Research Integrity and Assurance

Disclosure Process

Disclosure process

The Intellectual Property and Institutional Review Committee (IPIRC) may also assist in the evaluation and disposition of faculty financial conflicts of interest. The committee is made up of faculty and staff representing the diversity of academic and research disciplines of the university.  

IPIRC meetings are held in the Centerpoint Building (660 South Mill Avenue, Tempe) in suite 312-05 at 3:00 pm, unless noted otherwise. Upcoming meetings are scheduled for:

Meeting Dates
September 9, 2019
November 18, 2019
January 27, 2020
April 13, 2020

 

If you are not involved in research, you may complete a conflict of interest disclosure through the Office of General Counsel

For researchers, there is a single reporting system through the Enterprise Research Administration System (ERA). Conflict of interest certifications are automatically sent to investigators for completion when a proposal is submitted. 

How I disclose a relationship with an entity outside of the proposal submission process?
  1. Log in to the ERA system with ASURITE and password 
  2. Click the COI tab in the top left corner of the screen to get to the COI inbox
  3. Click the “Create My Certification” button
    01-COI-Create-My-Certification.png
  4. In the question below, indicate that a new disclosed interest is being added and select OK
    02-COI-Updating-Your-Disclosures.png
  5. Click the “Edit Disclosures” button to start the disclosure process
    03-COI-Edit-Disclosures.png
  6. Check “yes” or “no” for each of the six questions, as applicable
  7. Answering “‘yes”’ to any of the six questions on the previous screen will prompt the screen below. After answering “‘yes”’ to the question below, the "Disclosure Details" page will appear
    04-COI-What-to-Disclose.png
  8. Click the “New Disclosure” button to start the disclosure and follow the prompts to complete the disclosure
  9. After completing the disclosure, click the “Continue” button until the “‘Assurance and Certification”’ page appears. Check the box under the “‘Before you Finish”’ verbiage and then “‘Finish”’ to complete the disclosure process.
Review process

Once an investigator has submitted the conflict of interest disclosure form, the system will automatically generate an email and forward it to the supervisor of record. The email notifies the supervisor that the investigator has submitted a financial disclosure form to ORIA and provides a link to the form for the supervisor to review and acknowledge the financial interest.   

The supervisor reviews the information and submits the certification documenting that they have reviewed and are aware of the financial interest disclosed by the investigator. The certification is automatically routed to ORIA for review.

ORIA reviews the financial interest disclosure form and makes a recommendation regarding any potential financial conflicts of interest. If ORIA determines that no financial conflict exists or that disclosure only is required, ORIA will notify the individual who filed the disclosure.

If ORIA determines that the disclosure is a significant conflict of interest, the office will work with the investigator to set up a management plan to appropriately manage the conflict and identify a plan monitor to monitor compliance with the management plan. Once the investigator and ORIA reach a management plan agreement, the investigator, plan monitor and the institutional official will sign the management plan to formalize the agreement.

The investigator may not initiate research until an agreement is reached. 

ORIA also reports significant financial interests that are disclosed to ASU Financial Services as part of ASU compliance with the State procurement laws. ORIA will work with the investigator to eliminate or appropriately manage the conflict if/when procurement activity with the conflicting entity arises.  

Management plans

To manage a significant financial conflict of interest, conditions or restrictions may be instituted which can include, but are not limited to:

  • disclosing significant financial interests to all co‐investigators and trainers, and to journal editors
  • disclosure in publications, presentations and, in the case of human research, the informed consent document
  • monitoring the research by independent reviewers  
  • designating a substitute PI (peer or superior) who has no significant financial interest in the project
  • modifying the research plan to manage, reduce or eliminate the conflict of interest
  • disqualifying participation in all or a portion of the research  
  • divesting significant financial interests  
  • severing relationships that create actual or potential conflicts

Arizona state law may require the management of conflicting financial interests that arise if ASU enters into contracts for supplies, including subcontracts or with awards to third parties under sponsored projects.

Reporting

ASU will hold disclosures in confidence, except for business purposes or when required by law to disclose it. Where appropriate, ASU may share this information with supervisors and appropriate ASU, ABOR and Skysong Innovations, LLC administrative personnel in conducting the review under the applicable policies. ASU may also share information on conflicts of interest with sponsors when required by the sponsor.

For PHS-sponsored research, the regulations require public accessibility of disclosures when a request is made under a public records request or the Freedom of Information Act. When a public request is made, ASU will provide a written response within five (5) business days, as required, for financial interests that meet the following criteria:

  1. The significant financial interest was disclosed and is still held by key personnel
  1. The review determined that the significant financial interest is related to the PHS-funded research
  1. The review determined that the significant financial interest is a financial conflict of interest

For financial interests that meet the criteria, ASU will disclose the following information:

  • the investigator’s name
  • the investigator’s title and role with respect to the research project
  • the name of the entity in which the significant financial interest is held
  • the nature of the significant financial interest
  • the approximate dollar value of the significant financial interest using the following ranges:
    • $0–$4,999
    • $5,000–$9,999
    • $10,000–$19,999
    • $20,000–$100,000 by increments of $20,000
    • amounts above $100,000 by increments of $50,000
    • a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

Information concerning the significant financial interests must remain available for at least three (3) years from the date that the information was most recently updated.

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