PROTOCOL TITLE: _______________________________________________
PROTOCOL NUMBER: _______________________________________________
PRINCIPAL INVESTIGATOR: _______________________________________________
The word “you” means both the person who takes part in the research and the person who gives permission to be in the research. This form and the attached research informed consent form need to be kept together. The words “we” and “[CE]” mean the [Covered Entity].
What is the purpose of using and sharing my protected health information?
We are asking you to take part in the research study described in the attached informed consent form. We need to be able to collect, use, and share your protected health information in order for you to participate in this research study.
What protected health information about me will be collected, used, and shared with others during this research study?
For you to be in this research study, we need your permission to collect, use, and share health information that identifies you (your “health information”), which may include one or more of the following:
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Demographic information, such as, but not limited to, your name, date of birth, address, other contact information (e.g., telephone, fax, email address), gender, insurance information, and Social Security number;
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The results of medical tests, questionnaires, and interviews; and
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Information from your medical record, including your medical record number.
We will only collect, use, and share information that is needed for the research.