Financial Conflict of Interest Policy

Outcome Referrals is dedicated to maintaining public trust in the integrity of our research-related activities. The identification and responsible management of financial conflicts of interest (FCOI) are crucial both for safeguarding research objectivity and for compliance with federal regulations and Outcome Referrals policies.

 

As a research company, Outcome Referrals is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. Outcome Referrals has implemented this policy to identify, manage, reduce, and eliminate financial conflicts of interest.  We must enforce an FCOI policy that meets regulatory requirements to be eligible for NIH funding.  

 

The procedures described in this policy were created and designed primarily to comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulations, Promoting Objectivity in Research (42 CFR Part 50 Subpart F), which mandates standards for unbiased research design, conduct, and reporting under NIH grants or agreements.  This policy documents the process for identifying and managing financial conflicts of interest, ensuring the integrity of NIH-funded research at Outcome Referrals, Inc.  

 

DEFINITIONS

The following definitions are provided as a reference and are considered key definitions in understanding the Regulations of FCOI. A complete list of official definitions can be found at (42 CFR 50.603).

 

• Institution means any domestic or foreign, public or private, entity or organization (excluding a federal agency) applying for or receiving NIH research funding.

• Investigator means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, which may include, for example, collaborators or consultants.

• Responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

• Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.

• Financial interest means anything of monetary value, whether or not the value is readily ascertainable. 

• Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

• Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the Regulations.

• Financial Administrator (Designated Official) is the individual designated to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.

• Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.

• Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

• Significant financial interest (SFI) means a financial interest consisting of one or more of the following interests of the Investigator (and his/her immediate family) that reasonably appear to be related to the Investigator’s institutional responsibilities:

• With regard to any publicly traded entity, a significant financial interest 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 (e.g., stock, stock option, or other ownership interest) in the entity as of the date of disclosure, when aggregated, exceeds $5,000;

• With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12-months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or his/her immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests in excess of $5,000.

 

Investigators also must disclose the occurrence of any reimbursed or sponsored travel in excess of $5,000 related to their company responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by federal, state, or local  government agency located in the United States, a United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.  

 

Note: Reimbursed or sponsored travel from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income is more than $5,000. The details of the disclosure will include, at minimum, the purpose of the trip, the identity of the sponsor/ organizer, the destination, and the duration.

 

Significant financial interest does not include the following:

1. Salary, royalties, or other remuneration paid by Outcome Referrals to the Investigator if the Investigator is currently employed or otherwise appointed by Outcome Referrals;

2. Intellectual property rights assigned or licensed to Outcome Referrals and agreements to share in royalties related to such rights;

3. Any ownership interest in Outcome Referrals held by the Investigator, if Outcome Referrals is a commercial or for-profit organization;

4. 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;

5. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States, a United States institution of higher education, an academic teaching hospital; a medical center; or a research institute that is affiliated with a United States institution of higher education; or

6. Income from service on advisory committees or review panels for a federal, state, or local government agency located in the United States, a United States institution of higher education, an academic teaching hospital; a medical center; or a research institute that is affiliated with a United States institution of higher education.

   • Significant Financial Interest Disclosure Form (SFIDF) a company form by which required person provides an itemized disclosure statement with regard to SFI categories. The form is submitted to the Financial Administrator upon assignment of work sponsored by a federal, state, or local government grant, yearly thereafter, and when any occurrences of a new SFI arises. 

 

SUMMARY OF PROCESS

Significant Financial Interests (“SFI”; as defined above) shall be disclosed on the Significant Financial Interest Disclosure Form (“SFIDF”) by an Investigator requesting government-sponsored funds for a research project or by an Investigator when a Significant Financial Interest arises during the course of research. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFIDF annually.

 

It is Outcome Referrals, as well as the Principal Investigator’s responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal or application for human subjects’ approval.

 

It shall be the responsibility of the Principal Investigator of a Research project to identify all Investigators who have a SFI requiring disclosure under this policy and to ensure that a SFIDF is prepared and submitted. In addition, the Principal Investigator shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed. To assist PIs with this responsibility, the Financial Administrator will send out reporting reminders, SFIDF forms, and receive completed SFIDFs for review, these will occur yearly and just prior to application submissions. PIs are responsible for reporting SFIs that occur between these reporting timelines.

 

The SFIDF and supporting materials are forwarded to the company’s designated administrator of this FCOI Policy (“Financial Administrator”) for review. The Financial Administrator will be responsible for (in consultation with the CEO) evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy.

 

Advance approval by the Financial Administrator is required prior to engaging in government-sponsored research. An SFI review must be completed before any expenses are incurred under an award. Typically, the CEO provides approval as signatory of the research agreement, simple agreement, or engagement contract, or provides written approval for the Financial Administrator (an AOR) or company signatory to sign in their stead.

