Conflicts in Research
While all NC State employees are subject to REG 01.25.01 – Conflicts of Interest and Conflicts of Commitment, when they are involved in research sponsored by outside entities, including the federal government, NC State must also comply with those agencies’ regulations. The COI Office reviews awards for specific requirements and coordinates with affected personnel, but below are common agencies’ rules that affect NC State research and research personnel.
For questions related to agencies not listed below, please contact the COI Office at coi-support@ncsu.edu.
Federal Agencies’ Conflict of Interest Policies
National Science Foundation (NSF) COI Policy
Investigators’ Responsibilities
No later than at the time of application, have disclosed any Significant Financial Interests (SFI) through their annual Financial Interest disclosure in the RED system.
- NSF defines SFI to mean anything of monetary value, including, but not limited to, salary or other payments for services when aggregated, exceeds $10,000 (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights) from:
- Foreign and Domestic Publicly traded Entity
- Foreign and Domestic Non-Publicly traded Entity
Institutions’ Responsibilities
- Prior to the expenditure of funds on an NSF Award,
- Review all Investigator SFI disclosures
- Determine if any SFIs are related to the NSF-funded research
- Determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the NSF-funded research)
- Develop and implement management plans as needed to manage FCOIs
- Report to NSF Office of General Counsel any unmanageable FCOIs.
Department of Energy (DOE) COI Policy
DOE’s Policy (dated Dec. 24, 2021) is aligned with PHS with one significant difference. DOE Program Offices have the discretion to expand the definition of “Investigator” to also include any person who participates in the purpose, design, conduct, or reporting of the project funded by DOE or proposed for funding by DOE. The relevant Funding Opportunity Announcement (FOA) will include the expanded definition, if applicable.
Investigators’ Responsibilities
No later than at the time of application, have disclosed any Significant Financial Interests (SFI) through their annual Financial Interest disclosure in the RED system.
- DOE defines SFI to mean anything of monetary value, including, but not limited to, salary or other payments for services, when aggregated, exceeds $5,000 (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights) from:
- Foreign and Domestic Publicly traded Entity
- Foreign and Domestic Non-Publicly traded Entity
- Included in the definition of SFI is the occurrence of any reimbursed or sponsored travel (i.e. “sponsored travel” is travel which is paid on behalf of the Investigator and not reimbursed directly to the Investigator so that the exact monetary value may not be readily available), related to the Investigator’s institutional responsibilities.
Institutions’ Responsibilities
- Prior to the expenditure of funds on a DOE Award,
- Review all Investigator SFI disclosures
- Determine if any SFIs are related to the DOE-funded research
- Determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the DOE-funded research)
- Develop and implement management plans as needed to manage FCOIs
- Report FCOIs to DOE
U.S. Public Health Service (PHS) and PHS-like COI Regulations (Including National Institutes of Health (NIH))
All institutes and agencies within the PHS and several other federal agencies and non-federal sponsors (“PHS-like sponsors”) follow the PHS COI regulation. To meet the PHS and PHS-like sponsors’ requirements, the required COI training is integrated into the COI Disclosure form. When you file a COI Disclosure in the RED system, you will be asked to certify your understanding of the federal, state, and University regulations on Conflict of Interest.
Investigators’ Responsibilities
No later than at the time of application, have disclosed any Significant Financial Interests (SFI) through their annual Financial Interest disclosure in the RED system.
- PHS defines SFI to mean anything of monetary value, including, but not limited to, salary or other payments for services, when aggregated, exceeds $5,000 (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights) from:
- Foreign and Domestic Publicly traded Entity
- Foreign and Domestic Non-Publicly traded Entity
- Included in the definition of SFI is the occurrence of any reimbursed or sponsored travel (“sponsored travel” is travel which is paid on behalf of the Investigator and not reimbursed directly to the Investigator so that the exact monetary value may not be readily available), related to the Investigator’s institutional responsibilities.
Institutions’ Responsibilities
- Prior to the expenditure of funds on an NIH Award,
- Review all Investigator SFI disclosures
- Determine if any SFIs are related to the NIH-funded research
- Determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research)
- Develop and implement management plans as needed to manage FCOIs
- Report FCOIs to NIH
PHS Agencies and PHS-like Sponsors
PHS Agencies
- Administration on Aging
- Administration for Children and Families (ACF)
- Administration for Community Living (ACL)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Biomedical Advanced Research and Development Authority
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Planning and Evaluation
- Office of the Assistant Secretary for Preparedness and Response (OASPR)
- Office of Global Affairs (OGA)
- Office of Minority Health Resources Center
- Office of Population Affairs
- Office of Public Health and Science
- Office of Research Integrity
- Office of Research on Women’s Health
- Substance Abuse and Mental Health Services Administration (SAMHSA)
PHS-like Sponsors
- Alliance for Lupus Research (ALR)
- Alpha-1 Foundation
- American Asthma Foundation
- American Cancer Society (ACS)
- American Foundation for Suicide Prevention
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- CurePSP
- Department of Energy (DOE)
- Harrington Discovery Institute
- Juvenile Diabetes Research Foundation (JDRF)
- Lupus Foundation of America (LFA)
- Patient-Centered Outcomes Research Institute (PCORI)
- Susan G. Komen for the Cure