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Research Financial Conflict of Interest (FCOI) Policy

Purpose

CVS Healthspire Payor & Life Sciences LLC, (CVS HLSS) is committed to fostering and maintaining integrity and ethical conduct in all research activities. The intent of this policy is to ensure there is no potential bias by individuals who can affect the allocation and use of funding in the design, conduct, and reporting of research. This policy has been developed to address and promote compliance with specific U.S. Public Health Service (PHS) requirements as defined in 42 CFR Part 50 Subpart F. This policy is specific to CVS HLSS Financial Conflict of Interest (FCOI) requirements that apply to PHS/NIH funded research.

Definitions

The definitions that apply to PHS/NIH funded research terms and this policy which are used herein are defined in 42 CFR 50 (Subpart F) and 45 CFR Part 94.

Scope

This policy is applicable to individuals performing PHS/NIH funded research who are affiliated with CVS HLSS, identified as (“Covered Persons”) and Relatives of Covered Persons defined as a family member, such as a spouse, parent, child, sibling or close relative, whose personal interests could potentially influence or bias their decision making, creating a potential conflict due to their family connection. Covered Persons include the Principal Investigator and/or Contractor, as well as any other individual responsible for the design, conduct or reporting of applicable research and/or related funding activities. These research activities may include collaborators and consultants.

Training

Pursuant to Federal conflict of interest regulations, each Principal Investigator (PI) and/or Contractor or individual performing applicable PHS/NIH funded research must be informed of CVS HLSS policy on financial conflicts of interest, their responsibilities regarding disclosure of potential financial conflicts of interests, and applicable regulations. The Research Integrity Officer (RIO) is the CVS HLSS colleague responsible for managing the FCOI process and related activities, including training. Training must be completed prior to engaging in research related to any PHS funded research project and refreshed at least every four (4) years.  Additional training must be immediately completed: prior to engaging in research related to any PHS/NIH-funded grant; when FCOI policies are revised in a manner that change Covered Persons requirements; when a Covered Person is new to CVS HLSS; or, when a Covered Person is not compliant with FCOI policies and procedures or a PHS/NIH reportable FCOI Management Plan.  

Disclosure, Review and Monitoring Requirements

Each PI and/or Contractor of a PHS/NIH funded research project shall identify all Significant Financial Interest (SFI) as Relatives prior to time of application for PHS/NIH funded research, at least annually during the period of award, and within 30 days of discovering or acquiring a new SFI.

The ROI will solicit and review SFI disclosures related to a PI’s and/or Contractor’s institutional responsibilities for determination of FCOI in accordance with CVS HLSS policies.

A SFI is considered related to PHS/NIH-funded research when CVS HLSS   through its designated official(s), reasonably determines that the SFI could be affected by the PHS/NIH-funded research; or is in an affiliated entity whose financial interest could be affected by the research. If a FCOI is found, examples of restrictions to manage the conflict include a modification of the research plan or full public disclosure. The PI and/or Contractor may be involved in making the determination of whether the SFI is related to the PHS/NIH-funded research.

An SFI FCOI exists when  CVS HLSS through the RIO, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research.  

A PI and/or Contractor new to research covered by this policy – and any existing PI and/or Contractor with a new SFI – shall disclose any SFIs, which shall be reviewed within 60 days by the RIO to determine whether any SFI is related to PHS/ NIH funded research, whether a FCOI exists, and if so, implement a management plan that specifies the actions that have and will be taken to appropriately to manage the FCOI.

Before using any funds, the RIO will solicit and review PI and/or Contractor disclosures and determine whether a potential FCOI exists. The RIO will create a FCOI management plan to attempt to mitigate any FCOI and ensure compliance with regulations and this policy. PI and/or Contractor must formally agree to the proposed FCOI management plan. Compliance of the management plan will be monitored by the RIO.

Reporting

The RIO will report resolution of matters involving disclosures of SFI in accordance with applicable requirements and utilizing the following reports:

i. Initial report – prior to the expenditure of any funds under a PHS/NIH-funded research project, CVS HLSS must provide to the PHS Awarding Component /NIH an FCOI report regarding any PI and/or Contractor SFI found by the CVS HLSS to be a FCOI in accordance with the regulation.

ii. During on-going PHS/NIH-funded research projects – CVS HLSS shall submit an FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, CVS HLSS shall submit a FCOI report to the PHS Awarding Component /NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance.

iii. Annual FCOI report – For any FCOI previously reported to the PHS Awarding Component /NIH, CVS HLSS shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.  The RIO will notify PHS Awarding Component /NIH promptly if bias is found with the design, conduct or reporting of PHS/NIH-funded research and submit a Mitigation Report to explain what action(s) have been or will be taken to mitigate the effects of the bias in accordance with the regulation.

