Conflict of Interest and Conflict of Commitment Policy

 

 

 

 

 

 

 

 

 

 

The University of Arizona is dedicated to upholding the principles of free and unbiased inquiry, the transfer of ideas and technologies for the benefit of the public, and stewardship of the resources entrusted to it. The University also recognizes that its faculty and employees engage in increasingly complex relationships with private entities and with state and federal governments. It is essential, however, that financial and other relationships with outside entities do not create situations that are, or appear to be, in conflict with the values of free and unbiased inquiry. Thus, the University recognizes its obligation to ensure that research, scholarly, and business activities are carried out under the highest standards of integrity and ethical conduct. The following objectives should, therefore, guide research and relationships with external entities:

 

1)    To promote objectivity and integrity in the University’s research activities, purchasing, and all other business transactions;

2)    To protect the safety and welfare of all participants in research conducted at the University;

3)    To promote and protect the public’s trust in the University, its faculty, staff, contracting officers and other employees;

4)    To avoid situations in which an individual’s personal activities and commitments could interfere with that individual’s ability to effectively carry out his/her University duties and responsibilities; and

5)    To fully comply with applicable federal and state laws and regulations.

 

This Policy provides:

·      Mechanisms for identifying fiduciary relationships with, financial interests in, or benefits provided by, an outside person or entity that could give rise to a conflict of interest in connection with an individual’s performance of his/her research, purchasing, contracting or other activities on behalf of the University;

·      Mechanisms for identifying situations that may create a conflict of commitment between the individual’s primary obligations to the University and his/her outside activities;

·      Procedures for appropriately managing, reducing or eliminating conflicts of interest and commitment.

 

Nothing in this Policy is intended to restrict faculty members from choosing the subject matter of their research, scholarly work or other activities, subject to the budgetary and programmatic constraints of the unit and the University in any given year. Similarly, this Policy is not intended to preclude the types of external activities or business transactions normally allowed by the University as long as any potential or actual conflict of interest or conflict of commitment is reported and either eliminated or managed appropriately. The College of Medicine maintains a separate policy relating to Interactions between the College of Medicine and the pharmaceutical industry (see http://www.uph.org/portals/11/Vendorpolicymay08.pdf).

 

 

 

A “Conflict of Interest” is a situation in which an individual’s financial or other interests in an outside entity conflict, or appear to conflict, with that individual’s ability to carry out his/her responsibilities to the University. Those responsibilities include the design, conduct or reporting of research, decision-making in connection with a University business transaction, and commitments to students, trainees, and staff.

 

 

A “Conflict of Commitment” is a situation in which an individual’s outside activities interfere, or would reasonably appear to interfere, with that individual’s duties and responsibilities to the University. This includes any outside services, dual employment, consulting or other activity, regardless of the location of those activities (on or off campus), the type of entity (for-profit, not-for-profit or government), or the level of compensation (compensated or unpaid). Any outside activity that interferes with an individual’s ability to effectively carry out his/her University duties and responsibilities is a Conflict of Commitment and as such is not permitted by University policy, according to UHAP 2.06.06.

 

 

“Covered Individuals” are University employees, students and trainees who contribute to the teaching, research, public service, administration and business operations of the University. Examples of a “Covered Individual” include but are not limited to:

 

1.         Any person responsible for the design, conduct, reporting or approval of research (funded or unfunded); any person who is directly involved in the treatment or evaluation of research participants, or the evaluation of research results at the University of Arizona or any facility in which that person conducts UA research activities. This policy applies to both compensated and non-compensated persons;

2.         Any person who participates in decision-making in connection with contracts or subcontracts (including purchasing, research, licensing and all other types of agreements), sales or purchases on behalf of the University of Arizona;

3.         University students who have authority to supervise or impose discipline upon other students; graduate students, research and/or teaching assistants with supervisory or teaching responsibilities; and instructors, whether the individual is paid or unpaid;

