Covered individuals at the University of Louisville must comply with Board of Trustees Policy: Individual Conflict of Interest and all applicable federal and state laws and contractual terms related to conflict of interest. This procedure covers academic, business, clinical and research and scholarly activities conducted under the auspices of and/or for the benefit of the University of Louisville.

This procedure governs conflicts of interest and applies to situations involving Covered Individuals.

1.1.  DISCLOSURE

This section includes the general disclosure requirements pursuant to the Individual Conflict of Interest Policy. The sections included below covering procedures for academic, business, clinical and research and scholarly activities may also include additional disclosure requirements.

1.1.1. Attestation and Disclosure Form

External interests and activities are reported on the Attestation and Disclosure Form (ADF).  The ADF is located at: https:\\iris.louisville.edu. Covered individuals holding any of the following roles are required to complete the ADF annually, throughout their Term of Appointment:

• All University of Louisville employees.
• All individuals participating in research under the auspices of UofL, regardless of compensation.   

Term of Appointment means the duration of an individual's University employment, status as student or affiliation with the institution.

Special circumstances also exist which might require the filing of an updated ADF during the course of the year. The updated ADF must be filed within 30 calendar days of a change. The reporting period for the ADF includes the previous 12 months and the coming 12 months.

Each chair or unit head shall ensure that all persons within each department or unit who are Covered Individuals are accurately identified -- either as defined by this procedure or as individually determined to be involved in research by principal investigators, the chair or unit head -- and that all such Covered Individuals complete the ADF in a timely manner (within 30 days of hire and on an annual basis thereafter).

Deans or their designees shall ensure that the responsibilities of chairs or unit heads as described above are carried out in a timely manner, that ambiguities as to the identification of covered individuals are appropriately resolved, and that ADFs are submitted and forwarded as required by this procedure. In the case of a chair or unit head, the responsibility of ensuring the submission of the ADF will rest with the individual at the next higher level in the administration.

1.1.2.  General

Off campus, non-University commitments, such as lectures, speaker bureaus, or consulting activities for external entities that result in personal benefit or compensation are to be disclosed. Covered Individuals who are speakers for external entities, as well as researchers compensated by any external entity will:

1. Fully disclose their engagement with the external entity during presentations and interactions.
2. Disclose any potential commercial bias at presentations and interactions.
3. Not allow their own relationship to bias the content of the presentations and interactions.
4. Not accept compensation from an external entity for any such commitment that exceeds fair market value.

1.1.3.  Academic

The following constitutes interests that must be disclosed:

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.

1.1.4.  Business

Covered Individuals participating in a Request for Proposal/Bid (RFP/B) evaluation are required by Purchasing to complete a confidentiality agreement and ADF prior to reviewing any information submitted by vendors. Any external activity/interest will be disclosed to the Conflict of Interest Program for review of the requested exemption and any information will be referred to the CRB, as needed. If, given the time sensitive nature of this process, the issue cannot be resolved within the needed timeframe, the RFP/B reviewer will be replaced.

1.1.5.  Research

Certain research and scholarly activities and other supported activities may create the need to file additional or updated information. These situations may include, but are not limited to: substantial changes in external interests and activities; before initiating an activity or external relationship that has a potential for a conflict of interest; when submitting a proposal for supported activities, if the current ADF on file does not reflect the current situation; when receiving a contribution that creates or appears to create a conflict of interest; when involved in review or advisory activities; when involved with technology transfer; when communicating with external entities; or when submitting a paper for publication.

The following constitute external interests in supported activities that must be disclosed (non-exhaustive list):

1. Covered Individual or immediate family member 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. Covered Individual or immediate family member 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. Covered Individual or immediate family member 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. Covered Individual or immediate family member receiving any remuneration from any non-publicly traded entity, or the Covered Individual or immediate family member holds any equity interest (e.g., stock, stock option, or other ownership interest); and/or
5. Intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.

The Sponsored Program Grants Administration, Office of Industry Engagement and Clinical Contracting Division (SPGA; OIE; CCD) may not release for expenditure funds for a supported activity in which a required disclosure is not on file or where a significant financial interest has been disclosed until the interest has been reviewed by the COI Program, a determination has been made and a management plan, if required, has been implemented. In instances where previous clearance has been granted for the expenditure of funds, SPGA, OIE or CCD may discontinue expenditure approval if a new significant financial interest is disclosed or a required disclosure is not on file. Such expenditure stoppages may continue until the COI compliance is re-established.

