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What information about me may be collected, used or shared with others?

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Template – January 2016

INSTRUCTIONS: Add the following template language to the informed consent document. Change the title of the form to: Informed Consent and HIPAA Authorization Form. Note in submission to the IRB that a combined form will be used for the research protocol.
What information about me may be collected, used or shared with others?

Provide a description of the information to be used or disclosed for the research project. This may include, for example, information in the medical record, results of physical examinations, medical history, lab tests, or protected health information such as name, address or social security number, e.g.,

Why is my information being used?

Your information is used by the research team to contact you during the study. Your information and results of tests and procedures are used to:

Who may use and share information about me?

The following individuals may use or share your information for this research study:

List all names or all classes of persons involved in the research at Penn, e.g.,

Who, outside of the School of Medicine, might receive my information?

List all names or all classes of persons involved in the research at Penn, e.g.,

  • Those working under the direction of the investigator for the study, (e.g. under subcontracts).

  • All research centers participating in the study, even if they are not part of the School of Medicine

  • The funding sponsor and organizations supporting the sponsor

    Oversight organizations

  • The Food and Drug Administration

  • The Office of Human Research Protections

  • The Office of Biotechnology Activities and their committees overseeing gene therapy research

  • The study data and safety monitoring board

Once your personal health information is disclosed to others outside the School of Medicine, it may no longer be covered by federal privacy protection regulations.

The Principal Investigator or study staff will inform you if there are any additions to the list above during your active participation in the trial. Any additions will be subject to University of Pennsylvania procedures developed to protect your privacy.
How long may the School of Medicine use or disclose my personal health information?

Your authorization for use of your personal health information for this specific study does not expire.

Your information may be held in a research database. However, the School of Medicine may not re-use or re-disclose information collected in this study for a purpose other than this study unless:

  • You have given written authorization

  • The University of Pennsylvania’s Institutional Review Board grants permission

  • As permitted by law

Can I change my mind about giving permission for use of my information?

Yes. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the investigator for the study. If you withdraw your permission, you will not be able to stay in this study.

What if I decide not to give permission to use and give out my health information?

Then you will not be able to be in this research study.
You will be given a copy of this Research Subject HIPAA Authorization describing your confidentiality and privacy rights for this study.
By signing this document you are permitting the School of Medicine to use and disclose personal health information collected about you for research purposes as described above.

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