The principles articulated herein are intended to provide guidance in the management of formal relationships between members of the Cleveland State University (CSU) community and their external constituencies in order to ensure that the design, conduct, and reporting of sponsored research will not be biased by any conflicting financial interests. Under the Public Health Service (PHS) and National Science Foundation (NSF) final rules on Objectivity in Research (Federal Register, July 11, 1995), each University investigator is required to disclose to CSU a listing of her/his significant financial interests, as well as those of his/her spouse and dependent children, that would reasonably appear to be affected by the research proposed for funding by the PHS or the NSF. If, after review of these disclosures, it is determined that the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research, the University will report the existence of such conflicting interests to the sponsor and act to protect the resulting research from bias owing to the conflict of interest. This policy statement is intended to satisfy current Federal rules for disclosure with regard to projects funded by the PHS or the NSF. These policies also are intended to serve as exceptions to the Ohio ethics law and related statutes (O.R.C. Chapter 102, O.R.C. §2921.42, and O.R.C. §2921.43) which might otherwise apply. Matters outside the scope of these policies will be subject to such laws to the extent applicable.
B. RESEARCH AND THE FUNCTIONAL
The Functional Mission Statement for Cleveland State University commits University faculty and staff to the development of an educational environment where teaching, scholarship, and public service can thrive: Cleveland State University is a comprehensive urban university committed to providing an education of high quality to students, primarily from the metropolitan area, with diverse backgrounds, experiences, interests, and educational needs. As an active participant in the development of intellectual, social, cultural, and technological growth within the region and beyond, CSU serves as a catalyst, leader, and partner in the ongoing enhancement of the quality of life and economic viability of the region and the State. In particular, objectives 5.2, 5.3, and 7.4 of the Functional Mission Statement give emphasis to the complementary needs to establish a University research agenda that supports basic and applied research, to promote the scholarly activities of the University community by facilitating opportunities for innovative research and creative activities, and to develop research partnerships that address the critical needs of the University's constituent groups. Carrying out research for the benefit of society, therefore, is a key element of the University's functional mission. Such University research is facilitated and/or made possible through external funding, from private as well as public sources. It is the University's responsibility to assure the integrity of all aspects of such sponsored research while, simultaneously, taking care not to discourage the development of external funding opportunities for its faculty, staff, and students. The purpose of this document is to identify situations where potential conflicts of significant financial interest are likely to arise and to establish a process whereby such conflicts are either avoided or at least managed equitably to the satisfaction of all concerned parties.
C. RESEARCH, PROFESSIONAL
ETHICS, AND PUBLIC CONFIDENCE
Technology transfer and international competitiveness have been elevated to the status of national priorities, and our present national leadership actively encourages the development of relationships between industrial concerns and universities to achieve these goals. The competitiveness and economic viability of regional business and industry can be significantly advanced through sponsored program interactions with university investigators and their students. Such relationships provide efficient mechanisms for the early application of newly discovered technological innovations and, therefore, can make important contributions to the international competitiveness of the University's business and industrial partners. It is expected that members of the University community will maintain the confidence of the University's corporate partners, as well as of the public at large, in their research and other professional activities by embracing the highest standards of professional ethics. Membership in the academic community imposes on faculty, staff, and students the commitment to foster and to defend intellectual honesty in research and scholarship. The primary responsibility of the faculty is to their subject and to seeking and stating the truth. University faculty and staff pledge quality and integrity in their teaching, research, and public service primarily through self-regulation, through adherence to individual ethical principles, through dependence on accepted disciplinary professional standards, and by reference to the traditions and standards of collegiality characteristic of all institutions of higher learning. This document articulates University policy on one aspect of academic integrity in research: the management or elimination of conflicts of significant financial interest between outside constituencies and the associated funded activities carried out by members of the University community. While this institutional policy statement focuses upon avoiding, or at least managing, conflicts of significant financial interest, its primary purpose is to promote compliance with the highest ethical standards for the conduct of professional activities.
(1) Conflict of Significant Financial Interest is considered
to occur whenever a University faculty or staff member, or other
University employee, or a family member of the University employee, has
an existing or potential financial or other material interest that
impairs, appears to impair, or has the potential to impair the
University employee's independence and objectivity in the discharge of
his/her responsibilities to and/or for the University. Alternatively, a
conflict of significant financial interest is considered to occur
whenever a University employee receives financial or other material
benefit through inappropriate use of knowledge or information that is
or should have been known to be confidential to the University.