Prior to the expenditure of funds, the Institution will report, to the extent required by the entity providing support, the existence of any conflicting interest disclosed and provide assurance that the interest has been managed, reduced or eliminated. If a conflict is identified after this initial report, the Covered Individual must update the ADF and the Institution will submit a subsequent report in accordance with the requirements of the supported activity

1.1.6.  Research & Human Subjects

University of Louisville subcontractors or sub grantees, funded from contract or grant awards to the University of Louisville, must provide appropriate assurances that they are in compliance with University of Louisville policies relating to financial conflicts of interest in research or that they have the equivalent of these policies and procedures in place, before being included on a proposal. In the case of identified conflicts of interest, the subcontractor/sub grantee must provide the institution with documentation on the conflict of interest and the approved management. On an annual basis, the subcontractor/sub grantee must submit oversight updates to the institution for the duration of the contract period. The institution will report the existence of any conflicts of interest and subsequent management plans as required by sponsors.

The designee of the EVPRI serving on the CRB shall be responsible for professional level staff review under this procedure of each ADF submitted to the University by Covered Individuals related to research and scholarly activity, and make appropriate recommendations concerning the development of management plans for the elimination, reduction, or management of any potential conflict of interest in research.

Supported activities involving the participation of humans are reviewed with extra scrutiny because of the potential to compromise the welfare of human subjects. Normally, researchers are not permitted to conduct human subject research at the University when they hold relevant external interest related to the research. However, Covered Individuals may submit a rebuttable presumption statement to the CRB and present the circumstances they believe would justify a departure from this general principle.

Following the additional review, the CRB will forward their recommendation to mitigate the identified conflict to the CRB Chair.  The mitigation can involve acceptance or denial of the rebuttable presumption. The CRB Chair will review the CRB recommendation and formally approve the recommendation, modify the recommendation or reject the recommendation and approve an alternate management plan.

The COI Program forwards any approved conflict management plans involving human subjects' research to the Institutional Review Board (IRB). Even if the CRB has approved a management plan, the IRB has final authority to determine whether the plan adequately protects research subjects and whether the research may proceed.

1.1.7.  Exempt from disclosure on the ADF

The following activities do not create a potential conflict of interest and are exempt from reporting on the ADF, but may require disclosure via other methods based upon University policies and procedures:

1. Receiving income from seminars, lectures, or teaching engagements sponsored by 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 (as defined at 20 U.S.C. 1001(a));
2. 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 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 (as defined at 20 U.S.C. 1001(a));
3. 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;
4. Ownership of Mutual Funds, of any amount;
5. 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; or
6. 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.

1.2.  REVIEW

1.2.1.  Conflict of Interest Program

The COI Program will perform initial review of submitted ADFs and refer appropriate cases to the CRB for review and management determination.

1.2.2. Conflict Review Board

1. The convened CRB will review each case brought before the body and make an institutional determination as to whether the disclosed interests create a conflict of interest. 
2. In making that determination, the CRB will consider the following issues: the covered individual’s institutional responsibilities, the size and nature of the external interest, when the relationship commenced, whether the conditions of the relationship have changed during the past year, the likelihood of actual conflict (will the results of the activity likely be compromised by the external interest), how closely the University activity is related to the external interest, mechanisms to ensure integrity (peer review, other independent research sites, and independent monitors or controls), the importance of the proposed activity, the participation of human subjects, the availability of alternatives to avoid the conflict or apparent conflict and any other relevant information. 
3. The CRB will consult appropriate individuals, including the Covered Individual, as needed, to ensure a complete understanding of the relationship and its potential impact on University activities and any appropriate management requirements.
4. Based upon this review, the CRB will issue a recommendation that will be forwarded to the CRB Chair for review and approval. 
5. The CRB Chair will review the CRB recommendation and formally approve the recommendation, modify the recommendation or reject the recommendation and approve an alternate management plan.

1.3.  MANAGEMENT OF IDENTIFIED CONFLICTS OF INTEREST

The COI Program staff will consider the required management elements to protect the University’s missions in accordance with the highest standards of integrity and in compliance with legal, professional, ethical and other requirements that promote objectivity and protect against conflicts of interest.

