If you are a sponsored researcher, Research Compliance Services (RCS) recommends the following process to ensure that you’ve properly disclosed Significant Financial Interests (SFIs) and any additional outside activity or interest that may require disclosure/approval under the COI-COC policy:
- Complete your SFI declaration through EPCS.
- Complete the COI-COC self-assessment form (available in Word and PDF).
- If you answer yes to any questions on the self-assessment, and all of the information you are prompted to provide is in your SFI declaration, indicate “see SFI declaration” on the self-assessment form and submit it to RCS at email@example.com.
- If you answer yes or are unsure about how to answer any questions on the self-assessment form, and the information is not in your SFI declaration, provide the information requested and submit the complete self-assessment form to RCS at firstname.lastname@example.org.
- Be sure the self-assessment form you submit to RCS has information about any/all outside interests/activities for which you marked yes or unsure.
- If you answer no to all questions on the self-assessment, retain the form for your records.
Review of SFIs for compliance with FCOI regulations and UO FCOI policy
All SFIs declared by investigators will be reviewed by RCS alongside all sponsored projects for which the investigator is responsible for the design, conduct, and reporting of research, and considered in light of the investigator’s institutional responsibilities. A SFI declared by an investigator is not by definition a financial conflict of interest in research (FCOI). The majority of declared SFIs typically are not determined to represent financial conflicts of interest.
Based on UO policy and federal regulations, RCS will determine if a declared SFI is related to that investigator’s sponsored activities and if that SFI may present a potential or actual financial conflict of interest in research.
If RCS determines that an SFI does not represent any financial conflict of interest in research for an investigator, the determination is documented. If RCS determines the SFI may present an actual or potential financial conflict of interest, RCS will convey its determination and recommend a management plan to the Conflict of Interest in Research Committee (COIRC) to eliminate, reduce, or manage the conflict(s). The determination regarding whether or not an SFI presents a financial conflict of interest in the research ultimately rests with the COIRC.
Review of activity/interest for compliance with UO COI-COC policy
SFIs and any other activity or interests declared on a COI-COC self-assessment form submitted to email@example.com will be reviewed under the UO's COI-COC policy as well. If RCS believes a SFI you've declared requires review and approval under the COI-COC policy, a staff member will contact you and ask you to complete and submit a COI-COC self assessment. Whether you submit a COI-COC self-assessment on your own, or in response to a request by RCS staff, you can expect the following:
- After submitting a COI-COC self-assessment to RCS, you should receive a confirmation email from RCS within three business days that acknowledges receipt of your submission.
- If it is determined that there are no existing or potential conflicts and no approval is needed, that’s it! A staff member will email you with this determination.
- If we need more information to make a determination, we will follow-up with clarifying questions and/or a request for more detail.
- If the activity or interest requires approval under the policy, we will work with you to develop a management plan that appropriately and adequately manages any existing, potential, or apparent conflicts.
- After you have had an opportunity to review the plan and ask questions, we will send a draft of the plan to supervisors and other leadership who are required to sign the plan (other such leadership includes the unit director or divisional dean, and the President's designee for approving plans).
- Plans are posted in UO Forms for final review and approval by all signatories.
We will aim to deliver a draft management plan as soon as possible. Timeframes can vary for numerous reasons. Staff are readily available to answer questions and provide estimates regarding timelines for specific cases.