Washington State University
EXECUTIVE POLICY MANUAL

Executive Policy #27
Approved July 18, 2006

Washington State University
Ethics, Conflict of Interest, and Technology Transfer

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I. THE UNIVERSITY MISSION

Washington State University (University), as a premier public land-grant research institution, is committed to developing and applying knowledge and expertise to community, regional, state, and global issues. The University is equally committed to the state's economic development, competitiveness, and technological leadership. As such, the University supports an active technology transfer program to commercialize inventions or other intellectual property developed by University faculty and research employees.

II. PRINCIPLES FOR CONDUCTING RESEARCH AT THE UNIVERSITY

The University is a public institution and has a duty to the public to perform research in a manner that conforms to the highest ethical standards and complies with all applicable state and federal laws. To do so, researchers including faculty, staff, students, and associated entities must either avoid conflicts of interest or disclose all conflicts of interest that arise so that the University can work with the affected individual to manage, reduce, or eliminate those conflicts. Since such management helps ensure that the research is conducted in a way that will withstand public scrutiny and ethics concerns, University researchers must fully cooperate with the University's management of any actual or potential conflicts of interest.

Any financial interest of an investigator that may affect the design, conduct, or reporting of University research or which may compromise the University's duty to the public or the University's students or employees must be disclosed so that conflict(s) can be managed, reduced, or eliminated.

III. DEFINITIONS USED IN THIS POLICY

  1. Clinical Trial: Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. "Medical intervention" means any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, medical devices, behavioral treatments, process-of-care changes, and the like.

  2. Conflict of Interest (COI): The existence of an interest which may reasonably be determined to affect or appear to affect the design, conduct, or reporting of research. COI is not limited to financial interests but may include the existence of various ethical and commitment situations.

  3. Conflict of Interest Review Committee (COI Comm.): The Presidential committee which reviews all pertinent documentation, including COI resolution plans, relating to potential or actual financial COI cases based on federal and state law and University policy. The COI Comm. has the responsibility and authority to (1) assess whether a potential conflict exists, (2) assess the extent of the conflict and (3) manage, reduce or eliminate the conflict before approving the research.

  4. Disclosure of COIs is required for research employees to be protected within the Ethics in Public Service safe harbor provisions for technology transfer activities. Research employees must disclose and refer to the COI Comm. any actual or potential COIs of persons responsible for the design, conduct, or reporting of research and any significant financial interest in the conduct or outcome of the research. The COI Comm. is then responsible to manage, reduce, or eliminate the conflict before approving the research.

  5. Equity Interest: Stocks, stock options, ownership, partnership or limited liability company, or other ownership interests. Equity interest does not include interest in a mutual fund or other stock management not under the individual's control, but does include interest held in a deferred compensation plan that is under the individual's control.

  6. Family: The investigator or research employee, the investigator's or research employee's spouse/domestic partner, and dependent children and other dependent relatives living in the investigator's or research employee's household (investigator's or research employee's financial interest includes the aggregate financial interest of the family).

  7. Financial Interest: Financial interest is defined in accordance with federal law and includes monetary interest, and equity interest.

  8. Gift: Anything of value to the extent that adequate consideration is not received. A gift of greater than $50 from an outside entity is a significant financial interest and must be disclosed if it is from an entity that may be affected by the investigator's or research employee's technology transfer activities or research.

  9. Investigator: Any individual responsible for the design, conduct and reporting of research, including the principal investigator, a co-principal investigator or a collaborator.

  10. Research: A systematic scientific investigation designed to develop or contribute to generalizable knowledge including basic and applied research as well as associated instruction, scholarly, creative, public service, product development, and extension activities.

  11. PHS Awarding Component: A division of the Public Health Service (PHS), such as CDC, NIH, NIOSH, etc., which is sponsoring the research.

  12. Research Employee: The safe harbor for technology transfer provisions of the Ethics in Public Service Act apply only to technology transfer activities of research employees as a special class of University employee. The University defines research employees as individuals who are:

    1. Faculty with appointments in the professorial ranks whose terms of employment and advancement include contributions via scholarly research.

