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This document establishes the definitions followed by the University of North Carolina at Chapel Hill (UNC-Chapel Hill) Human Research Protection Program. This is a non-exhaustive list. Regulations and other documents (e.g. guidance documents issued by federal regulatory agencies) should be referenced when applicable.

This SOP establishes written procedures for ensuring prompt review and reporting of any Unanticipated Problems Involving Risks to Subjects or Others, Serious Noncompliance, Continuing Noncompliance, Suspension or Termination of IRB approval.

This procedure describes the requirements for obtaining consent from human research subjects participating in research conducted under the auspices of UNC-Chapel Hill.

UNC-Chapel Hill Library protects user privacy by limiting the collection and disclosure of personal information to what is necessary or legally required. The policy ensures confidentiality of library records, compliance with state laws, and responsible handling of electronic data, vendor interactions, and optional features like Reading History.

To designate the University of North Carolina at Chapel Hill (the “UNC-Chapel Hill”) as a HIPAA Hybrid Entity in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and all regulations promulgated thereunder (hereinafter collectively referred to as “HIPAA”).

To designate the privacy and security officials for the University of North Carolina at Chapel Hill (the “UNC-Chapel Hill”) in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and all regulations promulgated thereunder (hereinafter collectively referred to as “HIPAA”).

UNC-Chapel Hill is committed to conducting research in compliance with all applicable laws, regulations, and UNC-Chapel Hill policies. As part of this commitment, UNC-Chapel Hill has adopted this policy to clearly define the circumstances under which Research Health Information (RHI) may be used or disclosed in connection with research activities. Additionally, this Policy details the methods of reclassifying Protected Health Information (PHI) into RHI.

The purpose of this Procedure is to establish how requests to access patient records for research purposes will be reviewed, approved, and processed. This Procedure applies to all UNC Adams School of Dentistry personnel who seek to access Protected Health Information (PHI) for research purposes.

Pursuant to the Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information for Economic and Clinical Health Act of 2009 ("HIPAA"), individuals have the right to request restrictions to the use and disclosure of his/her Protected Health Information ("PHI") for treatment, payment and health care operations.

The University of North Carolina at Chapel Hill (The "University" or "UNC-Chapel Hill") has a responsibility to protect the privacy and security of protected health information ("PHI") that it creates, receives, accesses, maintains, uses or transmits. Inappropriate access, use, or disclosure of PHI may cause substantial harm to individuals whose information is used or disclosed, and may cause financial and reputational injury to the University.

This policy addresses access, disclosure and use of protected health information (defined below) for University research (including research in the School of Medicine, which is part of the UNC Health Care System HIPAA covered entity) in accord with the Privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The privacy and confidentiality of personal information, including personal health information is addressed in a variety of state and federal regulations and University of North Carolina at Chapel Hill ("UNC-Chapel Hill") policies. This policy addresses the specific privacy obligations required by the Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HIPAA").

Pursuant to the Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HIPAA"), individuals have the right to request an amendment or correction to their medical information. Under specified circumstances, entities may deny the request to amend or correct an individual's medical information.

PHI is health information created by or received from a health care provider, health plan, employer or health care clearinghouse that relates to the past, present, or future physical or mental condition of an individual, the provision of health care services to an individual, or the past, present, or future payment for the provision of health care services, and that identifies the individual.

Pursuant to the Health Insurance Portability and Accountability Act of 1996, as modified by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HIPAA"), individuals have the right to request reasonable alternative means of communications from health care providers in order to ensure confidentiality.