2/10/2018 Conflict of Interest, Ethics, and Commercialization: The Conflict of Interest Committee (COIC) https://research.wsu.edu/resources-researchers/operations-support/coi/ or.coi@wsu.edu

Top Areas of COI I Need to Know 2/10/2018 Top Areas of COI I Need to Know Federal, State, and University Policies COI Committee When might this apply to a faculty member? How do I know what to do, and who can help me? We want to work with you! Questions?

#1 - Federal, State, and WSU Regulations, Policies, Procedures Federal regulations 42 CFR Part 50 and 45 CFR Part 94 (PHS) NSF AAG - Conflict of Interest Policies State of Washington Ethics Laws RCW 42.52 WSU Policies EP #27 - WSU Ethics, Conflict of Interest, and Technology Transfer – See next slide WSU Faculty Manual BPPM 35 (Intellectual Property) BPPM 60.44 (Compensated Outside Service and Extended Professional Activities by Faculty) BPPM 95.05 (Travel Authority)

Scope and Implementation #1 - Executive Policy #27: Washington State University Ethics, Conflict of Interest, and Technology Transfer Purpose To promote integrity and objectivity in University research, including research funded by federal grants or cooperative agreements, and to meet regulatory requirements. Scope and Implementation This policy applies to all University employees, collaborators, and subrecipients (subcontractors, subgrantees) who are responsible for the design, conduct, or reporting of research or the transfer of University technology and/or associated expertise into the private sector. These individuals must comply with the University's policy to disclose financial interests, cooperate with the University processes, and abide by any management plan adopted to manage conflicts of interest (COI). The Vice President for Research is primarily responsible for the implementation of this University policy.

#1 - The Conflict of Interest Committee Presidential level Committee Members are tenured faculty and administrators Minimum of 6 faculty Ex officio, voting members Director, Office of Research Assurances Director, Office of Commercialization Director, Office of Research Operations and Support, who serves as coordinator Review potential Conflict of Interest applications and determine if a conflict can be managed. Work with faculty to create circumstances that allow the conflict to be manageable (via a Conflict of Interest Management Plan). Support entrepreneurship within an ethical framework. Monthly meetings.

#2 – When might this apply to a faculty member? 2/10/2018 Engaging in intellectual property activities Office of Commercialization Engaging in Sponsored Agreements, Subcontracts, or Facility Use Agreements, where you are an owner of a company working with WSU Grants from Public Health Services and Adopting Sponsor Grants (HHS/PHS) Significant Financial Interest – See following slides Outside salary and payments for service (overlap with institutional responsibilities) Consulting, working at start up company, Membership on advisory board, etc. Equity interest (overlap) Third Party Sponsored travel Gifts A gift of greater than $50 from an outside entity is a significant financial interest; Family connected to activities above

Conflict of Commitment Conflict of commitment is not within the purview of the Conflict of Interest Committee Faculty Manual Supervisor Managed by the Department

Standard SFI/COI Process Research Employee completes online SFI Form COI Admin. Team reviews with COI Chair as needed Potential COI? (Significant AND Direct) No: Thank you for disclosure! Yes: COI Admin. Team pre-reviews info and gets final forms Research Employee completes necessary annual reporting/updates COI Admin. Team works with COIC to review and approve

Disclosures: MyResearch Log in to MyResearch, Compliance tab, COI tab

Disclosures SFI Form

Disclosures SFI Form

Student Interactions Any student (undergraduate, professional, or graduate) who is involved in any way with a COI case will be advised of her or his rights and responsibilities through the COI Guidance for Students and Employees orientation. Applicant may not engage students in their company’s activities if such Applicant has any evaluative authority (e.g., course grading, member of student’s graduate committee) over those students, unless an approved COI Management plan is in place for the Applicant and the Applicant’s students. The COIC Coordinator must be contacted within 10 days if any new students are involved in the Applicants Laboratory or with any Entity activities.

#3 - How do I know what to do, and who can help me? We want to work with you. SFI – Sammy Conflict of Interest Applications and Management Plans – Dan/Derek COI Annual Reporting – Dan/Derek/Sammy

#4 – Questions?

2/10/2018 Palouse Region, Washington Template K - curved line

Extra Slides

Standard SFI/COI Process PI to complete SFI online. FCOI Admin Team (Sammy) reviews online SFI COI Chair, as needed (pre significant and direct) If potential conflict, FCOI Admin Team (Dan and Derek) work with Investigator on COI Application and Management Plan templates as necessary. A pre-screen of information may lead to a request for additional information (ensure significant and direct) Once complete, FCOI Admin Team works with COI Committee to review and recommend actions, including approval of the COI Application and Management Plan. Annual Reports due by PI and Plan Monitor. FCOI Admin Team sends reminders.

