Dynocardia - Financial Conflict of Interest (FCOI) Policy 

This policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under grants or contracts with Public Health Service (PHS) Organizations will be free from bias resulting from Investigator financial conflicts of interest (FCOI).  Dynocardia intends to use this FCOI standard for all other Federal agency grant and contract efforts, as tailored or amended accordingly.

Authority – Public Health Service (PHS) regulation at 42 CFR 50, Subpart F is designed to promote objectivity in PHS Funded Research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grant awards is not biased by any conflicting financial interests of an Investigator. PHS issued a final rule in the Federal Register, August 2011, that amended the PHS regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F). This policy became effective as of August 24, 2012.

Source: 76 FR 53283, August 25, 2011, unless otherwise noted. NIH financial conflict of interest policy: http://grants.nih.gov/grants/policy/coi/.

Dynocardia's FCOI policy requires that its investigators and collaborators be in compliance with 42 CFR Part 50, Subpart F, for PHS grants and cooperative agreements and 45 CFR Part 94 for contracts. Dynocardia believes that it has fully addressed the requirements of this ruling and will continue to update this policy as needed, particularly related to any changes in personnel, FCOI issues, or upon further PHS guidance.  Based on the implementation of this policy, Dynocardia can certify, in each application for funding, that Dynocardia:

• has in effect, an up-to-date, written and enforced administrative process to identify and manage FCOI

• will promote and enforce Investigator compliance with the regulation

• will manage FCOI and provide initial and ongoing FCOI reports

• will make FCOI and significant financial interest information available to the PHS Organization, promptly, upon request; and

• will fully comply with the regulation’s requirements.