(2) University Employee is any individual employed on a full- or part-time basis at Cleveland State University who is receiving, or will receive, compensation for such employment. This includes faculty, staff, and students on hourly pay, assistantships or tuition grants.
(3) Investigator is the principal investigator, co-principal investigators, or any other University employee responsible for the design, conduct, or reporting of externally funded educational, public service, or research activities.
(4) Family Member includes the University employee's spouse or domestic partner and children or other adults who qualify as dependents under the Internal Revenue Code definitions, and the employee's parents if the parents provide significant financial support to the employee.
(5) Project implies any externally funded activity such as basic, applied, or developmental research, instructional, curricular, or creative activities, student aid, career development, or other activity conducted by University faculty or staff members on behalf of the University.
(6) Significant Financial Interest is any item of monetary value including, but not limited to: (a) salary or other payments for services rendered such as consulting fees or honoraria; (b) equity interests such as stocks, stock options, or other ownership interests; and (c) intellectual property rights such as patents, copyrights, and royalties from such intellectual property rights. Significant Financial Interest does not include: Cleveland State University remuneration such as salary or royalties; consulting fees or honoraria from service on advisory committees or review panels for public or nonprofit entities; or financial interest in business enterprises or entities where the value of such interests would not be anticipated to exceed $10,000 per annum or represent more than a five per cent (5%) ownership interest. The value of such equity interests is to be determined on the basis of public prices or other reasonable measures of fair market value.
(7) Negative Finding means a determination has been made that no conflict of significant financial interest exists.
(8) Positive Finding means a determination has been made that a conflict of significant financial interest does exist and, therefore, appropriate administrative action will be required.
A. APPLICABILITY OF
GENERAL POLICY AND PROCEDURES
The general policy and associated procedures (Section IV) are applicable to all sponsored program activity at Cleveland State University carried out by University faculty members, professional staff, scientists, trainees, technicians and other staff members, students, fellows, volunteers, guest researchers, or collaborators. The general policy and the associated procedures are derived from the final rules on Objectivity in Research promulgated by the PHS and the NSF that were published in the Federal Register of July 11, 1995. These procedures will be followed whenever a member of the University community submits a request for funding from any external agency, whether a federal, state or local government agency or a private entity.
B. APPLICABILITY OF
(1) The specific policies and associated procedures regarding employee participation in companies commercializing their institutional research (section v) are applicable to all university employees (as defined in section ii above) who create intellectual property owned by the institution and who desire to hold an interest in a firm, corporation, or other association (hereinafter "company") to which the Board has assigned, licensed, transferred, or sold the university's interests in discoveries or inventions made or created by that employee or in patents issued to that employee commercializing their research.
(2) Private business activities that are not subject to the specific policies because they are unrelated to the employee's institutional research are nevertheless subject to other institutional policies on paid external consulting, conflicts of interest and commitment, and patents and copyrights.
(3) Private business activities that are not subject to the specific policies because they are unrelated to an employee's institutional research, and that do not fall within the definition of approved consulting activities may not be performed during institutional working hours, and institutional facilities, equipment or other resources may not be used in connection with these activities except as expressly authorized under other university policies.
(4) Decisions concerning the relationship between an employee's private business activities and his or her institutional research shall be made by the Vice Provost for Research.
A. MANDATORY DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS
(1) In accord with relevant Federal and State of Ohio regulations, the University is required to manage, eliminate, or reduce any potential conflicts of significant financial interest that may be inherent in the personal financial interests of an investigator. Cleveland State University, therefore, requires investigators on proposals to all external public and private agencies to disclose to the University, prior to submittal of the proposal, any significant financial interest, including those of her/his family members, which would reasonably appear to be affected by the project described in the proposal. Investigators are required to provide updated disclosure information during the time period in which the proposal is pending, annually during the time period of an award, or whenever new significant financial interests are obtained by the investigator.
(2) Private business activities that may relate to an employee's institutional research are also subject to the policies and procedures indicated in section v of the conflict of interest policy and must be reported in writing by the employee to the employee's supervisor or department chair and the Vice Provost for Research whenever a conflict of interest is discovered by the employee and annually thereafter. In accordance with O.R.C. §3345.14(D)(2)(a), conflicts shall be reported to the Board of Trustees at the first Board meeting following the disclosure.
