A s A safegu guard f rd for or Jay Jayhaw hawk int ntegrity September 9, 2020 Co Conflict of Interest + Co Commitment Reporting
Introduction Provost Barbara Bichelmeyer
KU manages COI to safeguard public trust • KU encourages entrepreneurial activities that may create the perception of conflicts. • A conflict of interest, itself, does not indicate that science is biased or individual is unethical. • The perception of a conflict can quickly erode public trust in an individual, the institution, the research. • We rely on policies and procedures to manage COI.
Policies + regulations Federal Employees and affiliates are agencies obliged to report outside State of interests and commitments. Kansas 1. Federal regulations KS Regents 2. State of Kansas ethics statutes 3. Kansas Board of Regents policy KU 4. KU individual financial conflict of interest policy
Disclosure is an individual responsibility.
Disclosures at KU 1% About 5,000 annual certifications 9% No disclosures Disclosed an outside interest 90% Under management plan
Disclosure ≠ conflict
Examples of outside interests • You own shares of stock in a big pharma company. • Your spouse works at local start-up company. • You provide professional services as a consultant. Is Is the he interest reaso sona nably related to your ur KU re responsibilities?
Potential disclosures • You have a private consulting agreement. • You serve on the editorial board of a journal. • You are the editor or author of a book and receive royalties. • You serve on the board of a professional organization, which includes a time commitment or paid travel.
Disclosure guide Is the Is it reasonably Does it involve Ownership in a aggregate related to KU an outside time privately held NO YES NO value ≥ responsibilities? commitment? company? $5,000?* YES YES NO YES Not necessary Disclose regardless of value Disclose to disclose (but err on side of disclosure) *KU policy. Investigators on federal research projects may have lower thresholds.
FY 2021 Annual COI Reporting New question for researchers You have indicated that you are or intend to be engaged as a PI, Co-I, or Senior/Key Personnel in Federally sponsored research. Additional disclosure requirements for Investigators engaged in Federal sponsored research: • Federal funders have recently clarified requirements for investigators to disclose other research support, including involvement with foreign entities, in funding proposals. Institutions must certify that information in the funding proposal is accurate. • Therefore, you must disclose certain other support and relationships, on this form, as described below, in addition to disclosing your significant financial interests and time commitments • Other Support which is already captured in University effort reporting systems (e.g. ECRT) does not need to be included.
Rationale for new question • Wh Why? Recent clarifications regarding proposal content for Current & Pending (NSF) and Other Support (NIH) expand institutional obligations to certify accuracy. • Disclose all resources in support of and/or related to your research efforts. • Disclose support in the form of direct and in-kind contributions, regardless of location of resource.
Examples of “research-related other support” • A manufacturer of scientific equipment has offered to provide an expensive instrument in your lab for one year in exchange for providing product feedback and a couple of demonstrations. • Another institution has granted you adjunct (unpaid) faculty status for the purpose of collaboration with their faculty member. • You receive an endowment gift to support your research. • You have a private consulting agreement.
Case studies
Case study # 1 Professor Ash at Big U: • Receives NIH and NSF funding • Has longstanding research collaboration with collaborator at Uni U • Coauthored papers • No direct remuneration • Receives honorary appointment at Uni U Adapted from COGR presentation
Additional details Honorary appointment: • Unsolicited by professor or collaborator. • Uni U gives Prof. Ash an honorary professorship and lab with 2 assistants. • Collaborator sends email to Prof. Ash with attachment written in a foreign language, asks Prof. Ash to sign and send back so assistants can start work. • Prof. Ash thinks it is “just a formality,” signs and returns it.
Additional details Discoveries in disclosure to Big U: • Prof. Ash discloses appointment as “other support.” • COI office requests documentation; Prof. Ash provides attachment & email. • Attachment is FT employment contract for 6 months, including $200,000. salary and housing allowance. • Uni U owns all rights to any IP on which Prof. Ash is an inventor.
When does an outside interest become a conflict?
Case study # 2 KU Professor Elm: • Co-founder of company Xco LLC. • Serves as chief scientific advisor. • Holds equity interests in Xco. • Prof. Elm will be PI on subcontract to KU from Xco. Adapted from UCI Scenarios
Additional details • The PI on Xco’s prime award is not Prof. Elm or anyone else on the KU research team. • Prof. Elm will not represent Xco or participate in KU subaward negotiations. • Scopes of work for Xco and KU are distinct, with minimal overlap. • Xco will use its own facilities and resources to conduct its portion of the project and will not use any KU facilities or resources.
How does management support external activity?
Management is a safety net created by KU community • KU creates COI management plans to support activities that might otherwise raise concerns. • Individuals are responsible for disclosing outside interests. • The university COI Committee is responsible for evaluating disclosures, determining what needs to be managed. • Good management is a collaborative effort of individual, supervisor and administrators.
Case study # 3 Professor Pine: • Holds financial interest in company Nord LLC. • Is conducting related research at KU involving graduate students. • Nord is collaborating on the research. Adapted from: UCI Scenarios
Additional details • Prof. Pine discloses his interests in Nord to GRAs and provides a contact should the students have any concerns. • Nord scientist may be eligible for affiliate status to collaborate on the related project. • Inventions arising from the collaborative research will be reported according to KU policy.
COI management protects our integrity • Fairness of research • Best interests of students • Appropriate use of university resources • Good stewardship of public funds
FY21 annual certifications due Oct. 1, 2020 • KU employees, including faculty and unclassified staff (includes all appointments less than 1.0 FTE) • Affiliates engaged in research • Questions? research.ku.edu/conflict-of-interest Bob Szrot , Compliance Officer Susan MacNally , Director sumac@ku.edu | 785-864-4148 coi@ku.edu | 785-864-3319
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