What happens if an investigator does not disclose their financial interests?
If an unreported significant financial interest of an investigator biases the design, conduct or reporting of the research, then upon discovery of this bias, ASU will promptly notify the sponsor and describe the corrective actions taken, or to be taken, in accordance with applicable law or policy. The sponsor may provide further directions to promote objectivity in the research or may impose sanctions.
A sponsor may review university and investigator records relating to the research to determine compliance with the corrective actions. If the sponsor determines that the conflict of interest has not been appropriately managed, reduced or eliminated, this may terminate the agreement or suspend funding until the matter is resolved.
If the investigator did not disclose or manage a conflict of interest in compliance with ASU policy, federal law may require the investigator to disclose the conflict of interest in all public presentations or publications of the research results. Research Compliance will promptly notify the sponsor as required.
I am a new investigator at ASU but completed all training and disclosure requirements at my previous institution. Do I have to redo everything at ASU?
Yes. Investigators must complete the ASU-required CITI COI training and disclosure requirements.
How often do I have to complete the disclosure process?
Regulations require disclosure at every proposal submission and at least every year thereafter. If there are any changes to the financial interests, you must also report them within 30 days of the change. COI training is required at least every 4 years and is met by completing ASU-required CITI COI training.
How do I get cleared for conflicts of interest to start spending on an award?
Research Compliance will verify that all investigators on an award have updated their Disclosure Profiles, that reviews for conflicts of interest are complete, and that ASU required COI training is completed. Investigators will be notified if there are any deficiencies in the requirements along with instructions on how to proceed to clear the deficiencies.
I need to apply for PHS or DOE funding immediately. Can I update my Disclosure Profile later, and if required, the PHS or DOE Financial Interests Form later?
No. Under PHS and DOE regulations, investigators must complete a Disclosure Profile update by reporting any applicable financial interests at the time of application for research funding. Furthermore, the DOE Interim COI policy requires Investigators to certify that each disclosure and updated disclosure is true, complete, and accurate. The DOE Interim COI policy provides a specific certification statement and requires its use.
I am a new investigator to ASU and will join an already funded PHS or DOE project. What do I need to do?
Investigators must complete a Disclosure Profile update and disclose their financial interests, as applicable, no later than the 30th day of initial employment.
Investigators must complete the required ASU CITI COI training prior to sponsored project participation.
What are my “institutional responsibilities”?
“Institutional responsibilities” are defined as an investigator’s professional responsibilities on behalf of the institution, and as defined by the institution in its policy on financial conflict of interest (per PHS and DOE Interim policy). ASU defines “institutional responsibilities” as an investigator’s professional responsibilities performed on behalf of ASU including but not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards or data and safety monitoring boards.
Who determines that a significant financial interest is a financial conflict of interest?
A designated reviewer is responsible for determining if there is an actual, potential or perceived financial conflict of interest. In cases where the designee in Research Compliance cannot make a determination, the information is submitted to the Intellectual Property and Institutional Review Committee for review at a convened meeting.
Do I need to disclose salary paid to me by the university as an investigator?
No. Salary, royalties or other remuneration from ASU employment or appointments do not require disclosure.
I serve as a section reviewer on NIH studies and receive financial payment for this service. Is this included as a financial benefit from an external agency? Am I required to disclose on this?
No. Income from service on advisory committees or review panels for a federal, state or local government agency; an institution of higher education as defined at 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education is exempt from reporting.
Does travel have to be reported?
Yes.
Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities.
Travel (foreign and domestic) sponsored or reimbursed by ASU does not need to be disclosed.
A graduate student is listed on a proposal as an investigator. Do they need to update their Disclosure Profile?
Yes. Any person, regardless of title, position or employment status, whom the principal investigator identifies as someone responsible for the purpose, design, conduct or reporting of research at, on behalf of or in collaboration with the university is considered an investigator. They must update their Disclosure Profile and disclose applicable financial interests. Note that the DOE Interim COI policy defines and investigator as “the principal investigator (PI) and any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE.” DOE Program Offices have the discretion to expand this definition which would be specified in the applicable funding announcement or terms and conditions of the financial assistance award.