Guidance: UW-Madison Office of Research Policy FCOI Policy and Procedures
Federal regulations require institutions to review reports from investigators for potential conflicts of interest. The federal definition of investigator is broad and includes more than individuals named as principal investigator (PI) or co-investigators (Co-Is) on federal grants. The federal definition may include UW-Madison academic staff who are involved in federally-funded or human subjects research.
The Public Health Service (PHS) definition is: “Investigator means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. For purposes of the requirements of this subpart relating to financial interests, "Investigator" includes the Investigator's spouse and dependent children” (42 CRF 50.603).
Similarly, the National Science Foundation (NSF) definition is: “The term "investigator" means the principal investigator, co-principal investigators, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF” (NSF, Grant Policy Manual 510).
Thresholds for Review
The COI Committee reviews academic staff members when:
- an individual reports outside activities that meet federal criteria for significant financial interests (42 CRF 50.603; NSF, Grant Policy Manual 510), AND
- the individual’s position at the UW-Madison would allow them to affect the design, conduct, or reporting of federally-funded research.
Identification of Individuals for Review
The COI Committee identifies academic staff members as possibly subject to review when:
- An individual is listed as a PI or Co-I on federally fund research in UW-Madison’s Extramural Support Information System (ESIS).
- An individual reports that he or she is a principal investigator or otherwise responsible for the design, conduct, or reporting of federally funded research or sponsored projects in his or her annual outside activities report.
- An individual has a significant financial interest in an entity, AND other individuals, who also have a significant financial interest in that entity, are being reviewed by the COI Committee.
- A Dean’s Office requests review of an individual.
Review of Academic Staff Who Conduct Human Subjects Research
Academic staff engaged in research with human subjects are reviewed under the UW-Madison Financial Conflicts of Interest in Human Subjects Research: Policies and Procedures.
Consulting businesses established by the unclassified staff are assigned for review by a COI Committee member based on the criterion of ownership in a privately held entity. If the privately held entity appears to be a consulting only business, the reviewer should determine if the following conditions apply:
- Solely owned by the individual;
- No other employees; and
- The assets or value of the entity come from only consulting work.
If all three conditions are true, the reviewer should recommend “no management, LLC letter” for the entity. Upon this approval, the COI Office will send a letter to the investigator with instructions stating that if the entity enters into a consulting agreement with an individual client with compensation greater than $5,000 that has not already been disclosed, then the individual must update his or her OAR to disclose this client as a separate entity. The COI Committee will review entities disclosed in response to this letter based on the existing review criteria.
If the COI Committee reviewer determines one or more of the three conditions described above are not true, and that a nexus exists between the consulting business and the individual’s institutional responsibilities, then the reviewer should recommend management for the entity.
An individual’s equity ownership in a publicly traded company requires review by a COI Committee member under the federal regulations if that ownership, by itself or when combined with compensation received from that company, equals $5,000 or greater.
The COI Committee will consider additional factors when reviewing an individual’s equity ownership in a publicly traded company:
- Whether the individual is a paid consultant for the entity;
- Whether the individual is engaged in research that is sponsored by the entity;
- Whether the individual oversees students who are supported by the entity; and
- Whether the entity sponsors travel on behalf of the investigator.
If the reviewer finds that any of the above conditions are present along with an individual’s equity ownership in the publicly traded company, then the reviewer may recommend management of that individual’s relationship with the entity. If none of these conditions are present and the individual only holds equity ownership in the publicly traded company, then the reviewer will not recommend management of the relationship. The COI Office will send a letter to the investigator thanking them for their disclosure and informing them that, should the investigator’s relationship with the company change in any of the above conditions, the investigator should inform the COI Committee within 30 days, which will require reevaluation of the investigator’s financial interest with that company.
Federal regulations require PHS-funded investigators to disclose the occurrence of any reimbursed (i.e., paid to the investigator) or sponsored travel (i.e., sponsored travel is that which is paid on behalf of the investigator so that the exact monetary value may not be known) related to the investigator’s institutional responsibilities. Investigators must file an updated OAR within 30 days of the start of a travel event. Please note that the federal regulation does not provide a de minimis threshold for the disclosure of reimbursed or sponsored travel, but instead simply requires disclosure of each travel event.
For investigators with PHS-funded research, the following types of travel need not be disclosed:
- Self-funded travel
- Travel covered through UW-Madison e-Reimbursement system
- Travel funded through the UW-Madison
- Travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education (defined at 20 USC 1001(a) (http://tinyurl.com/9fnyj77), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education (The exception described here applies only to U.S.-based institutions and agencies.)
- Travel reimbursed or sponsored by the National Research Commission or the related National Academies
UW-Madison investigators will provide the following information:
- Purpose of the trip,
- The identity of the sponsor/organizer,
- The destination, and
- The duration.
