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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.

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 ("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.

This policy establishes the University of North Carolina at Chapel Hill ownership of Research Data. The University is obligated, by federal funding agency grant terms, federal and state regulations, policies, other contractual terms, and its mission statement, to ensure that research data and materials are secured and appropriately accessible.

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.

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 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.

The University of North Carolina at Chapel Hill is committed to combatting Human Trafficking. Federal law mandates that federal contractors and subcontractors maintain an anti-trafficking compliance program to qualify for certain federal funds and grants. This policy establishes a compliance plan and reporting requirements that meet federal standards.

This document sets forth the standards of research conduct expected of members of the research community at The University of North Carolina at Chapel Hill, consistent with the Research Code of Conduct Policy.

The University of North Carolina at Chapel Hill, as one of the leading public research universities in the nation, is committed to maintaining the integrity and validity of the academic research conducted by faculty, staff and students. The guiding principles and standards set forth in this policy are in alignment with the University's goal to continually improve and to maintain its status as a world-class research university attracting the best faculty, staff and students.

This procedure explains how the University responds to allegations of Research Misconduct.

Public trust in the integrity and ethical behavior of scholars must be maintained if research is to continue to play its proper role in our University and society. While the primary responsibility for maintaining integrity in research rests with those who conduct it, the University has established standards to ensure a healthy environment for research and compliance with law.

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.

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.