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COI Disclosure Requirements

The Federal and State governments and the University of California require financial disclosures from researchers for certain types of projects (see Disclosure Chart).  Principal Investigators on sponsored research agreements and Lead Researchers on IRB protocols have additional disclosure responsibilities, including ensuring that their research personnel understand and comply with the applicable conflict of interest policies.

All Researchers

KR COI Annual Disclosure

Who: Researchers on Public Health Service and National Science Foundation compliant proposals and awards

What: Create and maintain an updated KR COI Annual Disclosure

How: KR COI Annual Disclosure

IRB Applications

Who: Researchers engaged in human subjects research

What: Need to notify the Lead Researcher if you have a disclosable financial interest related to the IRB protocol prior to the submission of the new and continuing IRB applications.  Also need to notify the Lead Researcher and the IRB if you have a new disclosable financial interest related to an ongoing IRB protocol (modification).

How: Lead Researcher or administrative contact will check "yes" to the conflict of interest question in the IRB application

Report new or changed significant financial interest

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Other Relevant Policies

Graduate Division

Conflict of Commitment

Foreign Influence

Principal Investigators/Lead Researchers

Form 700U

Who: Principal Investigators and Co-Principal Investigators on non-governmental funded research grants, contracts, gifts, and some material transfer agreements

What: Disclose financial interests in the non-governmental sponsor/donor

How: Submit an electronic copy of the Form 700U and forward the original, wet-ink signed copy to COI Team, Zot Code: 7600 141 Innovation, Suite 250, Irvine, CA 92697

IRB Applications

Who: Lead Researchers

What: Ensure all research personnel engaged in human subjects research understand the IRB COI discosure requirements and have disclosed any related financial interests in the IRB applications (new and continuing)

How: IRB application

KR Proposal Development

Who: Principal Investigators on PHS and NSF compliant proposals and awards

What: Ensure all individuals involved in the project who meet the definition of an "Investigator", a person responsible for the design, conduct, or reporting of the project, are listed in KR Proposal Development as Key Personnel.  Notify Sponsored Projects Officer if the list of Investigators needs to be updated during the period of the award.

How:

  • New Proposal: KR Proposal Development
  • Ongoing Award: Notify the C&G Officer if someone needs to be added or removed from the list of Investigators

Resources:

  • Identifying PHS Investigator
  • Identifying NSF Investigator

 

Inform lab personnel about disclosure requirements

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