1.4.  IMPLEMENTATION OF APPROVED MANAGEMENT PLANS

Once a management plan is approved, the Conflict of Interest Program will send the approved plan to the Covered Individual and Appropriate Authority for implementation. When a Management Plan has been communicated to the Covered Individual, a receipt form acknowledging receipt of the Management Plan and understanding of the required actions and time frames must be signed by the Covered Individual and returned to the COI Program staff. The Appropriate Authority is copied on this communication.

Unless a reconsideration request is filed (discussed in next section), all elements of the approved management plan must be put into practice and verified back to the Conflict of Interest Program on or before the established implementation date. If a reconsideration request has been filed, the Appropriate Authority should implement all elements not involved in the reconsideration.

1.5.  RECONSIDERATION REQUESTS

Any Covered Individual shall have the right to request reconsideration of any final decision under this Procedure involving that individual. A Request for Reconsideration must be submitted in writing to the CRB Chair within ten (10) business days. The Request should include, at a minimum, the management clause(s) needing reconsideration, an explanation of why the approved management will not work, and a proposed revision to the approved management clause(s).

The CRB Chair will present the Request for Reconsideration at the next convened meeting of the CRB. The convened CRB will review the Request and determine whether it has sufficient information within the Request to make a decision. If adequate detail is provided, the CRB will determine whether the original approved clause(s) will stand or if a modification is approved; otherwise, additional detail will be sought from the Covered Individual.  If a modification is approved, the CRB can accept the resolution proposed by the Covered Individual, or adopt an alternate resolution.

Regardless of the chosen resolution, the CRB will provide the Covered Individual with a written determination, including a justification for the chosen resolution, within fifteen (15) business days of the convened meeting. The reconsideration resolution is considered final and must be implemented.

Requests submitted that impact the design, proposing, conduct, perform or analysis of research may require a hold (including expenditures) to be placed upon the specific project in question until the management issue is resolved.

2.  CONFLICT REVIEW BOARD

The Conflict Review Board (CRB) was established to evaluate potential conflict of interest situations, develop, review, and assist with enforcing management plans, review information relating to post-approval implementation of conflict management plans, and generally serve as a resource for the Conflict of Interest Program and other members of the University community. The CRB is chaired by the Institutional Compliance Officer (who votes to break a tie vote).

2.1.  CRB MEMBERSHIP

The chair of the Compliance Oversight Council shall appoint members of the Conflict Review Board (CRB), consisting of faculty members and staff from a broad range of university areas that are involved in university operations and the local community.  The membership shall be sufficiently qualified through the experience and expertise, to promote respect for its advice and counsel in safeguarding the University’s mission in accordance with the highest standards of integrity and in compliance with legal, professional, ethical and other requirements that promote objectivity and protect against identified conflicts of interest. The CRB consists of the following representatives:

• Chair, COI Program Director (only votes to break a tie).
• One community voting seat.
• Ten tenured faculty voting seats.
• VP Finance and Administration voting seat.
• EVP Research voting seat.
• EVP Health Affairs voting seat.
• University Counsel - ex-officio.
• One representative from the Office of Technology Transfer - ex-officio.
• One representative from the Office of Industry Engagement - ex-officio.
• One member from the Office of Communications and Marketing – ex-officio.

The following additional criteria will be used in appointing the membership of the CRB:

1. The CRB will not consist entirely of men or entirely of women.  Qualified persons of both sexes will be considered so long as no selection is made to the CRB only on the basis of gender.
2. Members of the CRB may be removed if their participation in CRB activities is deemed inadequate, inappropriate or damaging to the reputation of the University and its mission. Removal may be initiated by the chair of the Compliance Oversight Council, at the recommendation of the dean or vice president of the area the member represents.

2.2.  CRB MEETINGS

In order to begin a CRB meeting, a quorum of members must be present.  A quorum is defined as presence of at least five voting members, with a minimum of three faculty members in attendance. Any actions taken at a meeting without a quorum are considered unratified. Should the quorum fail during a meeting, the CRB may not take further action or vote unless the quorum is restored. For issues related to institutional conflicts of interest, the community vote must be in attendance at the convened meeting. The CRB can consult other institutional officials and offices.

