Financial Conflict of Interest (FCOI) and Other

Transcript:Financial Conflict of Interest (FCOI) and Other:
Financial Conflict of Interest (FCOI) and Other Support NIH and Grantees Working Together Diane Dean Romeo Tengey 1 Introduction Key Topics: Commitment Transparency Financial Conflicts of Interest (FCOI) Other Support Disclosure Requirements for FCOI and Other Support Who, What, Why, When? Best Practices What is commitment transparency? Transparency and reporting of all research activities, domestic and foreign Openness and transparency enables productive collaboration and helps ensure appropriate disclosure of potential conflicts of interest and commitment The consequences of non-disclosure threatens the integrity of research, Federal interests, and distorts NIH funding decisions 3 Commitment Transparency 4 Key concepts: Financial Conflicts of Interest: A financial interest/relationship which could directly and significantly affect the design, conduct, or reporting of NIH-funded research Other Support/Conflicts of Commitment Conflicting obligations between or among multiple employers or entities. Financial Conflicts of Interest (FCOI) Requirements 42 CFR Part 50 Subpart F (grants and cooperative agreements) NIH Grants Policy Statement (NIH GPS), Section 4.1.10, Financial Conflict of Interest 5 Purpose To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of NIH-funded research grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. 6 Disclosure Requirements – Who? Who must disclose? Investigators Investigator is defined by the regulation as the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research that is proposed or funded by NIH. Other persons may include collaborators or consultants, for example. 7 Disclosure Requirements – What? What must Investigators disclose? Investigators disclose their significant financial interests (SFIs) and those of their spouse and dependent children to their institutions. What is a significant financial interest? Remuneration (for example salary and any payment for services, consultant fees, honoraria, and paid authorship) greater $5,000/year Equity interest in a publicly traded entity (subject to a dollar threshold) and in all non-publicly traded entities (no threshold) Intellectual property rights and interests (e.g., patents, copyrights) greater than $5,000/year Reimbursed or sponsored travel (e.g., greater than $5,000/year) 8 Disclosure Requirements – When? When must Investigators disclose this information to their institution? At the time of application Within 30 days of acquiring or discovering a new SFI On an annual basis as prescribed by the institution 9 How Information is Used by NIH NIH extramural staff review all FCOI reports NIH Program Officials: have scientific expertise