The University’s Individual Conflict of Interest in Research Policy seeks to identify the potential for bias in research and, where identified, to mitigate that risk by managing or eliminating the conflict. The COI Program collects disclosures from researchers across campus about their outside interest(s). Then the COI Program works with the faculty-based Institutional Review Committee (IRC) to compare those outside interests against the researcher’s University-based research projects to determine if there is a Financial Conflict of Interest. The following is a brief summary of the COI requirements that must be completed by investigators prior to the COI Program being able to complete its review.
- Each investigator (i.e., any individual responsible for the design, conduct, or reporting of research) must complete an annual disclosure of outside interests through the COI Disclosure System. These disclosure requirements apply to all foreign entities, including, but not limited to, employment at and/or payments from foreign entities.
- Where an investigator has disclosed an outside interest, the COI Program reviews all of the investigator’s research against that interest to determine whether a conflict exists.
- In order for the COI Program to conduct its review, the research project must appear in the COI Disclosure System. For sponsored projects that have reached the Institutional Proposal stage, this should happen automatically. For most other projects, each investigator will need to manually enter the project into the COI Disclosure System, providing sufficient detail to allow for a meaningful review by the faculty-based Institutional Review Committee. Instructions for manually entering the project into the COI Disclosure System can be found in STEP 6 on page 5 of these Instructions for using the COI Disclosure System.
A Financial Conflict of Interest exists when an outside interest “is Related to, or can be perceived to be Related to, the Covered Individual’s Institutional Responsibilities.”
Frequently Asked Questions
“Relatedness” means that it may reasonably appear that decisions made by the researcher in the performance of their Institutional Responsibilities could directly and significantly affect the value of (or be in conflict with) their outside interest(s). Relatedness includes situations in which a researcher’s outside interest(s) would reasonably appear to affect, or to be affected by, the individual’s Research or other Institutional Responsibilities, as well as situations in which the Outside Interest involves an entity whose financial interests would reasonably appear to affect, or be affected by, the researcher’s Institutional Responsibilities.
Importantly, a finding of a FCOI is not a judgment on whether the researcher would deliberately make choices in the Conduct of Research or the performance of their Institutional Responsibilities based on considerations related to their outside interests. Rather, “Relatedness” refers to the condition in which it may reasonably appear that choices made in the performance of the researcher’s Institutional Responsibilities could be directly and significantly influenced by the existence of outside interests.
Anyone who is an “Investigator” on a research project at the University (whether or not externally funded) must submit a disclosure. “Investigator” is a defined term in the policy, and generally means “any person who is responsible for the design, conduct, or reporting of Research.”
This includes but is not limited to the Principal Investigator (PI), Co-PI, Co-Investigator, Project Director (PD), Co- PD, Senior/Key Personnel, and any other persons involved in the Conduct of Research, regardless of title or position, who are responsible for the design, conduct, or reporting of Research performed by or under the auspices of the University. This may include students, trainees, collaborators, volunteers, and Consultants if those individuals have some degree of independence in performing some aspect of design, conduct, or reporting of the Research. The term “Investigator” does not include individuals whose performance within the Research is purely ancillary or occurs solely under immediate supervision.” Note: This may be a broader universe than the individuals included on the HSPP’s List of Personnel Form.
The investigator will still need to complete the required training and disclosure requirements even if they do not have outside interests that meet the definition of a significant financial interest or a significant personal interest as described above. In this case, they will simply certify that they have no outside interests to report on the form and submit the form.
The COI Disclosure System imports Institutional Proposals and Awards from the UAccess Research system and protocols that have been submitted to the IRB. Thus, if your research project is not reflected in UAccess Research as either an Institutional Proposal or an Award, it will not automatically appear in the COI Disclosure System.
For projects that are not automatically imported, investigators will need to manually enter the project into the COI Disclosure System. To do this, please see STEP 6 on page 5 of these Instructions for using the COI Disclosure System. If the project involves human subjects, please refer to the instructions in the Human Subjects Research tab under Investigators.
Conflict of Interest disclosure statuses can be found using the Conflict of Interest by Project dashboard. You can use this site to review who has completed the conflict of interest training and disclosure requirements and to see if there are outstanding requirements that an individual needs to complete.
What information is available in this dashboard?
The dashboard provides the determination status for COI Project/Protocol Disclosures, as well as the status of an individual’s COI training and annual disclosure certification. For each project, a determination status will either be: (1) COMPLETE [COI Requirements have been met and project is approved], (2) INCOMPLETE – AWAITING CERTIFICATION [individual must complete their annual COI Disclosure], (3) INCOMPLETE – AWAITING PROJECT CERT [individual must complete their project questionnaire], (4) INCOMPLETE – IN REVIEW [individual has completed disclosure requirements and COI Program is reviewing disclosure], or (5) INCOMPLETE – CONTACT COI. If an individual does not appear in the dashboard, it is because they have not completed a disclosure or do not have an active project (proposal, award or protocol). The status of manually entered projects is not captured in this dashboard.
How do I access the dashboard?
You can access the dashboard here.
How do I determine if an Investigator is up-to-date with their COI Disclosures?
To be up-to-date, an Investigator must have submitted a disclosure through the COI Disclosure System after June 1.
- The status of a COI project/protocol disclosure can be checked here: COI Project-Based Investigator Status.
- Investigators can check their own status by logging into the system.
Note: Being up-to-date on disclosures is different than the COI process being complete. Please review the subsequent FAQs to assess if you also need one or more investigators to confirm the completeness of the COI Program’s review of a disclosure.
Why is an Investigator recieving emails about a Sponsored Project or an IRB Project not being certified?
When an sponsored project or an IRB protocol is submitted to the appropriate office, the departments will upload the projects into their system and then those projects will automatically link to all Investigator's Disclosures. The Investigators will recieve an email telling them that they must certify the project. In the case of an IRB project, the Investigator must certify within 30 days or the project will be pulled from the IRB system.
An investigator is not involved in an IRB project or a Sponsored Project anymore but they are getting emails about updating their disclosure. What do I do?
For a sponsored project, the PI needs to email the COI office and let them know that someone is no longer on the project and we can make sure they do not recieve emails anymore. For an IRB project, the PI needs to contact the IRB office to update their list of personnel. They can be contacted at email@example.com.
What if I need approval of an Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Under the University of Arizona’s Institutional Conflict of Interest Policy, sponsorship of an Investigational New Drug (“IND”) or an Investigational Device Exemption ("IDE") application by UA or UA personnel may create an Institutional Conflict of Interest. Accordingly, if you are applying for an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) then you must get approval from the Executive Review Committee. Please submit an IND/IDE COI Worksheet to the COI Program as far in advance of your anticipated IND/IDE submission date as possible, to minimize the risk of delays while awaiting ERC review.