Industrial Sales

Scope

• Investigator: The project director / principal investigator (PD / PI) and any other person, regardless of title or position who is responsible for the design, conduct, or reporting of research funded by NIH or proposed for such funding, which may include for example collaborators or consultants.

o With regard to any publicly traded entity, a SFI exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

$5,000, or when the investigator (or the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest) in the entity.

 Salary, royalties, or other remuneration paid by the Institution to the investigator if the investigator is currently employed or otherwise appointed by the Institution;

 Income from service on advisory committees or review panels for a federal, state, or local government agency; an institution of higher education as defined at 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.

Policy

• Management: If the Institution determines that an FCOI exists, it will develop and implement a management plan to address the FCOI and ensure that the NIH-funded research is free from bias or the appearance of bias. The management plan may include conditions or restrictions such as:

o Change of personnel or personnel responsibilities;

• Reporting: The Institution will report any FCOIs to the NIH awarding component prior to the expenditure of any funds under an NIH-funded research project and within 60 days of identifying any new FCOIs for existing projects. The Institution will also submit annual FCOI reports to the NIH awarding component for the duration of the project period. The FCOI reports will include sufficient information for the NIH to understand the nature and extent of the FCOI and to assess the appropriateness of the Institution’s management plan. The Institution will use the eRA Commons FCOI Module to submit FCOI reports to NIH.

• Subrecipient Compliance: If the Institution carries out NIH-funded research through a subrecipient (e.g., subcontractors or consortium members), it will take reasonable steps to ensure that any subrecipient investigator complies with this policy or a comparable policy of their own institution that complies with 42 CFR Part 50 Subpart F. The Institution will establish, in a written agreement with each subrecipient, terms that specify whether this policy or that of the subrecipient will apply to subrecipient investigators and how FCOIs will be reported by subrecipient institutions to the Institution in sufficient time to allow the Institution to report FCOIs to NIH.

o The investigator’s title and role with respect to the research project;

o The approximate dollar value of the SFI or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

• Notification to NIH;

• Other actions as deemed appropriate by the Institution.

Name: Dr. Julian Henley Title: Founder Email: jhenley@henleyion.com

$• 42 CFR Part 50 Subpart F, Promoting Objectivity in Research

https: / / grants.nih.gov / grants / policy / coi / $tutorial2018 / $story_html5.html