procedures you undergo while in the study) and record it on study documents. The Investigator will keep this personal health information in your study-related records (that we will refer to as "your study records"). In addition, the Investigator may obtain, and include in your records, information regarding your past, present and/or future physical or mental health and/or condition. Your Investigator may ask you to sign a separate authorization to obtain some or all of your medical records from your doctor. Your study records may include other personal information (such as social security number, medical record numbers, date of birth, etc.), which could be used to identify you. Health information that could identify you is called "Protected Health Information" (or "PHI"). [Please note: You must list any other PHI that may be used or disclosed.] Under federal law (the "Privacy Rule"), your PHI that is created or obtained during this research study cannot be "used" to conduct the research or "disclosed" (given to anyone) for research purposes without your permission. This permission is called an "Authorization". Therefore, you may not participate in this study unless you give your permission to use and disclose your PHI by signing this Authorization. By signing, you are agreeing to allow the Investigator] and staff to use your PHI to conduct this study. [Please note: This document must be study-specific. You must list any other uses of PHI by the Investigator that are specific to your study.] By signing this Authorization, you also are agreeing to the Investigator to disclose PHI as described below: The sponsor of this study and anyone working on behalf of the sponsor to conduct this study (referred to as "the sponsor"). The sponsor will analyze and evaluate the PHI and may use it to develop new tests, procedures and commercial products. The study staff will assign a code number and/or letters to your records, which means that you will not ordinarily be identified in the records sent to the sponsor. The sponsor may, however, look at your complete study records that identify you. In addition, the sponsor may visit the study site to oversee the way the study is being conducted and may review your PHI during these visits to make sure the information is correct. The Institutional Review Board ("IRB") may have access to your PHI in relation to its responsibilities as an Institutional Review Board. [Please note: You must list other persons or classes of persons,
procedures you undergo while in the study) and record it on study documents. The Investigator will keep this personal health information in your study-related records (that we will refer to as "your study records"). In addition, the Investigator may obtain, and include in your records, information regarding your past, present and/or future physical or mental health and/or condition. Your Investigator may ask you to sign a separate authorization to obtain some or all of your medical records from your doctor. Your study records may include other personal information (such as social security number, medical record numbers, date of birth, etc.), which could be used to identify you. Health information that could identify you is called "Protected Health Information" (or "PHI"). [Please note: You must list any other PHI that may be used or disclosed.] Under federal law (the "Privacy Rule"), your PHI that is created or obtained during this research study cannot be "used" to conduct the research or "disclosed" (given to anyone) for research purposes without your permission. This permission is called an "Authorization". Therefore, you may not participate in this study unless you give your permission to use and disclose your PHI by signing this Authorization. By signing, you are agreeing to allow the Investigator] and staff to use your PHI to conduct this study. [Please note: This document must be study-specific. You must list any other uses of PHI by the Investigator that are specific to your study.] By signing this Authorization, you also are agreeing to the Investigator to disclose PHI as described below: The sponsor of this study and anyone working on behalf of the sponsor to conduct this study (referred to as "the sponsor"). The sponsor will analyze and evaluate the PHI and may use it to develop new tests, procedures and commercial products. The study staff will assign a code number and/or letters to your records, which means that you will not ordinarily be identified in the records sent to the sponsor. The sponsor may, however, look at your complete study records that identify you. In addition, the sponsor may visit the study site to oversee the way the study is being conducted and may review your PHI during these visits to make sure the information is correct. The Institutional Review Board ("IRB") may have access to your PHI in relation to its responsibilities as an Institutional Review Board. [Please note: You must list other persons or classes of persons,
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