Navigating Research Conflict of Interest
🎯 WHAT is a COI?
A COI exists when an investigator’s personal financial interests could potentially bias the design, conduct, or reporting of research, or affect the protection of human subjects in a study.
💡 WHY is it important?
- Protects Research Integrity:
- Maintains academic and scientific integrity.
- Ensures Unbiased Results:
- Identifies potential biases and allows for a management plan.
- Maintains Public Trust:
- Builds confidence among the public and sponsors.
- Ensures Compliance:
- Helps the university meet its legal and regulatory obligations.
📝 WHO needs to disclose?
All researchers and investigators on a project, including co-investigators, collaborators, students, and staff with a financial interest in the sponsoring entity.
📍 WHERE and HOW to disclose?
Disclosures are made using specific forms depending on the funding
source.
- PHS Financial Disclosure Form (NIH and PHS agencies): Disclose income, equity, IP income, and/or sponsored travel over $5,000.
- 700-U Form (State/non-government grants & gifts): Disclose income $500, equity $2,000, and/or gifts $50.
- Non-PHS Form (Federal sources like NASA, NSF, DOD): Disclose income $10,000, equity $10,000 or >5% ownership, and/or management positions.
- DOE financial disclosure form: Any income, equity interests (e.g., stocks), and/or IP income > $5,000
📂 SUBMISSION PROCESS
-
At the proposal stage:
- Answer COI question in Phoebe
- Upload the appropriate forms to the proposal record in Phoebe.
-
At the award stage:
- COI team initiates the review process.
- Approve the Phoebe record once the review process is complete and COI has been approved.
🔎 THE REVIEW PROCESS
- Initial Screening: The COI team reviews the disclosure to determine if a conflict exists.
- Expedited or Full Review: A potential conflict is reviewed by the COI team and determined to be either (expedited), which allows the COI team to approve, or full board, which recommends the COI be assessed by the Faculty COI committee for review.
- Determination: The committee makes a final determination and, if necessary, may recommend implementation of a management plan. Once the management plan is agreed upon, COI will approve the Phoebe record to move forward with the award setup.
- Monitoring: The COI team reserves the right to monitor management plans to ensure implementation and compliance.