4.         Any individual who represents or acts on behalf of the University and whose actions may bind the University.

 

 

For purposes of this policy, “Relatives” of Covered Individuals are:

 

1.         The spouse, child, grandchild, parent, grandparent, brother or sister (including half-brother and half-sister), their spouses, and the parent, brother, sister or child of the Covered Individual’s spouse (ARS 38-502); or

2.         A Domestic Partner (defined, for the purposes of this policy only, to mean: an adult (18 years of age or older) of the same sex who: (i) is not related to the Covered Individual under the definitions above; and (ii) who shares a primary residence, or otherwise is in a relationship of mutual financial support with the Covered Individual; and (iii) who intends to remain in such relationship for the indefinite future.

 

 

For the purposes of this policy, a “Remote Interest” is an interest related to or of:

 

1.         A nonsalaried officer of a nonprofit corporation;

2.         A landlord or tenant of the contracting party;

3.         An attorney of a contracting party;

4.         A member of a nonprofit cooperative marketing association;

5.         The ownership of less than $5000 income or less than 0.1 percent ownership of the shares of a publicly-traded corporation;

6.         A public officer or employee being reimbursed for actual and necessary expenses incurred in the performance of official duty;

7.         A recipient of public services generally provided by the incorporated city or town, political subdivision or state department, commission, agency, body or board of which s/he is a public officer or employee, on the same terms and conditions as if s/he were not an officer or employee;

8.         A public school board member when the Relative involved is not a dependent, as defined in A.R.S. section 43-1001, or a spouse;

9.         A public officer or employee, or that of a Relative of a public officer or employee, unless the contract or decision involved would confer a direct economic benefit or detriment upon the officer, employee or Relative, of any of the following:
(i) Another political subdivision
(ii) A public agency of another political subdivision.
(iii) A public agency except if it is the same governmental entity.

10.      A member of a trade, business, occupation, profession or class of persons consisting of at least ten members which is no greater than the interest of the other members of that trade, business, occupation, profession or class of persons;

11.      Stocks or equity held in a mutual fund;

12.      Reimbursement of reasonable costs associated with travel;

13.      Payment for seminars, lectures, or teaching when sponsored by a public or nonprofit entity;

14.      Income from service on advisory committees or review panels for public or nonprofit entities.

 

 

A “Substantial Interest” is any pecuniary, fiduciary, or proprietary interest, direct or indirect, other than a “remote interest,” as defined above. A “substantial interest” includes, but is not limited to, the following:

 

1.         Any income greater than $5000 annually when aggregated for the Covered Individual and Covered Individual’s spouse and dependent children;

5.         Ownership of greater than 0.1 percent of the shares in a publicly traded corporation for which the value of the shares owned by the Covered Individual, spouse, and dependent children, is, in the aggregate, valued at more than $5000;

6.         The ownership of any equity interest in a privately held corporation, partnership, LLC or other entity;

7.         Gifts to a Covered Individual or Relative, in cash or in kind, totaling more than $400 annually and in aggregate;

8.         Any income, equity or gift, of any value, from the sponsor of a clinical study;

9.         Royalties from patents, licenses, or other intellectual property ownership.

 

 

 

This policy applies to “Covered Individuals” and “Relatives” of Covered Individuals, as those terms are defined above.

 

 

Covered Individuals must report to the University when they (or their Relative(s)) have any financial, proprietary or fiduciary interest or relationship with an entity
(i) sponsoring a research project in which the Covered Individual is involved; or
(ii) related to the Covered Individual’s federally sponsored research.

Covered Individuals must report all financial interests of any value relating to research activities, including but not limited to:

 

·      All income or compensation paid by the sponsoring or related entity, including income from consulting activities and honoraria;

 

·      Any equity ownership (including stocks and stock options) in the sponsoring or related entity;

 

·      Any management positions (including but not limited to membership on the Board of Directors or Scientific Advisory Board) in entities sponsoring or related to the sponsored research;

 

·      Any ownership of intellectual property, patents, licenses, royalties, or gifts from the sponsoring or related entities;

 

·      All financial or fiduciary interests and relationships with the sponsor of a clinical study.

