2,050: Conflict of Interest Policy

Revised: June 2016

As an institution within the Nevada System of Higher Education (NSHE), the University of Nevada, Reno is dedicated to teaching, research, and the dissemination of knowledge to the public. The University recognizes that outside activities or interests may adversely affect, compromise, or be incompatible with the obligations of a university employee to the institution. Such situations may constitute a Conflict of Interest (COI).

The University fosters and encourages research and entrepreneurial activity while offering transparency and oversight related to potential, perceived, or actual conflicts of interest. The University requires prior notification and supervisor approval for administrative and academic faculty performing compensated outside activities. The University also requires all employees to disclose financial interests and business relationships that may involve a conflict of interest. As an institution that receives federal funds, the University must comply with agency requirements for employee training, and for disclosure, review, management, and reporting of research-related COI, including disclosure of reimbursed or sponsored travel for research funded by the Public Health Service.

Conflicts of Interest Prohibited (In accordance with BOR Handbook Title 4, Chapter 10, Section 1.7)

a. In addition to such conflicts of interest prohibited by law, it shall also be prohibited for a member of the Board of Regents or an employee of the NSHE:

1. to become a contractor or vendor for the purchase of supplies, equipment, services and construction under any contract or purchase order of any kind authorized by the NSHE under the provisions of this chapter, or
2. to be interested, directly or indirectly, through any member of a Regents' or employee's household, as defined by the Nevada Revised Statutes 281A.100, or through any business entity in which the Regent or employee has a financial interest, in any kind of contract or purchase order so authorized by the receipt of any commission, profit or compensation of any kind.

b. Except where prohibited by law, exceptions to this policy may be permitted:

1. for contracts or purchase orders for which the proposed contractor or vendor is the sole source for the contract or purchase order and has not participated in or otherwise actively influenced the consideration or acceptance of offers for the contract or purchase order, or
2. when, in judgment of a president of a member institution, the public interest would be best served by making such an exception.

Employee Conflict of Interest Disclosure Requirements

The University requires all full-time administrative and academic faculty to notify and obtain approval from supervisors before participating in compensated outside activities; and all employees to disclose potential, perceived, or actual COI when hired, immediately upon acquisition of a new interest, and annually at the end of the calendar year. Disclosures must be filed through the Conflict of Interest website.

Access the Conflict of Interest Disclosure Form

Conflict of Interest Policy, Extended Version

1. Introduction and Guiding Principles
2. General Definition of Conflict of Interests
3. Ethical Requirements and Prohibited Activities/Interests for All University Employees
4. Application of COI Reporting Requirements
5. Reporting Requirements for Faculty Involvement in Compensated Outside Activities
6. Supervisor Review of Compensated Outside Activities
7. Documentation of Advance Notification and Approval for Compensated Outside Activities
8. Overview of Requirements for Employee Disclosure
9. Employee Disclosure of Significant Financial Interests
10. Employee Disclosure of Business Relationships
11. Faculty Disclosure of Interests Related to Student Involvement in Research
12. Requirements for Investigator/Key Personnel Disclosure of SFI for Research Subject to PHS/NSF Regulations
13. Review of Employee COI and Investigator SFI Disclosures
14. Management of Employee COI
15. Appeal Process
16. COI Requirements for Subrecipients
17. COI Requirements for Human Subject Research
18. Additional COI Requirements for Federal Agencies or Sponsors
19. Noncompliance with COI Policy
20. COI Committee
21. Management of COI Records and Institutional Reporting Requirements
22. Institutional Conflict of Interests

1. Introduction and Guiding Principles

As an Institution within the Nevada System of Higher Education (NSHE), the University of Nevada, Reno (the University) is dedicated to teaching, research, and the dissemination of knowledge to the public. The shared values of the University include learning, diversity and inclusiveness, entrepreneurship, independent inquiry, respect for resources, collegiality, and community. University employees are encouraged to advance research, technology commercialization, and industry partnership.

The Conflict of Interest policy specifies the requirements and processes for prior notification and approval of compensated outside activities; and disclosure, review, and management of Significant Financial Interests, business relationships that may involve conflict of interests, and interests related to student involvement in faculty research. The policy also addresses appeal processes, noncompliance, reporting requirements, and conflict of interests in human subject research.

Schools, departments, and divisions within the University may have additional Conflict of Interest policies that address their specific needs and that include additional processes and/ or requirements.

2. General Definition of Conflict of Interests

A conflict of interests exists when any outside activity or interest adversely affects, compromises, or is incompatible with the obligations of a University Employee1 to the institution.

3. Ethical Requirements and Prohibited Activities/Interests for All University Employees

All persons employed by the University are considered public employees and must comply with the
Code of Ethical Standards of the State of Nevada as codified at NRS 281A.400-281A.660.

University Employees must not engage in prohibited conflict of interest activities. For details, see the following:

• NRS Code of Ethical Standards, 281A.400;
• NSHE Board of Regents Handbook (NSHE Code), T4, Ch10, Section 1, item 7); and
• University Administrative Manual (UAM), Section 2,050.

Employees involved in purchasing or procurement are advised to consult the Purchasing policies in the University Administrative Manual and Nevada State law (NRS 396.255) for more information.

