As used throughout this policy,
FACULTY MEMBER and/or EMPLOYEE (generally "a faculty member")
means any person possessing either a full-time or part-time appointment at the university receiving wages and/or benefits from Ohio University who we responsible for designing, conducting and reporting the results of research, educational or public service activities. This includes any individuals
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who have independent responsibility for the accomplishment of project objectives. The policy also includes those individuals, whether salaried or not salaried, who, on behalf of Ohio University, are responsible for writing, submitting and management of grants. For purposes of this policy, conflicts include those of the faculty member and his/her immediate family.
An ASSOCIATED ENTITY
of an faculty member is any business, trust, organization, or enterprise over which the employee, alone or together with his/her immediate family, exercises a significant financial interest.
BUSINESS
means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other nongovernmental legal entity organized for profit, not-for-profit, or charitable purposes.
EXECUTIVE POSITION
refers to any position that includes responsibilities for a significant segment of the operation or management of a business.
A SIGNIFICANT FINANCIAL INTEREST
in a business is anything of monetary value, including but not limited to; salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests that exceed $10,000 or represent a more than five (S) percent ownership interest); and intellectual property rights (e.g. patents, copyrights and royalties from such rights). It excludes any interest arising solely by reason of investment in such business by a mutual, pension, or other institutional investment fund over which the faculty member does not exercise control. For the purposes of this policy, disclosure is required when the interest in a business by an faculty member or by an immediate family member exceeds in the past twelve months $10,000 in annual income of all types, and equity or ownership interest from all sources in a single entity exceeds five(5) percent ownership. Disclosure is also required when an immediate family member holds an executive position in a business, or holds equity or ownership interest valued at five (5) percent or more in a business.
GIFT
means an unrestricted donation of assets to Ohio University or any affiliate of Ohio University. The donor may specify the general purpose for which the gift may be used, but there may be no other terms and conditions concerning Me use of such partnership assets. Assets may be in &e;form of cash, securities, tangible personal property, partnership interests, or pledges for acceptable assets that are assigned to Ohio University. For the purposes of this policy, disclosure is required when (a) a gift is from a business in which a faculty member has a significant financial interest or (b) the value of the gift exceeds $10,000 in a given year.
IMMEDIATE FAMILY or FAMILY
includes the faculty member's spouse or domestic partner,
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and dependent children as determined by the definitions of the Internal Revenue Service and State of Ohio law.
PARTICIPATE
means to be part of the described activity in any capacity, including, but not limited to, serving as the principal investigator, co-investigator, research collaborator, or provider of direct services or patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) or, in the case of research with human subjects, to the study participants, unless they are in an independent position to influence the study's results or have privileged information as to the outcome.
SPONSORED RESEARCH, SCHOLARSHIP or CREATIVE ACTIVITIES
means research, training, and instructional projects involving funds, materials, or other compensation from outside sources under agreements that contain any of the following: The agreement binds Ohio University or an affiliated entity to a line of scholarly or scientific inquiry specified to a substantial level of detail; a line-item budget is involved; financial reports are required; the award is subject to external audit; unexpended funds must be returned to the sponsor at the conclusion of the project; or the agreement provides for the disposition of either tangible or intangible properties that may result from the activity.
III. Types of Conflicts
Conflicts of Commitment
With the acceptance of a full-time appointment to Ohio University, an individual makes a commitment to the university that is understood to be full-time in the most inclusive sense. The members of the faculty are expected to devote their primary professional loyalty, time and energy to their teaching, research, and administrative responsibilities. Accordingly, they should arrange their outside activities and financial interests so as not to interfere with the primacy of these commitments. Ohio University recognizes that its faculty may engage in outside professional work, and to the extent these activities serve or do not interfere with the university's interests as well as those of the faculty member, Ohio University approves of such involvement.
When such participation necessitates a reduction in teaching load or administrative responsibilities, prior approval by the department chair and dean of the activity and the reduction in teaching and administrative responsibilities is required. Outside professional work by faculty members during the regular academic year should not exceed the equivalent of one day per week. A faculty member engaged in consulting or other outside professional work at any time during the year must avoid activities that involve a conflict of interest with assigned Ohio University responsibilities, particularly as it relates to an area of on-going
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sponsored research, educational activities or public service with specific contractual restrictions. A faculty member may not enter into a patent or some types of copyright agreements with an outside company or agency without the written approval of the Vice President for Research and Graduate Studies'. If Ohio University space, services, equipment, and/or materials are required to perform outside professional service, prior approval by the department chair, dean, and Vice President for Research and Graduate Studies must be obtained and a payment of fees set by Ohio University for the use of such facilities(2).
