It is a policy created in response to the 2011 revised FCOI federal regulation 42 CFR Part 50 Subpart F. Institutions are required to develop policies and procedures that will be maintained and enforced in order to participate in Public Health Service or PHS funded research. ACHE seeks to help all interested persons – investigators, faculty, and staff to avoid any financial conflict of interest through its policy.

An Interested Person is defined in the policy as, “any board trustee, officer of the corporation, faculty, staff, contractor, consultant of ACHE, or members of a committee with governing board delegated powers, who has a direct or indirect financial interest or an indirect interest…is an interested person.”

The Investigator(s) and Interested Person(s) have a duty to disclose any potential financial conflict (this includes those of spouses and dependent children).

Investigators are obligated to submit a financial disclosure and to disclose any financial interests as requested on the form. ACHE then determines whether a financial conflict of interest (FCOI) exists.

FCOI means a significant financial interest (SFI) that could directly and significantly affect the design, conduct or reporting of research. FCOI is a situation in which an investigator’s significant financial interest in an entity may compromise, or have the appearance of compromising, an investigator’s professional judgment in conducting or reporting research, the results of which could affect the aforementioned entity, either directly or indirectly.

An FCOI exists when ACHE, through its designated official(s), reasonably determines that an investigator’s SFI is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.

ACHE’S Research Conflict of Interest Committee (RCOIC) meets regularly to review financial disclosures, identify FCOIs in the conduct of research, and to assign appropriate management or mitigation plans for identified FCOIs.

ACHE’s FCOI policy promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by any conflicting financial interest of an investigator.

ACHE FCOI in Research policy requires disclosure of Significant Financial Interests (SFIs) with entities that are related to your institutional responsibilities and that meet certain criteria.

SFI means a financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:

With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve 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 or represents more than 5% ownership in any single entity. 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;

With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $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);

Intellectual property rights and interests (e.g., patents, licensing agreements, trademarks, or copyrights) upon receipt of income related to such rights and interests;

Any reimbursed or sponsored travel related to the investigator’s institutional responsibilities if the value when aggregated exceeds $5,000 from any single entity.

Investigators/Interested persons must submit or update their financial disclosure:

Annually (at the time of the annual disclosure, the investigator must disclose the current aggregated value of the SFIs received over the previous year);

Within thirty (30) days of the acquisition or discovery of a new reportable SFI;

Within thirty (30) days of reimbursed or sponsored travel in excess of $5,000 from a single entity possibly related to your institutional responsibilities.

ACHE Investigators/Interested persons must fill out and submit an FCOI Disclosure Form in order to participate in federally funded research activities and to apply for federal funding pursuant to the ACHE Financial Conflict of Interest in Research policy.

The policy can be found here.

Each Investigator (including subrecipient Investigators) are required to complete institutional and NIH FCOI training:

• Prior to engaging in NIH-supported research
• At least every four years AND
• Immediately under the designated circumstances:
• Institutional FCOI policies change in a manner that affects Investigator requirements
• An Investigator is new to ACHE
• An Institution finds an Investigator noncompliant with the Institution’s FCOI policy or management plan.