Financial Conflict of Interest
Seattle Children’s Research Institute is dedicated to maintaining public trust in the integrity of our research related activities. The identification and responsible management of financial conflicts of interest (FCOI) is crucially important both for safeguarding research objectivity and for compliance with federal regulations and Seattle Children’s policies. The ORC is responsible for administration of the FCOI program, which includes staff education about FCOI, review of all reported financial interests, effective management of any FCOI matters and reporting to appropriate federal agencies as needed. For questions regarding FCOI, contact Research Integrity Officer Nicole Jacobs.
Federal Regulations
The Research Institute's FCOI policy has been developed to address and comply with the specific federal agency requirements defined in the United States Department of Health and Human Services' Objectivity in Research Regulations 42 CFR part 50 subpart F (grants) and 42 CFR part 94 (contracts).
Terms and Definitions
Note that the terms below and other FCOI terms are officially defined in policy RIA-003 (PDF).
Investigator
For purposes of FCOI, investigator means any person who shares responsibility for the design, conduct or reporting of the results of a sponsored project, including the person's spouse (or domestic partner) and dependent children. Examples of an investigator include, but are not limited to, faculty, postdoctoral fellows, staff scientists, graduate students, lab technicians, technologists, research nurses or clinical research associates.
Financial conflict of interest
FCOI is a divergence between an individual’s financial interest and that individual’s hospital obligations, such that an independent observer might reasonably question whether the performance of the hospital obligations are adversely affected (or have the potential to be) by considerations of personal gain, and in the case of research, includes the existence of a significant financial interest of an investigator that could directly and significantly affect the design, conduct or reporting of the research.
Financial interest
Briefly, a financial interest is anything of economic or monetary value possessed by an investigator that could reasonably appear to affect or to be affected by the particular research under consideration, including, but not limited to, compensation in exchange for personal services (e.g., consulting fees, 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). For a more in-depth definition of financial interest, please refer to policy RIA-003 (PDF).
Significant financial interest (SFI)
To ensure that we comply with the federal regulations in all cases, Seattle Children’s uses lower thresholds for the definition of what constitutes a "significant" financial interest. These thresholds are established as recommended by the Association of American Medical Colleges and the Association of American Universities Joint Advisory Committee on Financial Conflicts of Interest.
Seattle Children’s definition of significant financial interest is:
- For all human subjects research, any financial interest is SFI. Please note this includes expense-paid travel to clinical trial investigator meetings.
- For all research other than human subjects research and any technology transfer activity, SFI is (i) any financial interest (compensation, equity and intellectual property interest) where the total aggregate value exceeds $10,000 or (ii) any equity interest representing more than a 5% ownership in any single entity.
Questions?
Contact ORC for questions or further guidance.