Pol-Conflict of Interest and Commitment

policy modified Fri Jul 26 2024 08:45:39 GMT-0400 (Eastern Daylight Time)

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University of Louisville

OFFICIAL
UNIVERSITY
ADMINISTRATIVE
POLICY

POLICY NAME

Conflict of Interest and Commitment

EFFECTIVE DATE

January, 2011

POLICY APPLICABILITY

This policy applies to the University Community (trustees, administrators, faculty, staff, and students) and its Statutory Affiliates.

REASON FOR POLICY

The University of Louisville and its Statutory Affiliates (“University”) expects Covered Persons to conduct University affairs with high ethical and legal standards and in a manner that supports the University mission. As part of this duty, Covered Persons must apply their University time and effort correctly and use University assets properly.

Use of University assets or University time damaging to the University mission or for Personal Benefit represents a conflict of interest. This policy sets standards to reduce or eliminate such conflicts and protect the financial well-being, reputation, and legal duties of the University.

POLICY STATEMENT

The University commits to teaching, serving, working, and conducting Research with integrity and free from unmanaged Actual or Apparent Conflicts. Covered Persons have a duty to Support University education, Research, and service missions with their primary commitment of time and intellectual energies. Personal Gain from external ventures or Financial Interests must not influence the decisions or actions of Covered Persons in performing University Responsibilities. Covered Persons must not act or make decisions on behalf of the University if Personal Gain, Interest, or advantage could influence (directly or indirectly) judgment in performing University Responsibilities.

No list of rules can provide direction for all the varied circumstances that may arise. The University reserves the right to address any internal or external circumstance that creates an Actual or Apparent Conflict with University Responsibilities. Covered Persons should discuss questions about conflicts with the University Conflict of Interest and Commitment Office (COIC Office).

CONFLICT OF INTEREST

Conflicts of Interest arise when personal or private considerations (financial or nonfinancial) compromise University priorities and interests. Covered Persons of the University shall exercise good faith and integrity in all transactions involving and/or relating to University Responsibilities and University’s property. Personal Gain must not unduly influence the decisions or actions of Covered Persons or the University in fulfilling University Responsibilities.

The University will exercise oversight and care in removing or Managing Actual or Apparent Conflicts that arise because of a Covered Person’s Interest related to their University Responsibilities. The University will not allow contracts, Gifts, buying, or other dealings to create an unmanaged Actual or Apparent Conflict.

Covered Persons must not exploit University faculty, staff, students, or administrators for Personal or Private Gain.

CONFLICT OF INTEREST IN EMPLOYMENT (NEPOTISM)

Covered Persons must comply with the University Conflict of Interest in Employment (Nepotism) Policy.

BUSINESS OPERATIONS

Covered Persons conducting affairs for the University, including hiring, and buying, must do so in an objective and ethical manner. This includes a Covered Persons use of a ProCard for buying goods or services for the University.

Covered Persons cannot make University contract decisions with an individual/ Entity under contract with the University owned or controlled by a Relative.

Covered Persons, acting in their private capacity, cannot rent, lease, or sell any realty, goods, or services to the University; this includes engaging a Relative as an independent contractor, subcontractor, or consultant.

Covered Persons or their Relatives must not provide an external party access to University programs, services, information, or technology without prior institutional approval.

Covered Persons making University contract decisions cannot have a familial or close personal relationship with an individual/ Entity under contract with the University. This includes but is not limited to developing specification or procurement standards, rendering advice, investigating, or auditing University contracts.

For transactions involving endorsement, print or digital media, use of UofL branding, etc., the COIC Office, the Office of Communications and Marketing, and appropriate University leadership must review and approve of involving Covered Persons in Entity marketing.

