University Rules

1. Introduction
   
   The core of a university consists of a congregation of scholars dedicated to the preservation, dissemination, and enlargement of the body of knowledge available to society. The research component of this effort has as one of its goals scientific discoveries that benefit society. In 1980, congress, in an effort to shorten the linkage between research and technology, passed legislation designed to stimulate the commercialization of faculty inventions by permitting academic institutions to retain title to the intellectual property resulting from federally-sponsored research that leads to commercial products. The university as a research institution is unique. Corporations finance their research internally and exist to generate profits as they supply needed goods and services to their customers. Nonprofit research institutions, unlike universities, do not have education as their central function. Universities have had a traditional dependence on federal funding to support research. However, during the past decade, the rate of growth of basic science, medical engineering, social science and humanities research and research scholarship has outpaced the traditional federal funding, compelling universities and hospitals to develop alternative sources of revenue to support the expenses associated with their educational, research and clinical missions.
   
   In response to these influences, research institutions have cultivated a growing variety of relationships with industry which promise to benefit the public as well as the institutions themselves, their faculty and staff, and their industrial partners. Over the last several years, these relationships have grown substantially, bringing new resources to the support of scholarship and science, and facilitating the translation of knowledge. The university of Cincinnati remains strongly committed to continued growth in these innovative and mutually beneficial relationships.
   
   Together with these benefits, the growing partnership between for-profit enterprises and the university has created new possibilities for conflicts of interest. These conflicts arise from an individual's opportunities to benefit either from the outcome of his/her research/scholarship or from the legitimate activites conducted in the course of his/her responsibilities as a member of the institution. In addition, there is emerging public concern regarding the appropriateness of some relationships between academe and industry.
   
   Public trust in the research enterprise and the legitimacy of its powerful role in society require a constant amenability to public scrutiny. Consequently, it is necessary at all times to ensure the continued confidence of the public in the judgment of scholars and clinicians and in the dedication of academic research institutions to the integrity of the research enterprise. The strength of this assurance is based on the assumption that the vast majority of scholars are honest and conduct their research with the highest standards and integrity.
   
   Based on this assumption, the university believes that with clear policies and principles, in conjunction with appropriate mechanisms for reporting and monitoring, cooperation between industry and academe will be consistent with the highest traditions of the academic profession and can energize research creativity.
   
   This policy is intended to serve the university and its members in structuring relationships with industry and other outside ventures so that they are compatible with academic responsibilities for teaching and scholarship. This policy is not intended to eliminate all situations of conflict of interest, but rather to enable individuals to recognize situations that may be subject to question and resolve them so as to avoid conflicts of interest. Thus, an integral part of the policy is a disclosure mechanism whereby individuals regularly review their professional activities. The policy is intended to maintain the professional autonomy of scholars inherent in the self-regulation of their research.
   
   This policy is predicated on the belief that disclosure of professional, external, income- and/or non-income-producing activities and relationships will reveal potential conflicts of interest and will effectively address the vast majority of situations. Ameliorative measures can be taken in most others. It is anticipated that very few conflicts will require formal resolution under this policy. The most important result of the formal disclosure process may be that it frequently serves as the catalyst for faculty, administrators, and others to think carefully about these issues.
   
   The policy fulfills two other purposes, as well. First, it provides individuals with meaningful guidance for the continued development and future structuring of productive relationships with industry. Second, by virtue of its explicit nature and provision for full disclosure, the policy will provide assurance to the faculty, the university, and most importantly the public, that such relationships have been examined and will be conducted in a manner consistent with institutional and public values, as expressed in university policy and all applicable laws. It is expected that these relationships will allow the university and its affiliated entities to continue to energetically pursue new knowledge.
   
   It is expected that this policy will be applied in accordance with the spirit of the mission of the university of Cincinnati in education, research, and patient care.
   
   
2. Scope of applicability
   
   Effective immediately for all university employees involved in the design, conduct, analysis or reporting of research at the university which is funded by internal or external sources.
   
   
3. Definitions
   
   When used in this policy, the term "employees" means all individuals paid by the university for their services.
   
   Family member includes spouse and children.
   
