Financial Conflict of Interest Management Plan Example
Entity or Entities: (example)
1. Publications and Presentations. Your relationship with __________ (hereafter "the entity") may not restrict publication or presentation, although publication may be delayed for the purpose of pre-publication review for a period consistent with UW-Madison policies.
You, your students, fellows, trainees, and other research workers whom you supervise in the course of your research must disclose the relationship with the entity in publications and academic presentations, if a) the entity supports research reported in the publication; or b) the publication or presentation is related to the entity's commercial interests or intellectual property. For researchers in the biomedical sciences, disclosure in publications should conform to recent uniform disclosure guidelines published by a group of editors of major medical journals (Davidoff et al. JAMA 286: 1232-1234, 2001). (See Appendix A: Disclosing in publications.)
2. Interaction with Students and Staff. UW-Madison has a duty to ensure that the entrepreneurial activities of its faculty and staff do not have a negative impact on students or research staff, especially on the academic progress of students. To fulfill this obligation, the COI Committee requires that individuals with potential conflicts of interest inform others who may be impacted by the potential conflicts.
You should provide information on potential conflicts of interest to all students, fellows, trainees, and other research workers whom you supervise in the course of your research (hereafter students and staff). The information should include explanations of: a) your relationship with the entity, and b) the right of students and staff to bring concerns about the effect of your relationship with the entity on their work, studies, or progress towards degree to your dean, director, his or her designee, or the COI Committee. The process for providing information should meet the following criteria:
- Includes a written summary of the information for each student or staff member
- Provides to the COI Program documentation that this process has occurred within 90 days of receipt of this management plan
- Provides any individuals who subsequently join the group comparable information in a timely manner
- Updates documentation to the COI Committee at least once a year
See "Appendix B: Informing students and staff of potential conflicts of interest" for additional guidance.
You must also notify all your co-investigators on federal grants of potential conflicts of interest.
Your relationship with the entity may not place restrictions on the ability of your students and staff to receive, analyze, or interpret data. In addition, students may not participate in research sponsored by the entity without permission from your dean’s office.
The COI Committee recommends that all involvement of students and staff with the entity be conducted under formal University agreements, such as sponsored research agreements or appointments approved by your dean or director's office.
You must direct any of your students and staff with significant financial interests in the entity to make an annual report of outside activities using the online process (https://research.wisc.edu/compliance-policy/outside-activities-reporting/), if they have not already done so and regardless of whether they would normally be required to make such a report. Any of your students and staff who independently have a reportable significant financial interest in the entity will be reviewed by the COI Committee and may be issued their own management plans.
3. Human Subjects Research. For any human subjects protocol in which the entity a) sponsors the study, or b) owns or licenses a technology used in the study, the following rules apply.
a. All studies
You must report the conflict of interest and provide this management plan to the IRB reviewing the study within 30 days of this management plan’s assignment.
b. More than Minimal Risk Studies
You may not serve as principal investigator (PI), co-investigator (co-PI), or key personnel on the human subjects protocol.
If you wish to apply for an exception to the restriction on participation in human subjects research, you must work with your Dean’s office to apply for the exception. This exception must be addressed to the COI Committee in writing. The COI Committee only grants exceptions for specific protocols. If the COI Committee approves an exception, the COI Committee may require modifications to the human subjects protocol, such as those outlined below in subsection c. For instructions on applying for an exception, see the Financial Conflict of Interest Policy and Procedures: Guidance Document.
c. Minimal Risk Studies
If a reviewing IRB determines that a study in which you are engaged is minimal risk, you may participate in the study, however, the following limitations apply:
i. i. You
must disclose the conflict to participants in the study, unless the IRB
determines that such disclosure would not be appropriate;
ii. You may not participate in the recruitment, enrollment or consent of participants in the study;
iii. If your study meets the definition of a clinical trial*, you must designate a non-conflicted co-Investigator or other key personnel on the study with responsibility for acting as an independent reviewer of the data analysis.
The reviewing IRB may impose additional requirements with respect to your participation in the study. If you wish to request an exception to any of the above-stated limitations, you must follow the exception request process outlined above in subsection b.
* A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
4. Payments and Incentives. You may not receive payments from University accounts or directly or indirectly from the entity for particular research results or for research outcomes related to human subject protocols conducted at or through UW-Madison. Further, you, or your immediate family, may not receive any personal incentives from University accounts or directly or indirectly from business entities, such as recruitment incentives, performance incentives, fellowships, or other research support, except through an agreement entered into by the University for a sponsored human subjects study. UW-Madison only permits payments for subject enrollment, or for the referral of potential subjects to human subjects studies, when all of the following are present:
- The payment reasonably relates to costs incurred, as specified in research agreements between the sponsor and UW-Madison.
- The payment reflects the fair market value of services performed.
- The payment is commensurate with the efforts of the investigator(s) performing the research.
5. Research Support from the Entity. Before accepting any research support (e.g., grants, contracts, unrestricted gifts, or materials) from the entity, you must specifically disclose details of the award to your dean or director’s office for approval, including the scope of the work and any award conditions. The written disclosure details must accompany a WISPER record and be routed from the department chair to the dean or director's office for approval. You must update your outside activities report and indicate that you have sponsored research.