GIFTS

Covered Persons may not seek Gifts, cash or special favors (including cash equivalents, meals, loans, rewards, promises of future employment, services or entertainments) from current or prospective Vendors, current or prospective subordinate employees, or current or prospective students. Covered Persons should not accept proffered Gifts when:

  • The individual or Entity offering the Gift has a current or future business relationship with the University;
  • The Covered Person receiving the Gift has authority or influence over the current or future individual or Entity doing business with University;
  • The Gift offered is cash or cash equivalent of any amount;
  • The noncash Gift is valued above twenty-five dollars ($25.00); or
  • The Gift is offered directly to the Covered Person’s Relative.

TEACHING MISSION

Covered Persons must follow unit guidelines when adopting course materials created by the Covered Person, a Relative or the Covered Person’s Appropriate Authority. In the cases where no unit guidelines exist, the Covered Person should follow the guidelines of the department in which the course is taught.

Covered Persons with leadership roles in nonprofit professional or scientific societies may take part in programs, meetings, and events that involve University Vendors. The policies and procedures of the society govern these Vendor exchanges.

Covered Persons with University leadership roles must not use their decision-making authority to influence course assignments buyouts for Relatives.

RESEARCH AND CREATIVE MISSION

Covered Persons serving as Investigators or Senior or Key Personnel on University Research may not use or disclose nonpublic Research information and/or technology for Personal or Private Gain.

University professional presentations must not involve Ghostwriting or Gift Authorship. Anyone named as authors must qualify for authorship.

Covered Persons must report SFI, external interests and foreign affiliations in publications (including articles, abstracts, manuscripts submitted for publication), presentations at professional meetings, and applications for funding, as directed.

Covered Persons or Relatives shall not take part in negotiating agreements (Research agreements, license agreements, equipment purchases, etc.) between the University and an Entity in which the Covered Person or a Relative has an Interest.

Covered Persons cannot serve as PI or equal role on University human subjects Research using their licensed technology and may not supervise Covered Persons who serve as PI or equal role on these projects without prior Conflict Review Board (CRB) approval.

Covered Persons with nonprofit professional and scientific society leadership roles may take part in programs, meetings, and events that involve University Vendors. The policies and procedures of the society govern these Vendor interactions.

CLINICAL MISSION

Clinical service provided to patients/clients, as well as the educational environment provided for students, must be free from undue bias and influence of external activities and interests. Covered Persons Supporting the clinical mission must comply with the University of Louisville Health Care Policy on Vendors.

INSTITUTIONAL OFFICIALS AND TRUSTEES

Members of the University Board of Trustees (“Trustees”) and Institutional Officials (IOs) have a heightened responsibility to foster an environment that is free from undue external influence. As members of the University leadership team, Trustees and IOs must take a strict approach to avoiding and recognizing Actual and Apparent Conflicts. Trustee or IO actions taken for the University must protect against using a position for Personal or Private Gain. Further, Trustees or IOs must ensure others do not use a Trustee or IO position, whether directly or indirectly, to claim benefits from the University or its faculty, staff, or students.

SMALL BUSINESS CONCERNS (START UP ENTITIES)

Covered Persons are responsible for separating their University Responsibilities for Research and education from their personal or private Financial Interests. Covered Persons must separate and clearly distinguish current University Research from work at the start-up companies or small business concerns (SBC).

Covered Persons should serve in advisory or advice-giving roles at the SBC as opposed to roles with management responsibility. Full-time Covered Persons wishing to engage in a management role, should consider the use of entrepreneurial leave to address Conflict of Commitment concerns. With respect to this requirement, full-time refers to 1.0 Full-Time Equivalent (FTE).

If the Covered Person elects to serve in any SBC roles, the Covered Person may not engage in any University projects related to the SBC without prior CRB approval.  The SBC and University must define project personnel, budget, scopes of work and resources of all projects involving the conflicted Covered Person.

Covered Persons or Relatives cannot negotiate with the University for the SBC. Covered Persons must not use University assets for the direct benefit of the SBC without a University approved agreement in place.

Covered Persons involved with an SBC must fully report SBC dealings and ownership to any students, fellows, or trainees working on their Research.

SBCs must have independent capacity to conduct business. SBCs may utilize core facilities if the SBCs pay established, publicized service center rates and have an institutionally approved agreement in place.