4. Application of COI Reporting Requirements

The University recognizes that a potential, perceived, or actual Conflict of Interests2 (COI) is acceptable with proper oversight and safeguards. When unknown or hidden, conflict of interests may dilute the public trust. The University fosters and encourages research and entrepreneurial activity while offering transparency and oversight related to a potential, perceived, or actual conflict of interests. The most effective way to ensure transparency and oversight of conflicts of interests is through use of prior notification; and disclosure, review, and management3.

Requirements for prior notification and approval for compensated outside interests and disclosure of Conflict of Interests for University faculty and employees are codified in the NSHE Board of Regents Handbook Title 4, Chapter 3: Professional Staff; and the following sections of the University Administrative Manual:

• 2,050: Conflict of Interest Policy 
• 2,690: Faculty Providing Consulting Services

Summary of COI Reporting Requirements

Type of ReportingWhat Must Be ReportedWho Must Report
Prior Notification  Compensated Outside Activities (see exceptions section 5.2) Full-time Faculty4 (includes both Academic Faculty5 and Administrators6) (PER NSHE Code T4, Ch3, Section 9.14).
Disclosure Significant Financial Interests7 (SFI) (excluding travel) All University Employees
Disclosure Interests related to business relationships All University Employees
Disclosure Interests related to student involvement in faculty research Professional Staff (Academic and Administrative Faculty)
Disclosure Significant Financial Interests (including travel) Investigators8 and Key Personnel9 for PHS* or NSF funded research

The University recognizes that outside professional and scholarly activities and service by University Faculty within their fields and for compensation10 are legitimate activities when these are represented in the faculty's University Contract11 and are not specifically prohibited by the contract. 
5. Reporting Requirements for Faculty Involvement in Compensated Outside Activities

Full-time University Faculty (whether A- or B-contract) must adhere to the requirements for compensated outside activities as enumerated in NSHE Code (T4, C3, Section 9) and University policy (UAM 2,690).

Also see NSHE Code, T4 Ch12, and University policy (UAM 6,507) for system and Institutional definitions, requirements, and processes related to Intellectual Property which includes inventions and copyrightable works.

5.1 Requirements for Advance Notification and Approval for Compensated Outside Activities

In accordance with NSHE Code (NSHE Handbook T4, Ch3, Section 9) and University policy (UAM 2,690), full-time University Faculty must provide advance notification to and request approval in writing from their immediate supervisor about the nature of the work to be performed, the company/organization for which the work will be performed, and the estimated time involved, except as specified in 5.2 below.

Advance notification and prior approval are managed through the University's InfoED software via the Compensated Outside Activities questions in the COI Disclosure form (available from the University's Conflict of Interest webpage).

Full-time University Faculty must complete or update the form before engaging in a new compensated outside activity and at least annually thereafter for continuing activities.

5.2 Compensated Outside Activities Requiring Advance Notification and Approval

Advance notification to the supervisor is required for compensated outside activities that result in textbooks, scholarly articles, musical and artistic works, and other forms of educational media when the title to the property remains with the creator and when these are considered for evaluations for performance, and tenure and promotion. Significant Financial Interests resulting from potentially patentable inventions, including patentable software, created or discovered by faculty in the course of their University activities, or with more than incidental use of University resources, must also be disclosed to the University as required.

Here are examples of activities that do not require advance notification and approval under this process:

• Delivering seminars, lectures, or invited talks sponsored by a Federal, state, or local government agency, an Institution of Higher Education (as defined by 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.
• Presenting at professional meetings, workshops, colloquia, symposia, seminars, or training programs.
• Serving on an advisory committee; review panel; or board of a public institution or agency, or non-profit organization.
• Serving as a reviewer or editor for a scholarly journal.
• Holding office in or undertaking an editorial office or duties for a scholarly journal, academic press, or professional organization.
• Site visits to public, academic or non-profit institutions in connection with accreditation, audits, sponsor project review, research or similar activities.

6. Supervisor Review of Compensated Outside Activities

Through the InfoED COI software, supervisors review and assess Compensated Outside Activities questions for all full-time faculty under the supervisor's charge. NOTE: The School of Medicine requires additional reviews for faculty participation in outside activities.

The primary purpose of the requirements for prior notification and supervisor approval is to provide supervisors with the opportunity to evaluate whether a compensated outside activity interferes or has the appearance of interfering with faculty performance of duties as contracted or as otherwise specified. A secondary purpose is to fulfill institutional requirements for reporting to NSHE.

NOTE: Faculty may conduct work outside of the traditional business day and outside of the office (e.g., course preparation, writing, and other forms of research/scholarship); therefore it can be difficult to determine whether the time devoted to outside activities conflicts with the fulfillment of an Employee's obligations to the University.

