University Community Hospital
Authorization to Use and Disclose (Share) Your Personal Health Information
Name of Clinical Study: <Insert Title of the Research Study>
Principal Investigator:<Insert the Name of the Primary Investigator>
You have agreed to participate in the study mentioned above and have signed a separate informed consent that explained the procedures of the study and the confidentiality of your personal health information. This authorization form will give you more detailed information about how your health information will be used and disclosed and will give permission for those uses and disclosures.
By signing this document you are agreeing to the uses and disclosures (sharing) of your personal health information as described below. You must sign this authorization to be able to take part in the study.
What personal health information is collected and used in this study and might also be shared (disclosed)?
-Your name, address, telephone number, date of birth, social security number
-Your and your family’s medical history, your allergies
-Your current and past medications or medical treatments
-The results of all medical tests performed as part of the study, physical examination results and information that you provide to members of the study team.
Who may use or disclose (share) your personal health information?
-The Principal Investigator and other his/her staff associated with the study
-Members of the University Community Hospital workforce
-The University Community Hospital Research Ethics Review Board (the committee that oversees research on human subjects for the hospital)
Who might receive your personal health information and how will they use it?
As part of the study, your personal health information may be disclosed to: [Modify this list as appropriate- delete or add items as necessary.]:
-The following drug company(ies) that pay for the study and that will be using the information to conduct and monitor the study, to report results of the study to government agencies and to use the combined data (without individual information) for sales and other purposes related to the study: [name those company(ies)]
-A research data coordinating company that will be responsible for coordinating findings and data for the sponsor: [name that group or company [who will be responsible for collecting results and findings from all the centers}]
-The following government agencies and/or their representatives that will be monitoring this study for safety and other purposes: the US Food and Drug Administration, US Center for Medicare and Medicaid Services, the National Cancer Institute [name any other agencies ]
-Others: [name the other group and why they will receive the results]
Once information is disclosed to others outside of University Community Hospital, the information may no longer be protected by law and might be disclosed to others without your knowledge.
How long will this authorization to use and disclose your personal health information last?
This authorization for use and disclosure (sharing) of your personal health information for this specific study will last______
Will you be able to see your study-related record?
You will be able to see your study-related record when the study is completed. Your ability to see your University Community Hospital medical record, if applicable, will be the same as if you had not signed this form.
Can you change your mind?
You may take back your permission for the use and sharing of any of your personal information for research, but you must do so in writing to the University Community Hospital Research Department at: 3100 E. Fletcher Ave., Tampa, Florida 33613. However, even if you take back your permission, the Principal Investigator for the research study may still use your personal information that was collected before you took back your authorization if that information is necessary to the study. Also, if you take back your permission to use your personal health information that means you will be taken out of the research study.
You will be given a copy of this form.
By signing this form I am agreeing to the uses and disclosures of my personal health information as described above.
______
Subject’s Name [print]Subject’s SignatureDate
______
Person obtaining authorization [print]Person obtaining authorization signatureDate
For subjects who cannot give authorization, the authorization is given by the following authorized subject representative:
______
Authorized subject representative [print]Authorized subject representative signatureDate
Provide a brief description of above person’s authority to serve as the subject’s authorized representative.
______
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