Project Specific COI Disclosure Process
Read more on federal conflict of interest disclosure requirements.
| Definitions | |
| “Investigators” | The Principal Investigator, key personnel or other personnel who are responsible for the design, conduct or reporting of research. |
| “Significant Financial Interest” | A significant financial interest (SFI) is defined as a financial interest consisting of one or more of the following interests of the Investigator (or those of their spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities including a publicly traded entity, a non-publicly traded entity, intellectual property rights, and/or sponsored or reimbursed travel. |
| Proposal Stage | |
| Project Specific COI Disclosures for ECU Investigators | Investigators must submit a project specific disclosure for each proposal and provide updates throughout the year if necessary. ECU employee disclosure site: Conflicts of Interest Risk Manager (COI RM). |
| Project Specific COI Disclosures for Non-ECU Investigators | Non-ECU employed Investigators must complete a disclosure prior to proposal submission. The PI should direct these individuals to the ECU COI website for subrecipients and contractors. |
| Project Specific COI Disclosures for Subrecipient Investigators | Investigators proposed under a subcontract or consortium may comply with their employer’s PHS-compliant COI policy. However, if the proposed subrecipient does not have a PHS compliant policy, the PI should direct the investigators to the ECU COI website for subrecipients and contractors. |
| Advance Notification to ORA | In advance of a proposal deadline, PIs should provide a list of all Investigators and subrecipients to the Office of Research Administration. ORA will confirm that all Investigators have an updated COI disclosure on file with the university. ORA will also confirm that any proposed subrecipient organizations have a PHS-compliant COI policy. |
| Proposal Submission | Remember, the proposal cannot be submitted until the COI disclosure requirement is met by all Investigators. |
| Award Initiation | |
| COI Disclosure Update | All investigators must update their project specific COI disclosures in the event a new SFI has been acquired. A COI Management Plan must be in place prior to acceptance of the award. |
| CITI Training on COI | Investigators must have completed CITI training on COI before the award account can be established. ORA will contact ORIC to confirm training through CITI records. |
| CITI Training for Non-ECU Investigators | The training requirement is waived only for subrecipient Investigators whose employers have a COI policy that is compliant with the prevailing PHS regulation. Other Investigators must complete the ECU CITI Training module. Confer with ORIC on how to proceed with this compliance requirement. |
| Award Duration | |
| COI Disclosures | Investigators must update COI disclosures within 30 days of acquiring or discovering new financial interests. |
| Travel | Update COI disclosures for any travel sponsored by extramural organizations. |
| Change in Investigators | Newly added Investigators must be checked for compliance with disclosure and training requirements. Please confer with ORA and ORIC. |
Additional Information
- Promoting Objectivity in Research
- ECU Online COI Disclosure System: Conflicts of Interest Risk Manager (COI RM)
- CITI COI Training
- Understanding Guidelines for Investigators
- For questions, contact ORIC.