In reviewing prior notifications, supervisors may consider the following factors:

• Degree to which participation in the activity may advance the faculty member's skills and abilities, with resultant benefit to the department or unit.
• Possible detriment to the University from faculty engagement in the activity.
• Relationship of an outside activity to the faculty member's role statement or job description.
• Status of the faculty member's standing with consideration for expected performance standards.
• Potential for the outside activity to compromise or appear to compromise a faculty member's professional judgment in performing her/his University duties, or bias research results.
• Possibility for the interest to influence a reasonable person in the faculty member's position to depart from the faithful and impartial discharge of her/his public duties.
• Sufficiency of arrangements to cover the faculty member's responsibilities to the University during her/his absence, including requirements for annual leave (per NSHE Handbook Title 4, Chapter 3, Section 9, item 2; and University policy (UAM 2,690)

NOTE: Leave is not required for outside activities that are scholarly in nature and advance the reputation of the institution (e.g., serving on a national review board), when the activity is compensated and the amount of compensation, above expenses, is less than the monetary value of taking a half-day leave (NSHE Handbook T4 Ch3, Section 9, item 2).

Following her/his review, the supervisor will select one of four options available in the online disclosure system:

• Returned to require faculty member to revise and resubmit
• Supervisor needs information or to ask a question
• No related interests
• Possible conflict of interests: forward to the Research Integrity Office (RIO) for review by COI Designated Official and consideration of a Management Plan

Through the InfoED system, faculty are notified via email when the form is submitted. Following supervisor review and determination, Faculty are notified when a supervisor selects an option other than No related interests.

The COI Designated Official reviews Compensated Outside Activities forms flagged for possible conflict of interests and may review forms with other determinations if such a review appears warranted.

7. Documentation of Advance Notification and Approval for Compensated Outside Activities

Advance notification and supervisor approval are documented via the University's InfoED software, using the Compensated Outside Activities questions in the COI Disclosure form (available from the
University's Conflict of Interest webpage). NOTE: The School of Medicine requires additional processes for advance notification and approval.

When a supervisor determines that a faculty member's outside professional or scholarly service activities conflict with the faculty member's obligations to the University, obligations of the University, or institutional policy, the supervisor must inform the faculty member of the concerns and negotiate a mutually acceptable course of action (per NSHE Code T4 Ch3, Section 9, item 8).
If a mutually acceptable course of action cannot be negotiated, the matter may be referred to the COI Designated Official and the University's Conflict of Interest Committee (COI Committee) for review and management.

8. Overview of Requirements for Employee Disclosure

Disclosure is central to the University's requirement to identify, review, and manage potential, perceived, or actual conflict of interests.

Therefore, all University Employees must complete a COI Disclosures form (via University's InfoED software, available from the University's Conflict of Interest website). COI Disclosures forms must be completed when new employees are hired. Thereafter, each Employee must immediately update her/his COI Disclosures form when a new potential, perceived, or actual conflict of interests is acquired or discovered; and annually at the beginning of each calendar year.
When determining what financial interests12 must be disclosed, the University adapted the Public Health Service (PHS) and National Science Foundation definitions of Significant Financial Interests (SFI). NOTE: The University's adaptation applies the requirement for disclosure of reimbursed or sponsored travel only to Investigators and Key Personnel involved in research supported by PHS or NSF. (See at 42 CFR 50.601-607; 45 CFR 94; and the NSF Grant Manual, Chapter V, item 510).

The University applies the PHS threshold of >$5000 for SFI to its disclosure requirements.

The University augments the PHS/NSF requirements for disclosure of SFI with the following:

• Employees must disclose business relationships including those resulting from an Employee's Commitment in a Private Capacity13 with a non-University entity that may compromise, or have the appearance of comprising an    Employee's professional judgment in performing her/his University duties.
• Faculty conducting research must disclose potential, perceived, or actual conflict of interests that may emerge from student involvement in faculty research.

9. Employee Disclosure of Significant Financial Interests

All University employees must disclose remuneration or compensation that constitutes a Significant Financial Interest as listed below:

1. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration14 received from the entity in the 12 months preceding the disclosure and the value of any equity interest15 in the entity as of the date of disclosure, when aggregated, exceeds
$5,000.
2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000; or when Employee or the spouse or dependent children of Employee holds any equity interest.
3. Intellectual property* rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests, except as exempted under 9.1 below.

9.1 Activities/Interests that Do Not Constitute Significant Financial Interests

As defined by PHS (see 42 CFR 50.603 and 45 CFR 94.3) and NSF (see NSF Grant Manual, Chapter V, item 510), the term Significant Financial Interest does not include the following types of financial interests:

1. Salary, royalties, or other remuneration paid by the University to Employee when she/he is currently employed or otherwise appointed by the University.
2. Intellectual property rights assigned to the University and agreements to share in royalties related to such rights, when Employee is currently employed or otherwise appointed by the University.
3. Income from investment vehicles (e.g., mutual funds and retirement accounts) when Employee does not directly control the investment decisions made in these vehicles.
4. Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of Higher Education (as defined by 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.
5. Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

10. Employee Disclosure of Business Relationships

When a University employee has a relationship with a private business or other non-University entity either personally or through a commitment in a private capacity the potential exists for perceived or actual conflict of interests.

When a University employee purchases goods or services for use by a University entity, she/he is advised to avoid situations that may influence or have the appearance of influencing her/his professional judgment. When the situation cannot be avoided, the relationship between the non- University entity and Employee or others through Employee's commitment in a private capacity must be disclosed for evaluation as a conflict of interests.

