Institutional Conflict of Interest (ICOI) - Conflict of Interest

An Institutional Conflict of Interest (ICOI) exists when the University of Utah, or its senior leadership, has a conflict of interest related to human subjects research.

Examples of institutional financial interests that may create an ICOI:

The University has an equity interest in a company involved in research,
The University has an ownership interest in intellectual property being researched,
Significant gifts or donations have been made to the University from an entity involved in research,
Senior leadership who may be in a position to influence the conduct of the human subjects research have a related significant financial interest (they might not be listed as an investigator, but have a supervisory role over the researchers involved),

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The Institutional Conflict of Interest Policy (7-006), which governs institutional conflicts of interest, requires that campus leaders disclose their external “significant financial interests” on an annual basis. A “significant financial interest” is defined in the Individual Conflict of Interest Policy (1-006).

Potential ICOIs are managed by the Institutional Conflict of Interest Officer, Dr. Caren Frost, in collaboration with the Individual Conflict of Interest Committee and the COI Officer. The COI Office performs preliminary reviews.

ICOI Review Process

After a new or continuing review application for human subjects research is filed with the Institutional Review Board (IRB), ICOI review will initiate immediately.
The Principal Investigator may be contacted for additional information. The ICOI review may be dependent upon the response of individual investigators during the individual COI review, which occurs at the same time.
If a potential institutional conflict of interest is identified, the review will be assigned to the next Individual Conflict of Interest Committee meeting, which typically occur every three weeks. ICOI reviews that do not involve senior personnel are not reviewed by the COI Committee and proceed directly to the ICOI Officer.
The ICOI Officer reviews and prepares a management plan.
Management plans are usually issued for acceptance within 1 week after the Individual Conflict of Interest Committee meeting.
Acceptance of the management plan by all required parties (including the Principal Investigator of the research) will conclude the COI review and IRB processing will continue.

Please contact Dr. Frost or the COI Office if you have any questions or concerns about the ICOI policy.

Caren Frost, Institutional Conflict of Interest Officer
caren.frost@socwk.utah.edu, phone: 801-581-7170

COMPONENT	MANAGEMENT PLAN CLAUSE	EXAMPLES OF HOW TO COMPLY
Disclosures to the Research Team	The University of Utah's institutional conflict of interest will be disclosed to all members of the research team. Members of the research team should discuss any concerns with the Institutional Conflict of Interest Officer.	The COI Office will also send an email notice to all University of Utah staff/investigators and contacts listed as members of the research team in the IRB application.
Recusal from Decision Making	The conflicted University Official(s) will be recused from all study-related decisions and identify a non-conflicted peer (not a subordinate) to serve as their designee for all study-related decisions.	The personnel asked to be recused may already not be listed as an investigator on the study, but is related to the study from their supervisory capacity. This person should identify someone else to serve in their position for all study-related decisions.
Disclosures on the University Public Website	The University of Utah's institutional conflict of interest will be disclosed on a publicly available website. The publicly available disclosure will include the conflicted party's name, the name of the business entity(ies), the nature of the financial interest(s) and the dollar ranges or value of the financial interest(s) as available.	The COI Office will post a disclosure on your behalf on the coi.utah.edu website.
Individual Management Plan	The conflicted University Official is an investigator on this project and has already accepted an individual management plan (proposed by the Individual Financial Conflict of Interest Committee) which provides the necessary management for the Institutional Conflict of Interest that exists due to their role as a University Official.	Abide by your existing individual COI management plan.
Disclosures in Presentations	The University of Utah’s institutional conflict of interest will be disclosed in all presentations regarding the study by University of Utah faculty.	Include a disclosure statement in PowerPoint presentations, on posters, verbally, etc., as appropriate to the situation: “The University of Utah has a significant financial interest in ABC Corp., Inc. that provided the materials being tested in this research.” “The University of Utah is a co-owner of 123 Inc. that licenses technology that is used in this research.”
Disclosures in Publications	The University of Utah's institutional conflict of interest will be disclosed to the journal upon submission of all publications related to the research.	Submit a disclosure statement to the journal editors or include it in the acknowledgements section of the article: “Dr. X is a consultant for XYZ Corporation, which funded this research.” “The University of Utah has a significant financial interest in ABC Corp., Inc. that provided the materials being tested in this research.” “The University of Utah is a co-owner of 123 Inc. that licenses technology that is used in this research.” Note that journal editors may opt to not publish your disclosure. If so, you may be contacted by the COI Office to provide evidence of your disclosure.
Multiple Site	To decrease the overall influence of the University of Utah, the study will be opened as a multi-site trial, with less than 50% of enrollment coming from the University of Utah.	During protocol development, external sites should be solicited for participation in the trial. Review accrual numbers on a regular basis after the trial launches, to ensure that most of enrollment is occurring at these external sites.
Disclosures to Human Subjects in the Consent Documents	The University of Utah's institutional conflict of interest will be disclosed in consent documents.	File an amendment to the IRB application to add your disclosure to the consent documents: “The University of Utah has a financial interest in [Company], the sponsor of this research, which is a conflict of interest as determined by the University of Utah Institutional Conflict of Interest Officer.” You may use the disclosure language provided in your management plan under the section ‘ICOI Office's Finding of Conflict.’
Recusal from Data Analysis	Investigators from the University of Utah will not have a lead role in data analysis.	During protocol development, external investigators/institutions should be solicited to perform data analysis for the trial.
Recusal from DSMB	Investigators from the University of Utah will not participate on the Data and Safety Monitoring Board.	During protocol development, external investigators/institutions should be solicited to serve as the DSMB.
Independent or External Data Safety Monitoring	A non-conflicted, independent and external data safety monitor will review the study on a regular basis. The monitor will approve study continuance, approve all dose escalations or modifications, evaluate study cancellation rules and provide approval for the study’s continuation, review and approve all SAEs and potential deviations, review and approve all data analysis and publications prior to submission.	The monitor’s responsibilities will likely depend on the design of the study. Contact the ICOI Officer for an individualized assessment of your potential study. Discussions should occur during the study concept stage (protocol design).
Independent or External Data Statistician	A non-conflicted statistician external to the University shall be appointed oversee trial data. The statistician will review and approve all data analyses and publications prior to submission, and this should be acknowledged within any publications.	During protocol development, external investigators/institutions should be solicited to perform data analysis for the trial.
OTHER		Contact the COI Office for guidance

