Title
Office of Sponsored Programs - 100.02 - Operating Standard Guide
Introduction
Management of sponsored research is a combined effort of the University of North Carolina System Office (UNC-SO), the University proper, the sponsors that provide their support to research efforts at the University, and the Principal Investigators (PIs) who spearhead the research itself. The Office of Sponsored Programs (OSP) considers the policies, regulations, and requirements issued by State, University, and Federal offices for every individual sponsored research project. This is also the case with non-Federal sponsors. While there are many research policies that govern the University, the State-regulated policies summarized below govern research administration at all UNC constituent institutions, including UNC-Chapel Hill.
UNC System Office - Policies Related to Research Administration
UNC-SO policies are established by the UNC Board of Governors, the legal body appointed by the North Carolina General Assembly. The Board is responsible for governing the collection of constituent institutions that compose the UNC multi-campus system.
- UNC-SO Policy 500.1 University Research Relations with Government Agencies and Private Entities, discusses three areas of concern regarding university research:
- Appropriateness in Research. Research collaborations must support teaching, research, and public service while allowing faculty and students freedom to pursue and publish research and findings. Research must be conducted under conditions that ensure academic integrity.
- Proprietary Information. University researchers have the basic right to disseminate their research findings, except in cases where agreements must be made to protect shared proprietary information. Any agreement involving joint use of University facilities for proprietary purposes, or one that restricts publishing research findings, must be reported to the President of the UNC-System.
- Classified Research. In general, sponsored research must be conducted while maintaining openness in teaching and research. In exceptional cases (including those involving the United States government), where classifications impose limitations on the dissemination of research findings, the Chancellor may waive the openness requirement in the greater interest of the University, State, or Nation.
- UNC-SO Policy 500.3 Authorizing the President to Execute Grant Applications and Assurances of Compliance gives the North Carolina Office of the President the authority to determine appropriateness and execute documents of compliance on behalf of the Board of Governors.
- UNC-SO Policy 500.4[R] Regulations on Administering Sponsored Programs establishes general requirements and responsibilities of the University of North Carolina Office of the President and constituent institutions of the UNC system. This includes the establishment and role of SPARC and delegating policy-making authority to the Board of Governors. It also provides general criteria that must be followed in the development of sponsored programs, including the roles and responsibilities of the Office of the President, constituent institutions, and faculty and staff involved with sponsored research.
- SPARC Guidelines Defining Sponsored Programs ensures compliance with Federal and State laws, as well as UNC-GA regulations by providing both general and specific definitions of what is and what is not considered a sponsored program. In addition, the guideline presents clear procedures for submitting and processing externally sponsored program funds to maintain uniform administration throughout the constituent UNC institutions.
UNC-Chapel Hill - University-Wide Policies Related to Research Administration
In adherence to policies and regulations set by the Board of Governors and the State of North Carolina, the University has established policies and procedures tailored to the needs of faculty, staff, and students at the University with regard to research. While there are many University research policies, the following form an essential foundation for conducting and administering sponsored research at the University.
- Responsible Conduct of Research
Faculty, research personnel, postdoctoral research associates, and students are expected to follow the policies and procedures at the University that govern the conduct of research including the Research Ethics Resources.
- UNC-Chapel Hill Policy on Information Classification Standard
In adherence to the University's longstanding commitment to academic freedom and service, the University does not usually participate in sponsored research that restricts or prevents investigators from publishing the results of their investigations. However, in rare instances, exceptions can be made only with the prior approval of the Chancellor or his designee, where certain considerations apply.
Federal Regulations on Research Administration
When it receives Federal funding for sponsored research, the University is required to comply with Federal laws and regulations related to the administration of contracts, grants, and cooperative agreements. These regulations are outlined below.
A. Uniform Guidance
The Office of Management and Budget (OMB) establishes the regulations governing the management of Federally funded grants and cooperative agreements. 2 CFR Part 200 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (commonly known as Uniform Guidance (UG)) house these regulations.
- 2 CFR §200 Subpart D outlines uniform administrative requirements expected of recipient institutions covering topics such as property management, procurement, financial monitoring, and reporting, as well as other compliance issues.
