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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.

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.

Investigators are ultimately responsible for the conduct of research. Investigators may delegate tasks to appropriately trained and qualified members of their research team. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities.

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.

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

This policy outlines the responsibilities of IRB members for making known any potential or perceived conflicts of interest (COI) concerning protocols reviewed by the IRB. No IRB member may participate in the review of any research project in which they have a COI, except to provide information, as requested. It is the responsibility of each IRB member to disclose any COI related to a study submitted for review and to recuse him/herself from the deliberations and vote by leaving the room.

Consistent with the University of North Carolina at Chapel Hill’s research, teaching and public service missions, the University encourages faculty, staff and students to engage in appropriate outside relationships, including but not limited to private industry and the nonprofit sector.

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.

A repository is a collection of data or biological specimens whose organizers: Receive data or specimens from multiple sources; Maintain the data or specimens over time; and Control access to and use of data or specimens by multiple individuals and/or for multiple purposes, which may evolve over time

Community based research (CBR) is research that is conducted as an equal partnership between academic investigators and members of a community. In CBR projects, the community participates fully in all aspects of the research process. Community is often self-defined, but general categories of community include geographic community, a community of individuals with a common problem or issue, or a community of individuals with a common interest or goal.

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 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.