Considerations of Financial Interest Management

When the CIRC reviews a financial interest in relation to a research proposal, it considers these factors and such interests could bias the research:

  • the nature of the research
  • the potential impact of the interest
  • the degree to which the conflict is related to the research
  • recommend steps designed to manage, limit or eliminate the impact of the interest on the research

Management Plans

After considering the financial interest, the research project, and all related materials, the CIRC first determines if the interest is manageable. If the interest is manageable, the Committee recommends a management plan that will include specific action items to be carried out by the investigator with the financial conflict of interest.

Typical management plans include disclosure actions -- to journal publishers, organizers and audiences of presentations, human subjects, other study team members, students/trainees, and the sponsor of the research, if required. It may include the appointment of a non-subordinate, non-conflicted data monitor. Please see COI Scenarios for examples.

Expedited Reviews and Universal Management Plans

Under certain circumstances, financial conflicts of interests can be managed outside of a CIRC meeting.

Expedited Reviews

If an investigator has a prior management plan for the same interest in a similar project, it may be eligible for Expedited Review and management. Please contact our office for details. This determination is made by the Conflict of Interest in Research Office leadership.

Universal Management Plans

More recently, the Conflict of Interest in Research Office has developed a Universal Management Plan process. 

When a project is eligible for a Universal Management Plan, the case is presented to CIRC. If the CIRC agrees, the plan can then be applied to future studies. Financial conflicts of interest may not be managed by a universal plan if any of the following apply to a particular study:

  • Phase I or II clinical trials.
  • Phase I SBIR/STTR or other sponsorship by or involvement of a faculty startup.
  • Multiple financial interests with a single entity (i.e. cash payment AND stock, cash payment AND fiduciary role, etc.). 

Eligibility criteria include, but are not limited to:

  • Investigator-entity relationship must have been held for at least one calendar year.
  • Interest has been managed at least one time through the traditional CIRC management process.
  • Interest is a single-stream (i.e. cash payment OR stock, rather than cash payment AND stock).
  • Phase II SBIR/STTR that does not involve human subjects.
  • Sponsor/financial interest is a nonprofit. 

Please contact our office for more information.