HRPP Policy - Conflict of Interest Reporting to the IRB

IU faculty, staff, and students responsible for the design, conduct, or reporting of IU research (i.e., key personnel) must disclose significant financial interests in accordance with the IU Policy on Conflicts of Interest and Commitment annually or when interests change or new interests occur.

For each protocol, the Principal Investigator (PI) is responsible for reporting to the IU Human Research Protection Program (HRPP) any significant financial interest held by research personnel or immediate family member which could affect the research.

For each protocol, the PI must report any institutional conflict of interest which could affect or be affected by the research.

Institutional conflict of interest may include:

• Institutional licensing, technology transfers, patents
• Investments by the institution
• Gifts to the institution when the donor has an interest in the research
• Financial interests of senior administrators or officials
• Other financial interests.

All IU intellectual property and investment is held and managed by the IU Innovation and Commercialization Office (ICO).  All major gifts to IU and investments of the Indiana University Foundation (IUF) are held and managed by the IUF.  IUF and ICO are committed in principle and practice to respecting and maintaining the autonomy of IU’s research integrity and operations. IUF and ICO are committed to non-interference with the IU HRPP and will provide relevant information as requested by the IRB in support of its reviews and deliberations.

Education regarding required disclosures and responsibilities related to financial conflicts of interest is provided to researchers via the annual disclosure process. The education consists of a review of federal and institutional policies related to financial conflicts of interest and information regarding IU’s disclosure and COI review processes.

For IU faculty, staff, and students, the process for annual disclosure of individual financial interests in research is facilitated by the IU Conflicts of Interest Office. Any management plans established to manage a disclosed interest related to a human subjects protocol are made available to the IRB. See the Office of Research Compliance website for detailed procedures.

Disclosures from non-IU research personnel which include outside interests are forwarded to the HRPP for review by the IRB.

Protocol-specific significant financial interests are reported in the IRB application. Conflict of interest reporting for non-affiliated individuals whose institutions have agreed to rely on the IU IRB for oversight of their participation in research is conducted in accordance with the associated reliance agreement for the protocol.

Institutional conflicts of interest are reported on a protocol-specific basis in the IRB application. If an institutional conflict of interest is reported, the HRPP will notify appropriate institutional officials and IRB review will not proceed until the conflict has been mitigated and/or managed appropriately.

HRPP staff confirm all key personnel have appropriately submitted annual disclosures as described above at initial submission and renewal, if required.

If research personnel indicates in the IRB application that he or she has a financial interest which could affect or be affected by the research, the IRB evaluates the interest as it relates to the research, including reviewing any COI Office or COI Committee determinations, and determines whether the management of the conflict is appropriate and whether additional action is required to protect human subjects. Additional action may include:

• Adding appropriate language regarding the conflict of interest in the informed consent statement
• Requesting that the personnel with the conflict not obtain consent from subjects
• Requesting an independent PI conduct the study
• Requiring independent safety monitoring
• Conducting renewal or review at an interval less than one year
• Any other audits/reviews or mitigating or restrictive actions deemed appropriate based on the nature of the conflict.

Management plans with human subjects related restrictions are periodically targeted for internal audits as described in the IU HRPP Policy on Auditing Human Subjects Research. Audit findings related to compliance with management plan restrictions are included in audit reports for the IRB’s review.