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1.25 Financial Conflicts of Interest

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s procedures for identification, management, and minimization or elimination of financial conflict of interest (COI) of responsible personnel, senior administrators, and the Organization itself that could influence the conduct of research or the integrity of the HRPP.

2.0 Policy

  • 2.1. It is the policy of the Organization that all potential financial COIs of responsible personnel engaged in non-exempt research (1) within the premises of the Organization, or (2) by any faculty, students, staff or other representatives of the Organization, or by Organizational officials, must be identified and minimized through appropriate management in accordance with a) PHS regulations at 42 CFR 50, Subpart F; b) National Science Foundation (NSF) regulations; c) FDA regulations at 21 CFR 54; d) University of Nebraska Board of Regents Policies #3.2.8.10 and #4.4.2, e) UNMC policy #8010, f) UNO Academic and Research Financial Conflict of Interest Policy, g) Children’s Hospital & Medical Center policy #ADM100, and h) Children’s Hospital & Medical Center Board of Directors Conflict of Interest Policy.
  • 2.2. It is the policy of the Organization that the IRB will interact with the COI Officers, Conflict of Interest Committees (COICs), and/or senior administrators of the applicable components of the Organization who are responsible for compliance and/or COI, in accordance with the above specified regulations and policies to ensure that appropriate COI management plans are in place to protect the rights and welfare of human subjects when investigators, senior administrators, or the Organization itself has a COI.
  • 2.3. It is the policy of the Organization that any changes in financial interest must be promptly disclosed and managed in accordance with Section 2.1 above.
  • 2.4. It is the policy of the Organization that the IRB will ensure that responsible personnel are appropriately trained concerning the identification, disclosure, and management of COI. This includes initial education, immediate re-education when there are policy changes and appropriate re-education when there is noncompliance with the COI policy.

3.0 Definitions

  • 3.1. Responsible Personnel: Responsible Personnel are defined as any faculty, students, staff or other representatives of the Organization listed in Section I of the IRB application who are responsible for the design, conduct, or reporting of research, or the development of proposals to conduct research. This includes: Principal Investigator, Secondary Investigator(s), Participating Personnel, and Protocol Coordinator(s). Data and Administrative Personnel are not considered Responsible Personnel for the purposes of this policy.
  • 3.2. Covered Persons: Responsible Personnel, as defined above, are considered Covered Persons for the purposes of this policy. In addition, any financial interest related to the research accruing to the immediate family, including the following: spouse, child, brother, sister, grandchild, or grandparent, by blood, marriage, or adoption of the Covered Person are bound by this policy.
  • 3.3. Conflict of Interest (COI): A COI refers to situations when the Covered Persons’ direct or indirect personal financial interests or fiduciary duties owed to third parties may compromise, or have the appearance of compromising, a Covered Person’s professional judgment or behavior in carrying out his or her research obligations including the individual’s obligation to protect the rights and welfare of research subjects. This includes indirect personal financial interests of a Covered Person that may be obtained through third parties such as a Covered Person’s immediate family, business relationships, fiduciary relationships, or investments.
  • 3.4. Significant Financial Interest: A significant financial interest means a financial interest of the Covered Person that reasonably appears to be related to the Responsible Person’s institutional responsibilities during the course of the research. A significant financial interest is defined as anything of monetary value that exceeds $5,000 which the Covered Person has received in the past 12 months preceding the disclosure, or any equity in a non-publicly traded company.
    • 3.4.1. Financial interests not considered in the determination of “significant financial interest include (1) salary or other remuneration from the Organization, (2) income from seminars, lectures, or teaching engagements sponsored by governmental entities, and (3) income from service on advisory committees or review panels for governmental entities
  • 3.5. Non-Significant Financial Interest: The Covered Person has a non-significant financial interest defined as any financial interest that does not qualify as a significant financial interest as defined in Section 3.4 of this policy.
  • 3.6. Organizational COI: Organizational financial COI includes: a) licensing, technology transfer, patents; b) investments of the Organization; c) gifts to the Organization when the donor has an interest in the research; d) financial interests of senior administrators; e) other financial interests.
  • 3.7. COI Committee (COIC): the Committee responsible for reviewing potential conflicts of interest which have been determined to be significant, developing the management plan, and providing the information to the IRB. If a component of the organization does not have a committee per se, COIC hereinafter will mean the Conflict of Interest Officer, or the senior administrator of the applicable components of the Organization who are responsible for compliance and/or COI.

4.0 Procedures for Disclosure of Potential COI

  • 4.1. Any Responsible Personnel listed on the IRB application who has a COI must disclose that financial interest in accordance with the applicable policy specified in Section 2.1 above.
  • 4.2. Responsible Personnel conducting FDA regulated research must disclose their financial interests in accordance with 21 CFR 54.4 by also submitting Form FDA 3455 to the sponsor. The IRB does not require a copy of this form.

