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This SOP establishes the process for identifying possible institutional conflicts of interests (ICOI) related to UNC-Chapel Hill human subjects research and the process for coordinating with the UNC-Chapel Hill Conflict of Interest Office. The goal of this SOP is to ensure timely, appropriate reviews of possible ICOI.

This SOP establishes written procedures for initiating a response to an emergency impacting the UNC-Chapel Hill Human Research Protection Program (HRPP) or HRPP operations.

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.

The University of North Carolina at Chapel Hill Institutional Review Board (IRB) will review all transnational research involving human participants to assure adequate provisions are in place to protect the rights and welfare of the participants. Approval of research is permitted if the procedures prescribed by the foreign institution afford protections that are at least equivalent to those provided in 45 CFR 46.

This scenario arises when: UNC-Chapel Hill is the lead coordinating center responsible for overall study conduct; or A UNC-Chapel Hill employee serves as principal investigator for the entire multi-site study, (unless coordinating function located elsewhere as in some NIH-sponsored groups), or UNC-Chapel Hill is the sponsor (initiates contracts with and disburses funds to other sites).

The purpose of this SOP to establish written requirements to ensure compliance with U.S. Environmental Protection Agency requirements regarding human subjects research.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the creation of a Privacy Rule for identifiable health information. Except as otherwise permitted, the Privacy Rule requires that a human research subject “authorize” the use or disclosure of the human research subject's "protected health information" to be used in research.

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 SOP provides examples and procedures for the reporting of Promptly Reportable Information (PRI) to the University of North Carolina at Chapel Hill's Institutional Review Board.

When some or all of the participants in a research conducted under the auspices of the University of North Carolina at Chapel Hill (UNC-Chapel Hill) are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity, the research must include additional safeguards to protect the rights and welfare of these participants.

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

This SOP establishes the processes and procedures for ensuring the rights, safety, and welfare of research participants are protected when UNC-Chapel Hill shares responsibility for research oversight with another organization.

The University of North Carolina at Chapel Hill has established an Institutional Review Board (IRB) to ensure the protection of human subjects in research conducted. All non‐exempt human subject research conducted under the auspices of the UNC‐Chapel Hill must be reviewed and approved by the UNC‐Chapel Hill IRB or another designated IRB prior to the initiation of the research unless it has been determined that the UNC‐Chapel Hill is not engaged in the research (See SOP 101.2.6).

This policy establishes the Human Research Protection Program (HRPP) as the body responsible for ensuring UNC-Chapel Hill conducts human subjects research that is ethical and that complies with all relevant laws and regulations.

Federal regulations and University of North Carolina at Chapel Hill (UNC-Chapel Hill) policies require Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals, or a group. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results, and place you and UNC-Chapel Hill in violation of federal regulations.