The RIO will notify PHS Awarding Component /NIH promptly if a PI and/or Contractor fails to comply with CVS HLSS’ FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research. The RIO and PI and/or Contractor will develop and undergo a corrective action plan for noncompliance with the CVS HLSS FCOI policy or the management plan.

Reporting to PHS Awarding Component /NIH will include reporting elements (e.g., affiliated entity name, name of the PI or Contractor with the FCOI, nature of SFI(s), value of the SFI(s), etc.) as required by the regulation.

Documentation of any retrospective reviews shall include at a minimum the following key elements: Project Number; Project Title; PI and/or Contactor PIs if multiple PI’s model is used; Name of the PI and/or Contractor with the FCOI; Name of the affiliated entity with which the PI and/or Contractor has an FCOI; Reasons for the retrospective review; Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed); Findings of the review; and Conclusions of the review.

CVS HLSS shall notify PHS Awarding Component /NIH promptly (and take corrective action) if a PI and/or Contractor (or subrecipient Investigator) fails to comply with the CVS HLSS’ FCOI policy or noncompliance with a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research.

Maintenance of Records

Maintain all FCOI-related records relating to all PI d and/or Contractor disclosures of financial interests and the CVS HLSS’ review of, and response to, such disclosures (whether or not a disclosure resulted in the CVS HLSS’ determination of a financial conflict of interest) and all actions under the CVS HLSS’ policy or retrospective review, if applicable: for three years from the date of the final expenditure report is submitted, or as required by 45 CFR 75.361.

Enforcement Mechanisms and Remedies and Noncompliance

PI and/or Contractor compliance with this policy – including any management plan – is required and CVS HLSS may take disciplinary action for any failure to do so in order to ensure compliance.

Consistent with federal regulations, there will be a retrospective review within 120 days of the CVS HLSS determination of noncompliance when an SFI is not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner, including: failure by the PI and/or Contractor to disclose a significant financial interest that is determined by CVS HLSS to constitute a financial conflict of interest; failure by CVS HLSS to review or manage such a financial conflict of interest; failure by the PI and/or Contractor to comply with the financial conflict of interest management plan. The required retrospective review elements can be found in 42 CFR 50.605(a)(3)(ii)(A).

For PHS/NIH-funded research, failure to comply with this policy or the applicable regulations shall result in the following:

  • If the PI’s and/or Contractor’s failure to comply with this policy or a financial conflicts of interest management plan has biased the design, conduct, or reporting of the PHS/NIH -funded research, CVS HLSS shall promptly notify the PHS Awarding Component/NIH of the corrective action taken or to be taken.
  • CVS HLSS will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts; and

If DHHS determines that a clinical PHS/NIH-funded research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a PI and/or Contractor with a financial conflict of interest that was neither disclosed nor managed, CVS HLSS shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if necessary.

Subrecipient Requirements

CVS HLSS shall establish a written agreement with subrecipients, if any, performing PHS/NIH funded research, confirming their compliance with either their own or CVS HLSS FCOI policy and obtaining a certification to that effect. The written subrecipient agreement shall contain a requirement for the subrecipient to report identified FCOIs for its PIs and/or Contractors in a time frame that allows CVS HLSS to report identified FCOIs to the PHS Awarding Component /NIH as required by the regulation.

Public Accessibility Requirements

CVS HLSS will publish this FCOI policy on its public facing website. Information concerning identified FCOIs held by the PI and/or Contractor, or any listed key personnel (as defined in Federal regulations) will be publicly accessible prior to the expenditure of funds. CVS HLSS will respond to all written requests for information within five (5) calendar days. It will then release the required information about a FCOI containing the minimum elements as provided by regulation. Publicly accessible FCOI information may be updated, at least annually and/or within sixty (60) days of a newly identified FCOI. Records of PI and/or Contractor FCOIs will be retained and made available three years from the date the information was most recently updated.

For question, please contact ResearchCompliance@cvshealth.com