a researcher calls you stating that he plans to submit a proposal to the nih for a human subjects research study. he wants to know at what point he and his study team must submit coi disclosures to comply with the phs regulation.

2 hours ago 3
Nature

A researcher and their study team must submit Conflict of Interest (COI) disclosures to comply with the Public Health Service (PHS) regulations no later than the time of proposal submission for PHS-funded research. This means that all investigators involved in the project, including the Principal Investigator (PI) and anyone responsible for the design, conduct, or reporting of the research, must disclose any significant financial interests (SFIs) at the time they submit their funding proposal to the NIH

. Key points include:

  • The PI must collect COI screening information from all investigators at proposal submission.
  • If any investigator has a significant financial interest, they must complete and submit a detailed financial disclosure form before the award is released.
  • Investigators must update disclosures annually, with non-competing continuation funding, when new investigators join, or within 30 days of acquiring new significant financial interests
  • Disclosures are required even if no significant financial interests exist, ensuring transparency and compliance

This process ensures that potential conflicts are identified and managed before research begins, maintaining the integrity of the study and compliance with federal regulations. In summary, COI disclosures must be submitted at the time of proposal submission and updated as required throughout the research project lifecycle