Sponsor Requirements
The Department of Energy (DOE) Interim Conflict of Interest Policy applies to investigators involved in or planning to participate in projects funded under a DOE financial assistance award and/or the National Nuclear Security Administration (NNSA) . The policy does not apply to Office of Indian Energy or Phase I Small Business Innovation Research (SBIR) /Small Business Technology Transfer (STTR) applications and financial assistance awards. As a term and condition of all DOE awards, the Financial Conflict of Interest (FCOI) requirements under this policy must be adhered to.
FCOI Disclosures: Investigators proposing to receive or already receiving funding from DOE and NNSA must disclose all domestic and foreign SFIs that are related to the Investigator’s institutional responsibilities. Investigators identified on a project funded by a DOE award are required to update the disclosures at least annually, during the period of the award, and also within thirty days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new significant financial interest. The designated official must review and manage any financial conflicts of interest and provide reports to the DOE.
FCOI Training: Investigators must complete the online CITI Conflict of Interest training prior to engaging in research related to any DOE/NNSA award. Investigators must undergo training at least once every four years, as well as, immediately under the following circumstances:
- Institutional FCOI policies change in a manner that affects Investigator obligations;
- An Investigator is new to UMass Dartmouth;
- UMass Dartmouth finds that an Investigator is not in compliance with the established FCOI policy or management plan;
External Resources:
To address undue foreign influence in NASA-supported research, NASA has developed a conflict of interest (COI) and conflict of commitment (COC) disclosure policy as an associated term and condition applicable to entities implementing NASA financial assistance awards ( i.e., grants or cooperative agreements).
FCOI Disclosures: Investigators who are planning to participate in NASA-funded research must disclose to the institution’s designated official(s) the investigator’s domestic and foreign significant financial interests no later than the time of application for NASA-funded research. Investigators must also update disclosures during the award’s period of performance, either on an annual basis, or as new reportable significant financial interests are obtained. Prior to an institution’s expenditure of any funds under a NASA-funded research award, the designated official(s) shall review investigators’ disclosures of significant financial interests, determine whether a COI exists, and, if so, determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate such COI.
External Resources:
- NASA: Grant and Cooperative Agreement Manual (GCAM)
- NASA Grant Information Circular: 23-07
- NASA Notice: 23-091 - Conflicts of Interest Policy for Recipients of NASA Financial Assistance Awards
The NSF encourages the increased involvement of academic researchers and educators with industry and private entrepreneurial ventures, but recognizes that such interactions carry with them an increased risk of conflicts of interest. The NSF Conflict of Interests Policy requires investigators to disclose all significant financial interests (SFI) of the investigator (including those of the investigator's spouse or dependent children): (i) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.
FCOI Disclosures: Investigators who are planning to submit a proposal to the NSF must submit a COI disclosure no later than at the time of application submission. Financial disclosures must be updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained. The designated official must review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the organization to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.
Note: Responsible Conduct of Research Training is also a term and condition of NSF funding. For more details, see Responsible Conduct of Research (RCR), Sponsor Requirements, NSF. NSF has also released a series of Research Security and Training modules, which are free for U.S. researchers and institutions.
External Resources:
The PHS regulation 42 CFR Part 50 Subpart F: Promoting Objectivity in Research establishes standards that provide a reasonable expectation that the design, conduct, or reporting of PHS-funded research (grants and cooperative agreements) will be free from bias resulting from any Investigator’s conflicting financial interest. PHS requires recipient institutions and their investigators to fully comply with all FCOI disclosure requirements. Under this policy, Financial Conflict of Interest related requirements serve as a term and condition of all PHSawards as well as those from any agency, office, organization or foundation that has adopted their policy. Accordingly, the University of Massachusetts Board of Trustees Policy for Promoting Objectivity in Biomedical Research (Doc. T96-039) was amended and adopted as the PHS FCOI compliance plan for the Amherst, Boston, Dartmouth and Lowell campuses. Investigators who are applying to PHS or any agencies adopting these regulations, or who currently have funding from same, must comply.
NOTE: NIH has also updated their policy regarding what must be disclosed on the Biographical sketch and Other Support. This update is detailed in NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support.
FCOI Disclosures: Investigators, including subrecipient Investigators, proposing to or receiving funding from PHS (or any of the entities listed below) must disclose all domestic and foreign SFIs (and those of the investigator's spouse and dependent children) that are related to the Investigator’s institutional responsibilities that are received from and/or held in an entity outside the institution no later than the time of application for PHS-funded research. COI disclosure submission is required at the time of application, even if there are no SFIs to report, and within 30 days of a new Significant Financial Interest or discovery of one not previously disclosed; and must be updated annually.
PHS Agency Divisions of Health and Human Services
- Administration for Children and Families (ACF)
- Administration on Aging (AoA)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare & Medicaid Services
- Federal Occupational Health (FOH)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian health Service (IHS)
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Commissioned Corps of the Public Health Service
- Office of the Secretary
Additional entities who adopted the PHS FCOI disclosure policy.
Offices and Non PHS Federal Agencies
- Administration for Community Living
- Office of Global Affairs (OGA)
- Office of Public Health and Science (OPHS)
- Office of the Assistant Secretary for Planning and Evaluation (ASPE)
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Office of the Assistance Secretary for Health (OASH)
Non-Federal Organizations and Foundations
- Alliance for Lupus Research (ALR)
- Alpha-1 Foundation
- American Asthma Foundation (AAF)
- American Cancer Society (ACS)
- American Foundation for Suicide Prevention (AFSP)
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- CurePSP
- Harrington Discovery Institute
- Juvenile Diabetes Research Foundation (JDRF)
- Lupus Foundation of America (LFA)
- Patient Centered Outcome Research Institute (PCORI)
- Sage Bionetworks
- Susan G. Komen for the Cure
FCOI Training: Each Investigator must complete CITI Conflict of Interest training prior to engaging in research related to any PHS-funded grant or contract. Investigators must undergo training at least once every four years, as well as, immediately under the following circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements,
- An Investigator is new to UMass Dartmouth;
- UMass Dartmouth finds that an Investigator is not in compliance with the established FCOI policy or management plan.
External Resources
- NIH Financial Conflict of Interest Policy
- NIH Grants Policy Statement
- NIH FAQs regarding the FCOI policy
- NIH Financial Conflict of Interest (FCOI) and Other Support: Reminders (NOT-OD-22-210).
- NIH FCOI Training module
- U.S Department of Health and Human Services Organizational Chart
- AAMC Implementing the Final Rule on Financial Conflicts of Interest in Public Health Service Funded Research