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A management plan may be issued to you by the Individual Conflict of Interest Committee. The Committee issues management plans to ensure transparency, promote data integrity, protect students and subordinates, and to safeguard human subjects in research.

Once you have accepted a management plan, you must comply with the requirements within 30 days. This may require you to file an amendment with the IRB (for example, to add disclosure to the consent forms).

EXAMPLES OF HOW TO COMPLY WITH A MANAGEMENT PLAN

COMPONENT
MANAGEMENT PLAN CLAUSE
EXAMPLES OF HOW TO COMPLY

Compliance Reporting

I will provide annual reports of my compliance with this management plan to the Conflict of Interest Office for review.

You will receive an email from the COI Office when your annual compliance report is due. Follow the link in the email to submit your report online in the ERICA system (a template is provided).

Disclosures in Publications

I will disclose my financial conflict(s) of interest to the editors of all publications (journals, books, etc.) when submitting manuscripts or other reports of the results of this research.

Submit your 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.”
  • “Professor Y has a significant financial interest in ABC Corp., Inc. that provided the materials being tested in this research.”
  • “Professor Z is a co-owner of 123 Inc. that licenses technology they invented 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.

Disclosure in Public Presentations

I will disclose my financial conflict(s) of interest in all public presentations of this research.

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

  • “Professor Y has a significant financial interest in ABC Corp., Inc. that provided the materials being tested in this research.”
  • “Professor Z is a co-owner of 123 Inc. that licenses technology they invented that is used in this research.”

Disclosures on the University Public Website

The University of Utah will disclose my financial conflict(s) of interest on a publicly available website. The publicly available disclosures will include my 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.

Disclosures to the Research Team

I will disclose my financial conflict(s) of interest in writing to all members of the research team. Members of the research team will be informed that if they have any concerns about my conflict(s) of interest, they can discuss those with the Individual Conflict of Interest Committee.

Send an email or hand out a printed letter of your disclosure:

“I am writing to formally notify you about a conflict of interest that I have in regards to [PROJECT NAME]. As you may already know, I [DESCRIBE RELATIONSHIP TO COMPANY, e.g. “am part owner of XYZ Corp” or “receive compensation from ABC Corp for consulting” etc.] Since this company stands to profit from this work, and since I stand to profit from the company, I have a “conflict of interest”, which has been officially disclosed to the University.

As part of my management plan, I am informing you about this conflict. If you have any other concerns, please feel free to discuss them with me, or the Individual Conflict of Interest Committee.”

Attach a copy of the written disclosure to your annual compliance report.

For human subjects research, 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.

Disclosures to Subordinates

I will disclose my financial conflict(s) of interest in writing to all subordinates working on this project. Subordinates will be informed that if they have any concerns about my financial conflict(s) of interest, they can discuss those with the department chair or the Individual Conflict of Interest Committee.

Send an email or hand out a printed letter of your disclosure:

“I am writing to formally notify you about a conflict of interest that I have in regards to [PROJECT NAME]. As you may already know, I [DESCRIBE RELATIONSHIP TO COMPANY, e.g. “am part owner of XYZ Corp” or “receive compensation from ABC Corp for consulting” etc.] Since this company stands to profit from this work, and since I stand to profit from the company, I have a conflict of interest, as determined by the University of Utah Conflict of Interest policy.

As part of my management plan, I am informing you about this conflict. If you have any other concerns, please feel free to discuss them with me, the department chair, or the Individual Conflict of Interest committee.”

Attach a copy of the written disclosure to your annual compliance report.

Evaluation of Subordinates

My evaluation of University subordinates will not be based, in whole or in part, on their participation (or refusal to participate) in non-University activities involving any business entity in which I have significant financial interest(s) as defined by the University Individual Financial Conflict of Interest Policy. The participation of subordinates in non-University activities involving such business entities will not be expected or required.

A supervisor cannot evaluate a subordinate based on that subordinate’s activity (or decision not to engage) with the supervisor’s business entity.