   Financial interest is an interest in a business consisting
   of:
   
   
   1. any stock, stock option or similar ownership interest in such business which is greater than five percent, but excluding any interest arising solely by reason of investment in such business by a mutual, pension, or other institutional investment fund over which the individual does not exercise control; or
      
      
   2. receipt of, or the right or expectation to receive, any income from such business, whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of technology not owned or controlled by the university, rent, capital gain, real or personal property, or any other form of compensation, or equity, or any combination thereof.
      
   
   Associated entity means any trust, organization, or enterprise over which the individual, alone or together with his/her family, exercises a controlling interest.
   
   
4. Conflict of interest
   
   A conflict of interest may take various forms, but arises when an individual is or may be in a position to influence the university business, research, or other decisions in ways that could lead to any form of personal gain for the individual or his/her family. Conflicts and potential conflicts of interest must be disclosed and resolved.
   
   
   1. Disclosure policy and reporting requirements.
      
      Individuals shall disclose their professional, external activities and relationships, whether income- or nonincome- producing, except those activities and relationships specifically excluded by this policy [see paragraph (D)(2) of this rule]. Individuals must complete and submit a disclosure statement form on an annual basis. If changes occur in these activities between annual submissions, the individual shall complete and submit an updated form.
      
      Individuals shall return disclosure statement forms to the appropriate unit head for review and further processing. To the extent permissible by the law, disclosure statement forms will be confidential.
      
      
   2. Excluded relationships and activities
      
      The following activities and relationships do not need to be reported and do not represent a conflict of interest because they have been generally accepted practices and do not violate fundamental ethical principles.
      
      
      1. An individual receiving royalties for published scholarly works and other writings.
         
         
      2. An individual accepting honoraria for commissioned papers and occasional lectures.
         
         
      3. An individual receiving royalties under institutional royalty-sharing policies.
         
         
      4. An individual receiving prizes and royalties from past and previously disclosed writings.
         
         
      5. Reasonable travel and lodging expenses related to presentations of scholarly work or to a person's academic endeavor.
         
         
      6. An individual's investments in mutual funds.
         
         
      7. Participation by a faculty member in a university approved practice corporation.
         
      
      
   3. Example of reportable activities
      
      The following is a representative and non-inclusive list of professional, external, income- and/or non-incomeproducing activities and relationships subject to this policy. These activities and relationships may be permissible following disclosure and, where necessary, the implementation of oversight procedures designed to ensure academic standards, intellectual values, and institutional integrity.
      
      
      1. An individual participating in applied and/or clinical research on a technology developed by that individual or a member of his/her family.
         
         
      2. An individual assigning students, postdoctoral fellows, or other trainees to projects sponsored by an associated entity for a for-profit business in which the individual, a member of his/her family, or an associated entity has a financial interest.
         
         
      3. An individual or his/her family member serving on the board of directors or a scientific advisory board or a business from which that individual receives university or hospital supervised sponsored research support or with which the university has a substantial contractual relationship known to the individual.
         
         
      4. An individual assuming any position in a not-forprofit business engaged in commercial or research activities.
         
         
      5. An individual's or family member's service on committees or review panels for university, government or professional organizations.
         
         
      6. An individual's or family member's relationships with companies that do business with the university.
         
         
      7. An individual's or family member's relationships with sponsors of his/her research.
         
         
      8. An individual's service as an officer, director, or trustee in businesses related to his/her professional field.
         
         
      9. An individual's or family member's ownership in, financial interest in, or management of organizations related to his/her professional field, including publishing contracts.
         
         
      10. An individual's or family member's external income- and/or non-income-producing activities and relationships involving university students or staff.
          
          
      11. Positions held at other institutions.
          
          
      12. An individual participating in applied and/or clinical research on a technology owned by or contractually obligated to a business in which the individual, a member of his/her family, or an associated entity has a consulting relationship, holds a stock or similar ownership interest, or has any other financial interest, other than receipt of university supervised sponsored research support or royalties under institutional royalty-sharing policies.
          
          
      13. An individual receiving hospital supervised sponsored research support (whether in dollars or in kind)for research (basic, applied, or clinical) from a business in which he/she, a member of his/her family, or an associated entity holds a stock or similar ownership interest.
          
