Financial Conflict of Interest Policy

IV. COMMITMENT TO OBJECTIVITY

Evidation is committed to maintaining the highest standards of integrity, transparency, and objectivity in research. Financial conflicts of interest must be identified and appropriately managed to ensure that research is free from bias or the appearance of bias.

V. TRAINING REQUIREMENTS

Each PHS/NIH supported Investigator shall be required to complete Financial Conflict of Interest (FCOI) training in accordance with Evidation’s Training Matrix LIST003 and SOP002 Employee Training and Personnel Qualifications Procedure, and relevant regulatory requirements regarding their responsibility to disclose foreign and domestic Significant Financial Interests (SFIs) under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training is comprised of this Policy and the PHS/NIH FCOI Training Tutorial (or equivalent). All training is assigned and traced via Evidation’s eQMS.

Training must be completed prior to engaging in research related to any PHS/NIH-funded grant and at least every four (4) years, when the policy is updated, and upon hire. Additional training may be required in the event an Investigator is found to be not in compliance with this policy. 

At a minimum, Investigator(s) must be informed of:

• The institution’s policy (this Policy)
• Federal regulation associated with FCO
• Investigator’s disclosure responsibilities of of all foreign and domestic significant financial interests (SFI) 

VI. SUBRECIPENT COMPLIANCE

A subrecipient relationship exists when federal funds flow from or through Evidation to another individual or entity that carries out a substantive portion of a PHS/NIH-funded research project and is accountable to Evidation for programmatic outcomes and compliance. Evidation will take reasonable steps to ensure that all subrecipient (e.g. collaborators, consultants, contractors, subcontractors, and sub-awardees) Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F.

Written agreements between Evidation and the subrecipient, such as a Statement of Work (SOW) or Master Service Agreement (MSA) may specify whether Evidation’s FCOI Policy or the subrecipient’s own FCOI policy applies to subrecipient Investigators

• If the subrecipient’s FCOI policy applies:
  
  • The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations.
  • The agreement specifies the timeframe for the subrecipient to report identified FCOIs to Evidation in time for Evidation to meet PHS/NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI).
  • Typically, this means requiring subrecipients to report FCOIs to Evidation within 50–55 days of identification. Evidation’s Designated Official (DO) then submits the subrecipient FCOI report to PHS/NIH through the eRA Commons FCOI Module.
• If the subrecipient cannot certify compliance:
  
  • The agreement specifies that Evidation’s FCOI Policy applies.
  • In this case, subrecipient Investigators must disclose their SFIs to Evidation. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for Evidation.
  • The agreement allows sufficient time for the DO to review, manage, and report any resulting FCOIs. When an FCOI is identified, the DO implements a Management Plan, monitor compliance by the subrecipient Investigator, and submit the required FCOI report to PHS/NIH via the eRA Commons FCOI Module.

VII. REQUIREMENTS FOR INVESTIGATOR DISCLOSURE

Each Investigator (as defined in this policy) is required to disclose their foreign and domestic SFIs (and those of the Investigator’s spouse and dependent children) related to the Investigator’s institutional responsibilities (as defined in this policy). The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the 2011 regulation. 

Investigators are required to disclose SFIs, using the POL026-F1 SFI Disclosure Form, at the following times:

• At the time of the application for PHS/NIH-funded research
• At least annually for the duration of the award period. Annual disclosures must include:
  ‍
  
  • Any new information that was not previously disclosed under this policy
  • Updated details for any previously disclosed SFI (such as change in the value of an equity interest).
    
• Within 30 days of discovering or acquiring a new SFI (e.g. through purchase, marriage, or inheritance).
• When an investigator is new to participating in a PHS/NIH-funded research project
  Within 30 days of any new reimbursed or sponsored travel

Disclosures must include sufficient detail to allow a determination of whether or not a FCOI exists.

VIII. REVIEW OF INVESTIGATOR’S DISCLOSURE

Evidation has designated its Chief Financial Officer (CFO) as the Designated Official (DO). The CFO can delegate this responsibility as required (such as in the instance the DO has a disclosed SFI related to the research under review, or where additional independence is warranted).

