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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.

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 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 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.

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 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 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 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.

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.

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.

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) is committed to ensuring that educational opportunities are offered to research participants, prospective research participants, and community members which will enhance their understanding of research involving human participants at UNC-Chapel Hill and provide them the opportunity to provide input and express concerns. This procedure describes how UNC-Chapel Hill fulfills that responsibility.

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.