B. IDENTIFICATION OF CONFLICTS
OF SIGNIFICANT FINANCIAL INTEREST
(1) In conjunction with the administrative review of applications for external support the Director of the Office of Sponsored Programs and Research (OSPR) will review each Financial Disclosure submitted. The Vice Provost for Research, in consultation with the Director of OSPR shall:
(a) determine if there is a relationship between an employee's private business activities and his or her institutional research such that section V of these policies apply; and
(b) make the determination of whether or not a conflict of significant financial interest exists.
(2) If the Vice Provost for Research determines that no conflict of significant financial interest exists, the resulting negative finding will be filed with OSPR. For negative findings no further review is required.
C. APPEAL OF POSITIVE FINDINGS OF CONFLICT
(1) Investigators may appeal a resulting positive finding to the University Research Council (URC) for a review of the conflict of significant financial interest determination reached by the Vice Provost for Research. The appeal must be filed with the Vice Provost for Research within 10 working days of the positive finding. The review of an appealed positive finding must be completed prior to the expenditure of any funds under an award.
(2) The URC shall review the decision of the vice Provost and make an independent recommendation to the Provost within 45 days of when the appeal is filed. In reviewing positive findings, the URC will be guided by the following principles:
(a) assure adherence to all relevant University policies and provisions of collective bargaining agreements;
(b) give full consideration to the nature and extent of the financial interests in the relationship of the investigator, and/or the investigator's family members, with the external constituencies;
(c) give special consideration to the terms and conditions of sponsored project agreements that mitigate or complicate the given situation; and
(d) consult fully with the investigator and obtain additional information from the investigator, as deemed appropriate to the management of the apparent conflict of significant financial interest.
(3) Within 10 days of receiving the recommendation of the URC, the Provost shall make a determination of whether a conflict of significant financial interest exists based on the decision of the Vice Provost, the recommendation of the URC, and an independent review of the facts. The decision of the Provost is final.
D. MANAGING CONFLICTS OF
SIGNIFICANT FINANCIAL INTEREST
(1) Following the determination of a positive finding, the Vice Provost for Research shall make a final determination involving one of the following administrative actions:
(a) Accepting the sponsored project award;
(b) Not accepting the sponsored project award; or
(c) Accepting the sponsored project award subject to suitable modifications in the award documentation or in the affiliation of the investigator or his/her family's affiliation with the external constituencies involved.
(2) Reasonable modifications under option IV(D)(1)(c) above might include one or more of the following actions:
(a) Requiring that public disclosure of the identified financial interests be made;
(b) Requiring that the data and research results be reviewed by independent reviewers identified by the URC and the investigator;
(c) Requiring that the research plan be modified;
(d) Requiring that the investigator be disqualified from participation in a portion of the research;
(e) Requiring that the investigator and/or her/his family member(s) divest certain significant financial interests related to the positive finding; or
(f) Requiring that the investigator and/or his/her family member(s) sever relationships that create the conflict of significant financial interest.
If an investigator who is required under this policy to file a conflict of significant financial interest disclosure fails to do so or fails to disclose a significant financial interest on the disclosure form, the investigator may be subject to discipline under the appropriate governing University disciplinary rules and procedures. If an unreported significant financial interest involves a research project administered by the University, through OSPR or otherwise, appropriate administrative action required by the funding agency will also be taken. Cleveland State University will promptly notify the funding agency if it is determined that the University is unable to manage satisfactorily any conflict of significant financial interest. Intentional disregard for this policy, including non-adherence to the agreed upon management plan, shall constitute serious misconduct and may be the basis for an academic research misconduct inquiry.
A. EMPLOYEE RESPONSIBILITIES
(1) Employees, other than faculty, may pursue research projects as authorized by their supervisors but may not perform private business activities of any kind during institutional working hours. Supervisors must take extra care to monitor the entrepreneurial activities of their staff employees. They should authorize only those staff research projects that will advance the mission of the university and the employing unit, without regard to the financial interests of individual employees. Non-faculty employees who wish to perform activities for companies commercializing their institutional research shall do so on their own time. These activities must not interfere with the performance of any of the employee's institutional responsibilities and must be undertaken in accordance with all applicable provisions of any applicable collective bargaining agreement, university policies and procedures, and state law.