 

Annual updates are required of all Investigators. Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately to the Financial Administrator. Annual updates and newly acquired interests are reported using the SFIDF. This process is meant to inform each Investigator of the (i) Institution policy; (ii) Investigator’s disclosure responsibilities; and (iii) the Regulations (42 CFR 50.604(b)).

 

TRAINING

The NIH’s FCOI tutorial on (42 CFR Part 50 Subpart F) was designed to provide training on what constitutes a financial conflict of interest. This course is required for anyone involved with an NIH-funded project, which includes all Investigators, consultants and employees who are or will be responsible for the design, conduct, or reporting of the research funded by the NIH.

 

1. Investigators involved in NIH-funded research must know Outcome Referral’s FCOI policy, the relevant federal regulations (42 CFR Part 50 Subpart F), and their disclosure obligations.

2. The Principal Investigator must identify all Investigators with disclosable SFIs and ensure the submission of an SFI Disclosure Form.

3. Investigators must complete training on (42 CFR Part 50 Subpart F) and Outcome Referral’s FCOI policy before starting NIH-funded research, every four years, when Outcome Referral’s FCOI policy changes, when they become a new employee, or if they breach the FCOI policy or management plan. 

4. Training requirements for Investigators requires: 

5. Outcome Referral’s FCOI Policy.

6. NIH’s FCOI tutorial on (42 CFR Part 50 Subpart F), necessary for all involved in NIH-funded projects. Certificates of completion should be turned into the Financial Administrator, so it can be filed in the company's records. A copy should be retained for the Investigators own personal files.  Training is mandated before any NIH-funded research begins, after FCOI policy updates, upon non-compliance, or when joining the company, and must be repeated every four years. 

The course can be accessed online at any time by visiting: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.

1. The FCOI Policy implementation includes:

2. Providing a written copy to each Investigator.

3. Adding the policy to the company's secure shared drive or public website.

 

 

PROCEDURES

• Disclosure and Submission of a Significant Financial Interest – Investigators must report SFIs (including those of their spouses and dependent children) that are pertinent to their institutional duties and meet or surpass the SFI criteria established by this policy, through the company's Significant Financial Interest Form.  The form is completed:

• At the NIH-funded research application stage.

• Annually throughout the award duration.

• Within 30 days of identifying or obtaining a new SFI.

 

All fully completed SFIDF shall be submitted to the Financial Administrator.

• Review of SFIDF – The task with eliciting and evaluating SFI disclosures from Investigators (and those of the Investigator’s family) connected to their institutional duties will be conducted by the Financial Administrator to determine whether a potential for conflict of interest exists.

• An SFI is related to NIH-funded research if the Financial Administrator deems that it:  

  1. Might be influenced by the NIH-funded research; or  

  2. Belongs to an entity that could be impacted financially by the research.

• Investigators may participate in determining the relevance of the SFI to NIH-funded research.

• An FCOI is present if the Financial Administrator believes that the SFI could notably sway the NIH-funded research's design, conduct, or reporting. In such cases, appropriate actions will be considered based on the SFI Disclosure Form, potentially necessitating a management plan that specifies the terms and conditions to adhere to this policy.

• Before utilizing any NIH funds, the Financial Administrator is required to:

  1. Assess all SFI disclosures from Investigators.

  2. Decide whether any SFIs relate to the NIH-funded research.

  3. Ascertain the existence of any FCOIs and, if they exist.

  4. Formulate and enforce a management plan to address the FCOIs.

e.   Should a new Investigator join, or an existing Investigator report a new SFI in an NIH-funded research project, the Financial Administrator must evaluate the SFI disclosures and ascertain the presence of an FCOI with 60 days.

• Identification of SFIDF – If it is determined that there is an actual or potential FCOI, then steps will be taken to establish the required measures needed to address it. A management plan may be required to outline the terms, conditions and restrictions to ensure compliance with this policy. 

• To manage, mitigate, or eradicate actual or potential conflicts of interest, the management plan might necessitate various actions, including but not limited to: 

  1. Making significant financial interests known to the public.

  2. Independent evaluation of research protocols.

  3. Independent oversight of the research.

  4. Altering the research strategy.

  5. Prohibiting participation in part or all of the funded research.

  6. Selling off significant financial interests.

  7. Cutting ties that pose actual or potential conflicts.

• All management plans are required to be signed by the Investigator and the Financial Administrator (in consultation with the Outcome Referral’s CEO). 

• Compliance of the management plan shall be monitored by the Financial Administrator and implemented within 60 days of identified FCOI.

• If Outcome Referrals discovers an SFI that an Investigator did not disclose in a timely manner or was not previously assessed during an ongoing NIH-funded research project, the Financial Administrator is required to review the SFI disclosures and determine if a FCOI is present within 60 days. If an FCOI is identified, a management plan detailing the actions undertaken and those planned for future management of the FCOI will be implemented.

• Outcome Referrals is tasked with overseeing FCOIs for all Investigators, including those of a subrecipient Investigator, ensuring adherence to management plans until the research project is concluded.  