A Covered Person cannot contribute to both SBC and University parts of a single project without an approved management plan. This includes serving as an employee or holding a management position in the Start-up, serving as Start-up project team or consultant. Covered Persons may not serve as both the SBC PI and the University subcontract PI.

The University may not subcontract to a Covered Person’s SBC, unless University Trustees grant an exception, per Procurement Regulation approved by the Board of Trustees on January 21, 2021. The University may accept Research subcontracts from a Covered Person’s SBC (for example STTR, SBIR programs). The SBC objectives must not compete with or impede the Research mission of the University.

Covered Persons must not involve personnel that they supervise, directly or indirectly, at UofL in the SBC’s dealings before review by the CRB. Covered Persons must avoid circumstances in which junior personnel might feel expected to Support the SBC.

Personal interests of Covered Persons or commercial Interests of Research sponsors may not impact the training experience and academic progress of University students, fellows, and trainees. Current students, trainees, or fellows asking to take a leave of absence to join the SBC should consult the CRB.

SPECIAL CONSIDERATIONS FOR THE UNIVERSITY

Institutional Financial Interests can be created by gifts, payments, royalty income, equity, and other financial benefits from or interests in for-profit entities. Institutional Financial Interests can also be created by financial and fiduciary interests of University Officials. The presence of an Institutional Financial Interest alone does not constitute an Institutional Conflict of Interest.

The University shall not engage in actions that create an unmanaged Institutional Conflicts of Interest (ICOI).

Philanthropy is important to the University mission. No charitable donation should be dependent on the result of University Research.

The University must not seek or accept gifts that impacts the ability of its researchers to conduct and report results with the highest scientific, medical, professional, and ethical standards.

This policy does not forbid the University from accepting philanthropy from companies that sponsor Research or conduct business with the University. This policy helps the University develop means of identifying and examining such circumstances and managing Actual or Apparent Conflicts of Interest that may result.

The Office of University Advancement, and external investment managers, cannot discuss nonpublic University Research with members of the University community to influence investment decisions. Maintaining this robust “firewall” is essential for ensuring the core activities of the University are not affected, or perceived to be affected, by the University’s interests in maximizing the value of its endowment pool.

Individuals must report Actual or Apparent Conflicts of Interest involving philanthropic practices to the CRB or to the COIC Office.

CONFLICT OF COMMITMENT

Covered Persons must comply with institutional requirements regarding work outside the University (Redbook 4.3.3 for Faculty, Redbook 5.6 for Staff, PER1.12 for Administrators).

Covered Persons may use their expertise to advance and share knowledge through collaboration with the public, the community, and external Entities. These actions strengthen performance of University teaching, advance University Research and public service missions, and bring credit to the University.

At the same time, the University has a responsibility to ensure that Covered Persons’ external dealings do not inappropriately influence their University actions and decisions.

Covered Persons may engage in Non-University Commitments of a professional, personal, or economic nature that do not conflict or interfere with University interests or with the Covered Person’s commitment to the University.

Covered Persons must meet the duties and professional activities that fulfill obligations to their units, departments, and programs.

Covered Persons may not hold a position at any other postsecondary educational institution, independent Research institutes or nonprofit entities while they are Full-time University Employees unless approved under this policy, including online teaching, participation in Foreign Government-sponsored talent recruitment programs, etc. Faculty on non-twelve (12) month appointments must apply these requirements for the term in which they are under contract with the University (nine (9), ten (10), and (11) months respectively).

Covered Persons may not participate in a Malign Foreign Talent Recruitment Program while they are a University Employee. Consulting and joint Research relations are subject to review and prior institutional approval.

When a dual appointment is approved, the Covered Person will list the University as the primary appointment on all Research and scholarly publications, presentations, and contact information.

Funding or Support related to the dual appointment must be reported to the University on the ADF, to OSPA and in funding submissions as needed. This includes all funding or Support from all added sources related to the dual appointment.