In what instances must an SFI be disclosed? PHS When the value of remuneration received from a publicly traded entity in the 12 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. When the value of remuneration received from a non-publicly traded entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator and his/her Family holds any equity interest in a non-publicly traded entity. The values above should include any IP rights and interests (e.g., patents, copyrights), held by the Investigator and his/her Family upon receipt of income related to those rights and interests ($1,000 tech transfer). Any travel reimbursed or sponsored (i.e., 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 the Investigator’s WSU Responsibilities; except travel that is reimbursed or sponsored by a non- conflicting institution. All gifts received from an entity other than a nonconflicting institution during the 12 months preceding the disclosure if the aggregate value of the gifts exceeds $50. NOTE: Gifts greater than $50 from nonconflicting institutions may be prohibited under Washington State law. See RCW 42.52.

In what instances must an SFI be disclosed? Non-PHS When the value of any financial interests in or remuneration from a business enterprise received by the investigator and/or the investigator's family in the 12 months preceding the disclosure exceeds $5,000 or represents more than 5% ownership interest for any one enterprise or entity. Other than the dollar value of SFI that must be disclosed, the same standards and rules regarding determination of SFI apply.

Definitions: Investigator The project director or PI, the co-PIs and any other person, regardless of title or position, including the PD/PI and Senior/Key personnel as defined in this policy, who is responsible for the design, conduct, or reporting of a research project, funding or proposal.

Definitions: Family HHS/EP27: The Investigator's or Research Employee's spouse/domestic partner, dependent children and other dependent relatives living in his/her household (Investigator's/Research Employee's financial interest includes the aggregate financial interest of the family) WSU: Appearance of a conflict

Definitions: WSU Responsibilities Investigator's WSU Responsibilities means an Investigator's professional responsibilities on behalf of the University, which may include for example: activities such as research, research consultation, teaching, professional practice, and institutional committee memberships.

Who is required to complete the SFI disclosure? All Investigators listed in the "Credit" section of the eREX for PHS funding are required to complete the SFI disclosure form Key Personnel: the project director or PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the HHS, or proposed for such funding

When to fill out an SFI Disclosure Form 2/10/2018 When to fill out an SFI Disclosure Form Within 30 days of submitting a proposal related to PHS funding (direct or flow-through funding) or to PHS FCOI applicable sponsors. Within 30 days of the discovery or acquisition of a new SFI (e.g., through purchase, marriage, or inheritance). Annually, when funded. When the Conflict of Interest box is checked on the eREX Form. When travel is reimbursed or is sponsored (i.e., travel expenses 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 the Investigator's WSU Responsibilities, with some exceptions (non-conflicting institutions).

Disclosures: Exceptions! Income from seminars, lectures, or teaching engagements or service on advisory committees or review panels sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C.1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Above entities are non-conflicting entities.

Confidentiality Information submitted will be kept confidential to the extent allowed by the regulations and Federal and State laws.

Conclusion Federal regulations and WSU policies regarding financial conflicts of interest exist to protect the public’s investment in research and faith in the results of such research. It is the responsibility of all WSU faculty and staff to adhere to the COI regulations and maintain an environment of respect and trust in all research and teaching activities.

Scenario #1 TurboBoost is a privately held company that was founded by Dr. Smith. Dr. Smith owns equity interest in the company but at the current time, the company is not making any money. The company specializes in providing solutions and improved quality of life for individuals with mobility challenges using robotic prosthetics. Dr. Smith’s teaching responsibilities and PHS-funded research at Washington State University focus on mobile robot navigation and wearable robotics. Does the Investigator’s relationship with TurboBoost have to be disclosed? Yes   No The answer is Yes researchmatters.asu.edu

How is a Financial Conflict of Interest Managed? Examples of Management Options Management of financial conflicts of interest may include: Public disclosure of financial conflict of interest (e.g. when presenting or publishing) Disclosure financial conflict of interests directly to human participants Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against any bias resulting from the financial conflict of interest Modification of the research plan Change in personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research Reduction or elimination of the financial conflict of interest Severance of relationships that create financial conflict of interest Students: Disclosure of conflict to the student Provide University contacts for students to air concerns Meet proactively with students to identify concerns Organize thesis/dissertation committees to minimize potential effects, e.g. delays in publication or graduation Academic integrity: Review timeliness of publications, publication content related to the conflict Faculty & student seminars Public presentations Direct discussions with the investigator Formation of an independent review committee University Resources Management of use of service centers or University resources is accomplished by individuals who are unrelated to the investigators and have no connection to the research Management of contracts by the Chair, e.g. financial oversight Disclosure of intellectual property development to WSU

Significant Financial Interest (SFI) A financial interest of the Investigator and his/her Family that is the amount and type which must be disclosed to the University or which creates a COI for the Investigator or Research Employee. The University and most federal sponsors have specific provisions establishing what constitutes SFI. Types of SFI Outside salary and payments for service Equity interest Sponsored travel Gifts If there is a financial interest that reasonably appears to be significantly and directly related to the Investigator's WSU responsibilities, then it is an SFI. A SFI that could significantly and directly affect the design, conduct, or reporting of funded research would be a Financial Conflict of Interest.