    2. Any other University employees, including research scientists, postdoctoral research associates, professional staff and graduate students, who are responsible for the design, conduct, or reporting of research.

    3. Appointees that do not have formal employment status but are obligated to follow the University Faculty Manual and the University policies and procedures. This may include visiting scientists.

    4. Faculty or administrative staff who directly manage the technology transfer process on behalf of the University including the Vice President for Research, the Director of the Office of Intellectual Property Administration, and the Director of the Office of Grant and Research Development.

  13. SBIR/SBTT: Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT) Programs.

  14. Significant Financial Interest exists whenever:

    1. The investigator, research employee or member of his/her family is a manager, officer, trustee, or current employee of an external entity whose financial interest would reasonably appear to be affected by the outcome of the research;

    2. The investigator or research employee, or member of his/her family receives aggregate a) fees for consulting, b) gifts and/or c) honoraria in excess of $1,000 in any 12-month period in the past 24 months from an external entity whose financial interest would reasonably appear to be affected by the outcome of the research;

    3. The research employee or member of his/her family has ANY financial interest that would reasonably appear to be affected by the outcome of the research that involves clinical trials of human subjects or other human subject research which requires the review of the full Institutional Review Board; and

    4. For all other research: The research employee or the employee's family has an interest in an external entity that exceeds $10,000 in fair market value, an ownership interest in any single entity in excess of 5%; compensation from an external entity in excess of $10,000 during a calendar year, or intellectual property rights and royalties from such rights in excess of $10,000 per year. A significant financial interest does not exist if such interest exists due to ownership of stock through diversified investments such as mutual funds in which the research employee does not control investment decisions.

    15. These thresholds apply to the aggregate interests of the research employee and the research employee's family. Include in the aggregate anything of monetary value, consisting of but not limited to salary, consulting fees, honoraria, gifts, equity interests, ownership interests, and royalty income. Do not include wages or salary from the University, income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities, or income from service on advisory committees or review panels for public or nonprofit entities.

  15. Sponsor: The entity which has or will provide financial support for the research, which may include corporate sponsors, state agencies, the University, or agencies of the federal government, including the Public Health Service (PHS).

  16. Technology Transfer: The efforts of University research employees that transfer intellectual property and technology to a third party, including a private enterprise. For federally-sponsored research, the Bayh-Dole Act requires the University to transfer resulting inventions and technology into the economy through commercialization whenever possible. Technology transfer necessarily includes interaction with and investment in external entities which may create actual or potential COI.

IV. PURPOSE OF THIS POLICY

  1. Protect investigators, research employees and students from the risk of COI or appearance of conflict and to ensure that such COI does not create doubt about the integrity of the research resulting in possible federal and state sanctions, or taint professional reputations.

  2. Protect research subjects from risks related to the investigator's and research employee's COI.

  3. Insure integrity of research conducted by University investigators and research employees and ensure all research is free from bias by reducing, managing or eliminating COI when necessary.

  4. Facilitate responsible transfer of University technology and transfer to the public and industry for the benefit of the society.

  5. Meet the University's obligations to the sponsors of University research, including federal sponsors, to adopt and enforce a COI policy which is effective in practice.

  6. Provide investigators and research employees guidance on requirements and processes for identifying and disclosing COI.

  7. Provide University administrators and the COI Comm. guidance on requirement and processes for managing COI.

  8. Guide investigators and research employees in making informed decisions on when and how to engage in technology transfer and outside professional activities to avoid compromising the integrity of their research or their responsibilities to the University.

V. APPLICATION

This policy applies to all University investigators and research employees and to all University research regardless of the source of funds including federal and non-federal funds, state funds, gifts, service center funds from non-WSU entities, and any other WSU fund that may apply.

