top of page

 

Financial Conflicts of Interests Policy 

NUMBER: FCOIv1.1

DATE: 02/17/2023

APPROVED BY: Marc Aafjes, CEO

​

  • INTRODUCTION

    • Deliberate Solutions, Inc (“Deliberate”) is committed to ensuring that any research conducted within the company is held to the highest ethical standard, such that Deliberate staff may continue to conduct research in a productive environment that positively contributes to our research areas of focus. As collaboration is an important part of advancing research, Deliberate recognizes the potential for partnerships to introduce conflicts of interest that can impact conducting of research in a productive manner. To ensure that Deliberate continues to advance crucial research areas of interest, while participating in fruitful collaborations, Deliberate has outlined financial conflict of interest (FCOI) policies and ground rules. These policies shall serve to safeguard the integrity of Deliberate by requiring the disclosure of financial interests, confirming the existence of a financial conflict of interest, and by determining the proper management of any financial conflict of interest that may arise. Additionally, these policies are intended to align with the Public Health Service (PHS) research federal regulations and the National Science Foundation (NSF) (42 CFR Part 50 Subpart F)

  • DEFINITIONS

    • Covered Persons

      • includes any Principal Investigator (PI), individuals identified as senior/key personnel in the grant application, and any other individual who holds responsibility for the design, conduct, or reporting of the research. This also includes collaborators, consultants, and technicians to the extent that they are responsible for the design, conduct, or reporting of the research.

    • Equity Interest

      • any stock of a corporation, or any options, warrants or rights to acquire stock of a corporation, or any notes, debentures or securities convertible into or exchangeable for any stock of a corporation: any membership interest in a limited liability company; any partnership interest in a partnership, limited partnership or limited liability partnership; and any contractual or other right, whether accrued or contingent, evidencing an ownership interest in an entity or a right to a share of the profits or losses of an entity

    • Financial Conflict of Interest

      • Financial interest that has the ability for notable and direct impact on the design, conduct, reporting or the direct administration of research

    • Institutional Financial Interest

      • Ownership by Deliberate of or receipt by Deliberate through its business  activities of:

        • Equity and ownership interests of any amount in a non-publicly traded, for-profit entity

        • Equity and ownership interests valued at more than $100,000 in a publicly traded, for-profit entity, excluding equity managed by Deliberate

        • Prior calendar year gross revenue, resulting from sales or through any other commercial arrangement greater than $250,000 per entity

        • Receipt by Deliberate, greater than $100,000 from a commercial entity or foundation that sponsors research at Deliberate

        • Receipt by an Institutional Official of direct payments (e.g., consulting fees, royalties) greater than $25,000 annually from a commercial entity or foundation that sponsors research at Deliberate; or equity and ownership interests of an Institutional Official in a non-publicly traded, for-profit entity that exceeds 5% of such entity’s diluted stock or exceeding $100,000 if a fair market valuation has been completed within the last year.

    • Intellectual Property

      • Pending or issued patents, copyrights, or trademarks, and all rights to share in the royalties from or income produced by any of the foregoing under licenses, contracts or otherwise, whether accrued or contingent 

    • Management Plan

      • Written plan setting forth specific restrictions or conditions approved by the FCOIC to manage, reduce, or eliminate an individual and/or institutional FCOI

    • Related Parties

      • a spouse/domestic partner and dependent children of Investigators

    • Research

      • A project intended to develop new and generalizable knowledge or to be presented in support of regulatory applications 

​

  • PURPOSE

    • This procedure establishes the process to evaluate a report of an individual financial interest of an investigator or research staff Related to the Research or an institutional financial interest Related to the Research. 

    • The process begins when an Investigator or research staff indicates that there is an individual or institution financial interest Related to the Research or an IRB staff member notifies the Deliberate Financial Conflicts of Interest in Research Coordinator (FCOIC) that an investigator or research staff has reported an individual or institutional financial interest Related to the Research

    • The process ends when the Deliberate FCOIC has evaluated the reported interest and communicated the results of this evaluation to the IRB.

​

  • POLICY

    • As part of the research application that is submitted to the respective funding agency, Investigators and research staff are required to complete a project-specific financial interest disclosure form to be sent to the Deliberate FCOIC. 

      • This form has individuals disclose individual financial interests related to the research.

      •  This form also notifies the Principal Investigator of the entities in which the organization has an institutional financial interest and asks the investigator to disclose whether these interests are related to the research.

    • The IRB may either accept the decisions of the FCOIC or adopt more stringent requirements in order for the research to be approved.

    • Individual Financial Interest means: Anything of monetary value that a Covered Person receives from or owns in a Financially Interested Company, including but not limited to: director's fees; consulting fees; honoraria; scientific advisory board fees; Equity Interest; and Intellectual Property. Individual Financial Interest also includes “in kind” compensation from a Financially Interested Company. PHS-funded investigators must also disclose as Individual Financial Interests all sponsored or reimbursed travel expenses paid for by any entity other than the government or another academic medical center

    • Individual Financial Interest does not include:

      • Salaries from Deliberate

      • Grant support for salaries from Deliberate

      • Royalties received from Deliberate 

      • Reasonable business meals and travel provided for scientific meetings consistent with Deliberate’s Policy on Relationships with Outside Entities. Exception: As indicated above, NIH-funded investigators must disclose such expenses if paid by an entity other than the government or an academic medical center

      • 401K/403B retirement funds or shares held in mutual funds not controlled by the Covered Person

      • Royalties paid to inventors by Deliberate 

        • Although royalties paid to inventors by Deliberate are not considered Individual Financial Interests, royalties which Deliberate receives from an invention or other intellectual property constitute Institutional Financial Interests and so must be disclosed by the Covered Person.

