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Updated COI Disclosure Review Process

With the upgrade to the COI module, COI disclosures will now be approved centrally by the COI administrator. As it was previously, any disclosure in which the reporter answers “No” to all six (6) screening questions, the disclosure will be auto-approved.

If the reporter answers “Yes” to any of the questions, the disclosure will be routed to the COI admin for review. If the COI admin is unable to make a determination, they will contact the reporter and the unit supervisor/department chair for more information.

If necessary, a management plan will be developed by the COI sub-committee working with the reporter and unit supervisor/department head.

Once the COI admin approves the disclosure, an email will be sent to the reporter indicating an approved disclosure. Unless a need to amend the disclosure arises, the reporter will not have to disclose again for 364 days due to the new rolling review process (see “What has changed with the CSU COI policy”).

COI Review Process Flowchart

Effective July 2019, COI disclosures are no longer due by May 15th. We have adopted a “rolling review” process whereby reporters will have 365 days from when they submit before they will need to submit another disclosure. If a reporter has a need to update due to a change in COI status (new PHS grant, change in SFI, etc.) then the new COI approval will reset the clock.

Example:

Dr. CAM the Ram has their COI approved on August 12th 2019, so they will not have to submit again until August 11th 2020. They receive a new grant and have to update their COI on October 15th 2019, so now they will not have to resubmit again until October 14th 2020.

CSU policy requires that all Faculty and Administrative Professional employees complete an annual disclosure, including those who are part-time, temporary, off-campus or on leave. Those who are listed as a PI, Co-PI or key personnel on a PHS agency research grant are also required to complete a disclosure regardless of the employee type (for example a postdoc may need to disclose as key personnel). Other employees may be asked to complete a disclosure as deemed necessary by their unit head. See the CSU policy on Conflict of Interest and Conflict of Commitment in the Academic Faculty & Administrative Professional Manual:

http://www.facultycouncil.colostate.edu/files/manual/sectiond.htm#D.7.6

Management plans are implemented when there appears to be overlap between an individual’s outside relationships and/or interests and their CSU responsibilities. The purpose of a management plan is to enhance transparency and create separation between CSU work and the work an individual may be doing outside of the university in order to avoid even the appearance that decision making was biased or influenced by that outside interest. Management plans strategies can vary depending on the circumstance. If a Financial Conflict of Interest determination is made, the conflict of interest sub- committee (working with Investigators and others as needed) develop a conflict of interest management plan to manage, reduce, or eliminate the Financial Conflict of Interest. Conflict of interest management plans are strategies designed to mitigate the potential for an Investigator’s Significant Financial Interests to impact or bias research objectivity and/or the safety or welfare of human research participants.

Conflict of interest management plans could include:

  • Recusal from decisions involving the outside company the person has a relationship with
  • Parameters around using Northwestern resources for activities with an outside entity
  • Restrictions on using direct reports or trainees in those outside activities without proper agreements and/or reporting line changes in place
  • Disclosure to collaborators and team members,
  • Disclosure in publications, presentations, and press releases
  • Disclosure in informed consent documents (as applicable)

Additional conflict of interest management strategies may be employed depending on the nature of the Financial Conflict of Interest and the nature of the research activity. In extreme cases, an Investigator may be prohibited from participating in research due to the level and extent of Significant Financial Interests deemed to present a Financial Conflict of Interest relative to specific research activity.

Some external sponsors, such as PHS, require CSU to provide initial and ongoing reports relative to Investigator’s Financial Conflict of Interest determinations as they relate to specific research activities. For Financial Conflicts of Interests relative to PHS-funded research, CSU must perform the required conflict of interest reporting prior to the expenditure of funds for new projects, within 60 days of newly-determined Financial Conflicts of Interest identified during the life of a project, and on an annual basis thereafter prior to progress report submission during the life of a project. In addition, PHS requires CSU to make available to the public, upon request, specific information regarding Financial Conflicts of Interest determined for senior and key personnel relative to PHS-funded research. CSU is required to provide specific information relative to such public requests within five business days of the request.