Financial Conflicts of Interest in Research

  1. Introduction
  2. Definitions
  3. UI Disclosure Requirements
  4. Review and Management Procedures
  5. COI in Research Involving Human Participants
  6. Federal Agency Regulations
     

1. Introduction

Financial conflicts of interest in research involve situations in which an investigator has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research.

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b. Definitions

Investigator means the principal investigator and any other person -- whether faculty, staff, or student -- who is responsible for the design, conduct, or reporting of research funded, or proposed for funding, by an external sponsor. In this context, the term investigator includes the investigator's spouse and dependent children.

Significant Financial Interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (patents, copyrights, and royalties from such rights) held by an investigator or the investigator's immediate family, individually or in aggregate, when such interest involves:

  • Payments in excess of $10,000 (including salary, consulting fees, royalty or licensing payments from intellectual property, and honoraria and/or gifts) received within the past 12 months or anticipated for the next 12 months (excluding salary and other payments for services from the University);
  • An equity interest in a publicly traded company worth more than $10,000 or more than 5 percent of the business entity as determined by reference to its publicly listed price (excluding mutual funds);
  • Any equity interest if the value cannot be determined by reference to publicly listed prices (i.e., an equity interest in a privately held company, such as a start-up company);
  • A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any other position of management; or
  • Intellectual property rights (patents or copyrights) or royalties from such rights whose value may be affected by the outcome of the research, including royalties distributable under University policy or any royalty-sharing agreements involving the University.

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c. UI Di​sclosure Requirements

In response to new federal regulations, all UI principal investigators and key personnel on research-related projects must file an annual certification to disclose or dispel any financial Conflict of Interest before they may apply for sponsored project funding. As of August 24, 2012, the Division of Sponsored Programs is no longer able to authorize a research-related grant or fellowship application or begin a contract negotiation until and unless the PD/PI and all other key participants have completed the required certification. DSP is unable to authorize exceptions.

This policy will be enforced through the UI routing system, which will communicate with the UI's electronic Conflict-of-Interest (eCOI) system, preventing the Routing Form from advancing until all key persons have completed the required certification. The Division of Sponsored Programs is prohibited from authorizing any application/contract until the COI certification has been completed and the fully approved Routing Form reaches its office. Likewise, the Institutional Review Board is unable to consider human subject protocols in the absence of COI certification.

To prevent any delay in your proposal submission, contract negotiation, or IRB application, investigators are urged to complete the required certification immediately and annually. You may do so online, at http://ecoi.uiowa.edu.

Additional information on the UI Conflict of Interest policy is available through the COI website at http://coi.research.uiowa.edu. Questions on the eCOI certification/disclosure process should be directed to the UI’s Conflict of Interest in Research Staff:

 

Critical ​Points

  • Disclosure is made by completing the Financial Interest in Research Disclosure Form, which is in electronic format and completed online, through the UI Research Information System at https://login.uiowa.edu/uip/login.page?service=https://uiris.research.uiowa.edu/coi/index.php; note that the UIRIS system is available University-wide, but requires registration and login.
  • The Division of Sponsored Programs cannot sign or otherwise approve and submit proposals until investigators with potential conflicts of interest have submitted the disclosure form.
  • Any change in the nature or amount of the interest -- e.g., a new significant financial interest is created, or a new investigator with a significant financial interest is hired to work on the research project -- must be disclosed within 60 days.
  • Investigators who have disclosed a conflict of interest will receive an annual request to update or confirm the status of the financial interest.

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d. Revi​ew and Management Procedures

In some cases, the extent of the significant financial interest and the nature of the research may be such that disclosure alone is adequate -- a determination that will be made through the standard conflict of interest disclosure and review process. Most projects in which an investigator holds a significant financial interest, though, will require management in addition to disclosure. The proposed research may not begin or expenditures made until until the University has reviewed the disclosure and all parties have agreed to any necessary management strategies.