Potential conflicts of commitment must be disclosed and resolved as described in the Ohio University Faculty Handbook, Section IV-D.
Members of the faculty whose appointments are less than full-time are expected to devote professional loyalty, time and energy to their teaching research and administrative activities in accordance with their agreed-upon time commitment.
Administrative employees who hold full-time appointments are expected to devote their full-time professional loyalty, time and energy to their position.
Conflict of Interest
A potential conflict of interest occurs when there is a divergence between the individual's private interests and his or her professional obligations to the university such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An actual conflict of interest depends on the situation and not on the character or actions of the individual. Actual conflicts of interest are prohibited by federal and/or state law [NSF Notice No. 117, Investigator Financial Disclosure Policy, as amended July 1995, FR 60(132):35820-35820; PHS Objectivity in Research; Final Rule FR 60(132):35810-35819, as amended FR60(146):39076-39077, 45 CFR 50, 50.601-50.607 and 45 CFR 941-94.6; State of Ohio ORC Chap. 10Q, and ORC Section 2921.421.
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(1) It Copyright agreements for scholarly publications (books and articles), works of art, musical compositions, etc., are excluded from this policy. This Conflict of Interest policy does not supersede any current Ohio University policy or any future policies on copyright ownership.
(2)For purposes of this policy, facilities use does not include the use of typewriters personal computers, printers, and other equipment used in the production of scholarly writing, including reports.
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The potential for conflicts arises because of the nature and scope of activities engaged in by Ohio University and its faculty members and employees. Ohio University assumes that potential for conflicts of interests will occur regularly in the normal conduct of activities. However, it is essential that the significant potential for conflicts of interest be disclosed and reviewed by Ohio University prior to entering into the situation or relationship. After a disclosure, Ohio University can then make an informed judgement about a particular case and require appropriate oversight, limitations, or prohibitions on the activity in accordance with federal and state law. Faculty members may not engage in activities in which a conflict of interest occurs as defined by this university policy.
Significant Combinations of Activities and External Relationships
The potential for a conflict of interest arises when certain activities are proposed by the faculty member and are coupled to the existence of certain external relationships. Some combinations (Category I below) are assumed to not represent a conflict of interest. Other combinations represent sufficient potential for conflict of interest (Category II below) that they require review and prior approval by Ohio University before the faculty member can engage in the activity. Category III below addresses an activity combined with an external relationship that is presumed to be a conflict of interest and is therefore not allowed.
The following is a representative, though not inclusive, list of activities and external relationships covered by this policy The categories are general guidelines, and the application of appropriate review and oversight will always be in accordance with maintaining the full integrity or reputation of Ohio University and its employees.
Any combination of activity and external relationship not specifically represented in Categories I-III that a faculty member reasonably believes constitutes a potential conflict of interest must be reported in writing according to the procedures described within this policy.
Category I - Allowable combinations of activities and external relationships
The following are not considered conflicts of interest and do not require disclosure. They are allowable, if they are consistent with other policies of Ohio University including the Consuming and Intellectual Property Ownership and Disposition policies:(3)
P>
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(3) This Conflict of Interest Policy does not supersede Ohio University's Policies No. 17.900 (Consulting Policy) and No. 17.001, (Intellectual Property Ownership and Disposition, Employee Involvement in Research Commercialization Endeavors), or any future
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a) A faculty member receiving royalties and honoraria for published scholarly works, lectures, seminars, or teaching engagements and other writings or creative works.4
b) A faculty member receiving honoraria for serving as a special reviewer or serving on review panels for academic, governmental, or not-for-profit entities.
c) A faculty member receiving royalties under Ohio University's Intellectual Property Ownership and Disposition policies and the faculty member does not have any other relationship with the royalty-granting entity as specified in Category II.
d) Clinical faculty members income through the private practice program of Ohio University Osteopathic Medical Center Inc. (MCI).(5)
Category II - Combinations of activities and external relationships in which there is a minimal to moderate potential for conflict of interest
The following combinations range from those that are considered to have minimal to moderate potential for conflict of interest (Section A) to those that have a moderate to high potential for conflict of interest (Section B). The activities in Section A are ordinarily allowable following disclosure and, where necessary, the implementation of oversight or other management procedures. The activities and external relationships listed in Section B require case-by-case review and only some of the specific relationships may be approved. Special oversight or management procedures are likely to be required (see Section 3 for disclosure and approval procedures).
Section A - Combinations of activities and external relationships in which there is a minimal to moderate potential for conflict of interest.
