Title
Office of Sponsored Programs - 300.04 - Pre-Submission Compliance Requirements
Purpose
In accordance with all relevant ethical, legal, and regulatory obligations, the University has established this operating standard demonstrating the University's commitment to have all required compliance-related elements in place before expending funds.
Policy Statement
The University and any persons conducting research on behalf of the institution are required by law to comply with established Federal standards regarding sponsored research. In conjunction, the University is responsible for maintaining compliance through training and education, communication between and among researchers, monitoring, and auditing systems to detect compliance issues, and preventing non-compliance by proactively accessing and responding to compliance concerns.
The University institutes its compliance policies through the combined efforts of University Administration, the Principal Investigator (PI), the Office of Sponsored Programs (OSP), the School of Medicine Sponsored Programs Office (SOMSPO), and the Office of Clinical Trials (OCT), as well as those University offices responsible for maintaining compliance.
Before the approval of a sponsored research proposal, OSP, SOMSPO, and OCT review the proposal to verify compliance information is accurate and complete in the following areas:
- Human Subjects Protection - Submission of Institutional Review Board (IRB) approval, waiver, or exclusion, excluding those pending Just-in-Time (JIT) approval;
- Animal Care and Use - Submission of Institutional Animal Care and Use Committee (IACUC) approval, waiver, or exclusion, excluding those pending JIT approval;
- Research Safety - Identification of research materials requiring Environment, Health and Safety (EHS) approval;
- Export Control
- Notification of intentions to transport materials outside the US;
- Identification of research team members who have foreign national status; and
- Identification of select agents for potential license or export control management.
- Conflict of Interest - Identification by each team member of potential financial interests requiring management by the University; and
- Intellectual Property - Identification of potential patent agreement requirements.
Exclusions
Early submission of a proposal does not guarantee any reduction in the five (5) business days required for final review and approval. OSP should be contacted with any questions regarding IPFs. SOMSPO is the administrative unit for School of Medicine proposals. OCT is responsible for executing clinical trial agreements and other research efforts associated with clinical research.
Related Requirements
Contact Information
For questions regarding this procedure and its related operating standard, please contact SponsoredPrograms@unc.edu.
For questions regarding Pre-Award management or Post-Award administration, please contact the assigned Sponsored Projects Specialist (SPS).
For invoicing, reporting and other financial matters, please contact the assigned Sponsored Projects Accountant.
OSP Staff assignments may be found in RAMSeS or on the OSP website.
History
History Table
| Date |
Description |
| 07/01/2022 |
Revised to reflect new office name. |
| 05/15/2018 |
Revised to coincide with the release of the new OSP Website. |
The operating standards in the Office of Sponsored Programs Operating Standards & Procedures Manual supersede any OSP operating standards, procedures and appendices previously included in the University Business Manual, a publication of UNC-Chapel Hill’s Division of Finance.