Federal funding provisions:

If PHS funds University research, this policy applies to all entities involved in the research project, including subcontractors, subgrantees, and collaborators. Certain PHS funding programs are not included in this policy based on PHS regulations, including phase 1 support for SBIR. (42 CFR 50, part F and 45 CFR 94.1 and 94.6)

The University must report any COI to PHS for all research sponsored by the PHS. Conflicts must first be reported prior to expending any PHS funds. Any subsequently arising conflict must be reported within 60 days of being identified.

The University must provide information on conflicts of interest to the Department of Health and Human Services (HHS) upon request.

When the University intends to collaborate with another institution on PHS and/or National Science Foundation (NSF) sponsored projects, the University must receive written assurance indicating that the collaborating institution has a COI policy which complies with the federal sponsor's regulations.

VI. TECHNOLOGY TRANSFER ACTIVITIES BY RESEARCH EMPLOYEES

Research employees' professional relationships with private industry, nonprofit institutions, and other government entities can facilitate technology transfer and fuel economic growth while providing investigators, research employees, faculty, and students with a rich environment in which to teach, learn, and conduct research.

  1. Travel to promote the University's technology transfer:

    1. The University can usually provide investigator and research employees with funds for travel, including related meals and lodging expenses, to meet with representatives from external entities when pursuing research collaborations through sponsored research agreements and when exploring opportunities for University technology transfer through intellectual property licensing. Travel must be justified and reimbursed following the University travel policies, BPPM Chapter 95, including the University's policy on travel paid by third parties. Refer to BPPM 95.16 for policy on third party reimbursement for travel.

    2. Investigators and research employees must avoid accepting gifts from external entities (not including gifts from friends and relatives that may have an interest in external entities--as long as the gifts are not related to the working relationships). This is particularly true if the external entity's financial interest would reasonably appear to be affected by the outcome of University research. However, travel, meals and lodging expenses can be provided by external entities and be exempt from the gift designation if the external entity's payment of the travel expenses will qualify under Internal Revenue Service regulation as a bona fide business expense of the investigator or research employee. Travel reimbursed by an external entity must be justified by the University traveler as a legitimate technology transfer activity or an outside professional activity related to the traveler's scholarly expertise.

  2. Technology transfer through outside professional activities and consulting:

    1. Outside professional activity related to an investigator's or research employee's field or discipline is a critically important method of technology transfer. Faculty members may perform such outside activity under the provisions of the Faculty Manual. Other employees should consult the terms of their employment to determine what activities are allowable.

    2. To avoid actual or perceived COIs, in accordance with BPPM 60.44, investigators and research employees must disclose all outside professional activities in their field or discipline beyond the employee's WSU duties and obtain approval from the appropriate department chair or other supervisor within five working days of the commencement of the activity. Such disclosure and approval must occur prior to receiving any wage, fee for services, honoraria, or other compensation.

    3. Investigators and research employees need not disclose scholarly activities, including publications, journal article reviews, grant applications, panel reviews, presentations, seminars and lectures unless they are aware of an actual COI. Scholarly activities are not generally considered "consulting" or "outside employment." Such activities need only conform to the standards in the Faculty Manual, or for nonfaculty investigators and research employees, their contract of employment.

    4. Outside consulting agreements are personal employment agreements, regardless of whether compensation is provided for the activities. The research employee may wish to seek personal legal advice prior to signing any such agreement. Although consulting agreements may require the consultant to assign all patentable discoveries to the external entity, the University research employee cannot transfer intellectual property to an outside entity if the University has ownership rights in that intellectual property. Thus, it is essential that care is taken by University research employees who are presented with such agreements to not violate the employment contract with the university, as articulated in Section IV(D) of the Faculty Manual.