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policies on intellectual property.
(4) Products produced for a specific university job assignment are excluded-and remain the property of the university. This Conflict of Interest Policy does not supersede Ohio University Policies No. 15.006 (Policy for the Ownership and Utilization of University-Sponsored Educational Materials) and No. 15.007 (Faculty Participation in Educational TV Productions).
(5) The signature of the Dean of the College of Osteopathic Medicine on the Assurance of Compliance and Disclosure of Information forms will affirm that a review of the faculty member's income through MCI has been made and there are no entities to report.
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- Research Activities
An faculty member participating in research on a technology, process, or product developed in whole or in part by that faculty member in which the faculty member, a member of his/her immediate family, or an associated entity is entitled to receive royalties from an existing agreement with a business under Ohio University's Intellectual Property Ownership and Disposition policy, but has no other significant financial interests in the project.
A faculty member assigning students, postdoctoral fellows, or other trainees to research projects in which the faculty member, a member of his/her immediate family, or an associated entity is entitled to receive royalties from an existing agreement with a business under Ohio University's Intellectual Property Ownership and Disposition policy, but has no other significant financial interests in the project.
Section B - Combinations of activities and external relationships in which there is a moderate to high potential for conflict of interest.
- Research Activities
a) A faculty member participating in clinical trials or evaluation or development of a technology, process, or product owned or controlled by a business in which the faculty member, a member of his/her immediate family, or an associated entity has significant financial interest, other than royalty income or the entitlement to future royalty income under Ohio University's Intellectual Property Ownership and Disposition policy.
b) A faculty member assigning students, postdoctoral fellows, or other trainees to projects supported by a business (through sponsored research or a gift) in which the faculty member, a member of his/her immediate family, or an associated entity has a significant financial interest, other than royalty income or the entitlement to future royalty income under Ohio University Intellectual Property Ownership and Disposition policy.
c)A faculty member receiving Ohio University-supervised sponsored research support or gifts (whether in dollars or in kind) for research from a business in which the faculty member, a member of his/her immediate family, or an associated entity has a significant financial interest, other than royalty income or the entitlement to future royalty income under Ohio University Intellectual Property Ownership and Disposition policy.
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Board Memberships
a) A faculty member receiving research support (sponsored research or a gift) from a business in which the faculty member or a member of his/her immediate family serves on the board of directors or advisory board, whether or not compensation is received for such services.
External Activities
a) A faculty member holding an executive position in a business engaged in commercial or research activities directly related to his/her Ohio University responsibilities.
Administrative Responsibilities
a) A faculty member having administrative responsibilities (e.g., department or school chair or director) on behalf of Ohio University with respect to the operation of Ohio University or any Ohio University-affiliated organization that is beneficial to a business in which he/she, a member of his/her immediate family, or an associated entity has a significant financial interest.
b) A faculty member having administrative responsibilities on behalf of Ohio University with respect to any supported research activity (sponsored research or a gift) in which the faculty member, a member of his/her immediate family or an associated entity has a significant financial interest in the sponsor or donor.
Professional Referrals
a) With the exclusion of consulting activities that conform to the consulting policy (Faculty Handbook Section IV.D), a faculty member while acting in the context of his/her Ohio University duties making professional referrals to a business in which he/she, a member of his/her immediate family, or an associated entity has a significant financial interest of which the faculty member is aware or reasonably should be aware.(6)
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(6) Only in very unique situations should full-time faculty members be permitted to engage in this type of activity. For example, if the function is not generally available from other sources and the faculty member fully discloses his/her relevant financial interests to prospective clients, this type of activity could be permitted. The faculty member should disclose the activity to his/her dean.
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Category III - A combination of an activity and an external relationship that is prohibited:
The following activity creates a conflict of interest and is not allowed for faculty members:
Purchasing goods or services
a) Faculty members responsible for or who may influence purchasing decisions or contracting on behalf of Ohio University must comply with Ohio University Policy No. 55.003 and Section 2921.42 Ohio Revised Code (ORC) or Chapter 102 of ORC.
V. Implementation - Assurance of Compliance and Financial Disclosure
Successful implementation of this policy assumes a shared responsibility by all faculty members and the administration of Ohio University. Faculty members are expected to comply with all the disclosure requirements described below. Once a faculty member's proposed research, educational or public service activities have been administratively reviewed, Ohio University administration has the responsibility to support the activity so long as the faculty member complies with the disclosure requirements, other Ohio University policies, and state and federal law.
