Documents

Policy on Conflicts of Interest in Sponsored Programs

Conflicts of Interest Flyer

Effective August 25, 2012

Contents:

[fa type=”arrow-circle-down”] 1. Introduction
[fa type=”arrow-circle-down”] 2. The Policy
[fa type=”arrow-circle-down”] 2.1 The Scope of the Policy
[fa type=”arrow-circle-down”] 2.2 Definitions
[fa type=”arrow-circle-down”] 2.3 Disclosure of External Interests
[fa type=”arrow-circle-down”] 2.4 Transacting Business with the State
[fa type=”arrow-circle-down”] 3. Administration of the Policy
[fa type=”arrow-circle-down”] 3.1 Responsibility
[fa type=”arrow-circle-down”] 3.2 The University Conflicts of Interest Committee
[fa type=”arrow-circle-down”] 3.3 UGA Requirements for Federally-Funded Sponsored Activities
[fa type=”arrow-circle-down”] 3.4 Records
[fa type=”arrow-circle-down”] 3.5 Reporting
[fa type=”arrow-circle-down”] 3.6 Enforcement Mechanisms and Sanctions

1. Introduction

While faculty and staff have a primary responsibility to the University of Georgia (UGA), it is not uncommon for them to engage in outside activities related to their professional interests. The Institution encourages these activities, as they often promote the careers of the individuals involved as well as the interests of the University. At the same time, outside activities may raise concerns about conflicts of interest, real or perceived. These conflicts may be about time, commitment, and primary responsibilities to the University, or they may be about ethical conduct or the potential for compromised judgment. To address these concerns while encouraging outside activities, the University has developed a Conflict of Interest Policy. This policy is designed to ensure that UGA employees meet their institutional obligations and maintain appropriate balance, objectivity, and integrity.

Federal and state agencies have developed regulations to avoid or manage conflicts of interest in federally sponsored programs. The University of Georgia Conflict of Interest Policy complies with all current rules and regulations promulgated by federal and other agencies and organizations. The intent of this Policy is to prevent or resolve, through management and/or mitigation, real or apparent conflicts that may exist in relation to sponsored instruction, research, and public service and outreach activities undertaken by University employees.

2. The Policy

2.1 The Scope of the Policy

This Policy applies to all employees who apply for and/or receive instruction, research, or service funding or other support from external agencies or organizations. It is effective August 25, 2012, and applies to new and ongoing sponsored activities funded by external agencies or organizations regardless of the date that such activities were initiated.

This Policy requires an annual disclosure of all Significant Financial Interests (SFIs) by any employee acting in the role of an Investigator on proposals submitted to any Department of Health and Human Services (DHHS) Public Health Service (PHS) entity prior to proposal submission. PHS entities include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Federal Drug Administration (FDA), the Indian Health Service (IHS), the Health Resources and Services Administration (HRSA), and the Agency for Healthcare Research and Quality (AHRQ). UGA’s disclosure vehicle is the Disclosure of Significant Financial Interests.

This Policy additionally requires disclosures of SFIs from UGA employees when, if funded, a proposal to any sponsor other than a PHS entity would create a conflict of interest.

