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This standard is to properly inform Principal Investigators (PIs) and Departmental Administrators (DAs) of their responsibilities when receiving sponsored projects and the steps required at project setup.

This operating standard describes general responsibilities for Principal Investigators (PIs) and Department Administrators (DAs) in maintaining essential data for reporting requirements.

This operating standard establishes the overall responsibility of Principal Investigators (PIs) in undertaking sponsored research projects and related components of those projects.

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.

An “Institutional-, investigator- or sponsor-initiated hold” refers to a voluntary action by the institution, investigator or sponsor of the study to place some or all research activities associated with that study on hold. Institutional, investigator or sponsor holds may be the result of interim data analysis, inadequate drug availability, response to a DSMB report/recommendation, pre-planned stopping point or other information.

For any employee who is not a full-time, permanent EHRA employee, a request to waive the University’s Principal Investigator (PI) eligibility operating standard must be submitted and approved by the Office of Sponsored Programs (OSP).

Since sponsored research is at the core of the University’s mission, it is essential that highly qualified individuals are designated to serve in the role of Principal Investigator (PI) in a manner consistent with the Board of Governor’s policy regarding the appropriateness of University Research, and aligned with the University’s policy on ethics in research.

The standards and procedures described in this document provide guidance in documentation to all researchers and animal handlers performing duties that would normally be performed by Division of Comparative Medicine (DCM) Husbandry staff (i.e. feed, water, cage change).

This SOP discusses rules governing investigator self-experimentation and experimentation on family members of investigators.

The standards described below provide guidance to Institutional Animal Care and Use Committee (IACUC) members and UNC researchers/investigators on changes and amendments to UNC approved IACUC protocols.

This operating standard recognizes the roles of lead administrators at the onset of proposed sponsored research and balances the responsibilities of the Principal Investigator (PI), deans, directors, and department heads.

Providing such general responsibilities clarifies expectations and specific tasks of award management that are ascribed to Principal Investigators (PIs) and Departmental Administrators (DAs).

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.

Community based research (CBR) is research that is conducted as an equal partnership between academic investigators and members of a community. In CBR projects, the community participates fully in all aspects of the research process. Community is often self-defined, but general categories of community include geographic community, a community of individuals with a common problem or issue, or a community of individuals with a common interest or goal.

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).