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CurieDx, Inc Financial Conflict of Interest (FCOI) Policy

Effective Date: October 11, 2024
Review Date: October 11, 2024
Last Revised: October 11, 2024

Policy Scope and Authority

This Financial Conflict of Interest (FCOI) Policy applies to all Investigators participating in Public Health Service (PHS)-funded research at CurieDx. It is established in accordance with 42 CFR Part 50 Subpart F to ensure objectivity in the design, conduct, and reporting of research free from bias due to financial conflicts of interest. All Investigators must comply with this policy as a condition for receiving federal funding.

Purpose

This Financial Conflict of Interest (FCOI) policy is established to promote objectivity in research by ensuring that the design, conduct, and reporting of research funded by Public Health Service (PHS) grants or cooperative agreements are free from bias due to financial conflicts of interest. This policy is consistent with federal regulations as outlined in 42 CFR Part 50 Subpart F.

Applicability

This policy applies to all Investigators, including principal Investigators (PIs), co-Investigators, collaborators, and any other individual responsible for the design, conduct, or reporting of research funded by the PHS at our Institution. It covers both internal and external Investigators who participate in PHS-funded projects.

Definitions

Investigator: Any person responsible for the design, conduct, or reporting of research funded by the PHS.

Significant Financial Interest (SFI): Any financial interest that exceeds $5,000 in value, including remuneration, stock, equity interest, or intellectual property rights.

Financial Conflict of Interest (FCOI): An SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Institutional Responsibilities: Professional responsibilities carried out on behalf of the Institution, including research, teaching, clinical practice, and service.

Disclosure Requirements

Regulatory Citation: 42 CFR 50.603; 42 CFR 50.604(e)(1)-(3); 42 CFR 50.605(a)(1)(2)(3); 42 CFR 50.605(b); 42 CFR 50.604(d); 42 CFR 50.604(f); 42 CFR 50.604(g); 42 CFR 50.604(i); 42 CFR 50.606(a); 42 CFR 50.606(c)

  1. Each Investigator must disclose any Significant Financial Interests (SFIs) related to their institutional responsibilities, including those of the Investigator’s spouse and dependent children. SFIs must be disclosed:
  2. No later than at the time of application for PHS-funded research.
  3. Annually during the period of the PHS award.
  4. Within 30 days of discovering or acquiring a new SFI.

Institutional Official(s):

The Institution designates Therese Canares to:

  1. Solicit and review SFI disclosures from Investigators.
  2. Determine whether an SFI is related to PHS-funded research and whether it constitutes an FCOI.
  3. Implement a management plan as necessary to manage identified FCOIs.

Process for Reviewing SFI Disclosures:

  1. Prior to the expenditure of PHS funds, the designated official(s) will:
  2. Review all Investigator SFI disclosures.
  3. This includes Investigators new to a research project, or existing Investigators with a new SFI
  4. Determine if any SFIs relate to PHS-funded research.
  5. Determine if an FCOI exists that could directly and significantly affect the research.
  6. Develop and implement a management plan to manage the FCOI.

Ongoing Monitoring:

  1. The Institution will monitor compliance with the FCOI management plan until the completion of the research project.

Subrecipient Requirements

Regulatory Citation: 42 CFR 50.604(c)

  1. The Institution will establish a policy for managing FCOIs involving subrecipients by determining whether the subrecipient will follow the FCOI policy of the awardee Institution or the subrecipient’s FCOI policy.

Written Agreement:

  1. The written agreement will require the subrecipient to:
  2. Certify compliance with federal FCOI regulations, or
  3. Report identified FCOIs to the awardee Institution, allowing the awardee to meet its reporting obligations to NIH.

Public Accessibility

Regulatory Citation: 42 CFR 50.604(a); 42 CFR 50.605(a)(5)(i)(iv)

  1. The Institution’s FCOI policy will be publicly accessible via the CurieDx, Inc website.

Public Access to FCOI Information:

  1. Information regarding identified FCOIs held by senior/key personnel will be made available to the public:
  2. Prior to the expenditure of PHS funds.
  3. Within five calendar days of a written request.
  4. The information will be updated at least annually and within 60 days of any newly identified FCOI.
  5. The information will remain accessible for at least three years from the most recent update.

Investigator Training

Regulatory Citation: 42 CFR 50.604(b)

  1. The institution requires that all Investigators participating in PHS-funded research complete FCOI training:
  2. Prior to engaging in PHS-funded research.
  3. At least every four years.
  4. Immediately, if:
  5. The Institution revises its FCOI policy in a way that affects Investigator responsibilities.
  6. An Investigator is newly employed or appointed to the Institution.
  7. An Investigator is found to be non-compliant with the policy or a management plan.

The training will cover the Institution’s FCOI policy, Investigator disclosure responsibilities, and applicable federal regulations.

Reporting to PHS

Regulatory Citation: 42 CFR 50.604(h); 42 CFR 50.605(a); 42 CFR 50.606(a)

  1. The Institution will submit initial, annual, and revised FCOI reports to the NIH, including:
  2. Prior to the expenditure of funds.
  3. Within 60 days of identifying a new FCOI for an Investigator newly participating in the project or an existing Investigator.
  4. Annually to provide the status of the FCOI and any changes to the management plan until the completion of the project.
  5. Following a retrospective review, if necessary, to update a previously submitted report.

The FCOI report will include details such as the nature of the conflict, the value of the financial interest, and how it relates to the PHS-funded research.

Noncompliance and Retrospective Review

If an FCOI is not identified or managed in a timely manner, the institution will conduct a retrospective review within 120 days to determine if the research was biased.

Mitigation Reports:

  1. The Institution will notify NIH promptly if bias is found with the design, conduct, or reporting of NIH-funded research and submit a Mitigation Report as required by 42 CFR 50.605(a)(3)(iii).

Noncompliance:

  1. The Institution will notify NIH if an Investigator fails to comply with the FCOI policy or management plan, and corrective actions will be taken.

Record Retention

Regulatory Citation: 42 CFR 50.604(i)

  1. The Institution will maintain all FCOI-related records for:
  2. At least three years from the date the final expenditures report is submitted to the PHS (NIH), or as specified in 45 CFR 75.361.

Enforcement

Regulatory Citation: 42 CFR 50.604(j); 42 CFR 50.605(a)(3); 42 CFR 50.606(c)

  1. The Institution will enforce its FCOI policy through appropriate sanctions or administrative actions to ensure Investigator compliance.

Retrospective Review and Documentation:

  1. The Institution will complete and document retrospective reviews within 120 days of determining noncompliance or failure to timely disclose SFIs.
  2. If an FCOI is identified after the commencement of the project, a retrospective review will be conducted, and any findings of bias will be reported to the NIH along with corrective actions.

Public Disclosure:

  1. For clinical research involving FCOIs that were not managed as required, the Investigator must disclose the FCOI in each public presentation of the results and request an addendum for previously published presentations.

Certification

The institution certifies in each application for PHS funding that it has implemented this policy, will manage financial conflicts of interest, and will comply with all applicable federal regulations.

This policy will be reviewed periodically and updated to comply with new regulatory requirements.