    5. If the employee anticipates that University facilities, personnel, equipment, land, or other resources will be used in an outside professional activity; such use must be declared and approved in advance. Despite the provisions in Section IV(D) of the Faculty Manual and 20.37 of the BPPM, when facilitating technology commercialization activities, use of University resources is conditionally allowed under this policy. Approval for such activities would typically take the form of an approved sponsored research or service center use agreement. Such agreements must clearly justify why the work is being conducted as a consultancy rather than an agreement between the sponsor and the University and must articulate how the work advances technology commercialization. Such an agreement between the university and the employee engaged in the outside professional activity must be executed prior to the use of University resources for private activities. It is anticipated that the employee engaged in the outside professional activity will pay full charges paid by others, including appropriate F&A fees, for the use of such resources. Agreements between the University and the employee to use resources for outside professional activities are considered a conflict only when the resources are those which the research employee normally uses in the course of his or her employment with the University or over which the research employee or a member of his family have direct input in determining the availability of a resource.

    6. In addition to disclosure and approval, the research employee is expected to perform his or her University duties and the outside professional activity ethically, legally and professionally. Care must be taken by the research employee to minimize the potential that the outside professional activity will damage the University's academic integrity, mission, or interests.

    7. A research employee must update his/her COI information annually in accordance with BPPM 60.44.

    8. The COI disclosure form (http://www.ogrd.wsu.edu/documents/Request_and_Approval_Form_1.doc) must be completed and forwarded to the research employee's chair or supervisor prior to engagement in an activity with potential for COI. The research employee's chair or supervisor (1) must review the information on the COI disclosure form and decide whether the outside activity is an actual or perceived conflict with the research employee's duty to University or the research in which the research employee is engaged. If such review leads the chair or supervisor to believe that an actual or perceived conflict exists, the chair or supervisor must immediately refer the disclosure to the Office of Research Assurances on behalf of the COI Comm., with a copy to the appropriate dean and/or chancellor and a copy to the Vice President for Research, to avoid undue delay in starting the research.

      (1): If a chair, dean or other administrator is disclosing COI, the COI should be disclosed to his or her immediate supervisor.

    9. If the research employee disagrees with the chair or supervisor's referral of the activity to the COI Comm., the research employee may ask that the Vice President for Research review the decision. If a determination is made that imposing conditions or restrictions will be either ineffective or inequitable, and that the potential negative impacts that may arise from a potential COI are outweighed by interests of scientific progress, technology transfer, or the public health or welfare, then, when permitted by applicable regulations, the Vice President for Research may allow the research to go forward without referring the disclosure to the COI Comm.

    10. Any COI's that arise during the course of a research project must also be disclosed. For PHS-funded research, the University must report any conflicting interest to the PHS awarding component that issued the award prior to expending any funds, AND any interest identified as conflicting subsequent to the initial report within 60 days of that identification. Upon request, the University will make information available to the HHS about all actual or perceived conflicting interests and how those interests are managed, reduced, or eliminated.

    11. The University, via the Office of Research Assurances, chancellor, dean, relevant department chair/director, and research employee must maintain records, identifiable to each research project, for each disclosure of COI, including the determinations by the COI Comm. and the research employee's actions in managing the conflict. These records must be maintained at least three years beyond the termination or completion of the research. This requirement complies with PHS regulation, Title 45 CFR 74.53(b). If a federal or state agency is reviewing the research or the conflict management, the records must be maintained for three years beyond such review.

  3. Technology transfer through research employee private enterprise involvement, including start-up companies:

    1. Research employee start-up companies that are founded by or have a close relationship with University research employees are a valuable method of transferring University-created knowledge and technologies into the economy.

    2. Companies started by others also encourage and foster the transfer of technologies from the University to private enterprise. Such companies may engage research employees in a variety of ways, including technical advice.

    3. When engaged in technology transfer through the formation of start-up companies, the research employee must disclose actual or perceived COI to her/his chair or supervisor using form http://www.ogrd.wsu.edu/documents/Request_and_Approval_Form_1.doc.
      The chair or supervisor will forward copies of the disclosure information to the appropriate dean or chancellor and the Office of Research and refer the situation to the COI Comm. for management via a copy to the Office of Research Assurances.

