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COI Frequently Asked Questions

About the disclosure process:

Follow the steps outlined in Request to Edit a COI Disclosure (PDF).

A COI disclosure must be updated annually and within 30 days of a significant change in the information provided. Follow the same steps provided here: Updating or Revising a COI Disclosure in KCOI (PDF).

The COI Delegate functionality allows Reporters to assign Delegates. Delegates can add, edit, and update answers and information within the Reporter’s KCOI disclosure. However, Delegates cannot submit the disclosure for review. This MUST be done by the Reporter. Once the Delegate completes their action(s) the Reporter must return to the disclosure, review the updates, certify, and submit. Steps to assign a delegate can be found here: Assigning a Delegate (PDF).

Delegates can add, edit, and update answers and information within the Reporter’s KCOI disclosure. Delegates cannot submit the disclosure for review. If you have been assigned delegate responsibilities, instructions can be found here: Delegate Instructions (PDF).

The COI Committee typically meets the 2nd Wednesday of month. The disclosure must be completed, electronically routed, and approved in KCOI by the first of the month for submission to that month's agenda.

The reporter (discloser), Unit Head/Chair, and Dean must approve the disclosure in KCOI. There is no delegation of these approvals to others.

UMD policy requires disclosures be updated annually and within 30 days of new or changed significant financial interests.

It is important to disclose in publications and presentations to maintain a level of integrity and transparency in research reporting. Sample COI disclosure statement: "Dr. [UMD PI] co-founded XXXX to commercialize technology developed in collaborations with their labs. Company XXXX has an exclusive license from the University of Maryland for the commercialization of this technology."

You can modify your view and create filters in KCOI.

  • Click +New Filter
  • +Add Rule --
  • You can then customize the display by adding columns like “Assigned Reviewers” or “Unit,” especially if there are multiple units you oversee.
  • Once you have a filter setting you like, name and save it.
  • You can create multiple filters.
  • To choose a different filtered view, click the “Apply filter” button and choose from the list of filters you have saved.

About the COI training course:

Register and enroll in the Conflict of Interest Mini-Course through CITI. Click on View Courses, select Add a Course, and scroll to Question 5: Conflict of Interest Mini-Course. This course and associated quizzes should take 30-60 minutes to complete. If you pass the quizzes, the training is good for four years. You will be sent an automatic reminder when your training is due to expire.

Gifts:

Yes, you must disclose all current or pending gifts in support of your research program to you or through the University. Gifts include funding and/or resources, for example, but not limited to: equipment, materials, software, and other items of value.

Information about the gift would be included under entity information. Question #4 under entity: Please describe the relationship you and/or your family member has with this entity (you must have at least one). A description of ALL relationships with an entity is required.

What to select:

4b. Relationship - Paid or underpaid activities
4c. Relationship type - gift

Disclosing Gifts

About FCOI:

Anything of value whether or not the value is readily ascertainable.

A significant financial interest that could directly and significantly affect the design, conduct, or reporting of funded research.

Typically defined as the value of any remuneration (salary, payment for services, consulting fees, honorarium, paid authorship, stock) exceeding $5000 in the prior 12 months. The UMD threshold is $0.

 

Please go to ORA’s site on FCOI Subcontractor Guidance and/or contact the COI office.

It does not include travel that is reimbursed or sponsored by a United States:

  • Federal, state, or local government entity
  • Institution of higher learning
  • Academic teaching hospital
  • Medical center, or
  • Research institute affiliated with an institution of higher learning.

Travel paid for by foreign institutions, including universities and governments, must be disclosed.

 

It means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Have you (or your spouse or child or dependent) made any reimbursed or sponsored travel that is related to your research, sponsors of your research, or your institutional responsibilities? If yes, create one entry for each trip. If no, click the red X to delete the entry and click Next to go to the next category.

Under the Remuneration and Equity Interest question, do not include the following: Income from investment vehicles, such as mutual funds and retirement accounts, as long as you do not directly control the investment decisions made in these vehicles.

Based on the regulatory guidance you should not need to include the travel if it was not "related to your institutional responsibilities". However, the regs don't discern between "current" and "former" institutional responsibilities. That being said, the best course of action would be to include the travel with a short description. This way it is clearly noted and you are covered.

Management plans and disclosing in presentations and publications:

Investigators share an obligation to identify and, when possible, avoid financial conflicts of interest. When conflicts cannot be avoided, investigators must disclose relationships that create, or reasonably appear to create, conflicts of interest, and work with university officials to manage or resolve those conflicts. All postdoctoral researchers, graduate students, and lab members, whether involved in the research/award or not, will be made aware of this COI in writing and will sign a memo indicating their acknowledgement.  These signed acknowledgement documents will be filed with the UMD COI Office and kept up to date.

You should disclose at the time of publication submission or within the initial slides of a presentation. Below are examples of language that can be used for such disclosures:

  • Example 1 (equity interest): [Researcher’s name] has a financial interest in [Entity] and could benefit from the results of this research. This conflict has been reviewed by the University of Maryland and has been appropriately managed to maintain objectivity.
  • Example 2 (licensed technology): [Researcher’s name] has a licensed [technology] to [Entity] and could benefit from the results of this research. This conflict has been reviewed by the University of Maryland and has been appropriately managed to maintain objectivity.
  • Example 3 (consulting): [Researcher’s name] has a financial interest with [Entity] and could benefit from the results of this research. This conflict has been reviewed by the University of Maryland and has been appropriately managed to maintain objectivity.

A disclosure should be made at study initiation or as soon as a management plan is issued, whichever is first. As new members join the research team or collaborators join the project, a disclosure should be made to them. Below are examples of language that can be used for such disclosures:

  • I have a financial interest in [Entity], and I could potentially benefit from the results of this research. To prevent any perceptions of bias or conflicts of interest, I am disclosing my financial interests to you and all of my research collaborators. This interest has been disclosed to and managed by the University's Conflict of Interest Office. If you have any questions or concerns, please feel free to contact me or the Conflict of Interest Office at any time.
  • I have licensed [technology] to [Entity] and therefore I could potentially benefit from the results of this research. To prevent any perceptions of bias or conflicts of interest, I am disclosing my financial interests to you and all of my research collaborators. This interest has been disclosed to and managed by the University's Conflict of Interest Office. If you have any questions or concerns, please feel free to contact the Conflict of Interest Office at any time.
  • I have a financial interest with [Entity], and I could potentially benefit from the results of this research. To prevent any perceptions of bias or conflicts of interest, I am disclosing my financial interests to you and all of my research collaborators. This interest has been disclosed to and managed by the University's Conflict of Interest Office. If you have any questions or concerns, please feel free to contact me or the Conflict of Interest Office at any time.

Working with Companies:

All potential COIs on MIPS awards - disclosed at the time of application or not - must be resolved prior to award setup/expenditure.

Examples of potential COIs include (but are not limited to) situations in which the university PI, a family member, another UMD project researcher, or any other university employee:

  • Holds equity ownership or equity option interest in the partner company (even if of no monetary value), 
  • Holds a company board membership (even if unpaid),
  • Is an employee of, officer of, or consultant to the company (even if unpaid),
  • Has any other contractual or financial relationship with the company.

Resolving Conflicts: Management Plans - Risk Level 2 for example plans for MIPS awards.

Visit the Collaborating with a Non-Federal Sponsor page for more information.

No personnel employed by UMD will be employed part-time or full-time by the company, including undergraduate students, graduate students, post-doctoral researchers, or technicians. UMD employees will not conduct research for the company or be allowed in the company’s research facilities. UMD students employed by the company cannot be students in classes taught by UMD researcher(s) and/or be their advisees.

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