(2) While faculty are permitted to engage in outside employment relating to their institutional positions, they continue to be responsible for the performance of all of their teaching, research and service obligations. Authorized private business activities must not be allowed to interfere with the performance of any of their institutional responsibilities and must be undertaken in accordance with all university policies and procedures, state law and when applicable, article 26 of the CSU-AAUP collective bargaining agreement.
(3) Faculty are encouraged to develop discoveries and inventions with commercial potential; however, they should do so with due regard to the broader teaching and research mission of Cleveland State. Faculty should not allow their interest in a financial opportunity arising out of their research efforts to negatively influence their faculty responsibilities or assigned duties. Specifically, research assignments for students must be selected solely on the basis of the students' interests and academic development. Faculty should respect and promote the cooperative nature of the academic environment by sharing information when appropriate and participating in joint research efforts with their colleagues.
B. APPROVAL OF REPORTED PRIVATE BUSINESS ACTIVITIES
(1) Employees must obtain approval from the Vice Provost for research and a conflict of interest management plan must be in place before any business agreements related to their institutional research are finalized. Employees may not enter into any agreements relating to commercialization of their research until final written approval from the Vice Provost for Research is obtained.
(2) Faculty shall not allow their management activities with newly formed companies commercializing their institutional research to consume a disproportionate amount of their professional attention. Faculty engaged in approved private business activities who are unable to perform all of their institutional responsibilities are encouraged to consider a reduction of appointment or other approved leave mechanism. Professional improvement leave available under O.R.C. §3345.28 shall not be used for private business purposes.
(3) Employees other than faculty who wish to perform management activities for newly formed companies commercializing their institutional research during Cleveland State working hours may do so only if they take approved leave. Staff who are unable to perform all of their institutional duties because of management responsibilities in their private companies are encouraged to consider a reduction of appointment or other approved leave mechanism.
(4) Immediate supervisors or department chairs are responsible for ensuring that employees participating in approved entrepreneurial activities continue to perform all of their institutional duties and obligations. Immediate supervisors or department chairs are also responsible for:
(a) ensuring any employee to whom this policy is applicable has filed the required conflict of interest management plan(s); and
(b) reviewing and making a recommendation as to the propriety of business activities reported by their faculty or supervisees in written disclosures required by CSU policies and any applicable collective bargaining agreement.
C. LIMITATIONS ON ACTIVITIES
(1) University employees who wish to participate in a start-up company may discuss initial company formation matters with the university legal counsel and/or the Vice Provost for Research. However, the employee may not participate in the ongoing negotiation of option and/or licensing terms between the company and the university. Third parties, such as company management and/or legal counsel must perform this function.
(2) Employees should not hold management positions in start-up companies commercializing their research. While they may initially find it necessary to play a management role in a newly formed company, it is expected that their management responsibilities will decrease as the company develops. Professional management should be brought in at the earliest opportunity. Agreements between the university and employee owned start-up companies shall contain enforceable milestones for the reduction of these management responsibilities. Failure to comply with these agreed-upon milestones may result in the company's inability to: (a) engage in sponsored research at the university; (b) utilize student employees; and (b) maintain or enter into new commercialization agreements with the university; and/or (d) participate in other activities otherwise allowed under these guidelines.
(3) A company wishing to obtain an exclusive license to the university's technology may be required to provide a viable business plan including, at a minimum, the following: (a) a capitalization plan addressing the acquisition of additional capital and the equity dilution of the employee member's ownership interests; (b) a proposed management team; and (c) milestones for capitalization, product development, and commercial sale.
(4) While significant employee equity ownership may be inherent in a newly formed company, it is expected that a university employee's ownership interests, as a percentage of the total outstanding shares, or membership interests in the company, will decrease as the company develops and attracts additional equity. Agreements between the university and employee owned start-up companies should contain enforceable milestones for the dilution of these equity interests. Failure to comply with these agreed-upon milestones may result in the company's inability to engage in sponsored research, employ students, enter into other commercialization agreements and/ or engage in activities otherwise allowed for under both the general and specific policies.
(5) An employee who acquires a significant financial interest in a previously established company that contracts with Cleveland State to commercialize his or her research shall not serve as a director or officer of that company while employed by the university.
