A SFI may be found by the Institutional Official to constitute a FCOI and may be subjected to a
requirement that the FCOI be Managed (including elimination of the FCOI, where appropriate) as a
condition to the Investigator's participation in the Research to which it is related. The
determination of whether a FCOI, including a FCOI involving a Clinical Trial, is manageable
without elimination of the Financial Interest should take into account relevant factors such as the
nature and design of the Research; the magnitude and nature of the Financial Interest; the extent to
which the Financial Interest could be influenced by Research; the uniqueness of the Investigator's
position with respect to the study; whether the interest is amenable to Management; in addition, with
respect to Clinical Trials, the degree of risk to human subjects, the role of the Investigator in the
study, and the degree of the Investigator's influence upon the recruitment and enrollment of
subjects or the results of the study.
A plan to manage the FCOI may be developed and recommended by the Institutional Official.
Examples of conditions or restrictions that might be imposed to manage a FCOI include, but are
not limited to:
- Public disclosure of financial conflicts of interest (e.g., when presenting or publishing
- For Research projects involving human subjects Research, disclosure of financial
conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the
design, conduct, and reporting of the research against bias resulting from the FCOI;
- Modification of the Research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel
from participation in all or a portion of the Research;
- Reduction or elimination of the Financial Interest (e.g., sale of an equity interest); or
- Severance of relationships that create financial conflicts.
The Institutional Official will communicate the findings and elements of the management plan to
the Investigator, and the Investigator will be granted the opportunity to review the management plan
and must acknowledge in writing his or her acceptance of the obligation to abide by the plan.
Once the management plan has been finalized, Inovio will prepare, if applicable, FCOI Reports
required to be submitted to the PHS. The Report will contain such information as prescribed in
section 10, below.
Establishment of the management plan also initiates responsibility for monitoring compliance with
the plan until completion of the Research project. As part of finalizing the management plan,
Inovio will establish an ongoing monitoring program to ensure compliance with requirements of the
The Investigator is required to cooperate fully with Inovio in all aspects of the administration of this
Policy. This includes, among other things, providing all information as required to allow Inovio to
understand and assess the Investigator's Disclosure of the SFI and the relatedness of the SFI to the
Investigator's Research, assisting in the conduct of retrospective reviews where appropriate, and
responding promptly and appropriately to implementation and monitoring of management and
mitigation plans or corrective action. In the event the Investigator fails to comply with this FCOI
policy or the FCOI Management plan, Inovio will notify PHS promptly and take corrective action