University employees must disclose the following types of business relationships, through the University's InfoED software, using the COI Disclosures form (available from the University's Conflict of Interest website):

• Business relationship (including equity ownership) of Employee or others through Employee's commitment in a private capacity with a non-University entity the employee makes decisions in the acquisition of supplies, goods, or services for the University; or fiscal interests of the University.
• Involvement in transactions or decisions on behalf of the University when Employee knows benefits will accrue to her/himself or others through Employee's commitment in a private capacity.
• Promotion or provision of information about goods or services to the University community when Employee or others through Employee's commitment in a private capacity may benefit from decisions resulting from the promotion or information.
• Involvement in the use of University proprietary or confidential information when the information will benefit Employee or others through Employee's commitment in a private capacity.
• Involvement in or recusal from voting on a University matter in which Employee has accepted a gift or loan, or has a business relationship or commitment in a private capacity. NOTE: In addition to complying with requirements for COI disclosure, the University employee must disclose the interest to the decision-making body at the time the matter is discussed.
• Assigning duties or offering employment to a student when the duties or employment are related to a faculty member's business relationship or commitment in a private capacity, and the student is enrolled in a course being taught by the faculty member or the student's academic work or research is being singularly and directly supervised by the faculty member.

11. Faculty Disclosure of Interests Related to Student Involvement in Research

According to University policy (UAM 6,515), the conduct of ethical research requires that faculty, and student scholars and researchers are free to:

• Choose the subject of research or scholarly activity;
• Seek the resources necessary to conduct such activity, and to exercise control over those resources;
• Initiate and conduct such activity; and
• Disseminate the results of such activity in an appropriate manner.

To protect students' rights as researchers and scholars, faculty conducting sponsored research involving student researchers must comply with the following requirements:

• Faculty must disclose restrictions on student publication or communication rights when the research is the basis for evaluation of the student or fulfillment of degree requirements. NOTE: The COI Designated Official will review the disclosure to ensure the restriction is necessary to protect intellectual property rights. The Management Plan for the conflict will include the requirement to lift the restriction within 60 days of completion of the project or the student's degree requirements.
• Faculty must disclose all present or proposed activities or relationships that may affect the objectivity of research or scholarship, give the appearance of being motivated by private financial gain, or involve unacceptable commitments for a scholar/researcher.
• Faculty must disclose when a student is working on a project and the research is driven primarily by commercial considerations and the sponsor is involved in the direction of the research.

Faculty must also disclose to the student his/her financial or business interests in a company when a student is both working on a project for a faculty member at the University and working at a company in which the faculty member has a Significant Financial Interest or a Commitment in a Private Capacity.

Disclosures of potential, perceived, or actual conflict of interests related to student involvement in research are completed via the University's InfoED software, using the COI Disclosures form (accessed from the University's Conflict of Interest website).

12. Requirements for Investigator/Key Personnel Disclosure of SFI for Research Subject to PHS/NSF Regulations

As noted previously, all University employees are required to disclose Significant Financial Interests as defined by the PHS except reimbursed or sponsored travel. However, all of the PHS requirements (42 CFR 50.601-607 and 45 CFR 94) apply when University employees are involved as Investigators or Key Personnel in research funded by federal agencies subject to the PHS Act (42 U.S.C. 201). The University will apply the PHS requirements to research funded by other entities upon notification the sponsor adopted the PHS regulations.

NOTE: These PHS requirements do not apply to Phase I applications for the Small Business Innovation Research (SBIR) Program16.Federal Agencies Subject to the PHS Act:

• Administration for Children and Families
• Administration on Aging
• Agency for Healthcare Research and Quality
• Agency for Toxic Substances and Disease Registry
• Centers for Disease Control and Prevention
• Federal Occupational Health
• Food and Drug Administration
• Health Resources and Services Administration
• Indian Health Service
• National Institutes of Health
• Substance Abuse and Mental Health Services Administration

Per 42 CFR 50.601-607, Investigators and Key Personnel involved in the design, conduct, or reporting of research subject to the PHS COI requirements must disclose Significant Financial Interests for themselves and their spouses and dependent children when the interest reasonably appears to be related to the Investigator obligations to the University or her/his Institutional Responsibilities17. In this context, SFI include Reimbursed18 or Sponsored Travel19, excluding travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of Higher Education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of Higher Education.

Travel disclosures must include purpose of the trip, identity of the sponsor/organizer, destination, and duration; and upon request by the COI Committee, the monetary value.

Disclosures for PHS-funded projects must be made no later than the date of submission of the proposal for PHS-funded research via the University's via the University's InfoED software, using the COI Disclosures form (available from the University's Conflict of Interest website). Annual and updated disclosures (within 30 days of discovering or acquiring a new SFI) are also required and must be reported using the same system.

13. Review of Employee COI and Investigator SFI Disclosures

The COI Designated Official uses the InfoED software to assess completed COI Disclosures forms for Significant Financial Interests; and potential, perceived, or actual conflict of interests resulting from business relationships and student involvement in faculty research.

