that time, the research information not already in your medical record will be destroyed or your PHI will be removed from the study research records at CHO. Any research information in your medical record will be kept in accordance with CHO medical records policy. Research reports can be used forever.
Your signature below indicates that all of the above has been explained to you and all your current questions have been answered. You give permission for the collection, use, and release of your protected health information as described in this form. A signed copy of this authorization form will be given to you.
Participant’s SignatureDate / Time
Legally Authorized Representative’s SignatureDate / Time
Description of Representative's Authority
(must be completed only if subject is a minor or otherwise incompetent to execute this authorization). For example: “father/mother of minor child”; or “court appointed legal guardian”; or “designated health care surrogate”; or “attorney-in-fact pursuant to durable power of attorney”
I certify that I have explained the nature and purpose of the research use and disclosure of the individual’s PHI in appropriate language. The participant has had an opportunity to discuss this with me in detail. I have answered all questions and the participant has agreed to allow the use and disclosure of identifiable health information for the purpose of this research study.
Investigator’s or designee's SignatureDate / Time
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