Investigator means the project director/principal investigator and any other person regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposal for funding, including persons who are subcontractors, collaborators, or consultants.

Financial Interest means anything of monetary value or potential monetary value held by the Investigator, the Investigator's spouse and/or dependent children.

Significant Financial Interest means, except as otherwise specified in this definition:

1. A financial interest consisting of one or more of the following interests of the Investigator (and/or those of the Investigator's spouse and/or dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

   1. 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 the 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, travel reimbursement). Equity Interests includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

   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 the Investigator (or the investigator's spouse or dependent children) holds any equity interest.

   3. Intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.

2. 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 the investigator if the investigator is currently employed or otherwise appointed by the university as long as the investigator does not have a financial interest in the sponsoring entity;

   2. Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local agency, or an institution of higher education;

   3. Income from service on advisory committees or review panels for a federal, state or local government agency, or an institution of higher education.

Institutional Responsibilities means an investigator's professional responsibilities on behalf of the university including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Research means a systematic investigation designed to develop or contribute to generalizable knowledge. It includes basic research and applied research and product development. It includes activities sponsored through a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.

Investigators are responsible for the following:

1. Reading and understanding this policy;

2. Disclosing significant financial interests to the university by completing appropriate forms on or before a specified date or before submission of the grant/contract application;

3. Completing any required training in a timely manner;

4. Updating disclosure statements as changes occur, so that the statement on file is current and accurate at all times when an award is pending or in force; and

5. Complying with any and all Management Plan provisions and monitoring requirements, as applicable.

Designated members of the Office of the Vice President for Research and Graduate Studies (VPRG) conduct an initial review of all disclosures. If necessary, they obtain additional information from the investigator and other individuals to help determine whether the SFI disclosed is related to a proposed or existing sponsored project or program. A VPRG designee then formally identifies activities that require further review. Barring unforeseen circumstances, the process of information collection and review will be carried out in an expeditious manner.

There will be two levels of review:

1. Level 1: The review group will include the VPRG designee, the investigator, and the investigator's supervisor. The group will work together to resolve potential or apparent financial conflicts of interest by implementing reasonable controls. These controls will be formalized in a Management Plan, which will be signed by the investigator, the investigator's supervisor, and the VPRG designee at the successful conclusion of the review.

If no acceptable conclusion is reached at the Level 1 review phase, the Level 2 review will be implemented. The investigator, at his/her discretion, may choose to have the disclosure reviewed immediately at the Level 2 stage.

1. Level 2: An Outside Interest Committee, which is a standing university committee, will work with the VPRG designee, the investigator, and the investigator's supervisor to resolve potential or apparent financial conflicts of interest and finalize a Management Plan. The final, formal Management Plan will be signed by the investigator, the investigator's supervisor, and the VPRG designee.

Whether a Level 1 or Level 2 review, the convened group will review the collected information to determine whether a financial conflict of interest exists by considering the following:

1. Impact on integrity of research data;

2. Risks to rights and safety of animal and/or human research subjects;

   1. Note: All disclosures related to human subjects research will be assigned a Level 2 review.

3. Risks to the rights of students and trainees participating in research; and

4. Appearance of conflict of interest.

Management means to take action to address a financial conflict of interest, which includes reducing eliminating the financial conflict of interest, to ensure that the design, conduct or reporting of research is free from bias or the appearance of bias. Typically, written Management Plans are developed according to the nature of the conflict of interest and of the sponsored research, and whether the investigator is conducting bench, animal or human subject research. Examples of conditions or restrictions that may be employed to manage conflicts include:

1. Public disclosure of significant financial interests (e.g., when presenting or publishing the research), if appropriate to the discipline;

2. Disclosure of significant financial interests directly to participants involved in human research;

3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of research;

4. Modification of research plan;

5. Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research;

6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

7. Severance of relationships that create the actual or potential conflict of interest.

Normally an investigator will be provided with a draft of the Management Plan to review and comment before it is finalized. At either Level 1 or Level 2 review, the proposed Management Plan will be made available to the appropriate dean or senior official. If the dean or senior official is unable to agree to the terms of the Management Plan, the matter will be referred to the Provost. The Provost's decision will be final.