In this review, the COI Official assesses disclosures to determine whether a Significant Financial Interest, business relationship, or interest related to student involvement in faculty research constitutes a conflict of interests, and whether further review and/or management is required. The COI Official may seek additional information and may refer the matter for review or discussion by the COI Committee.

For PHS-funded research, the COI Official assesses the disclosures of Significant Financial Interests, including travel, to determine if any SFI represent a Financial Conflict of Interest (as defined by the PHS).
Multiple factors are considered during the COI Designated Official and COI Committee reviews20.

When a conflict of interests is identified, the COI Official notifies the relevant supervisor and the employee.

14. Management of Faculty COI and Investigator FCOI

When a COI is identified, a COI Management Plan template is used to place the interests in context, identify the conflicts, and develop a plan to reduce or manage conflicted interests. A copy of the template is available from the University's Conflict of Interest website. The COI Designated Official works with the Employee in the development of the plan.

For research subject to PHS requirements for Promoting Objectivity in Research, the University abides by the federal regulations at 42 CFR 50.605 for managing FCOI; and 45 CFR 94.5 and §§ 94.6 for management, reporting, and remedies for FCOI. The University also complies with requirements for researchers to disclose related FCOI in each public presentation of the results of PHS-funded research.

The University monitors Investigator compliance with the Management Plan on an ongoing basis until the completion of the relevant project.

15. Appeal Process

15.1 Appealing Compensated Outside Activities Decisions

If following prior notification and supervisor review of compensated outside activities, the supervisor and faculty member cannot arrive at a mutually acceptable course of action, the matter may be referred to the COI Committee for review. The COI Committee may refer the matter to the appropriate vice president or the Provost. The vice president or the Provost may require the faculty member to cease performance of existing obligations while the faculty member remains an NSHE employee.

15.2 Appealing Conflict of Interests Determinations

Employees may appeal determinations made by the COI Designated Official or the COI Committee by notifying the Vice by President for Research and Innovation for a research-related conflict of interests, including SFI and interests resulting from student involvement in faculty research; or the Provost for a conflict of interests resulting from business relationships.

Employees may appeal to the President of the University concerning the decision of the Vice President for Research and Innovation or the Provost. The President's decision on this appeal is final.

A Vice President may appeal a determination that she/he has conflict of interests by notifying the President. The President's decision on the appeal is final.

16. COI Requirements for Subrecipients

Subcontractors and other external collaborators must either comply with the University COI Policy or provide written documentation to confirm the subcontractor's compliance with applicable federal regulations and Nevada state law.

The University Office of Sponsored Projects ensures compliance with federal regulations at 45 CFR 94.4, items (c)(1)(i) - (iii) for PHS-funded research, including PHS-funded research that involves subrecipients (e.g., subcontractors, or consortium members).

17. COI Requirements for Human Subject Research

Prior to engaging in any research involving human subjects, all research team members (including external collaborators) must notify the Principal Investigator of Significant Financial Interests, and financial or business relationships or interests that may affect a specific research project, regardless of funding. When preparing an application for exempt determination or for IRB review, the Principal Investigator must provide the names of individuals with potential, perceived, or actual conflict of interests.

The RIO and the IRB are responsible for evaluating researcher conflict of interests to determine if the conflict may adversely affect the rights or welfare of research volunteers or bias the research results. The IRB may review Investigator and/or study team members' Conflict of Interest Management Plans if needed for a thorough evaluation. If not specified in the Management Plan, the IRB may require that conflict of interests are described and disclosed to research participants.

IRB members, consultants and Research Integrity Office staff cannot review projects, or be physically present during the deliberation and voting for a project for which they have a conflict of interests, except to provide information requested by the IRB prior to the deliberation and vote.

18. Additional COI Requirements for Federal Agencies or Sponsors

The University must comply with additional requirements from federal agencies and sponsors for disclosure, review, management, or reporting of Investigator COIs for sponsored research. University employees with questions about agency or sponsor COI requirements are advised to contact the University Office of Sponsored Projects.

18.1 Public Health Service COI Requirements

As noted previously, the University adapted PHS requirements for disclosure of SFI by all University Employees (see policy sections 8 and 9) and applies the complete requirements (at 42 CFR 50.601-607 and 45 CFR 94) to Investigators/Key Personnel involved in the design, conduct, or reporting of research subject to the PHS regulations (see policy section 12).

The University also complies with the PHS requirements for Investigator training and institutional responsibilities as follows:

Training Requirements for Investigators and Key Personnel Engaged in PHS-funded Research

As required by 42 CFR 50.604, subpart (b), University Investigators/Key Personnel involved in the design, conduct, or reporting of PHS-funded research must complete the required training for PHS-funding before engaging in PHS-funded research and at least every four years thereafter.