All Covered Individuals are responsible for reporting financial interests that involve or may appear to affect any Business Transaction. This includes any agreement or arrangement (including but not limited to Memoranda of Understanding, purchasing contracts entered into by the University or ABOR, and agreements for individual consulting services), other than those activities and arrangements that are within the definition of research transactions.

All Covered Individuals are responsible for reporting to their Department Head or Supervisor any potential Conflicts of Commitment as defined in this policy, including but not limited to consulting and other outside employment both annually and prior to engaging in any outside activities.

 

When must reports be made?

All Covered Individuals must report their financial and fiduciary interests and relationships related to new research projects, grants, or contracts AT THE TIME OF THE SUBMISSION of the proposed agreement, grant, or contract to Sponsored Projects Services Office or Office of Research Contract and Analysis.

 

All Covered Individuals must report all financial and fiduciary interests and relationships related to a new clinical study, either sponsored or investigator-initiated, PRIOR TO THE START OF THE PROJECT.

 

All Covered Individuals must report PRIOR TO entering into any arrangement that results in a new reportable interest or event, or that modifies an existing report submitted by the Covered Individual in the preceding 12 months. This applies to both clinical and non-clinical studies.

All Covered Individuals must report the interests of any new investigators added to an ongoing Sponsored Project. Such reporting shall be coordinated through the Principal Investigator for the project and shall be made PRIOR TO the addition of the new investigator. This applies to both clinical and non-clinical studies.

 

All Covered Individuals must report all financial and fiduciary interests and relationships related to new purchasing agreements or contracts PRIOR TO the signing of such agreements or contracts.

 

All Covered Individuals must report all financial and fiduciary interests as well as external commitments and activities on an annual basis to their Supervisor or Department Head. All annual reports shall be submitted NO LATER THAN March 1st of each year.

 

All Covered Individuals must provide their Department Head of Supervisor with a Notice of Intent to Consult PRIOR to the start of any consulting activities with an outside entity.

 

 

 

 

 

All reporting forms are available on the Office of the Vice President for Research webpage: www.vpr.arizona.edu/conflict-of-interest. There are six (6) forms available, specific to the nature of the triggering event and type of report.

 

 

i.      Covered Individuals reporting a Substantial Interest in any entity related to a research project

ii.    Covered Individuals reporting any interest in an entity sponsoring or related to a clinical study

 

i.      are creating a company or other entity in which the Covered Individual (or Relative) will have an equity or other proprietary interest;

ii.    exercise an element of corporate control, if such company or entity will, or may reasonably expect to, enter into any contracts with the University or State of Arizona, including but not limited to, intellectual property licenses and contracts to supply any services, equipment, material, supplies or other property or materials;

iii. anticipate accepting a position with a company or other entity as an officer, director, or any other position that gives rise to a fiduciary relationship or duty of care to the company if such company or entity has, or may reasonably expect to enter into, any contracts with the University or State of Arizona.

 

 

 

 

The Covered Individual must sign all report forms. Signatory rights may not be delegated. In signing the report form, each Covered Individual certifies the truth and accuracy of the statement under penalty of perjury under Arizona state law.

 

 

Review of Report of Financial Interests Related to Research and Supplemental forms shall be conducted by the Office of the Vice President for Research; review of Business Transaction forms shall be conducted by the Office of the Senior Vice President for Business Affairs. The Office of Technology Transfer, Office of Research Contract Analysis, Sponsored Projects, and Human Subjects Protection Program are responsible for forwarding any information related to conflicts of interest or commitment to either the Office of the Vice President for Research or the Office of the Senior Vice President for Business Affairs, as applicable.

 

The Department Head or Unit Supervisor shall conduct review of Annual Conflict of Interest Report Forms and Notice of Intent to Consult Forms in accordance with UHAP 2.06.06. The Department Head or Supervisor shall forward reports that disclose Substantial Interests to the Office of the Vice President for Research for review.

