If an investigator has failed to comply with this Policy (RFMH’s FCOI Policy) or a financial management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, RFMH must promptly notify the PHS Awarding Component of the corrective action taken or to be taken.  The PHS Awarding Component may take appropriate action or require RFMH to enforce any applicable corrective actions prior to an award or the transfer of a PHS grant(s).

The PHS Awarding Component and/or HHS may inquire at any time into any Investigator disclosure of Financial Interests and RFMH’s review of and response to such disclosure, regardless of whether the disclosure resulted in a determination of a FCOI.

RFMH must permit HHS to review all records pertinent to reviews under this policy for PHS-funded research. HHS will keep records confidential to the extent permitted by law. The PHS Awarding Component may decide that a particular FCOI will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that RFMH has not managed the FCOI in compliance with 42 CFR 50.  The PHS Awarding Component may impose special award conditions, suspend funding, or take other enforcement actions as necessary until the matter is resolved. If HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted or reported by an Investigator with a FCOI that was not managed or reported by RFMH, RFMH shall require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

RFMH shall take additional actions as deemed appropriate, which may include restrictions on the ability to submit funding applications through RFMH and, for RFMH employees, disciplinary actions up to and including termination.