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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.

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.

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.

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.

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).

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 guideline provides a standard formula for distributing F&A when collaborations involve more than one department, school, center or institute, Dr. Waldrop has indicated (via the memo and in person) that units may establish their own agreements for sharing of F&A and that these may take precedence over the standard formula.

There is the inherent risk that incidental findings (IF) may be discovered on research- directed imaging procedures. These IFs may or may not be of clinical significance. The incidence of detected abnormalities when imaging varies depending on a number of factors including age of subjects, health status, the technology used and the expertise of the individual reviewing the image.

The health and safety of workers and building occupants is the most important factor to consider in laboratory work. In addition to these health and safety concerns, compliance with OSHA, Radiation Protection, and EPA regulations is also important because of the severe financial consequences, especially related to EPA hazardous waste regulations.