Institutional Responsibilities for FCOI in PHS-funded Research

The University complies with the requirements for PHS Contractors21 as codified at 45 CFR 94.4-5. These include requirements for the University to:

• Maintain a written, enforced policy on Financial Conflict of Interests, and make the policy available via publicly accessible Web site (§94.4(a)).
• Inform researchers of the University's COI policy (§94.4(b)).
• Take reasonable steps to ensure subrecipients of PHS funds comply with the University's COI policy or certify compliance with the PHS regulations (§94.4(c)).
• Designate a University Official to solicit and review disclosures of SFI (§94.4(d)).
• Ensure disclosure including updates, within in the PHS-specified timeframes, of SFI by Investigators who participate or plan to participate in PHS-funded research (§94.4(e).
• Provide guidelines for the COI Designated Official to assess Significant Financial Interests for relatedness and determination22 of Financial Conflict of Interests23 (FCOI) (§94.4(f)).
• Take the actions necessary to manage FCOI including those of subrecipients (§94.4(g)).
• Provide initial and ongoing FCOI reports to the PHS (§94.4(h)).
• Maintain records of Investigator disclosures; and review, response, and actions related to SFI and FCOI (§94.4(i)).
• Establish adequate enforcement mechanisms (§94.4(j)).
• Certify the required elements in each contract proposal subject to PHS requirements (94.4(k)).
• Develop a management plan for identified FCOI, including requirements for public disclosure of FCOI including in presentations or publications of results of PHS-funded research, and retrospective review and temporary management of SFI not disclosed in a timely manner (§94.5(a)).
• Report FCOI to the PHS Awarding Component before expenditure of PHS funds and within 60 days of newly disclosed SFI for ongoing projects (94.5(b)).

18.2 Environmental Protection Agency COI Requirements

According to EPA's Inter im Financial Assistance Conflict of Interest Policy, prior to submission, Investigators (including Investigators on sub-awards) must provide information to EPA about:

• EPA involvement in the review or preparation of the proposal;
• Family members24 working on an awarded project as consultants for or employees of the University; and
• Whether or not the proposal is competitive.

18.3 National Science Foundation COI Requirements

The National Science Foundation (NSF) (see the COI section in the NSF Grant Policy Manual) requires disclosure and assessment of SFI for conflict of interests. The NSF definition of SFI is similar to the PHS definition with these caveats:

• NSF includes intellectual property rights among interests that require disclosure and a financial threshold of $10,000 for an interest.
• NSF requires Institutions receiving NSF funding to manage, reduce, or eliminate any conflict of interests identified by the Institution, include adequate enforcement mechanisms, and to maintain records of financial disclosures and actions taken to resolve conflict of interests for at least three years beyond grant termination or completion.
• Institutions must inform NSF of a conflict of interests that cannot be satisfactorily managed.

19. Noncompliance with COI Policy

19.1 Disciplinary Actions and Enforcement Measures

Violation of this University policy may result in discipline as specified under NSHE Code Chapter 6 and University policy (UAM 2,370) and could result in civil and criminal penalties pursuant to NRS Chapter 281A.500-550.

Compliance with this policy may be enforced through the exercise of administrative responsibility for oversight of funded research and management of University facilities and other University property. Such enforcement measures include, but are not limited to:

• Freezing research funds or accounts;
• Rescinding contracts entered in violation of this policy or state law; and/or
• Bringing legal action to recover the amount of financial benefit received by an Employee as a result of Employee's violation of this policy.

19.2 Noncompliance for Research Subject to PHS Requirements

For PHS-funded research, the University abides by the following federal regulations:

45 CFR 94.5, part (a)(3) for retrospective review; implementation of an interim management plan; assessment for bias in the design, conduct or reporting of the research; and fulfillment of the documentation and reporting requirements for a Significant Financial Interest that was not identified or managed in a timely manner.
45 CFR 94.6 Remedies, when the failure of a University researcher to comply with the University financial conflicts of interest policy or a financial conflict of interest Management Plan appears to have biased the design, conduct, or reporting of the PHS-funded research.

The University will promptly respond to inquiries from the PHS Awarding Component and/or HHS regarding any Investigator disclosure of financial interests and the University's review of, and response to, such disclosure, regardless of whether or not the disclosure resulted a determination of a financial conflict of interest.

The University will submit or permit on-site review of all records pertinent to compliance with 45 CFR 94 and will abide by decisions made by the PHS Awarding Component, including corrective action, issuance of a Stop Work Order by the Contracting Officer, or other enforcement action.

20. COI Committee

20.1 Authority for Oversight of Conflict of Interests

As an Institution receiving federal funds, the University is required to designate one or more persons to review financial disclosures; to determine whether a conflict of interests exists; and to develop plans to manage, reduce, or eliminate identified conflicts. Towards this end, the University designated authority for review and management of conflict of interests, and the consistent application of the University's Conflict of Interest Policy to the COI Designated Official and COI Committee.

The COI Designated Official is the Director of the Research Integrity Office. The COI Official attends COI Committee meetings to provide advice and direction; reviews disclosures for completeness and to identify potential, perceived, or actual conflict of interests; and develops management plans.

The COI Committee conducts business through collaborative review and discussion of potential, perceived, or actual conflict of interests; and the plans for managing same.

20.2 Committee Membership/Composition

The COI Committee is comprised of a Committee Chair and five members consisting of faculty or staff from academic units: preferably units which are involved in research activities including grants, cooperative agreements, contracts, or subawards, including those funded by the Public Health Service. COI committee members are recruited by the COI Designated Official or through the Faculty Senate service opportunity questionnaire. The COI Committee Chair and members serve three year terms.

