Compliance & Integrity

• Existing University policies, State law, and Federal regulations dictate boundaries that employees must keep between their roles associated with the University and their private interests outside of the University.
• The substance and impact of the project should be appropriate to the mission of the University. That is, the project should contribute to advances in scholarship and/or provide educational opportunities for students.
• The conditions under which research and teaching take place should allow for the free exchange of ideas and materials, including the publication and dissemination of research results. Situations that would place restrictions on these activities should be carefully considered in light of University policies and should give reviewers pause.
• Any proposed use of University resources should be appropriate per University policy and State regulations. University resources should be defined in a broad sense, including equipment, office space, and staff time. This also includes resources unique to the university environment, such as students (e.g., in the testing of teaching materials), software (where license agreements often restrict use for instructional or academic purposes only), and the Institutional Review Board. University resources should not be used for personal or private gain, but are resources vested under our care for the public good.
• The potential effect of any given financial interest on a situation or project should be viewed in terms of
  • The reasonable likelihood that the results of the project could directly affect the value of related products, services or intellectual property in which an entity outside the University has an interest; and
  • The reasonable likelihood that the results of the project significantly impact the value of the outside entity or its sales.

Of special note are Small Business Innovation Research (SBIR) grants and Small Business Technology Transfer (STTR) grants. Employees may not serve as the Principal Investigator of an SBIR/STTR grant for both the outside small business and the University, as this would render it impossible for the interests of the business and the University to be kept distinct. In general, employees who have a financial interest in an outside entity may not serve as the Principle Investigator of an agreement between that entity and the University.   Additionally, there must be a very clear distinction between activities that are conducted at the University using University resources and activities performed at the small business site, and all work done using University resources must be consistent with University and State policy. Generally this means that the University’s involvement in the project should be focused on long-range exploratory work without immediate commercial value.

Family-Owned Companies:

All UNCG employees have the responsibility to disclose a spouse/partner or Family Member owned company that seeks to engage in collaborative research or any other project with UNCG.

Significant COI risks are involved whenever a Family Member is expected to perform a part of the project as a contract employee or contractor (non-university employee), or when a subcontract is anticipated with the Family Member-owned company.

In the case of ownership interests that present conflicts, a management plan needs to include the following management strategies at a minimum:

Management Strategies for Family-Owned Companies:

• A plan that outlines the independent oversight of the work to be conducted by the Family Member-owned business other than by the PI.  This would include any oversight for reimbursement, completion of deliverables, and supervision of any personnel.
• If the project itself is funded by a family-member’s company, the UNCG employee cannot be the sole PI.  Therefore, the management plan would need to identify another UNCG individual who can serve as Co-PI and is willing to take on the duties of independent oversight.

Additional management strategies may be required depending on the situation, including the possibility of not proceeding with the subcontract if adequate independence cannot be achieved.

Reporting Structure:
Conflicts can arise with respect to reporting structure such as where an employee’s spouse/partner or Family Member is involved in the same project or lab where the UNCG employee is the lead PI.  State law and university policy specifically prohibit an employee from directly supervising their spouse or immediate Family Member.[1] In the case of reporting relationships that present conflicts, a management plan needs to include the following management strategies at a minimum:

Management Strategies for Reporting Structure / Interpersonal Relationships:
A management plan must outline an alternative reporting structure and oversight for all financial transactions for the spouse and any other immediate Family Member. An organizational chart can be attached to the management plan showing the alternative reporting structure. Alternative supervisor should be of equal or higher rank than the individuals involved, preferably the department head.  The alternate supervisor must be able to supervise and sign off on the quality of the work/performance evaluations, attendance, and manage any personnel issues that might arise including remuneration.
If the Family Member is to be reimbursed from the research project, then a mechanism shall be established such that an independent person, of equal or higher rank than the PI, will need to be listed as the person who would approve any payments.  This might include the establishment of a sub-fund.  Ideally this individual would be the same as the person supervising the work.  This individual is often the department head, but can be another independent co-PI of equal or higher rank than the PI who may be already on the project (with the approval of the department head).  The co-PI providing oversight will be added to Banner as a co-PI with 0% credit, unless they are already a co-PI on the project.

[1] The UNC system Anti-Nepotism policy, to which UNCG is subject can be found here: Employment of Related Persons (Anti-Nepotism Policy) (UNC 300.4.2) and guidelines Implementing Anti-Nepotism Policy Guidelines (UNC 300.4.2.1[G])

The 2011 NIH/PHS revised regulation defines a “Significant Financial Interest” and provides for what is required to be disclosed as follows:

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s family members) that reasonably appears to be related to the Investigator’s institutional responsibilities:

• A significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.  For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

(3) The term significant financial interest does not include: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.”

The UNC Board of Governors’ policy on Conflict of Interest and Commitment provides provisions governing External Professional Activities of Faculty and EPS non-Faculty employees.

External Professional Activities should be reviewed and approved by a supervisor within 10 days of beginning the new activity. These situations (often in the form of consulting) may also result in conflicts of interest and/or commitment—both financial and professional.  External professional activities should generally be limited to no more than the equivalent of 20 percent (20%) of the Covered Employee’s contracted time.[1]  A faculty member’s consulting agreement with an outside sponsor must ethically balance the researcher’s responsibility to the university, to students, and to the sponsor.
 
