Office of Sponsored Research - 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 Research (OSR), the Sponsored Programs Office (SPO), 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, OSR, SPO, 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 licensure 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. OSR should be contacted with any questions regarding IPFs. SPO 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 ResAdminOSR@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.
OSR Staff assignments may be found in RAMSeS or on the OSR website.

History

05/15/2018 Revised to coincide with the release of the new OSR Website.

The operating standards in the Office of Sponsored Research Operating Standards & Procedures Manual supersede any OSR operating standards, procedures and appendices previously included in the University Business Manual, a publication of UNC-Chapel Hill’s Division of Finance.

Details

Article ID: 132284
Created
Thu 4/8/21 9:27 PM
Modified
Wed 4/21/21 10:15 AM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
02/19/2021 9:16 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Distinguished Professor
Last Review
Date on which the most recent document review was completed.
02/19/2021 9:16 AM
Last Revised
Date on which the most recent changes to this document were approved.
04/15/2019 12:00 AM
Origination
Date on which the original version of this document was first made official.
07/01/2008 12:00 AM