CONFLICT OF INTEREST GUIDANCE

Conflicts of interest can occur in many ways. The goal when managing conflicts of interest is to minimize the extent to which the design and conduct of research is influenced either consciously or unconsciously by prospective financial or non-financials gains for the researcher. Best practices governing the responsible conduct of research call for researchers to exercise judgement when entering into financial relationships that may include conflicts of interest, to acknowledge non-financial biases, and to disqualify themselves from participating in research when appropriate.

Norman campus researchers and key study personnel working with human subjects must follow University of Oklahoma policies governing conflicts of interest and for reporting and managing conflicts of interest.  Provided below are links to the policies as well as a summary of the IRB’s approval process and your responsibility for identifying and managing potential conflicts of interest.

      

Summary of IRB approval process

Before beginning a project involving human participants, researchers are required to disclose potential conflicts of interests in the IRB application and to complete the HRPP Conflict of Interest sub-form. Also, if the potential conflict of interest involves University or Public Health Service (PHS) financial conflict of interest, the management plan approved by designated University officials in those areas must be included with the IRB submission.

As part of the research review process, the IRB will review the HRPP Conflict of Interest sub-form and all study documents.  The IRB will also review the management plan from the University or the Vice President for Research (VPR), if applicable. In this review, the IRB’s function is to ensure a research design that includes participant notification and protection and upholds the integrity of IRB review and that ensures the conduct of the research project is not jeopardized by an undisclosed, unidentified, or unmanaged conflict of interest. Human research studies that involve researcher conflict of interest will normally be reviewed by the full IRB at a bi-monthly meeting.

The IRB will communicate its findings and management plan to the Vice President for Research (VPR) and/or the University designee.  If the VPR or the University designee have any additional concerns, they will inform the investigator and provide a copy of the communication to the IRB.  If additional changes to the management plan are needed, the investigator will submit a modification request to the IRB.  IRB final approval of a research submission that involves conflicts of interest is contingent upon the VPR and/or the University designee approving the management plan.  The IRB may request modifications or additional restrictions to the management plan.  The revisions must be reviewed and approved by the VPR and/or University designee.  The IRB may elect to disapprove the research submission if conflict of interest issues cannot be resolved to the IRB’s satisfaction.  All communication regarding conflicts of interest will be maintained in iRIS.