COI FAQs

GENERAL COI POLICY QUESTIONS

What is a conflict of interest?

A conflict of interest is any situation that may compromise or appear to compromise a covered individual’s (employee’s) professional judgment in carrying out their institutional activities because of an external relationship/interest of the employee or their immediate family.

What are some examples of an external interest that would need to be disclosed?

External interests that are related to a covered individual’s institutional role(s) (and activities) must be reported on the ADF. This includes, off campus, non-University commitments, such as company ownership, additional employment, or consulting/lectures/speaker bureau activities for external entities.

Business

Academic

Research

Are all external interests automatically a conflict of interest?

No, external interests are not automatically considered a conflict of interest.

Who determines if my external interest is a conflict of interest?

The Conflict of Interest Program, in conjunction with the Conflict Review Board as appropriate, reviews any disclosed external interest to identify conflicts of interest and determine if the conflict of interest can be managed or reduced, or if the interest would need to be eliminated. These external interests are reported through the Attestation and Disclosure Form (ADF). Disclosures are reviewed on an individual basis and management, as needed, is developed. Unique situations are brought before the Conflict Review Board for a determination on the management, reduction, or elimination of a conflict of interest. In situations where additional information is required, the COIC Office will contact the covered person with an information request.

Where do I report my external interests?

The Attestation and Disclosure Form (ADF) is a means for covered individuals (employees) to disclose any external financial interest that may be potential conflicts to their institutional duties/activities. Only external interests that are related to a Covered Individual’s institutional role (and/or activities) must be reported on the Attestation and Disclosure Form (ADF).

What happens when I disclose an external interest?

If you have reported disclosures, then your form will be reviewed to determine if a possible conflict of interest exists. If it is determined that your conflict requires management, then you will be contacted if further information is required and a management plan will be developed. You will have to agree and sign off on the management plan and your Appropriate Authority will be copied on the plan.

Review the Management Plan Process.

RELATED COI POLICY QUESTIONS

Am I allowed to work outside of the university?

Yes. For staff, this policy is prescribed by Human Resources and Section 5.6 of the RedBook. For Faculty, this is governed by Section 4.3.3 of the RedBook.

PER-1.12 May 1, 1992 Work Outside the University:

View HR Policy

Staff Work Outside the University

Faculty Work Outside the University

What is a conflict of commitment?

A conflict of commitment is an external activity they may have the potential to interfere with a covered individual’s time commitment to university terms of employment. This is an area that is monitored and addressed by an individual’s department chair and/or direct supervisor. This policy is prescribed by Human Resources under the following:

Commitment of Effort

View Red Book Policy for Annual Work Plan and Presence at the University

GENERAL PROHIBITED ACTIVITIES

What external interests and/or activities are prohibited?

Covered Individuals are prohibited from the following external activities/interests:

1. Using the University name, marks, or logos for advertising purposes without prior Institutional approval
2. Using any University address or communication method (including email, telephone, fax) for personal gain
3. Using the official stationery of the University for personal or non-University business
4. Giving as a consulting business address any University building or department name when participating in non-University commitments without approved license
5. Using University personnel, equipment, or services for personal gain
6. Using position or role to determine or influence the hiring, promotion, reappointment, evaluation, responsibilities, salary and termination status for an immediate family member
7. Using position or role to determine or influence the selection of a vendor, which you or your immediate family member have an Interest, to provide goods or services to the University
8. Participation in non-University commitments that interfere with the performance of regular duties, or compete with coursework offered by the University or services offered by the University, including non-University consulting that exceeds, on average, one day per week during the term of your appointment or the terms of a professional practice plan not addressed in an approved work plan or work assignment
9. Engaging in non-University sanctioned, (i.e. without the express approval of the Vice-President for Advancement) philanthropic or fund-raising activity related to one's University duties
10. Expression of endorsement or speech, actions or representations on behalf of the University in relation to the external activity, when rendering service to or cooperating with an organization outside the University

DISCLOSURE RELATED QUESTIONS - The form itself

What is the Attestation and Disclosure Form (ADF)?

The Attestation and Disclosure Form (ADF) is the means to disclose external activities related to an individual's institutional role(s) and/or activities.

Who is required to complete it?

Effective October 1, 2017, all covered individuals are required to complete an ADF at least on an annual basis. These individuals include:

• All University of Louisville Employees.
• All individuals participating in research under the auspices of U of L, regardless of compensation.

