Relatedness and Determination of Significant Financial Interest
The Director of Central Pre-Award as Chair of the CCIR follows the Policy guidelines to determine whether an Investigator’s disclosure of a significant financial interest is related to their research project or for federal sponsored projects, institutional responsibilities is related to the sponsored research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to sponsor research when the University, through its designated official(s), reasonably determines that the significant financial interest:
Could be affected by the sponsored research; or
Is in an entity whose financial interest could be affected by the research.
The policy encourages the Investigator to be involved with the CCIR Chair in determining whether a significant financial interest is related to the sponsored research. A financial conflict of interest exists when the Chair of the CCIR, with the involvement of the Investigator, the Department Chair and possibly other knowledgeable third parties, reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the sponsored research.
Actions to Reduce, Manage or Eliminate the Conflict of Interest
If it is found that a SFI could directly and significantly affect the design, conduct, or reporting of the federally-funded research, the CCIR Chair will take actions as necessary to reduce, eliminate or manage the financial conflicts of interest, including any financial conflicts of a subrecipient Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report.
In instances where the disclosed financial interest is minimal (when aggregated less than $5,000 per year) and/or only requires a straight-forward and modest plan to reduce, eliminate or manage the potential conflict, the Chair of the CCIR may elect to conduct an expedited review and approval. These actions are reported to the entire CCIR on a quarterly basis by the Chair so that all disclosures are shared with the membership of the committee.
Where there are questions or the COI is not determined to be minimal, the CCIR Chair will contact the PI and Department Chair in order to review the COI and determine the relatedness of the COI to the research, that is, how the SFI could directly and significantly affect the design, conduct, or reporting of the funded research. This determination will require the input of the members of the CCIR as well as third party faculty who understand the science, the COI and the potential for bias. Once the review is completed, the CCIR Chair and Department chair will prepare a draft Management Plan for the Dean’s review.
In the event the COI was as a result of a IRB protocol disclosure, the draft management plan will be submitted to the IRB for review and comment.
The Management Plan will be reviewed by the Dean of the involved school. Based on the information provided by the CCIR Chair, the Dean may approve the plan or require the conflict be eliminated or decline to allow the research to take place.
If the Dean recommends that the research proceed and approves the management plan, it will be sent to the CCIR for review and recommendation. The CCIR’s comments and disposition are sent to the Vice Provost for Research who will make the final decision on behalf of the University as to whether or not any conflict of interest can be appropriately managed or eliminated.
In cases where the University determines that it cannot manage the conflict, it may require that the conflicted be eliminated or that the research not proceed. Factors in this decision might include such considerations as the involvement of human subjects in the research:
the level of risk involved,
the nature and significance of the conflict,
the potential for having a serious adverse impact on the scientific field or on the reputation of the University, and
the level of difficulty involved in managing the conflict relative to the benefit of doing the research.
Decisions of the Vice Provost for Research may be appealed to the Provost, whose decision on these matters will be final. Deans must submit their own disclosure forms to the OVPR, which may, if there is a potential conflict, forward them to the CCIR. The Vice Provost for Research may report the existence of the conflict to funding agencies.
An approved plan for management or elimination of the conflict of interest must be in place before the research begins. Grant applications may be submitted while the University is considering a possible conflict of interest with the understanding that the University will not accept the funds unless the conflict can be managed or eliminated.
In situations where research could involve risk to human subjects, the protection of those subjects must be of paramount concern. With each protocol involving human subject research each Investigator must submit to the IRB a conflict of interest disclosure. Forms that indicate a possible conflict of interest will be forwarded by the IRB to the Office of the Vice Provost and will be subject to the review and management procedure described under “Review and Management of Conflicts of Interest” above. IRB approval will not be granted until the conflict of interest oversight or management plan has been set up and approved by the IRB, pertinent Dean, the CCIR, and the Vice Provost. The University may prohibit research that involves a conflict of interest even if the IRB approves the research.
In accordance with federal regulations governing human subject research, a study participant is to be fully informed of research related risks before he or she consents to participate in the research. Informed consent forms and procedures should include the disclosure of any conflict of interest that could reasonably appear to influence an investigator’s judgment in conducting the research.
Additionally, No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB (45 CFR 46.107(e)).