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HRPP Policy - COI reporting to IRB
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to the conduct of human subjects research under the jurisdiction of the IU Human Research Protection Program (HRPP). This includes research under the oversight of the IU IRBs and research for which IU and its affiliates are relying on an external IRB for oversight.Back to top
The institution and all individuals conducting human subjects research must report financial relationships related to research and, where appropriate, cooperate in the management of any potential conflicts of interest.
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 any significant financial interest to the IU Human Subjects Office (HSO) held by research personnel or immediate family member which could affect the research.
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 in general and to its HRPP in particular, and are committed to non-interference with the IU HRPP.
For each protocol, the PI must report any institutional conflict of interest which could affect or be affected by the research. IURTC and IUF are committed to providing relevant information as requested by the IRB in support of its reviews and deliberations.
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 HSO 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 IU HSO will notify appropriate institutional officials and IRB review will not proceed until the conflict has been mitigated and/or managed appropriately.
HSO 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 restrictive action deemed appropriate based on the nature of the conflict
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top