Disclosures to Students

I will disclose my financial conflict(s) of interest in writing to all students working on this project. Students will be informed that if they have any concerns about my financial conflict(s) of interest, they can discuss those with their department chair, the chair of their graduate committee or the Individual Conflict of Interest Committee.

Send an email or hand out a printed letter of your disclosure (keep a copy for your records):

“Dear Students and Committee Members,

I am writing to formally notify you about a conflict of interest that I have in regards to [PROJECT NAME]. As you may already know, I [DESCRIBE RELATIONSHIP TO COMPANY, e.g. “am part owner of XYZ Corp” or “receive compensation from ABC Corp for consulting” etc.] Since this company stands to profit from this work, and since I stand to profit from the company, I have a conflict of interest, as determined by the University of Utah Conflict of Interest policy.

As part of my management plan, I am informing you about this conflict. If you have any other concerns, please feel free to discuss them with me, any other member of your committee, the department chair, the chair of the graduate committee, or the Individual Conflict of Interest Committee.”

Attach a copy of the written disclosure to your annual compliance report.

Evaluation of Students

My evaluation of University students will not be based, in whole or in part, on their participation (or refusal to participate) in non-University activities involving any business entity in which I have significant financial interest(s) as defined by the University's Individual Financial Conflict of Interest Policy. The participation of students in non-University activities involving such business entities will not be expected or required.

A supervisor cannot evaluate a student based on that student’s activity (or decision not to engage) with the supervisor’s business entity.

Disclosure to Sponsor

I will disclose to the study sponsor that I have a financial interest in a competing company.

Send an email to the study sponsor:

“I am writing to formally notify you that I have a Financial Relationship with “Company X”, which provides goods and services that may compete with the “Sponsor’s”.

Publications of Students/Subordinates/Other Investigators

Publication of student, subordinate, or other investigator's work on the project will not be delayed beyond the standard University agreement for review of intellectual property issues.

For example, a graduate student will not have their dissertation defense delayed based on activities associated with an external business entity.

Regarding intellectual property review, please reference Policy 7-002: Patents and Inventions.

Intellectual Property Disclosures to TVC

I will promptly disclose any and all new intellectual property arising from this research to the University of Utah Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center.

File invention disclosures as applicable with PIVOT Center
https://pivotcenter.utah.edu/disclose/ 

Recusal from Licensing Negotiations for IP

I will recuse myself from negotiating licensing agreements on behalf of the University for any new intellectual property arising from this research.

Ensure that PIVOT Center is aware of your conflict and do not participate in licensing negotiations on behalf of the University.  

Recusal from Licensing Negotiations (SFI)

I will recuse myself from negotiating licensing agreements on behalf of the University with any business entity(ies) in which I have significant financial interest(s) as defined by the University's Individual Financial Conflict of Interest Policy.

Ensure that PIVOT Center is aware of your conflict and do not participate in licensing negotiations on behalf of the University.  

Peer Review (Research Integrity)

I will identify a non-conflicted peer (not a subordinate) subject to the approval of the Individual Conflict of Interest Committee to review the research and results prior to publication.

A non-conflicted peer (not a subordinate), who may be a member of the research team, should independently evaluate the conflicted individual’s methodologies and results and give approval before the work is submitted for publication.

Peer Consultation (Research Integrity)

I will identify a non-conflicted peer (not a subordinate), subject to approval of the Individual Conflict of Interest Committee, to consult and advise on all major research decisions.

 A non-conflicted peer (not a subordinate), who may be a member of the research team, should independently evaluate the conflicted individual’s methodologies and results continually throughout the research process.

Non-conflicted Data Analysis (Research Integrity)

I will identify a non-conflicted member(s) of the research team or third party(ies) to collect and analyze all data for this research.

The conflicted individual is prohibited from collecting data (i.e., conducting research procedures or methods stated in a protocol) or performing any analysis of the data (i.e., statistical analysis, assessing adverse events, etc.). These duties should be performed by a non-conflicted member of the research team.