To avoid real or perceived conflicts of interest by participants in the conflict review and oversight process, the following recusal procedures will apply:

1. At meetings of the CRB, individual members will disclose any relationships or conflicts they may have related to the case under review.
2. The CRB Chair will recuse him/herself from review and oversight of all potential conflicts of interest involving staff from the Conflict of Interest Program, including the CRB Chair.

3.  ENFORCEMENT

Breaches of this procedure include, but are not limited to, failing to file a ADF, intentionally filing an incomplete, erroneous, or misleading ADF, failing to provide additional information as required by the approving authority, or failing to follow an approved plan for managing, reducing or eliminating a potential conflict.

A violation of this procedure may result in sanctions, corrective measures and appropriate disciplinary actions, up to and including termination as determined by existing University policies.

To the extent required by a research sponsor, the Institution will notify the research sponsor of the violation and any corrective action taken or to be taken. If a research sponsor should report a case of non-compliance, by a Covered Individual, the Institution will require the Covered Individual to fulfill all reporting requirements, to the extent required by the research sponsor.

Conflict of Interest Program Standard Operating Procedures – available in iRIS (https://iris.louisville.edu).

Appropriate Authority. Means the Covered Individual’s direct supervisor.  In the case of the President, the Board of Trustees will serve as the Appropriate Authority.

Associated Organizations. Means University of Louisville Foundation, University of Louisville Research Foundation and University of Louisville Athletic Association.

Attestation and Disclosure Form (ADF). Means a Covered Individual’s (who are Faculty, Institutional Officials, or individuals conducting research under the auspices of the University of Louisville) annual attestation to the Standards of Conduct and disclosure of external interests to an Institution.

Conflict Review Board (CRB). A board established by the president or delegate to evaluate potential conflict of interest situations, develop, review, and assist with enforcing management plans, review information relating to post-approval implementation of conflict management plans, and generally serve as a resource for the Conflict of Interest Program and other members of the University community. The CRB is chaired by the Institutional Compliance Officer.

Covered Individual. Shall mean all University employees.  It also includes other individuals with responsibility for the design, performance, or reporting of Institution research, regardless of pay or enrollment status. It also includes individuals conducting research at the University of Louisville, or using University of Louisville researchers, or using University of Louisville facilities or resources.

Entity.Means any public or private organization, corporation, partnership, proprietorship, or firm, regardless of whether organized for profit or as a non-profit entity. The term does not include the University of Louisville, the University of Louisville Research Foundation, the University of Louisville Athletic Association or the University of Louisville Foundation.

FCOI Report. Means an Institution’s report of a financial conflict of interest to a Public Health Service Awarding Component.

Financial Interest. Anything of monetary value including, but not limited to:  an interest in a business consisting of any stock, stock option, or similar ownership interest in such business, but excluding any interest arising solely by reason of investment in such business by a mutual, pension, or other institutional investment fund over which the Covered Individual does not exercise control; or  receipt of, or the right or expectation to receive, any income in one or more of the following forms: a consulting fee, honoraria, salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of technology or other processes or products, rent, capital gain, or any other form of compensation.

Ghostwriting. Ghostwriting shall mean the provision of written material that is officially credited to someone other than the writer(s) of the material. Transparent writing collaboration with attribution between academic and industry investigators, medical writers, and/or technical experts is not ghostwriting. The unacknowledged, undisclosed provision of content should not be permitted under any circumstances.

Immediate Family Member. Immediate family member shall mean the Covered Individual’s biological, foster or adoptive parent, a stepparent, spouse, qualifying adult, a biological, adoptive or foster child, a step child, a legal ward or a person whom the Covered Individual  has (or had during the person's youth) daily responsibility and financial support, mother, father, brother, sister, son, daughter, mother-in-law, father-in-law, brother-in-law, sister-in-law, son-in-law, daughter-in-law, grandparents, and grandchildren of both the Covered Individual and spouse and / or qualifying adult.

Individual Conflict of Interest. A situation that compromises or appears to compromise a Covered Individual's professional judgment in carrying out University teaching, research, outreach, or public service activities because of an external relationship that directly or indirectly affects an external interest of the Covered Individual, an immediate family member, or an associated entity.