Upon receipt, the Office of the Vice President for Research shall review all Report Forms.

 

 

The Institutional Review Committee (IRC) (described below) shall review all reports of substantial interests, including all reports related to clinical studies.

The Office of the Vice President for Research retains to the right to request the IRC to review any report.

 

The Office of the Vice President for Research acts as staff to the IRC and maintains all forms, files, and a database of reports, allegations of non-compliance and sanctions that involve Research Transactions, according to state and federal regulations.

 

The Institutional Review Committee (IRC) shall be a University-wide committee, consisting of at least 10 voting members who are appointed by the Vice President for Research: 3 faculty from the Health Sciences; 1 faculty from the College of Engineering; 2 faculty from the College of Science; 4 faculty from other academic units. The committee shall also include 7 non-voting, ex-officio members: the Assistant Vice President for Research Compliance and Policy; Director of Technology Transfer; Director of Office of Research Contracts and Analysis; a representative from Sponsored Projects; the Human Subjects Protection Program; and Procurement and Purchasing. Legal advice shall be received from the Office of the General Counsel. The committee may invite other non-voting, ad hoc members to assist in discussions and decisions as needed.

 

A quorum of voting members shall be half-plus-one (or 6) members in attendance.

The Vice President for Research shall appoint a conflict of interest administrator and other Committee staff as needed. Adequate resources shall be allocated to support the duties of the IRC.

 

The Vice President for Research shall appoint members to renewable 3-year terms. The Vice President for Research shall appoint the Chair to one renewable 4-year term. The IRC shall elect a Vice-Chair to assume the duties of Chair in the absence of the Chair.

 

A committee member shall be recused from discussion and voting on a particular case if the committee member has a compelling personal interest in the case (such as research or academic affiliation or collaboration with the Covered Individual whose case is under consideration) or if the committee member has a financial interest in the entity involved in the case under consideration.

All Substantial Interests and all interests related to clinical studies will be reviewed by the IRC. The Office of the Vice President for Research may request that any report be reviewed by the IRC, including report of Remote Interests.

 

The IRC will review Covered Individual reports, supplemental reports, and any other material or supporting documents necessary to understand the nature and extent of the Covered Individual’s related interests. It is the Covered Individual’s responsibility to respond to requests for additional information from the IRC or VPR staff in a timely manner.

 

Upon review of the relevant materials, the IRC will make a recommendation whether:  a) the reported relationship represents a conflict of interest; and, if so, whether b) an appropriate management plan will mitigate or eliminate the conflict.

Examples of possible management plans that the IRC may recommend include, but are not limited to:

 

 

 

 

 

 

 

 

The Vice President for Research (or designee) shall review the recommendations of the IRC and decide on the appropriate course of action. The VPR’s decision shall be in writing with copies sent to the Covered Individual and the Covered Individual’s Supervisor or Department head.

 

The Covered Individual may appeal the VPR’s decision to the Provost within ten (10) business days of receipt of the VPR’s decision. All appeals must be in writing, must include all documents submitted to the IRC and all communication between the Covered Individual and the IRC, staff, and VPR, and must be copied to the Vice President for Research and the Covered Individual’s Supervisor or Department Head.

 

After receipt of these materials, the Provost may make a determination based on the materials submitted or may convene a meeting of an Appeals Panel consisting of one or more representatives from the University Committee on Ethics and Commitment (UCEC), the Vice President for Research (or designee) and the Provost. If appointed, the Panel will evaluate all materials presented and allow the Covered Individual to address questions in person. The Panel may either affirm the decision under review or refer the case back to the VPR for further consideration. The Provost’s or the Panel’s decision, as applicable, shall be final.