          
      14. An individual conducting research externally that could be conducted within the university or university-approved affiliated corporation.
          
          
      15. An individual participating in the consideration by a committee of the FDA, other governmental agency, or private supporter of clinical research on a technology which is owned by or contractually obligated to a business in which that individual, a member of his/her family, or an associated entity has a financial interest.
          
          
      16. An individual making referrals to a business in which that individual, a member of his/her family, or an associated entity has a financial interest.
          
          
      17. An individual possessing a financial interest in a business which competes with the services provided by the university.
          
          
      18. An individual intending to publish or formally present research results, or provide expert commentary on a subject without simultaneously disclosing any financial interest relating to such results or such subject.
          
          
      19. An individual taking administrative action within the university which is beneficial to a business in which he/she has a financial interest. (This may constitute a violation of Ohio ethics laws.)
          
          
5. Disclosure process and review criteria
   
   
   1. Disclosure process
      
      Individuals are required to submit disclosure statement forms annually. As noted in paragraph (D)(1) of this rule, updated disclosure statement forms must be submitted throughout the year as appropriate. The appropriate senior vice president or designee is responsible for overseeing the implementation of the disclosure and review process. These persons or their designees will address all breaches of the disclosure process including:
      
      
      1. Failure to comply with the disclosure requirement, whether by virtue of the individual's refusal to respond or by his/her responding with incomplete or inaccurate information;
         
         
      2. Failure to remedy conflicts; and
         
         
      3. Failure to comply with conditions in a prescribed oversight plan.
         
      
      The dean, appropriate vice president or the president may elect to send disclosure statement forms of any individual to the university standing committee for further review and recommendation as to whether the activities or relationships are allowable, and if so, under what conditions. Upon request, the standing committee will review the reported activities and relationships and recommend whether they are allowable, and, if so, under what conditions. All recommendations are returned to the dean or appropriate administrator who will make a decision which he or she will report to the individual. The vice president for research must be copied on the dean's/administrator's decision.
      
      
6. Standing committee on conflicts of interest
   
   The president of the university of Cincinnati will appoint a standing committee on conflicts of interest. The committee will be composed of five members serving three year terms with staggered rotation, who have sufficient breadth of experience to provide substantive reviews of the activities and relationships that come before them, and will include two members selected by the faculty senate. The committee will review all matters brought to its attention and will make its recommendations to the dean or other appropriate administration. The committee will develop its own procedures for the review process. The committee will respond to a review request in a reasonable period of time.
   
   In all cases, individuals will be provided an opportunity to respond in person or in writing to the issues raised in the course of such review.
   
   
7. Appeal process
   
   An individual may appeal if his/her disclosure statement is not approved or if he/she finds the conditions for approval are so burdensome as to affect the individual's ability to conduct his or her activities. The appeal process is as follows:
   
   To appeal the decision, an individual must send a written statement of the appeal to the vice president for research within fourteen days of notification of the decision.
   
   The vice president for research shall appoint a three member ad hoc committee to review the written appeal and record, and to make a recommendation. The ad hoc committee may develop its own procedures for handling appeals.
   
   Within thirty days of its appointment, the ad hoc committee shall send its recommendation to the vice president for research, or his/her designee, who shall make a final decision and send written notification to the individual.
   
   After the review and approval process is completed, copies of the forms will be maintained in each individual's personnel file.
   
   1. At each level of review, the factors to be considered include at least the following:
      
      
      1. Whether traditional financial conflict of interest situations would be avoided,
         
         
      2. Whether the proposed research is appropriate for the university,
         
         
      3. Whether the teaching and research environment is open,
         
         
      4. Whether there is any restriction on the freedom to publish and disseminate research results,
         
         
      5. Whether licensing agreements are appropriate,
         
         
      6. Whether university facilities and resources are used appropriately,
         
         
      7. Whether the arrangement would tend to afford the individual a financial incentive, or the appearance of such an incentive, to report biased results, and
         
         
      8. Whether graduate students or postdoctoral fellows would be appropriately employed.
         
         
   2. Failure to comply

      Failure to comply with this policy may result in disciplinary action. Procedures and sanctions are set forth in applicable collective bargaining agreements and university rules. The university shall provide prompt notification to grantee agencies of violations of this policy.