Conflicts of interest in technology transfer
How conflicts of interest arise in technology transfer
Conflicts of interest are a predictable and expected result of proper research and commercialization efforts at the University. Once a technology has been licensed, a potential revenue stream is created. That revenue can be influenced, positively or negatively, by the results of continuing research on that technology. When inventors, company founders, stockholders or others who stand to benefit from the technology’s commercial success are also involved in University research on the technology, a conflict of interest exists. The University’s policies and procedures on conflict of interest may be viewed at the Conflict of Interest Program website.
Implications for research
Most conflicts of interest can be managed by a combination of disclosure, oversight, and attention to the key principles of transparency, separation and independence.
At a minimum, the inventors’ relationships with licensee companies should be made known to:
- their immediate supervisors,
- the members of their research group,
- any co-investigators participating in research involving the licensed technology,
- the scientific community through disclosure of personal interests in any presentations or publications of research involving the licensed technology, and
- study subjects where human subjects research is approved by the Institutional Review Board and the Conflict of Interest Committee.
For any University research activity, principal investigators are responsible for ensuring that personnel effort, supplies and services are allocated to projects appropriately and charged to project accounts in proportion to their use. Where a licensee company sponsors University research through contract or subcontract, investigators must be cognizant of the potential appearance of preferential treatment of the company and ensure that all costs are assigned correctly. Where an associated company enters into a Facilities Use Agreement to occupy designated University space, collaborators must respect the boundaries of the company’s assigned space, preserving separation of activities, personnel, equipment and materials.
SBIR and STTR projects are of special concern. Because of the high potential for the appearance of an irresolvable conflict of interest, a University employee may not conduct research or administrative activities in conjunction with an SBIR or STTR project on behalf of both the University and the grantee or subgrantee company. This means that an individual may not serve as both the small business PI and the University subcontract PI, nor may that person contribute to both small business and University components of a single project as an employee, investigator or consultant. The activities conducted by the small business and by the University, as well as the personnel, budget and resources associated with each, must be delineated.
Inventors who continue to work with the licensing company, whether as officers, board members, consultants or in other roles, must be especially vigilant that their personal work with the company is distinct from their University activities. The Policy for Use of University Resources in Support of Entrepreneurial Activities and associated guidance describe what use of University resources, including facilities, communications and personnel, is allowed. Inventors also are reminded of their obligations to file the appropriate Notice of Intent to Engage in External Professional Activities for Pay.
While the University encourages commercial engagement and is committed to responsible management of the conflicts of interest that result, the potential for appearance of improper influence on research results, purchasing decisions, and assignment of resources remains. This is inherent to the situation and is not a reflection on the individual’s character or integrity.
Inventors can minimize the appearance of bias by recusing themselves from decisions related to the company where possible, and by ensuring independent review where recusal is not possible. Examples include review and analysis of research data by unconflicted statisticians or co-investigators; collaborative study design, designation of an unconflicted investigator to oversee data collection, study blinding; collaborative publication; peer review of manuscripts; and recusal from purchasing decisions or selection committees where the company is a prospective vendor.
Assigning any of these responsibilities to an individual who is supervised by, reports to or is otherwise subordinate to the conflicted individual will not ensure independence. Despite the individual’s best efforts to avoid any appearance of coercion, subordinates may still feel pressure to produce results favorable to the supervisor’s interests.
Management of conflicts of interest involves review by the Institutional Research Compliance Program. Most conflicts involve review by a School Conflict of Interest Committee, a written management plan, and concurrence of the appropriate chair, dean or director. Where relationships are complex, such as a start-up company, the School may appoint a monitoring committee to meet with the conflicted investigators and their research groups, ensuring that trainees and staff have opportunities to ask questions and express concerns to independent parties.
In order to disclose unpublished data and research from the laboratory of a University investigator to a third party, a confidentiality agreement must be negotiated between the University and the third party. Such an agreement is also necessary before a UNC startup begins discussing potential business opportunities with a third party if any unpublished UNC information will be disclosed to the third party.
UNC confidential information includes any research or data that (1) originates from the laboratory of a UNC faculty member and (2) has not been published. Please note that a CDA is no longer required once the information has published in a journal article, patent application, or otherwise.
A separate CDA with UNC is not required if the startup company has an executed license agreement for a UNC patent and the information to be disclosed is fully described in the licensed patent. While a CDA between the startup company and the third party would still be needed to protect any confidential startup company information, UNC would not need to be party to that agreement. Please note that a CDA between UNC and the third party is still necessary if the UNC information to be disclosed is not encompassed by the licensed patent or otherwise published.
Limitations to manageable activities
Though conflicts of interest can be managed in conjunction with most University activities, three limitations should be noted:
Human Subjects Research: University policy prohibits involvement of conflicted researchers in human subjects unless compelling circumstances can be demonstrated. In addition, human subjects research where the University has a financial interest in the sponsor, study product or technology are subject to review by the Institutional Conflict of Interest Committee.
Student Participation: Generally, students and other trainees are not permitted to participate in activities where the supervising faculty member has a conflict of interest with the sponsor. Exceptions may be made with the approval of the Conflict of Interest Committee and the student’s Director of Graduate Studies or training program director. Where exceptions are allowed, the student must be fully informed of the conflicting relationships, have the opportunity to decline to participate, and have an alternative project available. The training experience and academic progress of University students and trainees must not be subordinated to personal financial interest of Covered Individuals or commercial interests of research sponsors.
Conflict of Commitment: If, in the judgment of the individual’s supervisor, chair, dean or director, the conflicted individual’s commitments to the company cannot be met without compromising his or her University responsibilities, then a reduction in commitment must occur. This can be accomplished by reducing company involvement or by reducing University responsibilities through reduction of FTE or full or partial leave.
The University will make every reasonable effort to accommodate appropriate private sector relationships that arise from technology transfer, provided these relationships are compatible with University policy. For more information, please contact the Conflict of Interest Program:
Conflict of Interest Program
University of North Carolina at Chapel Hill
Bynum Hall, Room 301D
222 East Cameron Avenue, CB 9103
Chapel Hill, NC 27599-9103
Phone: (919) 843-9953
Fax: (919) 843-9005