The COI Committee includes ex officio members as appropriate for the conflict under consideration, for example the Director, Office of Sponsored Projects; representative from the School of Medicine; or Assistant Vice President, Business and Finance. As warranted by the nature of the conflict, the COI Committee may request the presence of the Director of Purchasing; the NSHE Office of General Counsel; or other faculty members, deans, or chairs.

21. Management of COI Records and Institutional Reporting Requirements

21.1 NSHE Report of Outside Activities

To fulfill NSHE annual reporting requirements for outside compensated activities (NSHE T4, Ch3, Section 9, item 15), the Research Integrity Office sends the NSHE Board of Regents an annual report of aggregate data for full-time faculty completing compensated outside activities. The RIO confirms potential conflict of interests were reviewed, and approved or managed as needed.

21.2 SFI and COI Records

The University Research Integrity Office maintains records of disclosures of Significant Financial Interests, and interests related to business relationships and student involvement in faculty research, and Financial Conflict of Interests management plans for three years after the date of the most recent disclosure or management plan update or three years after the final payment for PHS-funded research.

21.3 PHS Reporting Requirements

For research subject to the PHS requirements at 42 CFR 50.605 and 45 CFR 94.5, the University abides by the PHS requirements for record-keeping and reporting FCOI, including requirements for public accessibility.

22. Institutional Conflict of Interests

The University and its employees are bound by Nevada State Law regarding Ethics in Government (codified at NRS 281A). The University must avoid and/or manage Conflict of Interests where its beneficial relationship with corporate entities may place it in conflict with its responsibilities as a public institution. Also, the University must abide by NSHE Code. See Higher Education and the Common Good (NSHE Code T2 Ch2, Section 2.1.1)

The following additional NSHE Codes are relevant to minimizing/avoiding institutional conflict of interests:

General Policy Statements (NSHE Code T4 Ch1) addresses the ethical code of conduct and prohibitions for Regents (Sections 2 and 3); access to NSHE and Institutional records (Section 4); use of external lobbyists (Section 24); and personal use of NSHE property and resources (Section 25).
General Business Management (NSHE Code T4 Ch10) addresses the NSHE purchasing policy (Section 1); statement of investment objectives and policies for the endowment and operating funds (Sections 5 and 6); administration of gifts; contracts; and sponsored programs (Section 9); and institution foundations' and affiliation groups policies (Section 10).
Intellectual Property, Research and Entrepreneurial Activity (NSHE Code T4 Ch12) addresses NSHE's position related to use, rights, and ownership of inventions, intellectual property, and restricted access research produced by NSHE faculty, staff, and students.

University policy relevant to minimizing/avoiding institutional conflict of interests includes, but is not limited to the following:

• Under Fiscal and Business Affairs, the University's basic policy for contracts, grants, and other agreements is codified (UAM 500).
• Under Purchasing, the University recognizes the authority of the Office of Sponsored Projects (UAM 1,100) to protect the University's interests and provide guidance to ensure compliance for sponsored programs,
• Under Purchasing; the General Policy (UAM 1,501); Preference (UAM 1,506); Basic Purchasing Procedure (UAM 1,507); and Selection of Personal, Professional and Consultant Services..." (UAM 1,529) sections specify the basic requirements and procedures for vendor selection and purchasing to minimize bias and influence in the awarding of contracts; acquisition of goods; and selection of consultant services.
• Also under Purchasing, the Personal Use of University Property (UAM 1,525) specifies University employees may not use University time, property, equipment or facilities for personal benefit or financial interests except under limited conditions.
Ethical Standards in the Conduct of Research (UAM 6,515) describes the standards for University scholars and researchers to maintain integrity in scholarship and research pursuits.

Matters that may involve constitutional conflict of interests may be considered by the COI Designated Officer or the COI Committee or referred to University Counsel.

1University Employee: Any person who performs public duties for compensation paid by the University of Nevada, Reno.

2Conflict of Interest: Any interest, financial or otherwise, direct or indirect; engagement in any business, employment transaction, or professional activity, or acquisition of an obligation of any nature, which is in conflict with the proper discharge of an employee's duties or employment in the interest of the University.

3Management: Taking action to address a conflict of commitment or financial conflict of interest; includes reducing or eliminating the conflict of interest, to ensure to the extent possible that an outside activity does interfere with an employee's obligations to the University or that the design, conduct, and reporting of research will be free from bias.

4Faculty: The Professional Staff as established in Subsection 1.4.5 of the NSHE Code (see T2, Ch1).

5Academic Faculty: For the universities, includes instructional, research and library faculty, as defined by the Board of Regents (at NSHE Code, T4, Ch3, Section 2. Standards for Defining the Professional Staff):

a. At the universities only, Academic Faculty includes the following:
(1) Instructional faculty, which consists of persons teaching, tutoring, instructing and lecturing in the activity of imparting knowledge;
(2) Research faculty, which consists of persons with advanced scientific or academic training who are actively engaged in the research field, and are responsible for identifying research problems, developing designs or hypotheses, analyzing results of research investigations, reaching conclusions, publishing the results of research and investigations and obtaining research grants or funding; or
(3) Library faculty, which consists of persons with a degree of at least master of Library Science from an accredited institution who are employed in the libraries of the NSHE and who provide professional library services closely and directly supportive of teaching and research.