If the sum of all support from the entity is expected to be $250,000 or more in any two-year period, additional clearance from the Board of Regents may be required. You must contact your dean or director's office regarding this possibility well in advance of any award. Note that the $250,000 threshold applies to the total costs of all contracts between the entity and the University over a 24-month period, including subawards. A contract with a smaller dollar amount may still need Regent approval if there have been other contracts between the parties within the relevant timeframe such that the threshold is met.
6. Subagreements with Entity. If you anticipate engaging in a project for which the entity will be a subawardee or subcontractor, you must contact your dean or director’s office for approval prior to submitting a proposal. Additional clearance from the Board of Regents may be necessary for any contracts resulting from such a collaboration.
7. Reporting of Outside Activities. You are required to submit an annual report of outside activities each spring using the online process. In addition, if you have relevant changes in your outside activities between annual reports, you must update your report within 30 days of the change. You may access your Outside Activities Report at any time during the year. For guidance on what relevant changes in your outside activities are, please see: Conflict of Interest Policy and Procedures: Guidance Document.
8. Outside Activities Agreement. A departmental agreement on the appropriate balance between your outside activities and your faculty appointment needs to be established.
9. Use of University Facilities and Services. Any activity involving the use of University facilities or services for the benefit of the entity must be conducted in accordance with all relevant University policies pertaining to the use of University facilities. If you wish to use University facilities for the benefit of the entity, you must make arrangements through your department chair and your dean. You must have a written and approved facilities use agreement before the activity begins. Links to relevant resources are provided in the Conflict of Interest Policy and Procedures: Guidance Document.
10. Purchases. You may not be directly involved in making decisions involving the purchase of items from the entity using funding under your control. Any such contractual arrangements are to be delegated to an impartial party, who is not under your supervision or control, such as your department chair or someone designated by your chair. If you are a department chair, your dean should be asked to designate someone on your behalf.
11. Annual Review. You must meet annually with your department chair, center director, or, if you are the department chair or center director, with your dean or director, or his or her designee, to review information related to your relationship with the entity or entities, its influence on your University activities and compliance with the terms of this management plan. Meeting Confirmation Form
12. Amendments. UW-Madison reserves the right to modify this management plan and to impose new or additional conditions. Such modifications, conditions, and additional terms will be effective immediately and incorporated into this management plan. UW-Madison will notify you of these changes in advance by sending an email message to the email account used for your annual Outside Activities Report notifications. You will be deemed to have accepted these terms and conditions unless you appeal your management plan, which must be done in writing and sent to UW-Madison's Conflict of Interest Committee via firstname.lastname@example.org.
Appendix A: Disclosing in publications
The COI Committee provides the following examples to guide investigators disclosing their significant financial interests in publications and presentations. Investigators may use alternative approaches that meet the requirements laid out in the body of this management plan.
- Dr. A has an ownership interest in Company 1, which has licensed the technology reported in this publication.
- The research reported was supported by funding provided by Company 1, Company 2, and Company 3, with which Professor B has significant financial interests.
- Name [A member of Name's family] owns stock in [has stock options with] Company 1.
- Additional information on disclosing potential conflicts of interest in biomedical research can be found in:
- Davidoff F, DeAngelis C, Drazen J, et al. Sponsorship, authorship, and accountability. JAMA. 2001;286:1232-1234.
- DeAngelis CD, Fontanarosa PB, Flanagin A. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA. 2001;286:89-91.
Appendix B: Informing students and staff of potential conflicts of interest
The COI Committee provides the following guidance to help investigators communicate the details of conflict of interest management plans. Investigators may use alternative approaches, if they meet the requirements laid out in the body of this management plan.
Students, fellows, trainees, and other research workers whom you supervise in the course of your research a written summary should receive a written summary of your relationship with your managed entities. The following information may be included:
The written summary would be printed on department letterhead and include the following:
- Description of the investigator's involvement with the entity;
- Description of the purpose of the entity;
- Description of the relationship between the investigator's professional work (research) at the UW-Madison and the entity;
- Description of any relationships between the UW-Madison and the entity, such as sponsored research agreements, facilities use agreements, etc.;
- Description of any restrictions placed on the design, conduct, and reporting of research by the entity;
- Description of the ownership of any intellectual property resulting from research connected to the entity;
- Impartial contacts for students and staff;
- Investigator's signature; and
- Statement of acknowledgement to be signed and dated by the recipient.
You may provide a copy of your notification letter to students and lab personnel via email, making sure to CC the COI Program at email@example.com and listing out each recipient. A draft Notification Letter is located on your OAR Summary page.
Another effective way to communicate the details of your management plan is to hold a meeting to review the provisions of your plan. During this meeting, participants would receive two copies of a written summary signed by the investigator. They would sign and date one copy and return it to the investigator. The investigator would then provide copies of the signed letters to the COI Committee.
Keywords: Management Plan, outside activity, coi, conflict of interest