Process

  1. The Vice President for Research and Economic Development shall appoint a Conflict of Interest Officer (COIO) and a Conflict of Interest in Research Committee (CIRC).  
  2. The COIO will review disclosures of financial interests and determine if disclosure alone is adequate or if CIRC review is required.  
  3. If the COIO determines that no conflict exists or that disclosure only is required, he or she will notify the individual who filed the disclosure, the Vice President for Research and Economic Development, and the relevant Departmental Executive Officer and corresponding collegiate Dean.  
  4. Disclosures of financial interests that require the development of a management plan will be forwarded to the DEO and dean for their review and recommendation. University employees planning the development of a start-up company should consult the guidance document titled Start-Up Company Conflict of Interest Issues/Policies for additional information.  
  5. Upon receipt of the DEO and dean recommendations, these recommendations and the investigator's disclosure materials will be provided to the CIRC for review.  
  6. The CIRC will consider the nature of the research, the magnitude of the interest and the degree to which the conflict is related to the research, the extent to which the interest could be directly and substantially affected by the research, and any conflict management strategies proposed or already in place. The CIRC will develop a management plan, which may involve elimination of the conflict prior to initiating the activity, and notify the Vice President for Research and Economic Development of its recommendation.  
  7. The Vice President for Research and Economic Development will review the recommendations of the COIO and CIRC and make a final determination regarding the management plan. This final determination will be forwarded to the Investigator and copied to the DEO and dean. In the case of research involving human participants, a copy of the determination will be forwarded to the Institutional Review Board as well.  
  8. The investigator must agree in writing to accept the management plan prior to initiating the research.  
  9. No individual who holds a significant financial interest in a project may participate in the review of its management strategy.  
  10. CIRC meetings are closed to the public and documentation/records are confidential personnel records.  
  11. Any investigator may appeal the decision of the Vice President for Research and Economic Development regarding the management plan for a conflict of interest in research to the President of the University, and thereafter to the Board of Regents, State of Iowa.  
  12. Records of all disclosures made pursuant to this policy and of any action taken to resolve, manage, or eliminate any interest disclosed under this policy shall be retained for at least three years from the submission of the final expenditures report, in the case of grants or cooperative agreements; at least three years from the final payment, in the case of research contracts; or until the resolution of any sponsor agency action involving those records, whichever is longer.  
  13. Failure to file a complete and truthful disclosure as required by this policy, or to comply with the conditions or restrictions imposed in the resolution, management, or elimination of interests required to be disclosed, constitutes a violation of University policy and may violate state and/or federal law. In such cases, the investigator will be subject to appropriate sanctions consistent with University policies relating to faculty, staff, or other applicable disciplinary policies. In addition, the University may suspend an ongoing research project or technology transfer activity to prevent continued violation of this policy. In any case in which the investigator does not comply with any applicable conditions or restrictions imposed pursuant to this policy, the University shall withdraw any affected applications for funding if the project cannot otherwise be completed without the services of the investigator.
  14. In the event the University discovers that a failure to comply with this policy has biased the design, conduct, or reporting of the research, the University will promptly notify the sponsor of the research and describe the corrective action(s) taken or to be taken, consistent with applicable law and/or policy.
  15. Institutional officials holding a significant financial interest in an externally sponsored research project may not participate in the solicitation, negotiation of terms and conditions, oversight of the research (unless named as a member of the research team), or management of any conflict of interest held by members of the research team.  
  16. Any collaborator from another institution or organization who will share responsibility for the design, conduct, or reporting of research results must comply with the policies and procedures of his or her institution/organization relating to disclosure and review of any significant financial interest(s) held by that collaborator. Whether the collaborator's institution/organization has or lacks an established conflict of interest policy/procedure, that institution or organization must provide the University adequate assurances of its review of a significant financial interest as defined by this policy and its ability to manage, reduce, or eliminate such conflict consistent with this policy.

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e. COI in Research ​Involving Human Participants

Special consideration will be given to conflicts of interest when the research involves human participants. In addition to the procedures outlined above, the conflict must also be disclosed on the Institutional Review Board application form. In these situations, the IRB will communicate with the Conflict of Interest Office regarding the elimination, disclosure, and/or management of such conflicts.

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f. Feder​al Agency Regulations

Investigators conducting research funded by the Public Health Service, including the National Institutes of Health, or the National Science Foundation, as well as those conducting studies regulated by the Food and Drug Administration, should note that they are, in addition to University of Iowa policy and procedure, subject to agency-specific conflict-of-interest regulations. These federal regulations, available through the UI Operations Manual Part II, Division I, Section 18.8, set forth the investigator, sponsor, and institutional obligations and should be carefully reviewed by those with potential COIs.

The full COI policy is available in the UI Operations Manual Part II, Division I, Section 18.8. Navigate to Section 18.6 for information specific to the Conflict of Interest in Research Policy.

Information is also available through the Office of the Vice President for Research and Economic Development/Conflict of Interest website.

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