 

 

Department Heads and Supervisors shall review Annual Conflict of Interest and Commitment and Notice of Intent to Consult forms. Reports involving Substantial Interests shall be forwarded to the IRC and shall be reviewed according to the above procedures. Department Heads and Supervisors shall submit a recommendation to the IRC regarding Substantial Interests of their Covered Individuals, which the IRC will take into consideration when evaluating the reports. All appeals shall be conducted in accordance with the procedures detailed in Section IV(B) of this Policy. Department Heads and Supervisors shall maintain records of annual reports in accordance with federal and state Record Retention regulations (described below).

 

 

The Senior Vice President for Business Affairs’ designee in Procurement and Contracting is charged with reviewing Substantial Interest Reports involving Covered Individuals engaging in Business Transactions. The Designee will determine whether a conflict of interest exists pursuant to Arizona state law and this Policy.

 

The Designee will notify the Covered Individual in writing, with a copy to the Covered Individual’s Supervisor or Department Head and the IRC, that either: a) a conflict of interest exists such that the University cannot do business with the Covered Individual or company named in the report form without following the competitive bidding process AND removing the Covered Individual from all participation in the contract, sale, or purchase; b) a conflict of interest exists such that the University may do business with the company or Relative named in the report form BUT the Covered Individual must refrain from all participation in the contract, sale, or purchase; or c) no conflict of interest exists.

 

If a conflict of interest exists, the Designee will also notify Procurement and Contracting Buyers of the conflict via the Financial Reporting System (FRS).

 

If the Covered Individual wishes to appeal the decision of the Designee, the Covered Individual may present the case to the SVPBA within 10 business days of the decision. The SVPBA or his/her designee will notify the Covered Individual in writing of the decision, with a copy to the Covered Individual’s Supervisor or Department Head and the IRC.

 

 

The University Office of Technology Transfer (OTT) shall review all Enabling Disclosure Forms and related materials and then submit them to the IRC for committee review. The IRC will review Enabling Disclosures in accordance with the procedures for Research (detailed above).

 

Once the IRC has made a recommendation, the VPR will notify the Covered Individual and the Supervisor or Department Head of the recommendation. If the IRC recommends approval of the Enabling Disclosure, the IRC will route the document for signature by the VPR, Provost and President. The Enabling Disclosure will then be submitted for approval by the Arizona Board of Regents (ABOR Policy 6-908).

 

Upon receipt of approval by ABOR, the Vice President for Research will notify the Covered Individual, the Covered Individual’s Supervisor or Department Head and Director of OTT of the Board’s action. ABOR’s determination shall be final.

 

 

 

Each Covered Individual has a personal obligation to report all relevant financial and other interests, as described above, including the relevant interests of the Covered Individual’s Relatives. However, any third party who has a reasonable, good faith belief that a Covered Individual has failed to comply with this Policy may notify the Chair of the IRC, the VPR (Research) and/or the SVPBA (Business Transactions). Covered Individuals may also call the Ethics and Compliance Hotline (1-866-364-1908) to report possible non-compliance.

 

 

Non-compliance includes failure to:

·      Report financial interests accurately, fully and in a timely manner, pursuant to this Policy;

 

·      Provide additional information as requested by University officials responsible for reviewing reports;

 

·      Comply fully and promptly with recommendations and decisions made by the IRC, the VPR or SVPBA;

 

·      File an annual report or update an annual report as required by this policy;

 

·      Take any other necessary action required by this Policy.

 

 

Upon receipt of an allegation of non-compliance, the IRC (Research) or SVPBA (Business Transactions) will review the allegation and determine whether there is cause for investigation. If there is cause for an investigation, the IRC or SVPBA will provide a copy of the allegation to the Covered Individual and to the Covered Individual’s Supervisor or Department Heads. The Covered Individual shall have the opportunity to present a written response and may request to meet with the IRC or SVPBA.

 

If the IRC or SVPBA finds no violation, it shall inform the Covered Individual and the Covered Individual’s Supervisor or Department Head in writing. A copy of the notice will also be sent to the VPR or SVPBA.

