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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.

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

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.

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).

This procedure describes the requirements for obtaining consent from human research subjects participating in research conducted under the auspices of UNC-Chapel Hill.

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

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 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).

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 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.

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.

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.

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

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.