This includes all individuals with a research appointment.

Why am I required to complete this disclosure form?

UofL policy requires Covered Individuals to maintain a current ADF to ensure compliance with regulatory requirements and University Policy.

When does the disclosure need to be completed?

The ADF must be completed:

• At least annually
• Within 30 days of discovering or acquiring a new external or professional activity that would require disclosure

Where is the disclosure form?

The ADF must be completed in iRIS. You will need your UofL UserID and Password to enter the system. If you do not know your UofL credentials, please contact the Help Desk at (502) 852-7997.

Instructions for completing the ADF.

How do I update/amend my ADF?

Changes to your disclosure must be reported within 30 days of discovering or acquiring a new external or professional activity that would require disclosure.

All disclosure changes will require the completion of a new ADF (instructions) or can be completed by copying your current form in iRIS and making the appropriate changes to the newly created copied form.

What is the Travel Disclosure Form?

The Travel Disclosure Form is used ONLY to report any paid or reimbursed travel from an external entity (not UofL) that exceeds $5,000 annually from October 1 - September 30. This form will not fulfill your annual university disclosure requirement. The annual disclosure requirement is the Attestation and Disclosure Form (ADF), noted above.

The Travel Disclosure Form is available in iRIS.

The Disclosure Process

What will happen after the completion of my disclosure form?

If you make no disclosures, then it will be automatically logged and will not need to be updated for 12 months, unless you have a change to your disclosure(s). If you discover or acquire a new external or professional activity that would require disclosure, you are required to submit a new disclosure within 30 days.

If you have reported disclosures, then your form will be reviewed to determine if a possible conflict of interest exists. If it is determined that your conflict requires management, then you will be contacted if further information is required and a management plan will be developed. You and your Appropriate Authority will have to agree and sign off on the management plan.

Review the Management Plan Process.

Are my disclosures shared?

The items disclosed on the ADF are available to the Conflict of Interest Program Staff and Conflict Review Board. Appropriate Authorities may request to view disclosures of individuals which they supervise. Researchers are also subject to the release of their disclosed interests to the sponsoring agency and also to the public, upon request, as required by federal regulation.

Additionally, as a public university, all documents held by the university are subject to federal laws that may require the release of information, if mandated to do so.

DISCLOSURE REQUIREMENTS

What needs to be disclosed?

General:

External interests that are related to a covered individual’s institutional role(s) (and activities) must be reported on the ADF. This includes, off campus, non-University commitments, such as company ownership, additional employment, or consulting/lectures/speaker bureau activities for external entities.

Business:

See more detailed information in the PDF What to Disclose – Business

The following external interests of a covered individual (or immediate family member) must be disclosed on the ADF for the past 12 months and the anticipated upcoming 12 months:

• Serving in a management and / or operational role (president, officer, director, etc.), regardless of whether compensation is received for a for-profit (public or private) or not-for-profit entity.
• Receiving compensation from any public entity and/or the value of any equity interest (excluding purchase of mutual funds) in the entity, when aggregated, exceeds $5,000.
• Receiving any compensation from any private entity.
• Holding any ownership interest (e.g., stock, stock option, or other ownership interest).
• Anything of value (“gift”) greater than $25 per year from an outside organization that provides good, services, and/or funds to the university or associated organization (ULAA, ULF, ULRF). Examples include: Free meals, discounted items, gift cards, free tickets to entertainment events, software, or other tangible items.

Academic:

The following activities of a covered individual (or immediate family member) must be disclosed on the for the past 12 months and the anticipated upcoming 12 months:.

See more detailed information in the PDF "What to Disclose - Academic".

1. Receiving benefit or the perception of received benefit from the assignment of instructional materials, or selection of a vendor, for University coursework, including instructional materials developed by a supervisor in the Covered Individual’s reporting line.
2. Making purchasing and/or contracting decisions with vendors (including potential instructional material vendors) to the University, while maintaining a direct or indirect financial or business interest with that vendor.
3. Accepting any promise, obligation, or contract for a future award from a supplier or instructional material vendor.
4. Making professional referrals to any business while maintaining a direct or indirect financial or business interest with that vendor.
5. Assigning staff, students or faculty to tasks for personal financial or non-financial benefit, rather than for the University, or scholarship or the student’s educational needs. Tasks include internships, research, assistantships, and/or employment.
6. Using a University position/role to improperly influence the enrollment, academic progress, or degree confirmation of a student.
7. Entering into a romantic or sexual relationship with a student for which the Covered Individual grades, evaluates, supervises, admits to a degree program, makes an award to, promotes or employs.
8. Serving as an instructor, advisor, or lecturer for a student who is an immediate family member, or otherwise evaluate the student’s performance, or make a decision concerning an award or reward, or serve on a scholarship committee.

