Cleveland State University

Faculty Senate

Policy for Managing Conflicts of Interest at Cleveland State University

Prepared for the Board of Trustees February 12, 1997

I. INTRODUCTION

A. GENERAL POLICY

The principles articulated herein are intended to provide guidance in the management of formal relationships between members of the Cleveland State University 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 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 as well as several State of Ohio statutes (sections 102.03 and 2921.42-2921.43 of the Ohio Revised Code) involving conflict of interest situations with both private and public sponsors.

B. SCOPE

This policy and the associated procedures are applicable immediately 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 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 it is the PHS, the NSF, another Federal agency, or a private entity.

C. RESEARCH AND THE FUNCTIONAL MISSION STATEMENT

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 Universitys constituent groups. Carrying out research for the benefit of society, therefore, is a key element of the Universitys functional mission. Such University research is facilitated and/or made possible through external funding, from private as well as public sources. It is the Universitys 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 policy is to identify situations where potential conflicts of 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.

D. 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 Universitys business and industrial partners. It is expected that members of the University community will maintain the confidence of the Universitys 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 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 interest, its primary purpose is to promote compliance with the highest ethical standards for the conduct of professional activities.

II. DEFINITIONS

A. Conflict of Interest is considered to occur whenever a University faculty 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, or appears to impair, the University employees independence and objectivity in the discharge of his/her responsibilities to and/or for the University; or, alternatively, conflict of interest is considered to occur whenever a University employee receives financial or other material benefit through inappropriate use of proprietary knowledge or information of the University.

B. University Employee is any individual employed on a full- or part-time basis at Cleveland State University and receiving, or who will receive, compensation for such employment.

C. 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.

D. Family Member includes the University employees spouse, children, parents, siblings, or other persons who qualify as dependents under the Internal Revenue Code definitions.

E. Project is 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.

F. Significant Financial Interest is any item of monetary value including, but not limited to: 1) salary or other payments for services rendered such as consulting fees or honoraria; 2) equity interests such as stocks, stock options, or other ownership interests; and 3) intellectual property rights such as patents, copyrights, and royalties from such intellectual property rights. Significant Financial Interest does not include: 1) University remuneration such as salary or royalties; 2) consulting fees or honoraria from service on advisory committees or review panels for public or nonprofit entities; or 3) 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.

G. Negative Finding means a determination has been made that no conflict of interest exists.

H. Positive Finding means a determination has been made that a conflict of interest does exist and, therefore, appropriate administrative action will be required as given under III. D. below.

III. POLICY STATEMENT

A. MANDATORY DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS

In accord with relevant Federal and State of Ohio regulations, the University is required to manage, eliminate, or reduce any potential conflicts of 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.

B. IDENTIFICATION OF CONFLICTS OF INTEREST

In conjunction with the administrative review of applications for external support the Director of Sponsored Programs and Research Development will review each Financial Disclosure submitted. The Vice Provost and Dean of Graduate Studies and Research, in consultation with the Director of Sponsored Programs and Research Development, shall make the determination of whether or not a conflict of interest exists. If the Vice Provost and Dean of Graduate Studies and Research determines that no conflict of exists, the resulting negative finding will be filed in the University Office of Research and Economic Development (UORED). For negative findings no further review is required.

C. APPEAL OF POSITIVE FINDINGS

Investigators may appeal a resulting positive finding to the University Research Council (URC) for a review of the conflict of interest determination reached by the Vice Provost and Dean of Graduate Studies and Research. The review of an appealed positive finding must be completed prior to the expenditure of any funds under an award. In reviewing positive findings, the URC will be guided by the following principles:

1) assure adherence to all relevant University policies and provisions of collective bargaining agreements;

2) give full consideration to the nature and extent of a significant financial interest;

3) give special consideration to the terms and conditions of sponsored project agreements that mitigate or complicate the given situation; and

4) consult fully with the investigator and obtain additional information from the investigator, if management of the apparent conflict of interest is deemed appropriate.

D. MANAGING CONFLICTS OF INTEREST

Following the determination of a positive finding and upon receipt of the review by the URC, the Vice Provost and Dean of Graduate Studies and Research shall make a final determination involving one of the following administrative actions:

1) accepting the sponsored project award;

2) not accepting the sponsored project award; or

3) accepting the sponsored project award subject to suitable modifications in the award documentation or in the investigators, or his/her familys, affiliation with the external constituencies involved.

Reasonable modifications under option 3 above might include one or more of the following actions:

1) requiring disclosure to all affected parties of the identified conflicts of interest;

2) requiring data and research results to be reviewed by independent reviewers identified by the URC and the investigator;

3) requiring modification of the research plan;

4) requiring the investigator's disqualification from participation in a portion of the research;

5) the investigator and/or her/his family member(s)' voluntarily divesting certain significant financial interests related to the positive finding; or

6) the investigator and/or his/her family member(s)' voluntarily severing relationships that create the conflict of interest.

E. COMPLIANCE

If an investigator who is required under this policy to file a 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 conflict of interest involves a research project administered by the University, through UORED 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 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.