The DO must solicit and review Investigator SFI disclosure (and those of the Investigator’s spouse and dependent children) related to an Investigator’s institutional responsibilities for a determination of a FCOI related to PHI/NIH-funded research. Review of SFI must occur:

• No later than at the time of the application for PHS/NIH-funded research
• Prior to the issuance of a new award or before any expenditure of award funds
• At least annually for the duration of the award period
• Within 30 days of discovering or acquiring a new SFI
• Within 60 days in the event an investigator is new to participating in a PHS/NIH-funded project, or an Investigator discovers or acquires a new SFI during the project

SFI review responsibilities include: 

• Review all Investigator SFIs disclosed
• Determine if any SFIs related to the Investigators PHS/NIH-funded research
• Determine if a FCOI exists (i.e. an SFI that could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research)
• Develop and implement a Management Plan to manage the FCOI(s) (as required)

IX. REVIEW AND DETERMINATION OF FCOI

The DO is responsible for assessing the relatedness of SFIs to PHS/NIH-funded research and determining when they constitute a FCOI.

SFIs are reviewed by the DO in collaboration with the Investigator to determine whether or not the SFI is related to PHS/NIH-funded research such as in the event that the SFI

• Could be affected by the PHS/NIH-funded research; or
• Is in an entity whose financial interest could be affected by the research

A FCOI exists when the Institution, through its designated official(s), reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research (“significantly” meaning that the financial interest would have a material effect on the research).

X. MANAGEMENT OF FCOI

In the event Evidation identifies a FOCI related to PHS/NIH-funded research, the DO shall implement a Management Plan prior to the expenditure of funds, or within regulatory timelines (if identified later). Investigators are required to comply with all Management Plans.

Management strategies may include:

• Public disclosure of the FCOI (e.g. in publications or presentations, to study personnel, to the IRB etc.). While public posting of FCOIs is required only for senior/key personnel the DO may require disclosure of any Investigator’s FCOI as a condition of a Management Plan.
• Disclosure to research participants (e.g. in the Informed Consent document)
• Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of research
• Modification of the research plan
• Change of personnel, responsibilities, or roles
• Reduction or elimination of the financial interest
• Severance of relationships creating the conflict

The DO communicates the determination and the Management Plan in writing to the Investigator and the appropriate supervisor. The Management Plan should include the following key elements:

• The role and principal duties of the conflicted Investigator in the research project;
• Conditions of the Management Plan;
• How the Management Plan is designed to safeguard objectivity in the research project;
• Confirmation of the Investigator’s agreement to the Management Plan (e.g. Investigator Signature)
• How the Management Plan will be monitored to ensure Investigator compliance; and
• Other information as needed.

No expenditures on a PHS/NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DO submits an FCOI report to PHS/NIH via the eRA Commons FCOI Module.

XI. MONITORING INVESTIGATOR COMPLIANCE

In the event FCOI are identified and a Management Plan is required, Investigator compliance with the Management Plan is monitored for the duration of the award period in accordance with the monitoring requirements defined in the Monitoring Plan.

XII. NONCOMPLIANCE & RETROSPECTIVE REVIEW OF INVESTIGATOR DISCLOSURE

If an FCOI is identified that was not disclosed or managed in accordance with this policy and regulatory requirements, including:

• Failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI
• Failure by the institution to review or manage an FCOI
• Failure by the Investigator to comply with an established management plan

The DO will:

• Review the SFI within 60 days of disclosure to determine whether the SFI is related to the PHI/NIH-funded research and determine whether an FCOI exists.
• Implement a Management Plan (as described in section 12: Management of FCOI), if necessary
• Conduct a Retrospective Review within 120 days to identify occurrence of noncompliance, and/or bias in the design, conduct or reporting of PHS/NIH-funded research.
  
  • If the Retrospective Review identifies a noncompliance, and an update to a previously identified FCOI is needed, a Revised Report is required.
  • If the Retrospective Review found that bias occurred, a Mitigation Report is Required.
• Revised Report includes at a minimum:
  
  • Project number
  • Project title
  • Project Director/Principle Investigator (PD/PI) or contact PD/PI if a multiple PD/PI model is used
  • Name of Investigator with the FCOI
  • Name of the entity with which the Investigator has a financial conflict of interest
  • Reason for Retrospective Review
  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
  • Findings of the review
  • Conclusion of the review (determination of bias)
    
• The Mitigation Report must include at a minimum:
  
  • All elements included in the Retrospective Review (as described above)
  • A description of the impact of the bias on the research project
  • The Institution’s plan of action, or actions taken to eliminate or mitigate the effect of bias
• If no bias is found, no additional action is required.