  • Reporting Requirements to NIH – Outcome Referrals is required to submit initial, yearly, and updated FCOI reports containing all details mandated by (42 CFR Part 50 Subpart F) to the NIH through the eRA Commons FCOI Module for both the Institution and its subrecipients, where relevant, as outlined below:

• Before using any funds.

• Within 60 days of discovering an FCOI for an Investigator who is new to the project.

• Within 60 days upon finding new or previously unidentified FCOIs for current Investigators.

• Annually, concurrent with the submission of the annual progress report, detailing the FCOI’s status and any modifications to the management plan until the project’s conclusion

• Following a retrospective review to amend an earlier report if additional information comes to light after the review is completed.  

 

Outcome Referrals is obligated to immediately inform NIH if any bias is detected in the design, execution, or reporting of NIH-funded research. A Mitigation Report will be provided to outline steps taken to counteract the impact of the bias in line with (42 CFR Part 50 Subpart F). The report will include all required components such as the entity name, the Investigator with the FCOI, the nature and value of the SFI(s), among others, as specified by (42 CFR Part 50 Subpart F).  

 

Outcome Referrals must immediately inform NIH if an Investigator breaches this FCOI policy or if there's evidence suggesting that an FCOI management plan may have skewed the design, execution, or reporting of NIH-funded research. Outcome Referrals is responsible for implementing necessary corrective measures in response to any such noncompliance or influence on research outcomes.    

• Record Keeping – Outcome Referrals shall preserve all records pertaining to Investigator SFI disclosures, and the company’s examination and response to these disclosures— irrespective of whether a disclosure led to an FCOI determination—along with all proceedings in accordance with the company's policy or retrospective analysis, as applicable:

• For a minimum of 3 years following the submission date of the final expenditure report to the NIH.

• Or, if relevant, from dates delineated in (45 CFR 75.361).

  • Violations of FCOI Policy - Should an Investigator fail to adhere to the FCOI policy or management plan, disciplinary or administrative measures will be enforced, which could include a formal reprimand, restrictions on fund usage, forfeiture of compensation, or dismissal.

• The Financial Administrator shall make recommendations to the CEO regarding the impositions of sanctions or disciplinary proceedings against the violating individual. 

• The Financial Administrator and CEO will review together with the employee or Investigator the specific behaviors and consequences that are determined relevant based upon review, and any other administrative actions to assure Investigator compliance, including but not limited to supervised research activities. 

• If there is noncompliance due to untimely disclosure or management of an SFI or an FCOI, Outcome Referrals will conduct a retrospective assessment within 120 days to address:

  1. Non-disclosure of a significant financial interest by the Investigator which the company deems to be an FCOI.

  2. The company's failure to evaluate or manage an FCOI.

  3. The Investigator's non-compliance with the FCOI management plan.

• The retrospective review will be documented and will include, at minimum, the following:

  1. Project number

  2. Project title

  3. PD/PI and contact information

  4. Name of Investigator with the FCOI

  5. Name of the entity with which the Investigator has an FCOI

  6. Reasons for the retrospective review

  7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed)

  8. Findings of the review

  9. Conclusions of the review.

• If a project funded by NIH involves clinical research evaluating the safety or effectiveness of technology from Outcome Referrals and is designed, conducted, or reported by an Investigator with an FCOI not managed or reported as mandated by (42 CFR Part 50 Subpart F), Outcome Referrals will mandate that the Investigator:

  1. Reveal the FCOI in all public disclosures of the research findings.

  2. Seek an amendment to any previously published presentations of the research.   

• Subrecipient Requirements – When applicable, Outcome Referrals will comply with all subrecipient requirements according to (42 CFR 50.604(c)) and (NIH Grants Policy Statement 15.2.1).   

• Outcome Referrals will determine through a formal agreement if the subrecipient will adopt our FCOI policy or their own. 

• If the subrecipient’s policy is adopted:

  1. Outcome Referrals will acquire confirmation that the subrecipient’s FCOI policy is consistent with (42 CFR Part 50 Subpart F).

  2. Outcome Referrals will mandate in the subrecipient contract that the subrecipient must promptly report any FCOIs of its Investigators to enable the company to fulfill reporting obligations to the NIH as dictated by (42 CFR Part 50 Subpart F).

  3. As an alternative, Outcome Referrals will include a provision in the subrecipient contract obligating the subrecipient to submit and allow review of Investigator disclosures, assisting the company in identifying, managing, and reporting FCOIs to the NIH.  

• Public Accessibility Requirements – Outcome Referrals will provide public access to this policy on our publicly accessible page of www.outcomereferrals.com. The Financial Administrator will ensure that any updated versions of this policy are provided for immediate posting upon implementation.  The policy will:

• include the minimum elements for (42 CFR Part 50 Subpart F);

• be accessible within 5 business days upon written request;

• be updated annually, with current information provided upon request;

• be revised within 60 days of newly identified FCOI; and

• remain available for 3 years from the date of the last update.  

​