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Institutional COI Committee’s Mission

“Financial relationships with external entities give rise to impermissible institutional conflicts of interest when, in the interest of financial gain for the University and its internal units, the objectivity of the decision-making process or the allocation of resources is influenced in ways that (1) compromise the integrity of the University in fulfilling its mission, and (2) would not occur but for the existence of the external financial relationship.”

Why may a trial qualify for institutional COI review?

  1. UNC owns the intellectual property (IP).
    e.g., B7H3 CAR T cells, MRX-2843
  1. UNC owns equity in the Sponsor or Manufacturer of the study drug/device/product.
    e.g., UNC owns equity in Meryx Inc. as it is a company that spun off from UNC IP.
  1. UNC owns the IP, which has been licensed to the Sponsor.
    e.g., Meryx Inc. licensed MRX-2843 to run the 2843-1001 clinical trial.
  1. A drug/device/product is manufactured on UNC’s campus.
    e.g., 68Ga-PSMA-11 manufactured by the BRIC.

What can increase the risk?

  1. The inventors of the IP work at UNC.
    e.g., Barbara Savoldo, MD, PhD; Gianpietro Dotti, MD
  1. Conducting a phase 1 trial at UNC.
    e.g., LCCC 1818-ATL a phase 1 trial of B7H3 CAR T cells
  1. Seeking to use UNC resources to conduct the clinical trial.
    e.g., Use of the LCCC core resources to run the clinical trial.
  1. Qualifying the institutional COI for more than 1 reason.
    e.g., UNC owns the IP + UNC is manufacturing the IP on campus + UNC is conducting the phase 1 clinical trial.

What could happen to my trial as a result of institutional COI?

  1. Requirement to Use an External:
    1. Institutional Review Board (IRB)
    2. Institutional Biosafety Committee (IBC)
    3. Data and Safety Monitoring Committee (DSMC)
    4. Biostatistician
    5. Medical Monitor
  2. External Reviewers Added to the:
    1. IRB
    2. IBC
    3. DSMC
  3. An External DSMC Member Added to FDA Form 1571- Responsible for Monitoring the Safety
  4. UNC Cannot Hold the IND or Sponsor the Trial
  5. External Review of the Data Prior to Publication
  6. No Single Subject Exceptions Allowed
  7. COI Disclosure
    1. Informed Consent Form (ICF)
    2. Publications/Presentations/Press Releases
  8. Updated Documents and Bi-Annual Reports Sent to Committee
  9. Not Allowed to Manufacture the IP at UNC
  10. Inventor Cannot Be Involved in the Clinical Study
  11. Cannot Conduct the Phase 1 Study at UNC

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