Covered Persons cannot use University resources to aid work at the dual appointment. This includes but is not limited to use of University funds (including all types of sponsored program funds (e.g., NIH grant funds), Research infrastructure funds, endowments accounts, gifts, etc.), non-public or confidential Research information or intellectual property, facilities, equipment or personnel, services (e.g., IRB Review) and library subscriptions.

Covered Persons must coordinate travel and coverage of University duties with the Appropriate Authority when dual appointments compel absence from campus.

Covered Persons private interests cannot create a recurring conflict with their University Responsibilities.

Covered Persons may not enter a contractual arrangement, including employment, with an Entity that interferes with their University Responsibilities.

Covered Persons may not engage in use of University time or resources for professional, charitable, or community activities without appropriate University approvals.

Covered Persons or Relatives must not use the Covered Person’s position, University assets or resources for Personal or Private Gain.

Covered Persons must not influence or try to influence the actions of colleagues and subordinates with the intent of improving the Covered Person’s or Relatives’ Interests (financial or nonfinancial).

DISCLOSURE AND MANAGEMENT

Timely and accurate submission of the University’s Attestation and Disclosure Form (ADF) is a condition of employment at the University.

Covered Persons must disclose to the Appropriate Authority or administrative officer intent to engage in external activity or employment before such engagement and before a contract or transaction takes place.

Covered Persons must disclose external Interests by the ADF to the COIC Office at least each year or within thirty (30) days of the discovery or gain of a new external interest, for example, through purchase, marriage, or inheritance. Covered Persons will report external interests before an application for sponsored funding as needed by this policy and the sponsoring agency.

The University will manage or eliminate Identified conflicts. The Covered Person shall agree in writing to the approved Management Plan.

The approved Management Plan will be in place before any action subject to influence by the external interest. This includes any related contract, grant, sponsored project (for example, Research, instruction or outreach), dedicated Gift, or other transaction is carried out, or any relationship is started. The Board of Trustees reserve authority to review and approve plans for managing, reducing, or eliminating Actual or Apparent Conflicts of Interest and Commitment involving the University president.

COIC TRAINING

All Covered Persons will complete Conflict of Interest and Commitment (COIC) and Foreign Influence training identified by the University at least every four years or immediately following one of the three circumstances noted in the procedures.

COMPLIANCE

All Covered Persons are responsible for knowing, understanding, and complying with this policy.

Covered Persons are responsible for affirming that they have received and read this policy and will adhere to its conditions.

Violations of this policy include but are not limited to willful failure to disclose a Conflict of Interest or Commitment or willful failure or refusal to cooperate with an approved COIC Management Plan. Violations of this policy are deemed a serious violation of policies governing employment and may subject the employee to disciplinary action. Disciplinary action must consider the severity and frequency of the violation, its impact on the institution, and the extent to which the conduct in question deviates from standards of conduct, policies and procedures, or expectations. The University reserves the right to take appropriate actions that are commensurate with the nature of the violation and are consistent with the Redbook and other University policies and applicable laws. Possible actions or sanctions could include a letter of reprimand, increased monitoring of the identified Conflict of Interest or Commitment, Management Plan modifications, or other appropriate actions. Individuals should report concerns of noncompliance with this policy to the COIC Office. University will inform the Research sponsor of the violation and any corrective action, if required or required. For Public Health Service (PHS) or Department of Energy Supported projects, University will undertake the Retrospective Review and create any Mitigation Reports, as needed.

The COIC Office reports to the Vice President for Risk, Audit and Compliance, who serves as the COIC Officer. The COIC Officer authorizes the COIC Office and CRB to review and address reports of noncompliance with this policy, a Management Plan, or applicable federal, state, or local controls. The COIC Officer will address any concerns not resolved by the COIC Office or CRB.

DEFINITIONS

Definitions for this policy and procedure are located at: https://louisville.edu/conflictofinterest/coic-definitions.