XIII. CLINICAL RESEARCH REQUIREMENTS

If Health and Human Services (HHS) determines that a PHS/NIH-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, Evidation requires the Investigator to disclose the conflict in every public presentation of the research results and to request an addendum to previously published presentations.

XIV. INSTITUTION REPORTS TO PHS/NIH

Evidation will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to PHS/NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified (i.e. no award means no FCOI report, and no FCOI means no FCOI report).

Evidation will report FCOIs to the PHS Awarding Component:

• Initial Report
  
  • Prior to the expenditure of funds
  • Within 60 days of identifying a new, or newly existing FCOI for an existing investigator
  • Within 60 days of an identification of a FCOI for an Investigator who is newly participating in the project
• Revised Report (within 150 days of submission of the Initial Report)
  
  • After a Retrospective Review (to update a previously submitted report)
  • In the event new information is obtained regarding a previously identified FCOI
• Mitigation Report
  
  • After Retrospective Review (when bias is identified)
• Annual Report (required at least, annually, for the duration of the award)

Annual Reports indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable. The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report and at the time of any grant extension in accordance with PHS/NIH guidance.

Initial Report includes the following at a minimum:

• Project number
• Project title
• PD/PI or contact PD/PI if a multiple PD/PI model is used
• Name of Investigator with the FCOI
• Name of the entity with which the Investigator has a financial conflict of interest
• Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
• Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999;$10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), 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
• A description of how the financial interest relates to the PHS/NIH-funded research and the basis for the Institution's determination that the financial interest conflicts with such research
• A description of the key elements of the Institution's Management Plan, including:
  
  • Role and principal duties of the conflicted Investigator in the research project;
  • Conditions of the Management Plan;
  • How the Management Plan is designed to safeguard objectivity in the research project;
  • Confirmation of the Investigator's agreement to the Management Plan (e.g. Investigator Signature);
  • How the Management Plan will be monitored to ensure Investigator compliance; and
  • Other information as needed.
• The Annual Report must include at a minimum:
  ‍
  • All elements included in the Initial Report
  • Status of the FCOI (whether it is still being managed or no longer exists) and any changes to the management plan, if applicable.

XV. MAINTENANCE OF RECORDS

Evidation maintains FCOI-related records, for at least 3 years, in accordance with Evidation’s Record Retention Schedule (LIST009) and applicable regulatory requirements. Evidation will retain all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (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. Records retained may include:

• Disclosures
• Retrospective Reviews
• Responses to Disclosures and FCOI Determinations
• Management Plans and Mitigation Plans
• Initial and Annual Reports
• Any other documentation regarding actions taken under this policy or through retrospective review.

XVI. PUBLIC ACCESSIBILITY

Evidation’s policy for Financial Conflicts of Interests (this policy) shall be made available via Evidation’s publicly available website (https://evidation.com)

Identified FCOIs held by Senior/Key Personnel will be publically available upon request. Evidation ensures public accessibility, by providing a written response within five business days to request for information about any SFI that meets all three of the following criteria:

• The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and any other individual identified by Evidation as Senior/Key Personnel in the application, progress report, or other PHS/NIH submission)
• Evidation has determined that the SFI is related to the PHS/NIH-funded research.
• Evidation has determined that the SFI constitutes a FCOI.

When applicable, Evidation will make available at least the following information:

• Investigator name
• Investigator’s title and role on the research project
• Name of entity in which the SFI is held
• Nature of the SFI
• Approximate dollar value of the SFI (in the following ranges: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000) or a statement that value cannot be readily determined

The written response notes that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the institution’s identification of a new FCOI, which should be requested subsequently by the requestor.

XVII. ENFORCEMENT AND NONCOMPLIANCE

Failure to comply with this policy, including failure to disclose Significant Financial Interests, failure to comply with a Management Plan, or failure to complete required training may result in corrective action(s), which may include:

• Additional training
• Increased oversight
• Restrictions on participation in research activities
• Disciplinary action, up to and including termination

Corrective action(s) may be documented in a CAPA in accordance with Evidation’s Corrective and Preventative Action Procedure (SOP015).