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- Knowledge Base
- Finance and Operations
- Finance
- Procurement
This policy provides for efficient ways to procure small dollar items where the financial risks to the University are low and the State of North Carolina does not require competition.
- Knowledge Base
- Research
- Research Operations
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.
- Knowledge Base
- Research
- Animal Care and Use and IACUC
The standards described provide guidance to all researchers and animal handlers administering chemical agents, whether they be pharmaceutical or non-pharmaceutical grade.
- Knowledge Base
- Research
- Clinical Research
The policy defines the responsibilities of a UNC-Chapel Hill (“University”) Principal Investigator (“PI”) in the management of Investigational Drugs and establishes the specific circumstances under which a PI may directly manage Investigational Drugs in the conduct of a clinical trial.
This policy ensures alignment with applicable federal and state laws and regulations, accrediting agency standards, University policies, and sponsor requirements, to uphold research integrity and to ensure part
- Knowledge Base
- Research
- 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.
- Knowledge Base
- Research
- Clinical Research
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
The purpose of this SOP is to ensure compliance with Department of Defense (DoD) requirements regarding the conduct of human subject research.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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).
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.
- Knowledge Base
- Research
- Human Research Ethics and IRB
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.