PROCEDURES

DISCLOSURE OF EXTERNAL ACTIVITIES AND INTERESTS

Procedures describing academic, business, clinical, and Research and scholarly activities may also include extra reporting. Covered Persons report external Interests and activities on the ADF. The ADF is located at https:\\iris.louisville.edu. Covered Persons shall complete the ADF yearly and throughout their Term of Appointment. The reporting period for the ADF includes the previous twelve (12) months and the coming twelve (12) months. Annual disclosures follow the following standards:

  • Trustees shall file a disclosure statement yearly and report external Interests as governed by bylaws and KRS.
  • Institutional Officials shall disclose external Interests by filing an ADF, within thirty (30) days of appointment, yearly after that, and as described in this policy.
  • Covered Persons shall disclose external Interests by filing an ADF within thirty (30) days of appointment, annually thereafter, and under circumstances described in this policy. Covered Persons for which a Conflict of Interest or Commitment is identified are required to abide by the requirements of the approved Management Plan.
  • The president or delegate may designate other individuals who shall file a yearly ADF.

Newly secured external interests or newly started external affiliations must be reported on an updated ADF. The updated ADF must be filed within thirty (30) calendar days of a change in external interests or affiliations.

All disclosures filed route electronically to the Covered Person’s department or unit head for review. Once the department or unit head complete review, all disclosures route electronically to the COIC Office. Covered Persons’ ADFs with no disclosures will bypass department or unit head review and route directly to the COIC Office.

University will report disclosures made under this policy to governmental agencies or to the public as required by law or regulation.

Covered Persons reviewing a Request for Proposal/Bid (RFP/B) will complete a confidentiality agreement and ADF before viewing any Vendor information. COIC Office will review any external activity or Interest and consult the CRB, as needed. The RFP/B reviewer will be replaced if the review cannot be done timely.

REVIEW OF DISCLOSED EXTERNAL ACTIVITIES AND INTERESTS

The Appropriate Authority, as Primary Reviewer, will review the disclosure of Non-University Commitments and recommend approval or denial. The appropriate Dean/Vice President, as Secondary Reviewer, will make a final determination of approval or denial. Covered Person's expertise, the mission of the University and conclusion the Non-University Commitment does not conflict or interfere with the Covered Person's University Responsibilities will be the basis for approval. All approved Non-University Commitments shall comply with this policy.

Non-University Commitments needing prior approval include: 

  • Non-University consulting for more than the equivalent of one workday a week;
  • Holding office in a scholarly or professional society, for more than the equivalent of one workday a week;
  • Editing a professional journal for more than the equivalent of one workday a week; 
  • Any potentially compromising activities for more than the equivalent of one workday a week;
  • Seeking or serving on sponsored projects submitted and managed through other academic, federal, or commercial institutions;
  • Keeping a faculty appointment at another academic institution, federal organization, or Entity;
  • Keeping an employment position at another academic institution, federal organization, or Entity; and
  • Directing a program of Research at another Entity.

Covered Persons may put forward a Reconsideration Request in writing within ten (10) business days of the receipt of denial to the Provost, or designee. A three-person peer review ad hoc panel will review Reconsideration Requests. All member selections must be from within the University community. The panel will include one individual selected by the Covered Person, one individual selected by the Covered Person’s Dean or Vice President, and one individual selected by the Provost or designee from outside the Covered Person’s unit. The panel will make a final recommendation to the CRB.

CRB will review the ADFs, any reviews, the first determinations, and the Reconsideration Request. CRB will have the right to consult, as needed, with University management. The CRB’s determination shall be final for all Reconsideration Requests except those involving Procurement Regulation 21Jan2021.

Disclosed Interests and approved Non-University Commitments will be reviewed by the COIC Office. ADFs submitted will be screened to ensure:

a. Disclosures made are complete and accurate;

b. Institutional activities engaged in by the Covered Person are correctly identified; 

c. Additional information necessary for review of a Covered Person’s disclosures is obtained; and

d. Early identification of actual or proposed Research activities involving human subjects in which a Covered Person may have an identified Conflict of Interest or Commitment.

COIC Office will contact the Covered Person if more information or documentation is needed.

CRB will review potential Organizational Conflicts of Interest.

