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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

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SLIDE 1

September 9, 2020

Co Conflict of Interest + Co Commitment Reporting

A s A safegu guard f rd for

  • r

Jay Jayhaw hawk int ntegrity

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SLIDE 2

Introduction

Provost Barbara Bichelmeyer

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SLIDE 3

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.
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SLIDE 4

Policies + regulations

Employees and affiliates are

  • bliged to report outside

interests and commitments.

1. Federal regulations

  • 2. State of Kansas ethics statutes
  • 3. Kansas Board of Regents policy
  • 4. KU individual financial conflict of

interest policy

Federal agencies State of Kansas KS Regents KU

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Disclosure is an individual responsibility.

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Disclosures at KU

90% 9% 1%

About 5,000 annual certifications

No disclosures Disclosed an outside interest Under management plan

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Disclosure ≠ conflict

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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?

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SLIDE 9

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.

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Not necessary to disclose (but err on side

  • f disclosure)

Is it reasonably related to KU responsibilities? Does it involve an outside time commitment? Ownership in a privately held company? Is the aggregate value ≥ $5,000?* Disclose regardless of value Disclose

YES NO NO NO YES YES YES

Disclosure guide

*KU policy. Investigators on federal research projects may have lower thresholds.

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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.

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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.

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Examples of “research-related

  • ther 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.
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Case studies

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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

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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.
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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.
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When does an

  • utside interest

become a conflict?

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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

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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.

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SLIDE 21

How does management support external activity?

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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.

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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

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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.

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COI management protects

  • ur integrity
  • Fairness of research
  • Best interests of students
  • Appropriate use of university resources
  • Good stewardship of public funds
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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 coi@ku.edu | 785-864-3319 Susan MacNally, Director sumac@ku.edu | 785-864-4148