6Administrators: Includes Administrative Faculty employed in executive, supervisory or support positions, as defined by the Board of Regents (at NSHE Code, T4, Ch3, Section 2. Standards for Defining the Professional Staff):

a. Administrative Faculty excludes Academic Faculty and includes the following:
(1) Executive faculty, which consists of the chancellor, the secretary to the board, the vice chancellors and the presidents and vice presidents of the member institutions of the NSHE;
(2) Supervisory faculty, which consists of persons who perform predominately office or non-manual work of a supervisory nature as head of a college, school, center, division, laboratory or other administrative unit of a member institution or special unit of the NSHE; or
(3) Support faculty, which consists of persons, including but not limited to teaching assistants, laboratory assistants, athletic coaches and assistant athletic coaches, who perform predominately office or non- manual work:

i. Of a confidential nature performed under the direct supervision of a member of the executive faculty; or
ii. Of a predominately intellectual, specialized or technical nature requiring training, experience or knowledge in a field of science, learning or occupation customarily acquired by a course of specialized intellectual instruction, studies or experience, which is performed under general supervision only and requires the consistent exercise of discretion and judgment.

7Significant Financial Interest (SFI): A financial interest consisting of one or more of the following interests of the Investigator/Key Personnel (henceforth referenced as Investigator) and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

• With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); 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;
• With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income on behalf of the employee related to such rights and interests.
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
• Reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to the Investigator's institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or 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.

8Investigator: Project director or principal investigator and any other person, regardless of title or position , who is responsible for the design, conduct, or reporting of research funded by the PHS (or NSF), or is proposed for such funding, which may include, for example, collaborators or consultants.

9Key Personnel: Project director/principal investigator and any other personnel considered to be essential to work performance in accordance with HHSAR subpart 352.242-70 and identified as key personnel in the contract proposal and contract for PHS or NSF-supported research.

10Compensation: Any money, thing of value or economic benefit conferred on or received by any person in return for services rendered, personally or by another.

11University Contract: The primary professional commitment of University faculty as commensurate with her/his appointment percentages as specified in the Role Statement or Position Description Questionnaire; or her/his roles/responsibilities as specified in the employee's Individual Performance Objectives, annual activities plan, UNSOM Clinician Member Practice Agreement, or other employment agreement with the University.

12Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

13Commitment in a private capacity: A commitment, interest, or relationship of a public employee to a person

• Who is the employee's spouse or domestic partner;
• Who is a member of the employee's household;
• Who is related to the employee or the employee's spouse or domestic partner by blood, adoption, marriage or domestic partnership within the third degree of consanguinity or affinity
• Who employs the employee or the employee's spouse or domestic partner, or an employee or member of the employee's household;
• With whom the employee has a substantial and continuing business relationship; or
• With whom the employee has any other commitment, interest or relationship that is substantially similar to a commitment, interest, or relationship as described in the previous list.

14Remuneration: Salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

15Equity Interest: Stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

16Small Business Innovation Research (SBIR) Program: The extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.

17Institutional Responsibilities: An employee's professional duties or obligations on behalf of the Institution, and may include for example: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. Generally in keeping with the employee's University Contract.

18Reimbursed Travel constituting SFI: Costs for travel related to the researcher's Institutional Responsibilities as opposed to the researcher's responsibilities for a PHS-sponsored project.

19Sponsored Travel: Travel costs that are paid on behalf of a researcher and not reimbursed to the researcher so that the exact monetary value may not be readily available.

20Factors considered during COI Designated Official and COI Committee reviews:

• Was the required prior approval obtained before full-time University Faculty engaged in a compensated outside activity?
• Did the supervisor conclude the faculty member's interests may constitute a conflict of interests?
• Has all relevant information concerning the faculty member's interests been acquired?
• Is there any indication that the faculty member's obligations to the University were or may not have been met?
• Is there any indication the faculty member used University resources for an outside interest without the required authorization?
• Is there any indication the faculty member inappropriately represented her/himself as acting on behalf of the University to outside entities?
• Does the University Faculty's disclosed SFI (including travel as applicable) exceed the specified threshold of $5,000?
• Is there any indication the faculty member in her/his University role improperly favored an outside entity?
• Is there any indication the faculty member was involved in transactions that financially benefited her/himself or others with whom the faculty member has a commitment in a private capacity?
• Does the faculty member appear to be subject to incentives that may have led to inappropriate bias in decision-making or research activities, including those involving student investigators?
• Is there any indication that research results were not or may not be faithfully and accurately reported?
• Could the faculty member's circumstances represent any possible violation of federal, state, or local laws and requirements?

21Contractor: An entity that provides property or services under contract for the direct benefit or use of the Federal Government.

22Guidelines for Determination of FCOI:

• Is the SFI of the Investigator/Key Personnel or her/his spouse reasonably related to the researcher's Institutional Responsibilities?
• Might the SFI directly and significantly affect the design, conduct, or reporting of PHS-funded research?

23Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

24Family Member: Spouse and any other persons such a domestic partner, child, parent, sibling or other family member claimed on the Employee's tax return.