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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.

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Justice requirements regarding human subjects research. This SOP specifies requirements for research supported by the National Institute of Justice and/or conducted within the Bureau of Prisons.

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.

There is the inherent risk that incidental findings (IF) may be discovered on research- directed imaging procedures. These IFs may or may not be of clinical significance. The incidence of detected abnormalities when imaging varies depending on a number of factors including age of subjects, health status, the technology used and the expertise of the individual reviewing the image.

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.

All activities involving the collection of human biological specimens for research purposes, as well as the research use of specimens collected for clinical care, must be conducted under the terms of an IRB approved research protocol. The collection and use of human biological specimens (either identifiable or de-identified) must comply with all applicable laws and regulations for research involving human biological specimens or superseding requirements.

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).

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

In general, an anecdotal report on one or a series of patients seen in one’s own practice and a comparison of these patients to existing reports in the literature is not research and does not require IRB approval. Going beyond one’s own practice to seek out and report cases seen by other clinicians creates the appearance of a systematic investigation with the intent to contribute to generalizable knowledge and therefore is considered research and would require IRB approval.

The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Energy (DOE) requirements regarding human subjects research.

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.