Keep the following in mind:
 
1. Your primary commitment is to UNCG and your individual consulting agreements should not conflict with that obligation or with any federal or state regulations which the University operates under.
2. Your external engagement may be paid or unpaid positions of influence with an entity in which the interests of the entity appear related to your research or other institutional responsibilities. 
3. Your external activities need to be as separate from your research as possible, so that these activities are not seen as an extension of your research at UNCG. The scope of your consulting responsibilities needs to be very specific. The company/organization should not have access to any work done outside of the consulting agreement and must not  interfere with intellectual property disclosure or publications resulting from your academic work.
4. Utilizing students as a university resource for personal gain is not allowed. If students are encouraged to work with you on this consulting project, they must be paid or receive some sort of remuneration of value for their work with you on the consulting.
5. Any consulting agreements with your clients must explicitly recognize that rights to all potentially-patentable inventions conceived, or first reduced to practice, in whole or in part, as part  of your University responsibilities, or with more than incidental use of University resources, must be assigned to the University. This means that your consulting agreements must not allow access to ideas that did not arise as a direct result of your consulting activities or that would be deemed an extension of your University activities.
6. Your consulting agreements must not delay or prohibit publications resulting from your UNCG research. You must not provide the company/organization with early or exclusive access to results of your UNCG research, unless previously agreed to via a sponsored research agreement and approved by the Director of the Office of Sponsored Programs.
7. Remember that a consulting agreement is a legal document often drawn up by the company/organization’s lawyers. Who is your advocate? You may wish to have your attorney review any legal documents you sign.
8. You must disclose your relationship with the company/organization in publications and public discussions of any of your research that is sponsored by the company/organization or related to it.
9. Consider any long-term relationships that you foresee being engaged in. This document will be reviewed annually and should be revised if the situation changes. 

[1] Per UNC System Policy Manual 300.2.2.1[R]

The highest level of protection must be sought for UNCG students, and their participation in research or other activities with a company or entity in which a faculty member or researcher has a vested interest (ownership, consulting relationship, or other paid activity) cannot prevent or inhibit the student researcher from meeting applicable degree requirements. Potential conflicts of interest may occur in any relationship when there is a real or perceived imbalance in power or influence between a mentor, advisor, or supervisor and a student, trainee, or junior colleague, and the potential for financial benefit to the more powerful individual. Such involvement may require implementation of this management plan to appropriately manage student activity.

The faculty member/researcher is responsible for providing information on financial conflicts of interest to students, trainees, and other employees participating in external company’s work. Oversight mechanisms should be defined and put into place in order to ensure the protection of UNCG students. The information should include explanations of the relationship with the entity and the right of students and other personnel to take concerns about the effect of the employee’s relationship with the entities on their work, studies, or progress towards degree, to their dean, chair, director, or the Chair of the COI committee.

Examples of potential COIs in dealing with staff or students of the university:

1. A faculty member or researcher directs a student into a research area from which the faculty member or researcher may receive financial gain.
   
   The faculty member/researcher informs the student about the possible financial gain. Another faculty colleague makes an objective judgment about whether this research is in the student’s scholarly best interest.

A faculty member/researcher is offered a position on a scientific board of a company that has research contracts with the faculty member’s or researcher’s department.

The faculty member/researcher discloses his relationship with the company to the department’s students and staff, and in any published research results the faculty member/researcher takes part in for the company.

• Receiving consulting fees from, and owning stock in, a company while performing research on the company’s technology
• Conducting federally-funded research that could affect the financial interests of a company in which the Investigator has a personal financial interest
• Involving students or post-docs and other trainees in work that could directly benefit a company in which the advisor/faculty member has a personal financial interest
• Giving a company preferential access to results of university conducted research while having an ownership interest in, or providing personal consulting services to, that company

Incidental use of university resources is allowable for minor activities associated with community engagement activities, entrepreneurial activities, & consulting work (i.e. checking email, incidental use of resources). However use of licensed software is not allowed under any circumstance, as it puts the university’s educational license at risk. Use of university owned space and university equipment is not allowed without an agreement with the appropriate department, similar to what may be allowed by the university to a member of the community.

If the small business with which you have a personal and/or financial relationship is applying for SBIR or STTR funding, you may have a conflict of interest (COI). It is important to contact the Office of Research Integrity before or during the proposal stage so that preliminary COI management plan work can occur prior to award notification.

If postdoctoral fellows or students are involved in University research, even if sponsored by or involving a faculty member’s start-up company, it is considered university activity (and effort) in which the individual is engaged. Conversely, if they are engaged on the company side of research (e.g., serving as a PI or researcher on the company side of an SBIR or STTR award to the faculty start-up company {if they meet sponsor eligibility requirements to serve in that role}), that is considered external activity, and a COI management plan should be considered with respect to their University responsibilities.

