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Financial Conflict of Interest in Research

When to Disclose

When do you disclose?

New or increased Significant Financial Interest (SFI) needs to be disclosed:

  • Within thirty (30) days of the investigator’s initial employment date;
  • Annually, no later than August 31st;
  • Within thirty (30) days of acquiring a new SFI; and
  • Within thirty (30) days of starting a new, or joining an ongoing, research project.

Do you have to complete the FCOI disclosure even if you do not have financial interests to report?

Yes. If you are responsible for the design, conduct, or reporting of research you must complete the training and submit a disclosure form. Your responses to the disclosure form will document that you do not have any financial interests. After your disclosure form is accepted, you will still be required to update your disclosure form annually or when changes occur (within 30 days of the change).

When do you need to update your reimbursed or sponsored travel- before or after the trip?

All investigators must update their disclosure with information regarding travel within 30 days of the end of the trip.

What happens if you don’t disclose?

No expenditures of sponsored research funds will occur unless the COI disclosure has been reviewed and determined that no FCOI exists or that any identified FCOI is managed under a conflict-of-interest management plan.

If a FCOI is discovered that is related to PHS-funded research and is not timely identified or managed, or if an investigator fails to comply with a management plan, the member’s COI Official or designee must, within 120 days after determining noncompliance:

  • Complete a retrospective review of the investigator’s research activities and any PHS-funded research project to determine if any PHS-funded research, or portion thereof, conducted during the period of noncompliance, was biased in the design, conduct or reporting of such research; and
  • Implement any measures necessary, including but not limited to halting the investigator’s participation in any affected research project, to remediate the noncompliance between the date the noncompliance was identified and the date the retrospective review is completed.