    • The scope of financial interests to be disclosed is broad and must reflect both the Covered Person’s research responsibilities and institutional responsibilities. This information is needed to determine whether a financial interest constitutes a FCOI.

    • What Must Be Disclosed: All Covered Persons must disclose every Individual Financial Interest regardless of value; All Covered Persons must disclose Individual Financial Interests of Related Parties. Examples of Individual Financial Interests that must be disclosed include but are not limited to:

      • Consulting Fees

      • Compensation for service on an Advisory Board (including scientific advisory boards)

      • Officer’s/Director’s Fees

      • Honoraria for lectures or teaching (excluding one-time lectures at other institutions)

      • Equity Interest of any kind and in any amount in a non-publicly or publicly traded Financially Interested Company

      • License fees, royalty income or the right to receive such payments pursuant to a license, option or other entitlement that is directly or indirectly related to the proposed research or services

      • Payments or in-kind support (drugs, devices, or materials) paid or given directly to you from an outside entity

      • Payments made directly to you from foreign government agencies or research institutes

      • Support for personnel in your lab from another institution

      • Intellectual Property that is related to the proposed research or services

      • Travel (for PHS-funded studies only): Federal rules require that all PHS-funded investigators disclose the occurrence of any reimbursed or sponsored travel including the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration, unless the trip is sponsored by a government entity or an academic medical center.

    • Mandatory training on Deliberate’s Financial Conflict of Interest Policy must be completed by all individuals listed below. Following initial training, refresher training will be required at least every four years. If financial conflict of policies are revised in a manner that changes researcher requirements, the training will be updated accordingly.

    • FCOIC and Staff

      • Chairs/Alternates and those with signatory authority for grant approval

      • Investigators involved in research

      • Other staff involved in the grant submission process as determined by the FCOIC/IRB

    • Research Disclosure Forms must be completed as part of every research project submission. Annual disclosure updates must be made by all Covered Persons for the duration of the research. All Deliberate principal investigators, co-investigators, and mentors must complete a Report of Relationships with Outside Entities on an annual basis. Covered Persons who acquire Individual Financial Interests relevant to the research during the course of the study must disclose such interests immediately and must comply with any subsequently imposed Management Plan.

    • Deliberate Obligations to Identify, Review and Manage any FCOI: Under the direction of the FCOIC, its designated subcommittees and/or staff as appropriate, will review disclosures to determine whether there are Individual Financial Interests that are related to the research and pose a conflict.

    • If it is determined that a FCOI exists, an appropriate Management Plan will be developed to manage, reduce or eliminate the conflict. The elements of the Management Plan may include but are not limited to:

      • Disclosure to human subjects, sponsors, and/or the research team involved in conducting the study

      • Disclosure in publications and presentations and to the public

      • Modification of the research plan

      • Change of personnel or responsibilities, or disqualification from all or part of the research

      • Monitoring of research by independent reviewers (internal and/or external)

      • Reduction or elimination of the financial interest

      • Periodic Audits.

    • Non-adherence to this Policy, Management Plans or reporting requirements will be reviewed on a case-by-case basis by the FCOIC and will be reported to the FCOIC and/or the Chief Executive Officer (“CEO”) as appropriate. Individuals who violate this Policy will be subject to a corrective action plan that may include disciplinary action When non-compliance with financial conflict of interest policies and procedures is identified, additional education is immediately provided via direct discussion and additional education sessions with the affected researcher(s).

    • Record Retention: Records of all disclosures and Management Plans will be maintained by the FCOIC for a minimum of three years from the date of submission of the final expenditure report or, where applicable, from other dates as further specified in 45 CFR 74.53(b).

    • PHS/NIH/NSF Funded Research: PHS has specific training, reporting, and monitoring requirements for all federally funded grants. Pursuant to these federal requirements, Deliberate must report to the NIH all individual FCOIs in accordance with this institutional policy and provide the federal funding agency with certain prescribed information of any identified FCOI. 

      • For PHS/NIH or NSF grants, Deliberate reports to the funding agency the existence of a FCOI and certifies that it has been managed, reduced or eliminated satisfactorily. Deliberate also makes the requisite notifications to the NIH of any subrecipient investigator’s(s’) FCOI. 

      • More specifically, Deliberate provides the following information to the PHS Awarding Component:

        • Nature of FCOI

        • Value of Individual Financial Interest

        • Description of the Individual Financial Interest and how it relates to PHS-funded research

        • Elements of Management Plan

  • RESPONSIBILITIES

    • The FCOIC carries out the procedures below.

  • PROCEDURE

    • Perform a preliminary review of the reported financial interest and the research protocol to determine whether a conflict of interests exists. 

    • If there is no conflict of interest:

      • Create a letter that indicates that no conflict exists

      • Send a copy of the letter to the IRB

      • File the letter

      • Take no further action. 

      • If a conflict of interests exists, use the Template:Management Plan (v1.0) to develop a plan to manage, reduce or eliminate the conflict. 

    • Provide the written management plan to the FCOIC for review.

    • If directed by the FCOIC provide the written management plan to the full FCOIC for review.

    • Provide the written management plan to the Investigator for comment and review.

    • Have the plan signed by the CEO and FCOI Committee Chair

    • Provide the IRB with the written management plan for review and approval.

    • When required, provide the final determination to the funding or regulatory agencies.

    • Maintain a copy of determinations and management plans in the FCOIC records.

    • Provide education via the company website to the research community immediately when financial conflict of interest policies are revised in a manner that changes the researcher requirements.

  • MATERIALS

    • None

bottom of page