- 2 CFR §200 Subpart E establishes cost principles applicable to expenses on Federally sponsored projects. This includes the differentiation between direct and indirect costs, allowability, and examples of selected items.
- 2 CFR §200 Subpart F identifies the auditing requirements for grant recipients as well as the responsibilities under the Single Audit Act Amendment of 1996.
B. Federal Acquisition Regulations (FAR)
The Federal Acquisition Regulations System (FAR) establishes uniform policies and procedures for acquisitions of supplies and services by all executive agencies. The FAR is the principal document codified in Title 48 CFR Chapter 1 of the Federal Acquisition Regulations System that governs Federal contracts just as Uniform Guidance governs Federal grants and cooperative agreements.
C. Federal Demonstration Partnership
The University is a member of Federal Demonstration Partnership (FDP), a cooperative initiative among select Federal agencies and institutions that receive Federal funds. It is an effort to reduce the layers of administrative work associated with research grants and cooperative agreements.
D. Federal Register
Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.
UNC-Chapel Hill Research Compliance Components
The University is committed to performing sponsored research in accordance with all relevant ethical, legal, and regulatory obligations. As an indication of its commitment and high level of accountability, the University has structured several compliance programs to maintain effective monitoring, auditing, training, education, and communication regarding compliance issues. In addition, the University Research Compliance Officer in the Research Compliance Program (RCP) oversees institutional research compliance issues. These proactive programs coordinate administrative and operational compliance by actively accessing and responding to compliance needs. Concerns related to any of the compliance components listed below can be reported anonymously through the University Compliance Line (now called Carolina Ethics Line), via online submission, or by telephone (1.866.294.8688).
University programs responsible for various compliance proceedings are listed below.
A. Protections for Human Subjects in Research
The University’s Institutional Review Board and Office of Human Research Ethics (OHRE) manages the Human Subjects Protection Program, which provides assurance to the Federal government that the University upholds all ethical and regulatory requirements concerning research that involves human subjects. OHRE also supports and oversees the work of the Institutional Review Boards (IRBs).
B. Humane Animal Care and Use
Two University offices work together to oversee compliance issues pertaining to animal welfare, care, and use of animals used for research. They include:
- Institutional Animal Care and Use Committee (IACUC) - Committee that assesses and approves animal use on campus. Responsible for adherence to Federal regulations related to humane care and use of animals.
- Division of Comparative Medicine (DCM) - (formerly the Division of Laboratory Animal Medicine) Responsible for the care of all vertebrate animals on campus and for providing veterinary care, technical assistance, and laboratory and pathology services for diagnostic and research purposes.
C. Scientific Integrity
The entire University community is responsible for assuring that high standards of integrity and ethical behavior are practiced in all research endeavors. The University’s policy and procedures are outlined in the University Policy and Procedures on Responding to Allegations of Research Misconduct.
D. Research Sponsorship
OSP and the Office of Clinical Trials (OCT) coordinate with IRB and Conflict of Interest Committees, the Office of University Counsel, and Internal Audit, to account for compliance regulations mandated by Federal granting agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), and the Food and Drug Administration (FDA).
E. Research Safety
The Department of Environment, Health, and Safety (EHS) is responsible for adhering to regulations for laboratory, chemical, and health care environment safety.
F. Conflict of Interest
Both the Office of University Counsel and campus Conflict of Interest Committees serve to ensure that research team members and their family members do not have conflicting financial interests with the research they undertake.
G. Health Insurance Portability and Accountability Act
The Institutional Privacy Office works to protect the research data that includes a person’s private Protected Health Information (PHI).
H. Export Control
The Federal government’s export control regulations may prohibit the unlicensed export of specific technologies for reasons of national security or protection of trade. Such exports may require the University to obtain a license from the Department of State or the Department of Commerce before allowing foreign nationals without US citizenship or permanent resident status to participate in research. OSP works with the community to relay important information on export control as it relates to sponsored research at the University.
Contact Information
104 Airport Drive, Suite 2200
Campus Box 1350
Chapel Hill, NC 27599
Phone: 919-966-3411
Fax: 919-962-5011
Email: SponsoredPrograms@unc.edu
OSP Staff assignments may be found in RAMSeS or on the OSP website.