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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 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.

For any employee who does not meet the PI eligibility criteria in OSP operating standard 200.03 - Principal Investigator (PI) Eligibility, a request to waive the PI eligibility operating standard must be submitted and approved by the Office of Sponsored Programs (OSP).

The standards and procedures described in this document provide guidance to all researchers and animal handlers for the responsibility of the Principal Investigator (PI) to ensure that all institutional regulations are implemented within the PI maintained areas, for animals maintained and tested for limited periods greater than 12 hours for USDA-regulated species and 24 hour for non-USDA regulated species.

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

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.

This operating standard presents various types of final reports requested at the end of a project period to close out a sponsored project, with emphasis on collaboration amongst central offices, Office of Sponsored Programs (OSP), and the Principal Investigator (PI) in providing and reconciling all pertinent information.

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.

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.

This Policy seeks to preserve the benefits of life sciences Dual Use Research of Concern (DURC) at the University while minimizing the risk that the knowledge, information, products, or technologies generated from such research could create the potential negative consequences identified in the Federal DURC Policy.

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

While any person may make a report if they have reasonable cause to believe that a child or elder was abused or neglected, North Carolina law mandates that certain persons who suspect child or elder abuse or neglect report this.

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 standards and procedures described in this document provide guidance to all researchers and animal handlers for the establishment and maintenance of a Satellite Animal Facility.

The standards and procedures described in this document provide guidance to all researchers and animal handlers on submitting requests for exceptions to federal and institutional Standards in place for the humane care and use of animals used in teaching and research at UNC-Chapel Hill.