FCOI report will be issued for identified COICs meeting Relatedness criteria and involving a PHS project. COIC Office will directly file report or report will be sent to the prime awardee. Reports are filed at the time the determination is made.

MANAGEMENT OF IDENTIFIED CONFLICTS OF INTEREST AND COMMITMENT

COIC Office will decide management level to protect the University’s missions to promote objectivity and protect against COIC. Measures taken in managing COIC include, but are not limited to:

  • Public disclosure of Financial Interests.
  • Reformulation of work plan.
  • Monitoring of project by an independent review committee.
  • Substituting supervisors or personnel.
  • Divestiture of Financial Interests.
  • Halt or reduce involvement in relevant projects.
  • Halt inappropriate student involvement in projects.
  • Remove relationships that pose real or potential conflicts.
  • Remove Covered Person from human subject Research in the critical areas of recruitment, inclusion or exclusion evaluation, enrollment, and adverse event evaluation and reporting.
  • Naming third-party, for example department or unit head, oversee or control the Gift funds from an Entity with which the Covered Person has an identified Actual or Apparent Conflict.

Covered Person has the onus of providing information that would help University in reviewing identified COIC.

RECONSIDERATION

Management requirements based upon regulatory mandates are exempt from reconsideration, including disclosure requirements dictated by federal funding agencies. Any Covered Person may to seek reconsideration of any other final decision under this procedure involving that individual. Covered Persons must present a written request to the CRB Chair within ten (10) business days of receiving decision. The request should include, at a minimum, the clause (s) needing change, a reason of why the approved Management Plan will not work, and a proposed revision to the approved management clause (s).

The CRB Chair will present the Reconsideration Request at the next called meeting of the CRB. The CRB will review and decide whether it has necessary information. 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. The CRB will communicate the need for more detail to the Covered Person. The CRB will determine whether the original approved clause (s) will stand or be altered. The CRB can accept the resolution proposed by the Covered Person or adopt an alternate resolution. The CRB resolution is final (except for items related to Procurement Regulation 21Jan2021) and must be carried out.

IMPLEMENTATION OF APPROVED MANAGEMENT PLANS

The COIC Office will send the approved plan to the Covered Person and Appropriate Authority for implementation. The Covered Person must acknowledge receipt of Management Plan and perform required actions, on or before the implementation date, to the CIOC Office. The Appropriate Authority is copied on this communication. The Appropriate Authority will apply all clauses not involved in pending Reconsideration Requests.

COMPLIANCE WITH POLICY

The COIC Office will conduct a preliminary review to decide whether reported noncompliance concerns are valid.

The COIC Office will tell the COIC Officer and University Counsel. COIC Office may:

  1. Investigate concerns and make written report of conclusions;
  2. Ask Appropriate Authority to conduct investigation and make written report conclusions; or
  3. Appoint CRB member to conduct investigation and make written report of conclusions.

Investigation will, at a minimum, include interview with reporter (if available) and interview with the Covered Person(s). Investigations will be conducted in according to University’s Reporting and Investigation Procedures.

Investigations confirming noncompliance may result in corrective action as noted in the Compliance section of this policy. The COIC Officer and Executive Vice President for Research and Innovation have authority to suspend Covered Person’s Research impacted by Actual or Apparent Conflicts, pending conclusion of an investigation or, on conclusion of an investigation, that they be suspended pending correction of any policy violations.

SPECIAL MANAGEMENT FOR RESEARCH AND SPONSORED ACTIVITIES

University presumes Covered Persons with identified COIC may not conduct the activity in question. Covered Persons with identified COIC who wish to show reasonable or compelling circumstances must convince University, CRB and COIC Officer, that facts rebut the presumption. The Covered Person will present to CRB, in writing, an explanation of reasonable or compelling circumstances to conduct proposed activity. The CRB will review documentation submitted and make final determination. The CRB will formally approve the rebuttable presumption and change the Management Plan or reject the rebuttable presumption and affirm the approved Management Plan.