5.0 COI Management Plan

  • 5.1. The COI management plan will include, at a minimum, an appropriate disclosure of the presence of a financial COI of the Responsible Person(s) in the consent form, as well as in any presentations, publications, or news articles regarding the research.
  • 5.2. The COI management plan may also include any of the following in consideration of the nature and magnitude of the financial interest of the Covered Person:
    • 5.2.1. More frequent monitoring of the research.
    • 5.2.2. Independent monitoring of the research.
    • 5.2.3. Modification of the research protocol to manage potential bias through means such as blinding; modifying the scope of the project; and setting timetables for delivery of the product.
    • 5.2.4. Designation of a peer or supervising co-investigator with no COI in the project to assume the lead investigative role.
    • 5.2.5. Monitoring of the consent process.
    • 5.2.6. Divesting or appropriately reducing the financial interest giving rise to the COI with restrictions on re-investment for an appropriate period to provide for publication and critique of the completed research.
    • 5.2.7. Severing relationships existing between the Covered Person and the company or other entity that is the source of the COI.
    • 5.2.8. Removing contract terms which create the COI.
    • 5.2.9. Disqualification of the Covered Person from participation in all or a portion of the research (e.g., may not obtain informed consent or analyze data).
    • 5.2.10. Any additional management strategies as determined by the appropriate COIC and/or the IRB.
  • 5.3. The following are prohibited:
    • 5.3.1. Any arrangement where the value of ownership interests will be affected by the outcome of the research.
    • 5.3.2. Any arrangement where the amount of compensation will be affected by the outcome of the research.

6.0 Full IRB Review of Significant Risk COI Management Plans

  • 6.1. The full IRB will be provided with the COI management plan approved by the COIC.
  • 6.2. The COI Officer, the IRB Executive Chair, the IRB chair or designee will verbally describe the nature of the financial interest, and the specifics of the management plan proposed by the COIC. Note: Members of the full IRB are not provided written copies which detail the specifics of the financial interest, but are given ranges of the financial interest (e.g., $5,000 to $9,999; $10,000 to $19,999). It is the position of the Organization that the financial interests of its employees should remain as confidential as possible.
  • 6.3. The full IRB must approve the COI Management Plan proposed by the COIC before the protocol is approved and released, or may require a more stringent COI management plan. The IRB may not adopt a less stringent plan than that approved by the COIC.
  • 6.4. The IRB’s COI Management plan may be reviewed by Organizational officials, who may require a more stringent COI management plan. The Organization may not adopt a less stringent plan than that approved by the IRB.

7.0 Management of COI in Research Conducted by Subgrantees, Contractors, and Collaborators

  • 7.1. If the research is conducted at an external site and involves subgrantees, external contractors or collaborators with any financial interest related to the research, the PI must provide verification to the ORA that the individual(s) are in compliance with the external institution’s COI policy which meets the requirements of 42 CFR 50.604.
  • 7.2. If the external site does not have a COI policy which meets the requirements of 42 CFR 50.604 the requirements of the applicable policy under Section 2.1 above must be met.

8.0 Documentation of COI Management

  • 8.1. The COI Management Plan approved by the IRB will be maintained in the protocol file in the ORA for no less than seven years following cessation of the outside activity to which they relate.

9.0 Management of Organizational Financial COI

  • 9.1. Organizational financial COI may occur when the Organization itself, or any of its component parts, has a financial interest in the design, conduct, or outcome of human subject research.
  • 9.2. In accordance with Board of Regents Policies 3.2.8.10 and 4.4.2, the University of Nebraska may accept royalties, equity, or other forms of compensation when technology is licensed, or new companies are formed to commercialize University technology.
  • 9.3. Every potential Organizational COI must be reported to the appropriate COI Officer as soon as it is identified.
  • 9.4. Organizational COI may be identified through the required disclosure of financial interest of the Responsible Personnel at the time the IRB application is submitted.
  • 9.5. Organizational COI may be identified through the required annual disclosure of financial interest of senior administrators when it relates to human subject research.
  • 9.6. Organization COI may be identified by technology transfer officials or other officials at UNMC, UNO, and CHMC.
  • 9.7. If an Organizational COI is identified the COI Officer of the involved component shall convene a group of senior Organizational officials and unaffiliated individuals, appointed by the appropriate Chancellor, CEO or designee, to review the potential Organizational COI and propose any required management plans for approval.
  • 9.8. The COI Officer will provide the full IRB with the COI committee’s approved COI Management Plan.
  • 9.9. The COI Officer or the IRB Executive Chair/designee will describe the nature of the financial interest, and the specifics of the management plan proposed by the COIC.
  • 9.10. The IRB will review the management plan and if any concerns are identified, these will be conveyed to the COI officer for further consideration and action.
  • 9.11. The IRB must be assured that any Organizational COI is appropriately managed in the interest of the safety and welfare of human subjects.
  • 9.12. Organizational COI management plans approved by the IRB will be maintained in the ORA for no less than seven years following cessation of the activity.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 13, 2018

 INITIAL APRIL 14, 2016 (PREVIOUS POLICY #3.12)

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