      The University will:

      1. Ensure that the chancellor, dean, and relevant department chair/director are aware of the research employee's enterprise;

      2. Manage any COI through the COI Comm. and through the chancellor, dean, department chair/director, and Office of Research;

      3. Manage all intellectual property disclosed to the Office of Intellectual Property Administration or assign the intellectual property to the Washington State University Research Foundation (WSURF) for management. The University will not take equity ownership in the private start-up enterprise that utilizes University intellectual property. WSURF has policies related to its equity ownership in start-up companies and avoidance of any institutional COI.

      4. The research employee is responsible to:

      1. Fully disclose any significant financial interest or other potential, actual, or perceived COI to the research employee's supervisor, chair, or when appropriate to the Vice President for Research, chancellor, dean, or director.

      2. Comply with all applicable University policies, including employment, intellectual property, and COI policies.

      3. Fully disclose her/his relationship to any start-up company, to anyone working on his/her research or related research, including co-investigators, research assistants, trainees, fellows, or students, and to subcontractors working on related research.

      4. Not allow the investigator's or research employee's relationship to the start-up to impair the rights of any graduate or undergraduate student or the University employee. A research employee must never allow outside interests to impair a student's best interests including right to publish, progress toward degree, or opportunities for related training and experience.

      5. Never compromise the safety and health of a research subject based on the research employee's outside interests. Any outside COI related to research involving human subjects should be disclosed to the Institutional Review Board (IRB) for their consideration in the IRB review and management of research protocols as well as the COI Comm.

      6. Disclose any potential COI's to the COI Comm. The research employee, in collaboration with the COI Comm., must develop a suitable management strategy for an identified COI.

    4. Specific stipulations regarding research support by the start-up company:

      5. The Ethics in Public Service Act (RCW 42.52) was revised in 2005 with respect to University-approved research, researcher consulting, and technology transfer. A new section (safe harbor provisions) of RCW 42.52 provides that the University may have an administrative process to allow approved private use of University facilities, equipment and staff time to advance the University's technology transfer mission. The University costs must be either de minimis or the activity must be a pre-approved outside professional activity. The University must be reimbursed for all costs which are more than de minimis pursuant to a contract with the University for use of facilities or resources. If the contract only utilizes existing University resources, a facility use agreement (enterprise account) may be used; if the contract includes deliverables such as experimental design or data analysis, a contractual, sponsored program agreement (http://www.ogrd.wsu.edu/docs/Sra.pdf), which includes a description of expectations and deliverables, should be utilized. In no instance may a philanthropic donation be used to reimburse the University for the costs of providing such facilities or resources.

      Related University policy will allow the start-up company to support research projects at the University in the research employee's lab provided that:

      1. Appropriate University offices, including the Office of Grant and Research Development, the Office of Intellectual Property Administration, the Office of Research Assurances and the Office of Business and Finance shall work closely to collectively determine that private use is acceptable under tax law and does not conflict with grant requirements or existing University obligations. Such offices will consult, as appropriate, with the University's legal council.

      2. All projects which include a potential COI must have COI Comm. assurance that a COI does not exist or that the COI can be appropriately managed prior to facility use.

      3. All projects are subject to approval by the appropriate dean and/or chancellor using established university approval mechanisms, such as the REX form. As noted above, such activities may not be supported by philanthropic donations.

      4. All projects must comply with and not interfere with state and federal research projects underway in the research employee's lab.

      5. If any employee(s) of the start-up company wish to be included as named participants on any research contract with the start-up company, the request will be referred to the COI Comm. The COI Comm. will determine whether the integrity of the research will be compromised by the proposal and if the COI can be managed, reduced, or eliminated.

      6. All inventions arising from University research are owned by the University and subject to an option to negotiate additional licenses. Joint inventorship is possible if company employees separately contribute to the invention.

      7. Students (as opposed to employed graduate research assistants) in the research employee's lab will not be permitted to function as employees of the start-up company without obtaining prior permission from the chair/director, dean, chancellor (as appropriate), and Provost. The students must be free to pursue publication, advance in their line of study, and publish their thesis or dissertation without restriction.