The COIC Office shares approved Management Plans with the IRB. The IRB has final authority to decide whether approved plan protects Research subjects and whether Research may continue. The IRB may impose added conditions on Covered Persons but may not lift controls approved by the CRB.

Yearly, the subcontractor or subgrantee must send oversight updates to the University for duration of contract period. The University will report existence of Actual or Apparent Conflict and resulting Management Plans as needed by sponsors.

The University does not allow subcontracts or subawards from the University to an external Entity in which a Covered Person or Relatives hold equity Interest or serve in a fiduciary or management role. In rare occasions, Covered Persons may seek prior approval from the Trustees, through established University processes, if only source of materials or expertise resides with external Entity. Where approval is granted, the Covered Person will not, under any circumstances, engage in any project, study, or transactions for the University.

COIC TRAINING

The University will identify suitable COIC and Foreign Influence training completed by Covered Persons at least once every four years or immediately after circumstances listed below. The training will provide each Covered Person awareness of the policy, Covered Person's responsibilities about disclosure and of applicable federal, state, and local regulations. Immediate training for Covered Persons will be required:

  • When University makes revisions to the policy that impacts Covered Person’s responsibilities;
  • When the Covered Person is new to the University; or

When the University finds Covered Person is noncompliant with the policy or with an approved Management Plan.

RESPONSIBILITIES

The first responsibility for compliance lies with the Covered Person directly involved.

Covered Persons are responsible for knowing, understanding, and complying with this policy and procedures. Covered are responsible for accurate and timely completion of the ADF and updating it as external interests change. Covered Persons are responsible for accepting their approved Management Plan, or timely seeking changes to their Management Plan, and agreeing to their approved Management Plan. Covered Persons are responsible for upholding all terms, conditions, and actions set forth in their Management Plan. Covered Person must respond to calls for information from COIC Office or CRB. Covered Person are responsible for complying with corrective actions, enforcement, and sanctions imposed by the University related to findings of noncompliance.

Department or Unit Heads. Each department or unit head will ensure that Covered Persons identified within the department or unit complete an ADF as required by this policy. Deans or their designees will ensure the department or unit heads complete duties related to this policy in a timely manner, resolve ambiguities of a Covered Persons identification, and that ADFs are filed and sent.

University. The University is responsible for maintaining this policy, making it available publicly as required by law or regulation, and ensuring it complies with applicable federal, state, and local regulations. The University will make COIC training available to Covered Persons in compliance with policy and applicable federal, state, and local regulations. The University will provide FCOI Reports to Research sponsors as required by federal, state, and local regulations, sponsor terms and conditions, or as required by an approved Management Plan. The University is responsible for setting up enforcement to ensure compliance with policy and federal, state, and local regulations. The University will keep records about ADFs and the University's reviews and determinations.

Initiating Authority. The Vice President for Risk, Audit and Compliance serves as the Conflict of Interest and Commitment Officer (COIC Officer) and charged with oversight of this policy and procedures. Executive Vice President for Research and Innovation (EVPRI) shares a joint responsibility with the COIC Officer, for complying with FCOI reporting for federal regulations about sponsored programs.

For questions, added detail, or to seek changes to this policy, please contact the COIC Office.

FORMS/ONLINE PROCESSES
ADMINISTRATIVE AUTHORITY

Vice President for Risk, Audit, and Compliance

RESPONSIBLE UNIVERSITY DEPARTMENT/DIVISION

Conflict of Interest and Commitment Office

Email: coi@louisville.edu

Phone: 502-852-7612

HISTORY

This policy supersedes the University’s Addressing Individual Conflicts of Interest Policy and Procedures and the University’s Addressing Institutional Conflicts of Interest Policy and Procedures.

Revision Date(s): June 27, 1983; January 28, 2013; July 11, 2017 (Reformat only); January 17, 2024; July 26, 2024

Reviewed Date(s): July 11, 2017; January 17, 2024

The University Policy and Procedure Library is updated regularly. In order to ensure a printed copy of this document is current, please access it online at http://louisville.edu/policies.