(6) An employee who acquires a significant financial interest in a previously established company that contracts with Cleveland State to commercialize his or her research may work as an employee of the company only if:
(a) the employment is in compliance with all other applicable university policies and collective bargaining agreements; and
(b) before employment starts with the outside company: (i) the conflict of interest is disclosed in writing to the employee's supervisor or department chair and the Vice Provost for Research; and (ii) a conflict of interest management plan is submitted to and approved by the Vice Provost for Research,
(7) Employees who are not directly involved with research and development of technology licensed to an employee owned start-up company may hold equity interests in that company only to the extent not prohibited by O.R.C. Chapter 102 and sections 2921.42 and 2921.43
(8) Companies may not enter into any agreements with the institution relating to the commercialization of an employee's research until final written approval from the university legal counsel is obtained.
(9) Companies in which an employee holds an interest may enter into agreements with the institution unrelated to research or technology development for the purchase, sale or rental of equipment, supplies, or services only to the extent not prohibited by O.R.C. Chapter 102 and O.R.C. §2921.42 and §2921.43.
D. RESEARCH WITH COMPANIES IN WHICH EMPLOYEES HAVE INTERESTS
(1) Institutional facilities, equipment and other resources may be used for research benefiting a company in which a CSU employee has an interest only pursuant to a sponsored research agreement, facilities use agreement or other appropriate contractual arrangement in accordance with institutional policies. This includes, where required by the nature of the research, review and approval of Cleveland State's Institutional Review Board and the University Animal Care and Use Committee.
(2) Faculty and staff permitted to be principal investigators (PI) under other institutional policies may assume the role of pi in sponsored research projects funded by companies in which they have an interest only if:
(a) the proposed project is reviewed and approved by the Vice Provost for Research;
(b) a formal resolution of the Board of Directors or equivalent governing body of the company is passed including acknowledgement that the Board is aware of the conflict of interest represented by the company's funding of the project;
(c) a duly authorized company representative (other than a CSU employee) and the Vice Provost for Research sign a sponsored program agreement; and
(d) the research project has obtained all necessary approvals from Cleveland State's Institutional Review Board and/or the University Animal Care and Use Committee if the research involves the use of human subjects or animal experimentation.
(3) Graduate and undergraduate students may use institutional facilities, equipment and other resources to perform research benefiting a company in which an employee has an interest only pursuant to a sponsored research agreement. At all times, research assignments for students must be selected solely on the basis of the students' interests and academic development.
E. STUDENT EMPLOYMENT BY
COMPANIES IN WHICH EMPLOYEES HAVE INTERESTS
(1) A Cleveland State student may not be employed by a company in which a CSU employee has an interest if:
(a) The student is enrolled in a course taught by the employee;
(b) The employee is a member of the student's thesis or dissertation committee;
(c) The employee is the student's advisor or the director of his or her thesis or dissertation research; or
(d) The employee is the student's supervisor or is in any way overseeing the student's work at Cleveland State.Such students may perform research benefiting a faculty owned company only through the university and pursuant to a sponsored research agreement or formal internship agreement as specified in section V(D)(4).
(2) Students not covered by section E(1) may be employed by companies in which university employees hold an interest. Prior to such employment, an agreement that clearly sets forth the roles, rights, and responsibilities of the respective relationships must be signed by:
(a) In the case of an undergraduate student, the student (or a legal guardian if the student is under 18 years of age), the employee, the chair of the student's department, the dean of the academic college in which the student's program is housed, and an authorized company representative other than the employee.
(b) in the case of a graduate student, the student, the employee, the chair of the student's department, the chair of the student's graduate committee, the dean of the graduate college, and an authorized company representative other than the employee.
F. INTELLECTUAL PROPERTY
Employees participating in start-up companies as approved pursuant to these guidelines continue to be bound by Cleveland State's policy on patents and copyrights and any applicable collective bargaining agreements. New inventions and/or discoveries made as a result of an employee's research efforts for the company, including those made under formal consulting agreements, will be owned by the university unless otherwise agreed to in advance, in writing, by the company and the Vice Provost for Research. New inventions and/or discoveries developed by the employee for the company must be immediately disclosed in writing to the Vice Provost for Research.
(1) If an investigator who is required under this policy to disclose a financial interest in a company or otherwise report or comply with the guidelines of Section V does not disclose, report, and/or comply, that investigator may be subject to discipline under the applicable university disciplinary rules and procedures.
(2) If non-compliance involves a research project administered by the university, through OSPR or otherwise, appropriate administrative action required by these rules will also be taken. Intentional disregard for this policy, including non-adherence to the agreed upon management plan, shall constitute serious misconduct and may be the basis for an academic research misconduct inquiry.