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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.

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).

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.

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).

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.

A Laboratory Safety Plan must be prepared for each campus laboratory by the Principal Investigator and submitted online to the Environment, Health and Safety Office. The purpose of the Laboratory Safety Plan is to provide safety information specific to that laboratory for the benefit of the laboratory workers and for emergency response planning.

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).

The Office of Sponsored Programs (OSP) approves Just-in-Time (JIT) Requirements for National Institutes of Health (NIH) awards through eRA Commons.* The Principal Investigator (PI) first supplies the information in eRA Commons and in Research Administration Management System and eSubmission (RAMSeS), then notifies OSR, who then reviews and approves the information before submitting the approval to NIH and updates University records.