Start-up Guidance 2022

University Start-ups/Institutional Advisory Memo

What is a Duke University start-up? A Duke start-up is a company primarily built around university-owned assets that arise from internally and externally-funded research projects and core operations, such as patents, copyrights, software, technical information, and trademarks.

Why must financial conflict of interest (COI) be disclosed? The goal of Duke University (“Duke” or “the University”) and its faculty/staff is to work collaboratively to be transparent, protect the integrity of research, ensure compliance with applicable regulations and institutional policies, protect students’ academic interests, foster an open academic environment, and ensure that the primary professional commitment of faculty and staff is to the University. Thus, Duke faculty and staff must report the existence of or intent to engage in any financial interest (equity, options, consulting fees, etc.) with University start-up companies.

How do I report my relationship or financial COI with the start-up?  All Duke faculty and staff must use the electronic COI/Conflict of Commitment (COC) disclosure form annually to disclose relationships and financial interests with a start-up.  Moreover, whenever there is a change in the nature of the relationship or the start of a new one, that change must be disclosed within 30 days.  The form can be accessed at: https://radapps.duke.edu/oi-form. The disclosure should describe the disclosing individual’s financial interest(s) and any planned commitment to the start-up as well as any University research that could potentially be related to the start-up or influenced by the disclosing individual’s relationship with the start-up.

What does “related” to the start-up company mean? Examples of when a financial interest or commitment is “related” to University research include, but are not limited to:

  • Using intellectual property (IP) of the start-up in research at the University
  • Using a product of the start-up in research at the University
  • Plans to issue a sub-award to or receive a subaward from the start-up
  • Any planned involvement in research sponsored by the start-up
  • When the interests of the start-up could be affected by the results of University research

What happens after disclosure? Duke Office of Scientific Integrity (DOSI)-COI will review your disclosure documentation and determine whether a real or apparent COI exists and is associated with faculty, staff, and/or students/trainees involved in the start-up.  If a conflict exists, DOSI-COI will determine whether it can be managed in accordance with federal regulations and institutional COI-related policies. If the conflict is deemed manageable, a COI management plan will be developed, approved by the University COI Committee, and signed by the conflicted individual(s) prior to the commencement of related research. The Institutional COI Committee will review management plans on an annual basis, or more frequently, as deemed appropriate by institutional policy or procedure.

What else do I need to know? You should familiarize yourself with the entire Duke COI/COC policy including Appendix A – Conflict of Interest considerations for faculty involved in startups. Key points to consider include:

  • A clear separation between your work at Duke and your role and ongoing work at the start-up
  • Restrictions on managerial positions at the start-up company
  • Restrictions on negotiations, monetary gifts, supervision of Duke faculty, staff, and students/trainees, and Duke resources/facilities involving the start-up
  • Allowable time for outside activities/conflict of commitment as described in the Duke Faculty Handbook (Sections 5.2.2.2 and 5.2.2.4)
  • Required approvals at the local/academic unit, e.g. Chiefs, Chairs, and Deans as described in the Duke COI/COC policy
  • Unless specifically delegated, Duke faculty and staff do not have authority to execute agreements on behalf of Duke. 

What should I do if I am not sure if my relationship with the start-up meets the COI reporting requirements? If you are not sure if your situation is related or have other questions about your start-up and COI management, consult DOSI-COI dosicoi@duke.edu

 

CLINICAL TRIALS INVOLVING START-UPS or COMPANIES WHERE DUKE HOLDS EQUITY

Can I conduct clinical trials at Duke that involve my start-up? Proposed clinical trials involving start-ups to be conducted at Duke as a single site are limited to Phase 1 trials with an un-conflicted Duke Principal Investigator (PI) unless compelling circumstances are presented and approved by the COIC in advance. Phase 2-4 clinical trials involving a start-up must be multi-site. If Duke serves as a site for a Phase 2-4 trial, the Duke PI must be un-conflicted. If the national PI is a Duke PI, the PI must be un-conflicted.

What does “involving start-ups" mean? Some examples of clinical trials involving start-ups are:

  • Using the start-up's IP (whether licensed through Duke or externally)
  • Using the start-up's products or devices
  • The start-up sponsoring the study

Can clinical trials involving start-ups use the DUHS IRB? An external IRB review is required for all clinical trials involving start-ups/ Duke equity. The DUHS IRB will provide an administrative review. More information on this process and policy can be found on the IRB website: https://irb.duhs.duke.edu/node/4081.

Can the regulatory application for clinical trials involving start-ups be held at Duke? The conflicted faculty member may hold the regulatory application for Phase 1/early feasibility trials conducted at Duke as a single site with an un-conflicted Duke PI. For phase 2-4/pivotal trials, the regulatory application should be held by the start-up. Investigator initiated studies by un-conflicted investigators proposing to use the IP can be sponsored by the un-conflicted investigator at Duke. Faculty members are responsible for notifying the Office of Regulatory Affairs and Quality (ORAQ) and applicable parties of any changes in status for the above items after submission of a regulatory application or interactions with FDA.

Are there other considerations that need to be taken into account when planning a clinical trial involving a start-up? To manage existing conflicts of interest presented through engaging in a clinical trials involving a start-up, the study may be required to have a Data Safety Monitoring Board (DSMB) or Independent Safety Monitor (refer to: https://irb.duhs.duke.edu/policies-and-regulations/policies).

Exceptions to the above restrictions will not be granted without the existence of compelling circumstances. Faculty members are responsible for presenting information that would substantiate an exception; DOSI-COI is responsible for reviewing and processing these requests PRIOR to any research-taking place. For more information contact dosicoi@duke.edu.

Helpful Links

Annual Electronic COI/COC Form: https://radapps.duke.edu/oi-form

Duke COI/COC Policy: https://dosi.duke.edu/sites/default/files/atoms/files/Policy_FacultyCOI_COCinResearch.pdf

Duke Institutional COI Policy: https://dosi.duke.edu/sites/default/files/atoms/files/Aproved%20ICOI%20Policy_0.pdf

DUHS IRB Policies: https://irb.duhs.duke.edu/policies-and-regulations/policies

DUHS IRB External IRB Policy: https://irb.duhs.duke.edu/policies-and-regulations/policies/external-irbs

Compelling circumstances information: https://dosi.duke.edu/conflict-interest/compelling-circumstances