COMPONENT

MANAGEMENT PLAN CLAUSE

EXAMPLES OF HOW TO COMPLY

Disclosures to the Research Team

The University of Utah's institutional conflict of interest will be disclosed to all members of the research team. Members of the research team should discuss any concerns with the Institutional Conflict of Interest Officer.

The COI Office will also send an email notice to all University of Utah staff/investigators and contacts listed as members of the research team in the IRB application.

Recusal from Decision Making

The conflicted University Official(s) will be recused from all study-related decisions and identify a non-conflicted peer (not a subordinate) to serve as their designee for all study-related decisions.

The personnel asked to be recused may already not be listed as an investigator on the study, but is related to the study from their supervisory capacity. This person should identify someone else to serve in their position for all study-related decisions.

Disclosures on the University Public Website

The University of Utah's institutional conflict of interest will be disclosed on a publicly available website. The publicly available disclosure will include the conflicted party's name, the name of the business entity(ies), the nature of the financial interest(s) and the dollar ranges or value of the financial interest(s) as available.

The COI Office will post a disclosure on your behalf on the coi.utah.edu website.

Individual Management Plan

The conflicted University Official is an investigator on this project and has already accepted an individual management plan (proposed by the Individual Financial Conflict of Interest Committee) which provides the necessary management for the Institutional Conflict of Interest that exists due to their role as a University Official.

Abide by your existing individual COI management plan.

Disclosures in Presentations

The University of Utah’s institutional conflict of interest will be disclosed in all presentations regarding the study by University of Utah faculty.

Include a disclosure statement in PowerPoint presentations, on posters, verbally, etc., as appropriate to the situation:

“The University of Utah has a significant financial interest in ABC Corp., Inc. that provided the materials being tested in this research.”
“The University of Utah is a co-owner of 123 Inc. that licenses technology that is used in this research.”

Disclosures in Publications

The University of Utah's institutional conflict of interest will be disclosed to the journal upon submission of all publications related to the research.

Submit a disclosure statement to the journal editors or include it in the acknowledgements section of the article:

“Dr. X is a consultant for XYZ Corporation, which funded this research.”
“The University of Utah has a significant financial interest in ABC Corp., Inc. that provided the materials being tested in this research.”
“The University of Utah is a co-owner of 123 Inc. that licenses technology that is used in this research.”

Note that journal editors may opt to not publish your disclosure. If so, you may be contacted by the COI Office to provide evidence of your disclosure.

Multiple Site

To decrease the overall influence of the University of Utah, the study will be opened as a multi-site trial, with less than 50% of enrollment coming from the University of Utah.

During protocol development, external sites should be solicited for participation in the trial. Review accrual numbers on a regular basis after the trial launches, to ensure that most of enrollment is occurring at these external sites.

Disclosures to Human Subjects in the Consent Documents

The University of Utah's institutional conflict of interest will be disclosed in consent documents.

File an amendment to the IRB application to add your disclosure to the consent documents:

“The University of Utah has a financial interest in [Company], the sponsor of this research, which is a conflict of interest as determined by the University of Utah Institutional Conflict of Interest Officer.”

You may use the disclosure language provided in your management plan under the section ‘ICOI Office's Finding of Conflict.’

Recusal from Data Analysis

Investigators from the University of Utah will not have a lead role in data analysis.

During protocol development, external investigators/institutions should be solicited to perform data analysis for the trial.

Recusal from DSMB

Investigators from the University of Utah will not participate on the Data and Safety Monitoring Board.

During protocol development, external investigators/institutions should be solicited to serve as the DSMB.

Independent or External Data Safety Monitoring

A non-conflicted, independent and external data safety monitor will review the study on a regular basis.

The monitor will approve study continuance, approve all dose escalations or modifications, evaluate study cancellation rules and provide approval for the study’s continuation, review and approve all SAEs and potential deviations, review and approve all data analysis and publications prior to submission.

The monitor’s responsibilities will likely depend on the design of the study.

Contact the ICOI Officer for an individualized assessment of your potential study. Discussions should occur during the study concept stage (protocol design).

Independent or External Data Statistician

A non-conflicted statistician external to the University shall be appointed oversee trial data. The statistician will review and approve all data analyses and publications prior to submission, and this should be acknowledged within any publications.

During protocol development, external investigators/institutions should be solicited to perform data analysis for the trial.

OTHER

Contact the COI Office for guidance