Dynocardia - Financial Conflict of Interest (FCOI) Policy

Publication of PHS Research Performed by an Investigator with an FCOI

If a PHS Funded Research was conducted by a Covered Individual with a FCOI that was not disclosed or managed, the Institution will disclose the FCOI in each public presentation related to the results of the PHS Funded Research, and request an addendum to each previously published presentation. 

 Any PHS Funded Research that is performed despite an FCOI triggers a requirement to publish details of the FCOI on the Institution’s web page, and to update the details annually on the web page, within 60 days of newly discovered FCOI, and remaining for at least three years from the most recent update.  It is Institution’s policy not to permit PHS Funded Research to proceed with an FCOI; if FCOIs are avoided, such a publication requirement will not be triggered.

Subawards for PHS Research Effort

The Institution shall have a process in place to assure that any contractor or collaborator who carries out PHS Funded Research with the Institution (“Sub-awardee”) certifies, via written agreement, that it will follow this FCOI Policy or the Sub-awardee’s own FCOI policy

  • If the Sub-awardee certifies that it will comply with this FCOI Policy, the agreement shall specify the time periods for the Sub-awardee to report all SFI to the Institution. Such time periods shall be sufficient to enable the Institution to comply with timely review, management and reporting obligations required by this FCOI Policy.

  • If the Sub-awardee certifies that it will comply with its own FCOI policy, the written agreement with the Subcontractor shall include:

  • A copy of the Sub-awardee FCOI policy

  • A certification by the Sub-awardee that its policy complies with all applicable laws, regulations, and rules (including, but not limited to the PHS Regulations); and

  • Time periods for the Sub-awardee to report any identified FCOI to the Institution defined to permit sufficient time to enable the Institution to provide timely FCOI reports under this FCOI Policy, as necessary, to the PHS Organization.

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