Financial Conflict of Interest Policy

September 2024

OBJECTIVITY IN RESEARCH POLICY

This policy outlines HEAL Trafficking’s responsibility to ensure objectivity in research, in compliance with 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible Prospective Contractors.”

The U.S. Department of Health and Human Services regulations require institutions that apply for or receive funding from the Public Health Service (PHS) to adopt a financial conflict of interest (FCOI) policy and fulfill specific reporting obligations. This policy reflects HEAL Trafficking’s commitment to transparency and compliance.

Definitions

Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of sponsored research.
Financial Interest: Anything of monetary value, whether or not its value is easily determined.
Investigator: The project director, principal investigator, or any person responsible for the design, conduct, or reporting of sponsored research, including HEAL Trafficking employees, collaborators, and consultants.
Key Personnel: The project director, principal investigator, and others identified as senior or key personnel in grant applications or reports.
Significant Financial Interest: A financial interest related to the investigator’s professional responsibilities at HEAL Trafficking, such as research, teaching, or consultation, that meets the threshold for disclosure.
Sponsored Research: Research funded by a PHS agency through grants, contracts, or cooperative agreements.
Sponsor: The PHS organizational unit providing funding for sponsored research.

Effective Date

This policy applies to all sponsored research issued on or after September 1, 2024.

Reporting Significant Financial Interests

All HEAL Trafficking investigators must disclose significant financial interests, including those of immediate family members. Disclosures must occur under the following conditions:

Publicly Traded Entities: Disclose if income (salary, consulting fees, honoraria, etc.) or equity interests exceed $5,000 in the 12 months preceding disclosure.
Non-Public or Private Entities: Disclose if income or any equity interest exceeds $5,000.
Intellectual Property: Disclose any income from intellectual property rights (e.g., patents, copyrights), excluding HEAL Trafficking income.
Sponsored Travel: Disclose any sponsored travel expenses, excluding government agencies or educational institutions.

Salaries, payments from HEAL Trafficking, intellectual property rights assigned to HEAL, and income from certain government or academic engagements are excluded from reporting.

Disclosure Process

Each investigator must disclose in the following situations:

New Sponsored Research: Disclose any new significant financial interests before submitting funding proposals.
New Investigators: Disclose significant financial interests when joining a sponsored research project.
New Financial Interests: Disclose within 30 days of acquiring a new financial interest.

If a potential FCOI is identified, the CEO, CMO, or Board will request additional information and potentially develop a management plan.

Review Process

HEAL Trafficking’s CEO, CMO, or Board will review all disclosures to determine if a significant financial interest constitutes a financial conflict of interest. If a FCOI is found, the CEO, CMO, or Board will create a management plan within 60 days of disclosure.

Retrospective Review

If a financial interest is discovered that was not timely disclosed, the CEO, CMO or Board will review the affected research within 120 days to assess if the research was biased. A mitigation report will be submitted to the Sponsor if bias is found.

Management Plan

The management plan may include actions such as public disclosure of the FCOI, modification of the research plan, monitoring the research, or changing personnel roles. The investigator must comply with the management plan and provide documentation if required.

Failure to Comply

Non-compliance with this policy will trigger a retrospective review of the research to determine if it was biased. If bias is identified, a corrective action plan will be developed and reported to the Sponsor.

Notice to Sponsor

HEAL Trafficking will notify the Sponsor of any FCOIs prior to expending research funds. If a FCOI is identified after funds have been expended, HEAL Trafficking will submit a report to the Sponsor within 60 days, along with any mitigation measures.

Public Disclosure

HEAL Trafficking will make this policy publicly accessible on its website, including information about key personnel and their financial conflicts of interest, in compliance with applicable regulations.