Data Blinding (Research Integrity)

I will blind the data during the collection and analysis phases of this research.

When possible, incorporate data-blinding in the study design.

Peer Monitor (Research Integrity)

I will identify a non-conflicted peer (not a subordinate), subject to approval of the Individual Conflict of Interest Committee, to review this research and results at least annually and submit reports to the Conflict of Interest Office for review.

When filing your annual compliance report, you will be asked to identify your peer monitor. Then, the COI Office will solicit a report from your peer monitor regarding their opinion on whether you have complied with the management plan. The peer monitor should evaluate the conflicted individual’s methodologies and results through interviews and submit a report to the Individual Conflict of Interest Committee (suggested questions are provided by the COI Office “Peer Monitor Guide”). There is no legal risk to any faculty member who takes on this role (assuming they do not engage in fraud), as this is not a legally binding opinion.

Disclosures to Human Subjects in the Consent Documents

I will disclose my financial conflict(s) of interest to all potential research participants in the informed consent documents.

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

  • “Investigator [Person] has a financial interest in [Company], the sponsor of this research, which is a conflict of interest as determined by the University of Utah Individual Conflict of Interest Committee, and a management plan has been implemented to ensure transparency, promote data integrity, and to safeguard human subjects in the research.

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

Disclosures to Human Subjects in the Consent Process

A member of the research team who does not have any conflicts of interest related to this research or an appropriate third party will inform potential research participants of my financial conflict(s) of interest during the informed consent process.

A non-conflicted member will make potential research participants aware of the existing conflict of interest.

Recusal from Obtaining Informed Consent from Human Subjects

I will recuse myself from participation in the process of obtaining informed consent from all potential research participants for this study. Informed consent for all potential research participants will be obtained by a member of the research team who does not have any conflicts of interest related to this research or by an appropriate third party approved by the Individual Conflict of Interest Committee.

File an amendment to the IRB application to ensure you are not listed as consenting participants. Abstain from the process of informed consent.

This clause does not prohibit your participation in enrollment on the study, or providing the potential research participant with information about the study, but a non-conflicted member of the research team must obtain consent instead of the conflicted individual.

Business Transactions

I have disclosed a significant financial interest in the entity(ies) named above, which currently transact, or may in the future transact, business with the University of Utah. I will advise my immediate supervisor of the existence of this financial interest. In the event that the University transacts business with this entity, I will not participate in any aspect of that process (e.g., negotiating license agreements, research proposals, subcontracts, and procurement contracts, including the preparation of specifications, evaluations or bids, committee deliberations/voting) on behalf of the University. To the extent that my University responsibilities would normally result in my participation in such transactions, I will assure that any minutes associated with that transactional process reflect my recusal from the decision making process. If my University responsibilities require me to provide input into the selection of products or services from or to this business entity, at the time of providing such input, I will clearly disclose in writing to the University decision-makers the existence of my financial interest in the business entity. I am aware that the Utah Public Officers and Employees Ethics Act, Utah Code Ann. §§ 67-16-1 to -15 (the Ethics Act) creates additional legal obligations for me, including obligations related to my participation in a private business that enters business transactions with my public employer, and I acknowledge that I remain personally responsible for complying with the Ethics Act.

The Utah Public Officers’ and Public Employees’ Ethics Act prohibits a conflicted individual’s participation in business transactions on behalf of the University when the University engages in a transaction with a company in which the individual has a substantial interest.

This does not necessarily prohibit you from serving as Principal Investigator on a given research project.

Eliminate the Conflict

The Committee also determined that this conflict of interest is not manageable and must be eliminated. To eliminate the conflict, you may relinquish your significant financial interest or you may choose not to participate in this research.

Sever your financial relationship (sell your shares or reduce consulting to less than $5,000/12 months for the duration of the research project) or be removed as an investigator from the IRB application.

OTHER

 

Contact the COI Office for guidance.

Last Updated: 10/12/21