The UW-Madison is responsible for determining whether travel constitutes a financial conflict of interest with PHS-funded research. Travel to scientific meetings and to present investigator’s research to colleagues and other interested parties are integral parts of the scientific research enterprise and afford important opportunities for forging relationships and collaborations among researchers. UW-Madison COI Policy is not intended to discourage this type of travel.
When present, reimbursed or sponsored travel events will be included in the evaluation of all aspects of the relationship with an outside entity, and whether financial conflicts of interest exist as an aggregate of these aspects.
UW-Madison FPP 8.05 "Use of University Facilities" and 8.07 "Contracting & Leasing"
UW-Madison ASPP 12.05 "Use of University Facilities, Services, and Staff" (PDF)
Wisconsin Administrative Code, UWS Chapter 8.03(2) "Contracting & Leasing"
Guidelines for Appropriate Use of UW-Madison IT Resources
Please follow this link for detailed information on Submitting PHS Proposals with Sub-recipients: https://www.rsp.wisc.edu/subfcoi/index.html
UW-Madison is required to monitor compliance with COI management plans and to provide reports on financial COI and instances of noncompliance to the U.S. Public Health Service (PHS).
Noncompliance with this policy can have serious consequences with respect to an investigator’s ability to initiate or continue spending on PHS-funded research projects or other federally funded projects or to participate in human subjects research.
If the UW-Madison COI Program finds noncompliance (either because you have failed to disclose an outside financial interest related to your institutional responsibilities or because you have failed to comply with the terms of your management plan), then you may be required to complete additional training; research funding can be withheld; and/or other appropriate disciplinary action may be undertaken by the UW-Madison.
If you have a conflict of interest that is being managed you may choose to reduce the value of the COI to below the financial threshold or you may decide to eliminate it altogether to end your management plan.
Steps to end a management plan:
- Update your OAR to disclose the change in circumstance.
- The COI Committee will review your updated OAR and vote whether to end your management plan.
- The COI Program Staff will notify you of the Committee’s decision.
- If the Committee ends your management plan, you will receive a memorandum indicating the date of the termination.
Please note: Termination of an existing management plan requires explicit action of the UW-Madison COI Committee and institutional notification of PHS regarding the change. See Terminating a Management Plan.
If your management plan prohibits you from participating on a human subjects protocol that is either sponsored by or tests a device or technology licensed to the entity, you may work with your Dean’s Office to request an exception to your management plan.
- Contact your Dean’s Office and they will discuss with you the possibility of requesting an exception to your management plan.
- If the Dean’s Office agrees to support your exception request, they will prepare a memorandum outlining the basis for the exception and their willingness to participate in additional management actions and present it to the COI Committee.
- The Dean’s Office representative will present and defend your exception request to the COI Committee.
- The COI Committee will review and discuss your exception request. Often times, the Committee makes recommendations regarding modifications to the Dean’s Office representative.
- The Dean’s Office will work with you to revise the memorandum to address any of the COI Committee’s concerns.
- The Dean’s Office representative will present the revised exception request to the COI Committee.
- The COI Committee will then discuss and vote whether to grant the exception request.
- If the exception request is granted, all of the management conditions of the original management plan, as modified by the exception, must be followed. The Dean’s Office assumes responsibility to monitor the additional management/safety conditions.
- An exception is granted for a specific protocol only. Separate exception requests must be made for each affected protocol.
Requesting Reconsideration of a COI Committee Determination
In instances where you feel there may have been an possible improper assessment of your significant financial interests or possible incorrect assessment of the relationship between your significant financial interest and your research, you may request reconsideration by the COI Committee within 10 days of receiving notice of the management plan. The request must be in writing and directed to the Graduate School’s Associate Vice Chancellor for Research Policy.
If the circumstances of a managed outside activity change so that it meets one of the criteria listed below, please contact the COI Program Staff to request termination of your management plan.
Please note: Termination of an existing management plan requires explicit action of the UW-Madison COI Committee and institutional notification of PHS regarding the change.
Management plans can be terminated if:
- An individual is no longer employed by the UW-Madison.
- An individual no longer has the ability to affect the design, conduct or reporting of federally funded research at UW-Madison related to the significant financial interest and is not seeking such funding.
- The managed entity has been dissolved.
- An individual no longer has any relationship with a managed entity.
- An individual still has a relationship with an entity, but the relationship has changed such that management is no longer necessary.
- Management Plans for Human Subjects Researchers only: An individual is not an investigator or senior/key personnel on any entity-related human subjects research protocol at UW-Madison, does not have the ability to affect the design, conduct or reporting of entity-related human subjects research at UW-Madison, and does not anticipate future involvement in entity-related human subjects research at UW-Madison.