2.2 Definitions

  • An apparent conflict of interest arises when an employee is involved in an activity and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the employee’s impartiality.
  • conflict of interest (COI) arises when an employee (or an employee’s spouse or dependent child) has a Significant Financial Interest (SFI) that could directly and significantly affect decision making in the design, conduct, or reporting of externally funded instruction, research, or service activities performed on behalf of the University.A COI does not necessarily arise in connection with the following activities, and this Policy does notautomatically prohibit activities such as:
    • Equity participation in a corporation;
    • Service as an officer in a corporation;
    • Service on a governing board;
    • Service on a scientific or academic advisory board;
    • Receipt of funding from an external entity in which an employee has an interest;
    • Reimbursement of travel expenses by an entity outside the Institution;
    • Acceptance of publication royalties, royalties under the terms of the UGA Intellectual Property Policy, or honoraria for papers and lectures; or
    • Service to outside educational, professional, scientific, artistic, cultural, civic, business, or other organizations that furthers the career of the individual while enhancing their value to UGA and does not adversely affect their primary commitment to UGA.
  • Employee means a University employee or any other individual serving as the principal investigator, co-principal investigator, or co-investigator, or any person at UGA (including a student) who is responsible for any portion of the design, conduct, or reporting of instructional, research, or service activities, or any other sponsored activity funded or proposed for funding by an external sponsor, agency, or organization.
  • Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
  • Institution means the University of Georgia or the University of Georgia Research Foundation (UGARF) as entities applying for or receiving external funds for instructional, research, or service activities.
  • Institutional Responsibilities mean an Investigator’s professional responsibilities on behalf of the University of Georgia and span teaching, research, internal and external service activities, and related or professional activities for which written institutional permission is given in advance (for example, consulting or starting a company).
  • Investigator means the project director or principal investigator, co-investigator, and any other person, regardless of title or position, who is responsible for any portion of the design, conduct, or reporting of sponsored activities undertaken by UGA and funded or proposed for funding by an external sponsor, agency, or organization. “Investigator” includes the investigator’s spouse and dependent children. “Investigator” may include non-UGA employees; and in such cases, these Investigators and their institution or organization must be in compliance with applicable Federal laws regarding financial conflicts of interest in order to be included on UGA/UGARF proposals.
  • Research means a systematic investigation, study, or experiment designed to develop or contribute to general knowledge relating broadly to any discipline of scholarly endeavor. This term encompasses basic and applied research and product development. As used in this Policy, “research” includes any such activity for which funding is sought, available, or offered from external sources.
  • Senior/Key Personnel means the Project Director/Principal Investigator and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to an external sponsor.
  • Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of the Investigator (and of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:(i) 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 held 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); and 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. Mutual funds and retirement accounts are excluded so long as the Investigator does not directly control the investment decisions made in these vehicles.(ii) With regard to any non-publicly traded entity (which would include most start-up companies), a SFI 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) that result in the receipt of income related to such rights and interests.
  • The term significant financial interest (SFI) does not include the following types of financial interests: salary, royalties, or other remuneration paid by UGA to the Investigator if the Investigator is currently employed or otherwise appointed by UGA, including the transfer of intellectual property rights to UGARF and royalty-sharing related to such rights; any ownership interest in an entity such as a start-up company held by the Investigator, if the entity is the applicant for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (SBTT) proposal; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C.1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher educational.
  • Sponsored activity means a research, creative activity, training, or instructional and service project involving funds, materials, or other compensation from one or more outside sources (sponsors).

2.3 Disclosure of External Interests

At the time of proposal submission all employees must disclose the presence of Significant Financial Interests (SFIs), including those of the employee’s spouse and dependent children, that are related to the employee’s institutional responsibilities, except that a detailed annual disclosure of Significant Financial Interests (SFIs) shall be made by any Investigator submitting proposals to any Department of Health and Human Services (DHHS) Public Health Service (PHS) entity. These annual disclosures must cover SFIs incurred for the previous 12-month period and must be made prior to the submission of PHS proposals on which the UGA employee will serve as Investigator(s), if funded.

UGA employees serving as Investigators on proposals submitted to a non-PHS entity will not need to submit an annual disclosure prior to proposal submission. Such investigators or senior/key personnel will indicate annually on the Office for Sponsored Programs Transmittal Form whether or not a potential financial conflict of interest (FCOI) exists. If a potential FCOI exists, the employee will be required to submit a disclosure. All UGA employee disclosures of SFIs shall be made by completing the Investigator’s Disclosure of Significant Financial Interests. All UGA employees must annually update their disclosure and within 30 days of incurring new reportable significant financial interests.

2.4 Transacting Business with the State

Georgia state law provides that it is unlawful for a state employee to transact business with the agency by which that person is employed, whether such transaction is for himself, on behalf of a business in which the employee or his spouse or dependents has a substantial interest, or on behalf of anyone as agent, broker, dealer, or representative. Generally, an employee of UGA (or his family, business or agent) “transacts business” with UGA when the employee (or his family, business, or agent) sells or leases any personal property, real property, or services to UGA or purchases surplus, real, or personal property from UGA. Certain exceptions are provided. Employees are required to file annual disclosure statements of certain business transactions with the state. (O.C.G.A. §§45-10-20 through 45-10-28.) The Institution cannot permit sponsored activities in which an employee (or his family, business, or agent) transacts business with the Board of Regents/UGA.

3. Administration of the Policy

3.1 Responsibility

The President of the University has delegated the Office of the Vice President for Research to be responsible for collecting and reviewing Disclosure of Significant Financial Interests filings related to sponsored activities, whether filed annually as required for Investigators who submit proposals to Department of Health and Human Services (DHHS) Public Health Service (PHS) entities or when a disclosure is made in conjunction with any other proposal submission. In all cases, the Institutional Integrity Officer will conduct a review, which at a minimum will require an assessment of the relatedness of an Investigator’s SFI disclosure to the project, whether proposed or on-going. If a Conflict of Interest (COI) is found to exist, the matter will be mitigated, managed, or eliminated. The Institutional Integrity Officer may seek assistance from the University Conflicts of Interest Committee (UCIC) regarding any disclosure and its relatedness to sponsored project, as well as the management, mitigation, or elimination of a COI.

