COI Issues Related to Technology Transfer (Licensing and Commercialization)

Notice of Conflicts of Interest and Commitment Related to Technology Transfer
(Licensing and Commercialization)

Conflicts of interest are a predictable and expected result of proper research and commercialization efforts at the University. The University will make reasonable efforts to accommodate appropriate private sector relationships that arise from technology transfer, provided these relationships are compatible with University policy. The University’s policies and procedures on conflict of interest may be viewed at the Office of Research Integrity’s website.  With this document we provide an overview of the principles and procedures relevant to conflicts of interest.

1. Key Principles

Most conflicts of interest can be managed by a combination of disclosure, oversight, and attention to the key principles of transparency, separation and independence.

Transparency

At a minimum, the inventors’ relationships with licensee companies should be made known to:  immediate supervisors, members of their research group, co-investigators participating in research involving the licensed technology, the scientific community through disclosure of personal interests in presentations or publications of research involving the licensed technology, and study subjects where human subjects research is involved.

Separation

For any University research activity, personnel effort, supplies and services must be 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.

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 Personal Use of University Resources and associated guidance describe what use of University resources, including facilities, communications and personnel, is allowed. Inventors should also avoid depriving GW of appropriate financial gain from support of GW research or in intellectual or tangible property rights that ought to accrue to GW.

Independence

Inventors can mitigate the impact of a conflict on research by recusing themselves from decisions related to the company where possible, or by ensuring independent review in academic research. Examples of steps taken to ensure independence 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 these responsibilities to an individual who is supervised by, reports to or is otherwise subordinate to the conflicted individual may not ensure independence. Despite the individual’s best efforts to avoid the appearance of coercion, subordinates may still feel pressure to produce results favorable to the supervisor’s interests.

2. Procedures

Inventors are reminded of their obligations to disclose annually and update their conflict of interest disclosure forms on an ad hoc basis prospectively when establishing business relationships that are likely to be reportable under the appropriate conflict of interest and commitment policy (for Faculty and Investigators, or for Non-Faculty Employees).  For a disclosure form, contact the Office of Ethics, Compliance, and Privacy at [email protected].

The identification of a potential or actual conflict of interest through the disclosure process does not imply wrongdoing. While there may be circumstances in which the university determines that a conflict cannot be managed, the university makes every effort to help employees manage and mitigate potential, actual, or perceived conflicts of interest.

Though conflicts of interest can be managed in conjunction with most University activities, three topics should be noted:

  • Human Subjects Research:  Investigators at the School of Medicine and Health Sciences must adhere to the Policy on Conflicts of Interest Related to Clinical Care.  Research protocols approved by the IRB may have components related to a conflict of interest management plan. For example, a consent form may need to include disclosure language regarding a principal investigator’s financial interest.
  • Student Participation:  The training experience and academic progress of University students and trainees must not be subordinated to the personal financial interest of GW faculty or staff, or the commercial interests of research sponsors. Students must be fully informed of the conflicting relationships, have the opportunity to decline to participate, and have an alternative project available.
  • Conflicts of Commitment: Work with startups and other ventures may be undertaken in accordance with the faculty code and other relevant policies. While outside entrepreneurial activities can contribute to university goals and provide valuable public and personal benefits, one's primary commitment must be devoted to the university. Outside activities must not distract significantly from primary responsibilities and must not require such extensive absence as to cause you to neglect course and research obligations or become unavailable to students and colleagues.

For more information on conflicts of interest, please contact Kristen Schwendinger ([email protected]) Research Compliance Officer, Office of Research Integrity.