Institutional Official. Persons holding administrator positions, including those holding these positions in a temporary capacity. This term includes, but is not limited to individuals serving as: Deans, Associate Deans, and Assistant Deans; Institute and Center Directors; General Counsel; University Compliance Officers; Director of Audit Services; Provost, Vice Provosts, Associate Vice Provosts, and Assistant Vice Provosts; President, Executive Vice Presidents, Senior Vice Presidents, Vice Presidents, Associate Vice Presidents, and Assistant Vice Presidents; and chairs of the Institutional Review Board, Institutional Biosafety Committee, Institutional Animal Care and Use Committee, Conflict Review Board and other similar committees that might be created in the future.

Institutional Responsibilities. Means an Covered Individual’s professional responsibilities on behalf of the Institution including, but not limited to, 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.

Interest. Means shall mean direct (ownership) or indirect (receipt by Covered Individual of direct financial) gain, benefit, monetary value, right, claim or share.

Instructional Materials. Includes textbooks, software, laboratory equipment, etc.

Manage. Means to take action to address a conflict of interest, which includes reducing or eliminating the conflict of interest, to ensure that affected activity is free from bias or the appearance of bias.

Management Plan. Means a written plan for the management, reduction or elimination of a known or likely conflict of interest. It relies upon good faith disclosures about external interests and activities made in the ADF, as well as other information provided, by the Covered Individual to the University. In general, the management plan shall contain provisions appropriate for the purposes intended (e.g. management, reduction or elimination of the conflict), for the identity, nature and any monetary amount of the conflict, and for the other circumstances in question.

Non-University Commitment. Non-University commitment shall mean outside consulting or other activity, paid or unpaid, that is beyond the work assignment of the individual's University employment responsibilities.

Non-University Consulting. Non-University consulting shall mean an outside commitment that is paid professional service intended to further the interests of an external entity, regardless of whether such services are provided as an employee of the external entity, an independent contractor, a business owner, or a director or manager.

Participate. To be part of the Institution activity in any capacity, including, but not limited to, serving as the principal investigator, co-investigator, research collaborator, or provider of direct services or patient care. The term does not apply to individuals who provide primarily technical or advisory support and have no direct access to the data or control over its collection or analysis. The term also does not apply to the study participants, unless they are in a position to influence the study's results or have privileged information as to the outcome.

Personal Benefit. Includes cash, profits, securities, gifts, performed work, sex, and other benefits.

Personal Gain. Utilize University Resources for personal commercial purposes or personal commercial financial benefit.

Qualifying Adult. A qualifying adult must be over 18 years of age, and, if a blood relative (or relative by adoption or marriage) must be of the same or younger generation of the covered individual (as used in KRS 391.010), and, must be residing in the covered individual's household and have done so for a period of at least 12 months, and, must be financially interdependent (for example, have joint checking account or joint mortgage) for 12 months or longer, and, must be unmarried.

Remuneration. Includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel reimbursement); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

Research. Means a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research, service and testing, and product development. The term includes any such activity for which research funding is available through a grant, cooperative agreement, or contract, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

Support. Means providing anything of value (e.g., funds, supplies, equipment, staff, etc.), regardless of whether restricted or unrestricted.

Supported Activities. Means any agreement with an external entity that is providing support.

Term of Appointment. Means the duration of an individual's University employment, status as student or affiliation with the institution.

Vendor. Means businesses and individuals who provide goods and services to the University of Louisville. This term includes pharmaceutical company and medical equipment representatives, as well as equipment and service providers.

Covered Individuals are responsible for knowing, understanding, and complying with this procedure as it relates to their role, position or employment, or enrollment at the Institution.

Each chair or unit head shall ensure that all persons within each department or unit who are Covered Individuals are accurately identified -- either as defined by this procedure or as individually determined to be involved in research by principal investigators, the chair or unit head -- and that all such Covered Individuals complete the ADF in a timely manner (within 30 days of hire and on an annual basis thereafter).

Deans or their designees shall ensure that the responsibilities of chairs or unit heads as described above are carried out in a timely manner, that ambiguities as to the identification of covered individuals are appropriately resolved, and that ADFs are submitted and forwarded as required by this policy and any associated procedures.

In the case of a chair or unit head, the responsibility of ensuring compliance with this procedure and ensuring the submission of the ADF will rest with the individual at the next higher level in the administration.

The Attestation and Disclosure Form (ADF) is located at: https:\\iris.louisville.edu.