3.2 The University Conflicts of Interest Committee

When the assistance of the University Conflicts of Interest Committee (UCIC) is needed, one will be appointed by the University President. The UCIC shall be chaired by the Vice President for Research or his/her designee. It shall also include not less than five additional appointed members with broad representation across UGA and a member who is not a University employee. Members shall serve three-year staggered terms.

Upon referral from UGA’s Institutional Integrity Officer, the UCIC shall review all material related to a potential or apparent conflict of interest. If the UCIC identifies a conflict, it will work with the Institutional Integrity Officer and the Investigator(s) to resolve the conflict by management, mitigation, or elimination.

Examples of conditions or restrictions that might be imposed to manage, mitigate, or eliminate conflicts of interest and/or commitments include, but are not limited to:

  • Public disclosure of significant financial interests including disclosure on manuscripts submitted for publication, on abstracts and posters submitted for presentation, and in informed consent documents;
  • Monitoring of instruction, research, or service activities by independent reviewers;
  • Modification of the instruction, research, or service activity plan;
  • Disqualification of an individual from participation in the portion of the externally funded activity that would be affected by that individual’s significant financial interest;
  • Divestiture of an individual’s significant financial interest;
  • Relinquishment or reassignment of duties that could exacerbate the conflict;
  • Severance of relationships or holdings that create conflicts;
  • Placement of holdings in a blind trust for a specific period of time; or
  • Reduction in time allocations, in cases of conflict of commitment.

3.3 UGA Requirements for Federally-Funded Sponsored Activities

When submitting a proposal to a federal agency for a sponsored activity, the Institution must certify on a Proposal Transmittal Form that it is in compliance with this Policy and with applicable federal rules and regulations, including the following:

    • UGA (and all sub-recipients on PHS projects) has written and enforced policies on conflicts of interest and such policies are consistent and compliant with all current federal requirements when such instruction, research, or service is sponsored by a federal agency (federal requirements do not apply to non-federally funded research).
    • To the best of its knowledge, all financial disclosures required by the conflicts of interest policies of UGA and any sub-recipient institution(s) have been made.
    • All identified conflicts of interest will have been satisfactorily managed, mitigated, or eliminated, in accordance with the University’s conflicts of interest policy, prior to UGA’s expenditure of award funds and, if required, a sponsoring federal agency has been informed that a disclosed conflict of interest has been managed, mitigated, or eliminated.
    • Conflicts that cannot be satisfactorily managed, reduced, or eliminated will be disclosed to a sponsoring federal agency.
    • UGA agrees to disclose, when required by federal funding agencies or by the public, all conflicting interests identified by UGA and the manner in which those interests have been managed, reduced, or eliminated to protect the instruction, research, or service projects from bias.
    • UGA will otherwise comply with applicable federal agency rules and regulations for promoting objectivity in sponsored activities.

In addition, when submitting such a proposal, each individual Investigator also must certify:

  • That he/she has read and understands the UGA Policy on Conflicts of Interest in Sponsored Programs and other relevant policies, and has signed an acknowledgement of the same;
  • That to the best of his/her knowledge, all financial or other disclosures required by the UGA’s Policy were or will be made; and
  • That he/she will comply with all conditions or restrictions imposed by UGA regarding conflicts of interest and conflicts of commitment up to and including possible forfeiture of the award; and
  • That disclosure updates will be made annually and within 30 days after adding a new significant financial interest.

3.4 Records

All Disclosure of Significant Financial Interests documents and all records of actions taken to resolve or mitigate conflicts of interest will be maintained in OVPR for a period of at least three (3) years beyond the termination or completion of the sponsored award to which they relate or until the resolution of any action involving those records, whichever is longer.

3.5 Reporting

The University must report any identified COI to the sponsor of externally funded activities prior to expending any funds, and any COI identified subsequent to the initial report must be reported within 60 days of that identification. The University will also make PHS-funded Investigator COIs (name, project title and role, and the entity in which the SFI is held, along with its nature and dollar value) available in response to a written request for such information from the public within five (5) business days of such a request. In cases where a project to evaluate a drug, medical device or treatment was conducted by an Investigator with a COI that was not disclosed or managed, the University will require investigators to disclose the COI in each public presentation or publication of the results of the research.

3.6 Enforcement Mechanisms and Sanctions

The Institution will not submit instruction, research, or service proposals to PHS entities, or allow employees to submit instruction, research, or service proposals to PHS entities if the annual Disclosure of Significant Financial Interests has not been provided by all Investigator(s) listed on a proposal. UGA or UGARF will not allow expenditures of award funds from any external sponsor if an identified FCOI has not been resolved and documented, if the Investigator(s) does not agree to abide by any and all Management Plan conditions or restrictions imposed by UGA, and in the case of PHS award recipients, if required FCOI training has not been completed. A failure to disclose SFIs under this Policy could result in loss of funding and disciplinary action.