Human Subject Research - Special precautions must be taken to protect human subjects who participate in university research. Normally, an investigator with a financial conflict of interest will not be allowed to participate in such research. However, if an investigator provides a compelling justification, it will be reviewed to determine if a waiver of this policy is appropriate. The IRB must review and approve any Management Plan for human subject research to proceed. The IRB may also require additional safeguards.

Students and Trainees - Students and trainees, hereafter referred to as "students," may perform research related to an investigator-owned company only through a written sponsored research agreement or formal internship agreement through the university. Such agreements shall not limit a student's normal right to intellectual property and research data, allow for inappropriate publications delays, or hinder the normal progress of attainment of the applicable degree.

Special provisions for students employed by a company or outside entity where an investigator has a financial interest will be specifically called out in the investigator's Management Plan.

Prior to expenditure of any funds or within 60 calendar days for any interest that the university identifies as conflicting subsequent to the university's initial report under a PHS-funded research project, the university must provide the PHS Awarding Component with a Financial Conflict of Interest (FCOI) report regarding the related FCOI and implemented Management Plan. This report must include the following information:

1. Grant/Contract Number

2. Project Director/Principal Investigator (PD/PI) or contact PD/PI

3. Name of investigator with FCOI

4. Nature of the FCOI (e.g., equity, consulting fees, or honoraria)

5. Value of the financial interest

6. Description of how FCOI relates to PHS-funded research

7. Key elements of the Management Plan

Annual updates are also required for the duration of the research project.

If a significant financial interest (SFI) is not disclosed or reviewed in a timely manner, the university must review the SFI, determine if it is related to PHS-funded research; determine whether a financial conflict of interest exists, and, if so:

1. Implement a Management Plan for ongoing research; and

2. Implement a mitigation plan to determine whether any bias exists in previously conducted research.

Disclosure via University Website

PHS also requires that information regarding the financial conflicts of interest noted above be made available via a publicly accessible website. At a minimum the website shall include, the investigator's name, position relative to the research project, nature of the SFI, approximate dollar value of SFI, or a statement that the value cannot be readily determined.

Subrecipients

For PHS research that involves subcontractors, subgrantees or subawardees (collectively "subrecipients") at other institutions, the university requires written assurance from subrecipients that they and the individual investigators who work for them have a conflict of interest policy that conforms to the requirements of all applicable regulations, including, but not limited to those set forth at 45 CFR Part 94 and 42 CFR Part 50, Subpart F. If any subrecipient does not have such a conflict of interest policy, then the university shall require that subrecipient follow this policy, and subrecipient's failure to promptly do so upon request from the university shall be considered to be grounds for immediate termination by the university of any applicable subcontract or subaward. Any assurance required by the university shall contain the provision that subrecipients will report to the university as the awardee institution, any identified financial conflict of interest. The university will require a specific assurance from the other institution that any such financial conflict of interest has been managed. The university, in turn, will report the financial conflict of interest to PHS as described above.

Investigators should be aware that as a result of their financial interest or fiduciary role in an outside entity/company they may have additional obligations under various state and federal laws, in addition to this policy. These laws include, but are not limited to, the following:

State

1. Ohio Revised Code (Sections 102.03, 2921.42 and 2921.43)

Federal

1. Public Health Service (PHS) 42 CFR, part 50, subpart F and 45 CFR part 94

2. National Science Foundation (NSF) Grantee Conflict of Interest Policies

3. U.S. Food and Drug Administration (FDA) 21 CFR 54

4. Federal Office of Management & Budget Circular A-21

5. Securities and Exchange Commission (SEC)

Investigators should also be aware that research sponsors may have additional requirements regarding financial interests that would be defined in the grant or contract.

Possible violations of this policy include, but are not limited to, the following:

1. Intentionally or recklessly providing incomplete, false, or misleading information on the disclosure form;

2. Failing to make required disclosures; or

3. Failing to provide information requested by the university to adequately review a financial interest and/or manage an identified conflict of interest.

The university may take appropriate disciplinary action against covered individuals who violate this policy. This disciplinary action may include, but not be limited to:

1. Written reprimand

2. Suspension

3. Non-renewal of appointment

4. Involuntary termination of employment

Disciplinary action under this policy for non-bargaining unit faculty shall be consistent with and subject to applicable provisions of the university's Human Resources Policies or applicable sections of the Faculty Handbook. For bargaining unit faculty, any disciplinary action shall be consistent with and subject to applicable sections of the Collective Bargaining Agreement between AAUP-WSU and the university.