 

If the IRC or SVPBA finds non-compliance, it shall make a written finding and recommendation for appropriate action and send a copy of the letter to: the Covered Individual, the Supervisor or Department Head, and the VPR or the SVPBA.

 

After receipt of the finding and recommendation, the VPR or SVPBA shall 1) give the Covered Individual an opportunity to present a written response and meet in person within 10 business days of the finding; 2) consider the finding and recommendation, as well as any further/additional information provided by the Covered Individual; 3) decide the appropriate action to correct the situation or begin the process of imposing sanctions (as set forth below); and 4) notify the Covered Individual in writing of the decision (with a copy to the Covered Individual’s Supervisor or Department Head). The SVPBA or VPR will also notify the party making the allegation of the final disposition of the matter.

 

The Covered Individual may appeal by sending written notice to the Provost within 10 business days after the VPR’s or SVPBA’s decision. The appeal proceedings shall be conducted in accordance with the procedures of the University Committee on Ethics and Commitment (UCEC), UHAP 2.13.09. Copies must be submitted to the Provost, VPR or SVPBA and the Covered Individual’s Supervisor or Department Head.

 

After receipt of these materials, the Provost may make a determination or convene an Appeals Panel consisting of one or more representatives from the University Committee on Ethics and Commitment (UCEC), the VPR (or designee) and the Provost. If convened, the Panel will evaluate all materials presented and allow the Covered Individual to address questions in person. The Panel may either confirm the decision under review or refer the case back to the VPR for further consideration. The Provost’s or the Panel’s decision, as applicable, shall be final.

 

 

Non-compliance with this Policy may result in sanctions or disciplinary action, including but not limited to one or more of the following:

 

·      Removal of the Covered Individual from a particular project;

·      Special monitoring of current or future research;

·      Written reprimand;

·      Suspension of project funding;

·      Restriction of investigator’s privileges;

·      Suspension of rights and responsibilities for a specified period of time;

·      Suspension without pay;

·      Dismissal; and/or

·      Other appropriate sanctions or discipline, depending on the severity and nature of the non-compliance.

 

Existing Arizona Board of Regents (ABOR) and University policies and procedures, and applicable state and federal laws shall govern the procedures for imposing sanctions or discipline, and the nature of the sanctions.

 

Non-compliance with this Policy by a Covered Individual involved in any externally sponsored research projects shall be reported to the research sponsor. Any penalties imposed by the external sponsor shall be deemed to be separate from, and without limitation on, any imposed by the University or ABOR.

 

 

 

The Office of the Vice President for Research acts as staff to the IRC and, in keeping with Arizona State Records Retention laws, maintains all Report forms and related files, a database of all reports, allegations of non-compliance, and sanctions related to research transactions. Records related to federally sponsored research are subject to the federal records retention regulations as well.

 

All reports and records related to business transactions shall be maintained by the Office of the SVPBA and kept in accordance with Arizona State Records Retention laws.

 

Annual reports made to Department Heads and Supervisors shall be maintained and kept in accordance with Arizona State Records Retention laws.

 

 

This Policy deals with individual Conflicts of Interest and Commitment, and not with conflicts that arise as a result of the University’s institutional financial interests.

 

This Policy does not cover conflicts of interest arising in connection with Personnel Transactions (i.e., matters concerning appointment, retention, promotion or compensation, or responsibility for managing or evaluating the work of a Relative or other party with whom there is a personal or romantic relationship). Policies and procedures related to Personnel Transactions are set forth in the Interim Policy for Management of Personal Conflicts of Interest for the University of Arizona - July 2002.

 

This Policy incorporates all policies and procedures related to conflicts of interest and commitment set forth in the Arizona Board of Regents (ABOR) Policy Manual, the University Handbook for Appointed Personnel (UHAP), the Classified Staff Human Resources Policy Manual, Arizona Conflict of Interest statute (ARS § 38-501, et seq.), and all applicable federal laws and regulations.