A. Disclosure Requirements
Requirements for disclosure of significant financial interests:
Federal and state regulations require that any time a faculty member plans to initiate an activity that may be classified under Category II of this policy, the faculty member must obtain prior approval for the proposed activity. For the purpose of this policy, disclosure is required when the interest in a business by an faculty member, an immediate family member, or associated entity exceeds $10,000 in the past twelve months or represents more than a five (5) percent ownership interest for any one enterprise or entity when aggregated for the faculty member and his/her immediate family and the associated entity, or when salaries, royalties or other payments when aggregated for the past twelve months exceeded $10,000.
- Annual disclosure
All faculty members making an application to any external agencies requiring compliance are required annually to complete and submit to their department head the Assurance of Compliance Form reporting all significant financial interests relevant to the discharge of their Ohio University duties. A list of the agencies can be obtained from the Office of Research and Sponsored Programs. Whenever substantial changes occur that the faculty member believes may alter the significant financial interests previously disclosed, an updated form must be submitted within thirty (30) days of that change including possible stock transfers, splits or other changes that affect the 5% criteria.
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The Assurance of Compliance Form presents two options: a declaration that the faculty member is familiar with this policy and has no conflicts of interest or potential conflicts of interest to report; or the completion of Disclosure of Information Form for review of potential conflicts of interest. A copy of the Assurance of Compliance Form will be reviewed by the department head and forwarded to the dean and, then, forwarded to the Vice President for Research and Graduate Studies. The Disclosure of Information Form will be reviewed by the department head and dean and forwarded to the Vice President for Research and Graduate Studies with comment and, if appropriate, a recommendation by the dean for a strategy to manage, reduce or eliminate such conflicts of interest. The recommendation will be reviewed by the Vice President for Research and Graduate Studies and, in consultation with the faculty member, department head and dean, a strategy to manage, reduce or eliminate such potential conflicts of interest will be implemented.
A potential conflict of interest will be deemed to exist when it is determined that a significant financial interest could affect the design, conduct, use of facilities in or reporting of research, educational or public service activities performed as part of the faculty members discharge of their duties at Ohio University.
Disclosure when submitting a proposal for sponsored activities with an external agency:
All faculty members will be required to affirm on the university proposal transmittal form (Office of Research &;Sponsored Program's blue transmittal form) at the time of submission of a research proposal to an external agency requiring disclosure that their most recent annual Assurance of Compliance Form and/or Disclosure of Information Form remains accurate. Submission of the application will not be made for the faculty member until the Assurance of Compliance Form and/or Disclosure of Information Form are complete.
Disclosure when involved with review or advisory activities:
All faculty members must temporarily excuse themselves from any Ohio University committee or review process that is considering an activity in which they have a significant financial interest.
In addition, faculty members must also disclose to committee chairs and/or the appropriate administrator or executive officer any interest (business, financial, or family) that might cause the faculty member to compromise his/her judgement while
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serving as a committee member or making advisory decisions. An example is serving in an executive position for any organization that does business with the Ohio University or sets policies or rules that affect Ohio University's activities.
Disclosure to external entities
Faculty members must disclose relevant significant financial interest to sponsors of research and in reporting by either written or oral communication research results.(7) Disclosure must also be made by any faculty member who makes an appearance, either in person or by way of a written communication, before any public body, commission, group, or individual, to present facts or to give an opinion respecting any issue or matter up for consideration, discussion, or action.
Additional Information
When considering a Disclosure of Information, the Ohio University may require the faculty member to submit additional clarifying information pertinent to the activity under review.
B. Review of Disclosures
Review Process
The general purpose of reviews is to assist employees and Ohio University in avoiding or controlling risks to integrity and reputation engendered by such relationships, while at the same time protecting and furthering the interests of faculty members, Ohio University, and society in the activities supported by sponsored research and gifts.
- Assurance of Compliance Form Review
A faculty member will submit the Assurance of Compliance Form and, if necessary, the Disclosure of Information Form by October 1 of each year to his/her department head. The Assurance of Compliance Form will be forwarded by the dean to and maintained by the Vice President for Research and Graduate Studies.
Disclosure of Information Form Review
If the faculty member has submitted a Disclosure of Information Form, the disclosure will be reviewed by the department head and he/she will review and make comment or recommendations for a strategy to manage, reduce or eliminate any potential
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(7) When submitting a paper for publication, a faculty member must disclose to the editor any financial interest that may affect or be affected by publication. This provision also applies to release of information to news media.
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conflicts of interest and forward their recommendations to the dean with the Disclosure of Information form. The dean will review the comments and recommendations forwarded by the department head and make a similar review and recommendation to the Vice President for Research and Graduate Studies. Working in consultation with the faculty member, the department head and dean, the Vice President for Research and Graduate Studies will determine the strategy to manage, reduce or eliminate the potential conflict.
Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate actual or potential conflicts of interest include but are not limited to:
- public disclosure of significant financial interests,
- monitoring of research by independent reviewers;
- modification of the research, educational or public service activities plan;
- disqualification from participation in all or a portion of the research;
- divestiture of significant financial interests; or
- severance of relationships that create potential conflicts of interest.
If the Vice President for Research and Graduate Studies determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific or educational progress, technology transfer, or the public health and welfare, then the Vice President for Research and Graduate Studies may allow the activities to go forward without imposing any conditions or restrictions as long as the activity does not violate state or federal law.
Appeal/reconsideration processIf a faculty member believes the conditions or restrictions are inappropriate, the faculty member may appeal or ask for the decision to be reconsidered. The Vice President for Research and Graduate Studies will then refer the appeal to the Conflicts of Interest Review Committee (see below) to have the activity reconsidered. Upon completion of the review, the Vice President for Research and Graduate Studies will consider their recommendation(s), if any. If a faculty member feels that he/she has cause for further grievance, the faculty member may petition the Committee on Professional Relations of the Faculty Senate (or appropriate grievance committee for their employment status) for a review of the case; the Committee shall submit its recommendations to the President who shall make a final determination of the grievance in accordance with the provisions of the Ohio University Faculty Handbook or Administrator's Handbook.
Conflicts of Interest Review Committees (CIRCs)
The Vice President for Research and Graduate Studies will determine whether a review committee(s) should
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be organized to assist in his/her review or upon an appeal by a faculty member. In consultation with appropriate deans, he/she will be responsible for appointing CIRC committee members. Faculty members will have the opportunity to meet with the CIRC to discuss their situation and possible solutions.
C. Reporting and Record Retention
The Vice President for Research and Graduate Studies will report the existence of a conflicting interest found by Ohio University and actions taken to manage, reduce, or eliminate the conflicting interest to external sponsoring agencies as required by the agencies. He/she will maintain records of all Assurance of Compliance and Disclosure of Information Forms filed and all actions taken by Ohio University, on an award-by-award basis, for at least three (3) years beyond the termination of the award or until resolution of any action by Ohio University or governmental agencies involving the records. All records will be maintained in a manner to protect sensitive and confidential information consistent with state and federal law.
VI. Compliance
Ohio University expects faculty members to comply fully and promptly with all the requirements of this policy as they apply to applicable federal and state regulations. Breaches of this policy include, but are not limited to, failure to file the Assurance of Compliance and/or Disclosure of Information Forms, intentionally filing incomplete, erroneous, or misleading forms, or failing to provide additional information as required. A violation of this policy may be the basis for discipline of a faculty member. If sanctions are necessary, they will be imposed in accordance with Ohio University Policies and Procedures. The potential sanctions may include, but are not limited to, the following:- Letter of admonition;
- Ineligibility of the faculty member to submit grant applications,
- Withholding Institutional Review Board (IRB) or Institutional Animal Care and Use
- Committee (IACUC) approval, or supervision of graduate students;
- Suspension;
- Non-renewal of probationary appointment;
- Loss of Tenure.
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VII. Conflict of Interest Review Committees
The Vice President for Research and Graduate Studies will form one or more Conflict of Interest Review Committees (CIRCs) to review the potential for conflicts of interest respecting sponsored research, funding and gifts. A CIRC may be organized by area (multiple colleges) or for particular colleges where the number of such cases or their nature justify a separate committee. Three-quarters of the voting membership of each CIRC will be faculty members from the area or college(s) to be served. The remaining one-quarter of the voting members will include faculty from outside the college(s). Some of the members should be individuals who have participated in approved external relationships. Each CIRC will also include nonvoting staff representation from the Office of Research and Technology Transfer. The Vice President for Research and Graduate Studies will decide on the composition of each CIRC and select its members in consultation with the appropriate deans.
B) Guidelines
The principal objective for the CIRC is to help guard faculty members and Ohio University from engaging in activities where the risk to integrity and reputation as a result of an external relationship outweighs the value of the activity to academic and societal goals. Relevant factors to consider are the nature of the financial interest, when and where the relationship commenced, whether the conditions of the relationship have changed during the past year, the likelihood of a conflict of interest (will the results of the activity likely be affected by or affect the significant financial interests), mechanisms to ensure integrity (peer review, other independent research sites, and independent monitors or controls), the importance of the proposed activity, and the availability of alternatives to avoid the conflict of interest.
