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The University of North Carolina at Chapel Hill ("University") recognizes the potential value of Human Embryonic Stem Cells in research, including clinical research. The University encourages their responsible use as a means of advancing knowledge, with the eventual goal of using these cells in therapeutic practice in hopes of curing disease and ameliorating other disabling or debilitating health conditions.

The policy establishes the requirements for using University-approved electronic research systems to obtain legally valid electronic signatures on essential documents for clinical research at the University of North Carolina at Chapel Hill (“University” or “UNC-Chapel Hill”). Its purpose is to ensure regulatory compliance, enhance efficiency, and improve oversight of electronic signatures in clinical research.

This Standard is meant to provide the minimum expectations for users of the University of North Carolina at Chapel Hill’s Data Management System (“DMS”) for Clinical Research Administrative Data. This Standard is intended to further the University’s goals of providing DMS users with efficient and accurate administrative data and to promote legal and regulatory compliance.

This Policy is meant to describe how the University of North Carolina at Chapel Hill manages Research Administrative Data for certain types of Clinical Research studies.

This policy outlines the requirements for the delegation of Clinical Tasks to personnel in the conduct of Clinical Research within the University of North Carolina at Chapel Hill facilities. It ensures that individuals to whom Clinical Tasks are delegated for Clinical Research purposes are appropriately licensed, qualified, and trained for their specific responsibilities.

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.

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 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 purpose of this SOP is to ensure compliance with Department of Defense (DoD) requirements regarding the conduct of human subject research.

The UNC IRB has developed this SOP to describe a series of consistent, deliberate steps to mitigate fetal exposure to risk in clinical research studies among women of child-bearing potential (CBP).

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.

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.

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).

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

The purpose of this SOP is to establish written requirements to ensure the University of North Carolina at Chapel Hill's compliance with U.S. Department of Education requirements regarding human subjects research.