Research:

The following external interests of a covered individual (or immediate family member) must be disclosed on the ADF for the past 12 months and the anticipated upcoming 12 months:.

See more detailed information in the PDF "What to Disclose - Research".

1. Serving in a fiduciary role (officer, director, or in any other fiduciary role for a financially interested entity, regardless of whether remuneration is received for such service) for a public or private, for-profit or not-for-profit entity
2. Receiving remuneration in connection with the supported activity that is not directly related to the reasonable costs of the supported activity (as specified in the agreement between the entity providing support and the institution), including any bonus or milestone payments to the investigators in excess of reasonable costs incurred
3. Receiving remuneration from any publicly traded entity and the value of any equity interest (other than through purchase of mutual funds) in the entity as of the date of disclosure, when aggregated, exceed $5,000
4. Receiving any remuneration from any non-publicly traded entity
5. Holds any equity interest (e.g., stock, stock option, or other ownership interest); Intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights

What DOES NOT need to be disclosed?

The following activities are exempt and do NOT need to be reported on the ADF:

• Receiving income from seminars, lectures, or teaching engagements sponsored by a federal, state or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education
• Receiving income by serving as a special reviewer or on a review panel for a federal, state or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education
• Receiving royalties under the University's royalty-sharing policy but not having any other relationship with the royalty-granting entity that could result in a conflict of interest
• Ownership of Mutual Funds, of any amount
• Salary, royalties, or other remuneration paid by the University to the Covered Individual if the individual is currently employed or otherwise appointed by the University
• Receiving travel, lodging and/or per diem expense for meals as required per University work assignments for serving on (federal, state, local or) peer-review panels or research agencies

Additional information on these requirements as prescribed in the University Individual COI Policy.

I am not sure if I should disclose something. What should I do?

You have two options. You may disclose it in the last section of the ADF in “Additional Disclosures” (please include any dollar amounts of the disclosure if it is monetary) or you may contact the COIC Office or call (502) 852-7612 for assistance.

PHS FCOI QUESTIONS

Where can I find additional information on the PHS FCOI Requirements?

Information on 42 CFR Part 50 Subpart F is available on the NIH website.

Where can I find a list of all of the current agencies and organizations that follow the PHS FCOI regulations?

The Federal Demonstration Partnership maintains a current list of organizations that follow this policy.

What are the COI Requirements at the time of proposal when submitting to PHS funded agencies?

• Study Personnel - Current Attestation and Disclosure form (ADF)
• Subcontracts/Subrecipients - Federally assured, assures to having a compliant policy, or certifies to have personnel comply with our COI policy upon award.
• Consultants - ADF completion or certification (TBD by the COIC Office).
• Any other individual named on the project who has a role consistent with the PHS definition of an investigator. Additional information on investigators is available here.

What are the COI Requirements in order to release award funding from PHS funded agencies?

• Study Personnel- (1) annual ADF, (2) COI training course (included in the ADF, effective Oct. 1, 2015) and (3) management plans (if needed). Transactional reviews of the ADFs will also be conducted at this time by the COIC Office.
• Subcontracts/Subrecipients - Assurance of compliant policy or all project personnel must complete the COI requirement for external personnel (distributed through the COIC Office) and any management plans will be developed (if needed).
• Consultants – Completion of the COI requirement for external personnel (distributed through the COIC Office) and any management plans will be developed (if needed) OR COI certification (TBD by the COIC Office).
• Any other individual named on the project who has a role consistent with the PHS definition of an investigator. Additional information on investigators is available here.

Where are these COI Requirements located?

The Annual Attestation and Disclosure Form (ADF) is available in iRIS. Download the updated instructions for completing the ADF to ensure proper completion.

The ADF now also contains the Conflict of Interest training element. The additional Conflict of Interest Training Course will remain available on the CITI training platform for optional use. Instructions are available for download.

The COI requirement for external personnel is distributed through the COIC Office. Please email the COIC Office for additional information.