UNCG faculty members, through their research and academic pursuits, may develop technologies, processes, and innovative procedures that are used in the formation of nascent startup companies. Graduate students often work with and for faculty member-developed start-ups and businesses. The process of reducing or managing a conflict of interest for faculty becomes more challenging when graduate students are involved in the faculty’s business enterprise. A “conflict” does not suggest wrongdoing but rather that a potential conflict exists for the faculty advisor between the academic needs of the student and the interests of the company.

These activities require review by the Office of Research Integrity, and creation of a management plan for oversight by the Conflict of Interest Committee (COIC). To address the potential faculty conflict of interest regarding graduate student research or employment with the faculty member’s business enterprise, the ORI will help to develop a management plan for the faculty member and their role regarding the student.

It is imperative the graduate students understand their rights and responsibilities as students and scholars when engaged with faculty-owned industry or industry in which a faculty member has an outside interest. In addition to the limitations described above for academic-industry relationships:

• Students Must Always Have Freedom to Publish.
  Freedom to publish and disseminate results are major criteria for assessing the appropriateness of any research project, particularly those involving graduate students. The integrity of a student’s academic/research experience shall be preserved, including the ability to complete and publish a thesis or dissertation and to freely publish, present, or otherwise disclose the results of research both within the academic community and to the public at large. The University precludes assigning to extramural sources the right to keep or make final decisions about what may or may not be published with respect to a student’s dissertation or thesis project. Within this general understanding, the University also realizes that circumstances may arise where certain restrictions or limitations may be appropriate. Short, reasonable delays may be appropriate, for example, to allow the research sponsor to review publications for inadvertent disclosures of proprietary data or potentially patentable inventions. When at all possible, these potential delays should be discussed with the student as early in the research process as possible. In the case of a dissertation or thesis, the review MUST be completed prior to submitting the document to the Graduate School. Policies that govern graduate student thesis/dissertation publication allow for a short embargo of the dissertation/thesis but it is advisable to ensure the dissertation, in its entirety, contains no proprietary information prior to submission.
• Freedom of Choice Regarding Involvement in Adviser’s Company.
  Graduate students have the freedom to decide whether to participate in faculty research or business activities. They have the right to say no, to change advisors and to change research interests to avoid engagement in faculty activities that may be outside the scope of the student’s academic interest.
• COI Management Plan Requirement.
  Graduate students may not be involved in a company in which their dissertation/thesis adviser or faculty mentor has an outside interest unless a COI Management Plan can be arranged for the faculty involved. “Involvement” means they may not be employed in the company in a research capacity, undertake training in the company, or do their dissertation research in the company. In addition, if there are other faculty involved in that company, only one faculty member may serve on that student’s committee.

Concerns regarding student academic progress/success identified by the COIC will be addressed with the faculty member and may potentially result in removal of the student from the enterprise if the COIC determines the conflict cannot be managed.

Prior to engaging postdoctoral fellows in any faculty start-up company activities, the faculty member should ensure to have a discussion with the postdoctoral fellow around the topics included in this guidance. Postdoctoral fellows are considered staff members, and any external activities must be approved in advance by the individual’s supervisor. External activities must occur outside of University work hours and must not involve UNCG resources. If a faculty member is the primary postdoctoral supervisor and also engages the postdoctoral fellow in their external start-up activities, a COI management plan should be established that adjusts the individual’s administrative reporting line or assigns independent oversight, as the faculty member may not be in the most objective position to assess whether the postdoctoral training and the activities within the start-up company are in conflict and whether the external activities are interfering with or detracting from the individual’s University responsibilities and engagement in postdoctoral training.

“The right of individual professors to select their own instructional materials, a right protected under principles of academic freedom, should be limited only by such considerations as quality, cost, availability, and the need for coordination with other instructors or courses. Professors should assign readings that best meet the instructional goals of their courses, and they may well conclude that what they themselves have written on a subject best realizes that purpose.” (AAUP Policies & Reports)

http://www.aaup.org/AAUP/comm/rep/owntexts.htm

An apparent conflict of interest may be present when textbooks and other educational materials produced by an instructor are required for a class that instructor teaches, and where the sale of such materials produces financial gain for the instructor. The instructor and the department are therefore encouraged to consider the following:

1. It is not in the best interest of students to prohibit instructors from assigning textbooks they have written, given that such materials may be the best materials available.
2. As with other course-level academic issues (e.g., establishing student learning goals, determining course content and structure, identifying individual course contributions to the department’s curriculum), selection of instructional materials is properly determined by the instructor and the department sponsoring the course.
3. Instructors can employ a number of strategies to mitigate the apparent conflict of interest when they assign materials from which they may receive financial gain:

• Confer with the department (e.g., curriculum committee or similar body) to establish that these materials are, indeed, the best (if not only) materials available to students.
• Accommodate students who choose not to purchase the materials by placing copies on reserve in the library.
• Avoid personal financial gain by donating royalties. Some instructors have been known simply to reimburse students who provide proof of purchase.
• Disclose this issue (and efforts to address it) to students.

Given the variety of situations under which instructional materials are created, published, and ultimately assigned, one or more of the above strategies may be appropriate and may be pursued at the individual’s discretion.