Financial Conflict of Interest Policy

Financial Conflict of Interest ("FCOI") Policy for PHS-Funded Research

Parabon is committed to protecting the integrity and objectivity of its PHS-funded research activities by ensuring that the design, conduct and reporting of research will not be biased or appear to be biased due to a personal significant financial conflict of interest ("FCOI") of one or more of Parabon's Investigators. This policy has been written in order to help Investigators and Parabon officials determine whether or not FCOIs exist, and comply with the FCOI requirements set forth in 42 CFR Part 50 Subpart F, Promoting Objectivity in Research , which applies to both grants and cooperative agreements funded by the Public Health Service ("PHS") [1] of the United States Federal Government.

I. Resources Needed to Comply With This Policy:

· NIH's FCOI training module ( https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html )

· FCOI Disclosure Form Available from Parabon's Research Integrity Officer (RIO)

II. Applicability:

The term "Investigator" used in this policy refers to anyone, regardless of job position or title, who is responsible for the design, conduct or reporting of PHS-funded research conducted at Parabon.

If subcontractors, consortiums or consultants are utilized in a PHS-funded research effort, Investigators working for those outside entities must either adhere to Parabon's policy or provide assurances that the subcontractor's processes and procedures have been carried out and are in compliance with 42 CFR Part 50, Subpart F.

 III. Exceptions & Exclusions:

(1)  PHS proposals and awards under the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Phase I program are not subject to this policy.

(2)  The term significant financial interest ("SFI") does not include the following types of financial interests:

(a) salary, royalties, or other remuneration ^[2] paid by Parabon to the Investigator if the Investigator is currently employed or otherwise appointed by Parabon, including intellectual property rights assigned to Parabon and agreements to share in royalties related to such rights;

(b)  any ownership interest in Parabon held by the Investigator (e.g., stock or stock options, etc.);

(c) income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;

(d)  income from seminars, lectures, or teaching engagements sponsored by 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; or,

(e) 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.

 IV. Definitions

For purposes of this policy, the term significant financial interest ("SFI") means:

(1) 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 research and/or responsibilities:

(a) With regard to any publicly traded entity, a significant financial interest 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 ² ;

(b) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration ² 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); or

(c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(2) Any type of (professional or recreational) reimbursed or sponsored travel ( i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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.

V. Investigator Requirements

All Parabon-employed Investigators are responsible for the following:

(1) FCOI Training

All Parabon Investigators, as defined by this policy, must complete the NIH's FCOI training module (See link in Section II) or an equivalent program approved by Parabon's RIO and provide a certificate of completion to Parabon's RIO.

(a) The Investigator must take this training:

(i) prior to engaging in PHS-funded research for the first time, and

(ii) every four [4] years, thereafter; and/or,

(iii) immediately if the following circumstances apply:

· Parabon revises this FCOI policy in such a way that the Investigator's requirements are changed;

· a new investigator joins a PHS-funded research program; or,

· Parabon's RIO determines an Investigator is not in compliance with this FCOI policy and/or a previously developed management plan.

(2) Regularly Complete FCOI Disclosure Statements

Investigators must complete Parabon's FCOI Disclosure Statements and disclose all relevant SFI's for themselves, their spouses and their dependent children related to each PHS-funded research effort under the following circumstances:

(a) Before a qualifying research proposal is submitted to a PHS agency, either by Parabon as a prime applicant or by a collaborator for which Parabon is a service provider or subcontractor;

(b) If the PHS proposal is awarded, each Investigator will be required to provide an updated FCOI Disclosure Form annually for the duration of the project; and/or,

(c) Anytime there is a change in the status of SFI's for an Investigator, their spouse and their dependent children.

Investigators who provide false or misleading information and/or fail to comply with this policy in any way may result in disciplinary action and/or termination.

Investigators who are subcontractors or other collaborators working for outside entities must either adhere to Parabon's policy or provide assurances that the subcontractor's processes and procedures have been carried out and are in compliance with 42 CFR Part 50, Subpart F.

 VI. Parabon's Requirements

Parabon's RIO is responsible for:

(1) maintaining and enforcing this policy;

(2) regularly reviewing and determining if the SFI's disclosed by Investigators pose an FCOI for Parabon's PHS-funded research projects and programs, and if so, take action to manage or eliminate the FCOI;

a. If an FCOI exists, an FCOI management plan will be implemented to minimize, manage, reduce or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:

· Disclosure to research participants or the public that significant financial interests exist (e.g., when presenting or publishing the research or in a participant consent form);

· Monitoring of research by independent reviewers;

· Modification of the research plan;

· Disqualification of staff from participation in all or a portion of the research;

· Reduction or divestiture of a financial interest; or

· Severance of relationships that create actual or potential conflicts.

(3) If an investigator's failure to comply with this policy or an FCOI management plan has biased the design, conduct or reporting of the PHS-funded research, Parbon's RIO shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken as required under 42 CFR part 50 Subpart F;

(4) If the RIO identifies that a significant financial interest was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the RIO shall consult the current requirements under 42 CFR Part 50 Subpart F and use his/her best efforts to manage and/or resolve the matter in accordance with the PHS guidelines;

(5) The ROI will provide initial and ongoing FCOI reports to the PHS as required pursuant to §50.605(b); and,

(6) The RIO will maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of a financial conflict of interest) and all actions under the Institution's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.