Conflicts of interest frequently asked questions
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 (COI) 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. ORIA 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?
How often do I have to complete the disclosure process?
Regulations require disclosure at every proposal submission and at least every (1) year thereafter. If there are any changes to the financial interests, you must report them within thirty (30) days of the change. Training for Public Health Services (PHS) investigators is required at least every four (4) years. ASU has tried to simplify this process as much as possible utilizing the Enterprise Research Administration (ERA) system.
Can a consultant be listed as an investigator on a PHS proposal or funded activity?
If the consultant meets the definition of “investigator” and is a member of another organization, then you must administer payment through a subcontract rather than paying through a consulting agreement. If the consultant is self-employed and meets the definition of “investigator” you must hire the consultant as an ASU employee through the normal recruitment process. Refer to the Subrecipient vs Consultant vs Vendor guide to assist with this determination.
I would like to list a consultant as a co-author on a publication. Does this make the consultant an investigator?
The act of listing a consultant on a publication does not automatically define them as an investigator. You should only list individuals who are responsible for the design, conduct or reporting of PHS proposed or funded activities as an investigator.
How do I get cleared for conflicts of interest to start spending on an award?
ORIA will verify that you have submitted a COI Research Initiated Certification (RIC) for all investigators on an award and that reviews for conflicts of interest are complete. For PHS awards, ORIA will also verify your training prior to clearing an award for spending. 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 funding immediately. Can I submit a COI Research Initiated Certification later and if required, PHS Financial Interests Form later?
No. Under PHS regulations, investigators must complete a COI certification and disclosure of any applicable financial interests at the time of application for research funding.
I am a new investigator to ASU and will join an already funded PHS project. What do I need to do?
Investigators must complete the RIC for the proposal related to the project, and disclose their financial interests, as applicable, no later than the 30th day of initial employment.
Investigators must complete the required training prior to PHS project participation.
What are my “institutional responsibilities”?
“Institutional responsibilities” are defined by the PHS regulations 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. 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 ORIA cannot make a determination, the information is submitted to the Intellectual Property and Institutional Review Committee (IPIRC) 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?
For PHS investigators, yes. You must report travel equal to or >$5,000 per entity (or below the threshold but when aggregated with other financial interests per entity equal to or >$5,000) for any expenses that are not reimbursed through ASU or a sponsored project. Reporting of travel expenses paid by an external entity includes registration, transportation, per diem, lodging and any other incidentals that are a normal part of travel reimbursements.
The de minimis threshold for reporting reimbursed or sponsored travel is equal to or >$5,000. Investigators must report the travel if their financial interest is below the travel threshold for reporting but they have other financial interests in the same entity which, when aggregated with the travel, is equal to or >$5,000.
The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following: 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.
The reporting period is one (1) year preceding the disclosure. Investigators planning to participate in PHS-funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous twelve (12) month period no later than the date of application for PHS-funded research. Investigators must submit an updated disclosure form for reimbursed or sponsored travel within 30 days of each occurrence.
A graduate student is listed on a proposal as an investigator. Do they need to submit a COI Research Initiated Certification?
Yes. Any person, regardless of title, position or employment status, whom the principal investigator identifies as someone responsible for the design, conduct or reporting of research at, on behalf of, or in collaboration with the university is considered an investigator. They must submit a Research Initiated Certification and disclose applicable financial interests.