Note that the above issues will be reviewed by the appropriate University offices in accordance with University policies and procedures.

VII. GUIDANCE FOR DE MINIMIS AND CONTRACTED USE OF UNIVERSITY RESOURCES IN TECHNOLOGY TRANSFER ACTIVITIES

  1. The revised Ethics in Public Service Act, RCW 42.52.360(2)(c) recognizes that limited personal use of University resources by the University research employees for technology transfer activities will not undermine public trust and confidence and can advance the mission of the University.

    If the activity to transfer University technology and the planned use of University resources has prior approval by the supervising department chair and dean, a research employee may use his or her personally-assigned offices, telephones, computer, e-mail account, internet connections, and comparable types of personally-assigned equipment to conduct outside technology transfer activities if:

    1. There is little or no additional cost to the University;

    2. Any use is reasonable in duration and frequency and is the most effective use of time or resources;

    3. The use does not interfere with the performance of the official duties of either the University research employee, other University employees, or students;

    4. The use does not disrupt or distract from the conduct of University business due to volume or frequency;

    5. The use does not disrupt other University employees and does not obligate other University employees to make unauthorized uses of University resources; and

    6. The use does not compromise the security or integrity of University property, information, or IT network.

  2. The following resources may not be used for outside technology transfer activities unless a sponsored research agreement between the outside entity and the University has been approved to use the stipulated University resources for the contractual purpose pursuant to BPPM 20.37.

    1. Long-distance or other toll calls or use of a University cell phone.

    2. Paper and other University consumables.

    3. Time of other University employee's during the employee's assigned work.

    4. Assistance of a graduate student.

    5. University laboratories, laboratory supplies, or hardware.

    6. University research support including but not limited to grant and sponsored project administration, regulatory committee review and monitoring, health and safety units, specialized office and publishing equipment, vivarium, greenhouses, agricultural research stations, pastures, and feeding stations.

    7. Equipment that is assigned to another University employee or student.

    8. University-owned intellectual property.

VIII. FAILURE TO COMPLY WITH UNIVERSITY COI POLICY--SANCTIONS

  1. Any University employee shall report to the Vice President for Research any investigator or research employee who he or she believes has:

    1. Failed to file a required report or knowingly filed a false or misleading report.

    2. Refused to cooperate with the COI Comm. or compliance officer in implementing this policy.

    3. Substantially and knowingly failed to observe the terms of a conflict management plan adopted by the COI Comm.

    4. Knowingly failed to report a COI.

    5. Used University resources for outside technology transfer activities in a manner that did not comply with this policy, which includes breach of a contract between the research employee and the University for use of resources.

  2. The Vice President for Research, in consultation with the COI Comm., shall review the report and attempt to resolve the matter. If a resolution is not achieved, and if the Vice President for Research determines that a violation of University rules may have occurred, he or she may initiate such action or disciplinary procedure as may be indicated. The Provost will determine the action or disciplinary procedure or action. Corrective actions or disciplinary sanctions may include: mandatory training or counseling regarding COI; transfer or reassignment; verbal or written warning; censure; demotion; reduction in salary; withholding of salary increases; denial of professional or retraining leave; withholding of promotion; termination, including, in some incidents, summary suspension and dismissal.

  3. Failure to comply with this policy may result in action under federal or state law against the investigator or research employee. If the COI involves a research project administered by the University, any action legally required by the funding agency will also be taken.

  4. For PHS-funded research: In accordance with 50 CFR, if the investigator or research employee's failure to follow conflict of interest policy has biased the research, the University is required to promptly notify the PHS-awarding component of the corrective action taken or to be taken.

  5. If the Department of HHS determines that a PHS-funded project to evaluate a drug, medical device, or treatment was conducted by an investigator or research employee with a conflict that was not disclosed or managed, the University requires the investigator or research employee to disclose the conflict in each public presentation of the results of the research.