Financial Conflict of Interest (FCOI) Policy for the Latino Medical Student Association – Northeast (LMSA-NE)
This policy is designed to ensure compliance with NIH FCOI regulations and to protect the integrity of research conducted by LMSA-NE. By identifying and managing potential financial conflicts of interest, the organization seeks to maintain transparency and ensure the credibility and objectivity of all research activities.
Effective Date: April-1-2025
Approved By: Juan Carlos Ball, Chief Financial Officer
This document supersedes any previous version.
1. Purpose
The purpose of this policy is to ensure that all research conducted by LMSA-NE, including NIH-funded research, is free from bias resulting from any financial conflict of interest (FCOI). This policy provides guidelines to identify, manage, and disclose financial conflicts of interest in compliance with the U.S. Department of Health and Human Services (HHS) regulation 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, and other relevant federal regulations.
2. Scope
This policy applies to all individuals involved in the design, conduct, or reporting of NIH-funded research at LMSA-NE, including all investigators, subrecipients, consultants, collaborators, and any other individuals engaged in research-related activities.
3. Key Definitions
4. Investigator Responsibilities
5. Institutional Responsibilities
6. FCOI Reporting
7. Maintenance of Records
The institution will maintain records of all financial interest disclosures, FCOI determinations, and management plans for at least three years after the completion of the related research. These records will be made available to the NIH upon request and will be retained in accordance with applicable regulations.
8. Enforcement
Failure to comply with this policy may result in disciplinary action, which may include removal from the research project, suspension, or termination of the investigator's participation, or other actions deemed appropriate by the institution. Investigators who fail to disclose financial interests or who violate the terms of an FCOI management plan may be subject to institutional disciplinary procedures.
9. Policy Accessibility
This FCOI policy will be posted on the organization’s publicly accessible website. All investigators and personnel involved in research will be informed of this policy and must acknowledge receipt and understanding of the policy before engaging in NIH-funded research.
10. Amendments
This policy will be reviewed periodically and updated as necessary to ensure compliance with the most current NIH regulations and to reflect any changes in institutional practices. The organization will notify all relevant stakeholders of any amendments to the policy.
Effective Date: April-1-2025
Approved By: Juan Carlos Ball, Chief Financial Officer
This document supersedes any previous version.
1. Purpose
The purpose of this policy is to ensure that all research conducted by LMSA-NE, including NIH-funded research, is free from bias resulting from any financial conflict of interest (FCOI). This policy provides guidelines to identify, manage, and disclose financial conflicts of interest in compliance with the U.S. Department of Health and Human Services (HHS) regulation 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, and other relevant federal regulations.
2. Scope
This policy applies to all individuals involved in the design, conduct, or reporting of NIH-funded research at LMSA-NE, including all investigators, subrecipients, consultants, collaborators, and any other individuals engaged in research-related activities.
3. Key Definitions
- Investigator: Any individual who is responsible for the design, conduct, or reporting of NIH-funded research, including Principal Investigators (PIs), Co-investigators, collaborators, consultants, and other individuals who contribute to the research.
- Significant Financial Interest (SFI): A financial interest that could reasonably be determined to directly and significantly affect the design, conduct, or reporting of NIH-funded research. This includes:
- Remuneration (e.g., salary, consulting fees, honoraria, paid authorship)
- Equity interests (e.g., stocks, stock options)
- Royalties
- Reimbursed or sponsored travel
- Financial Conflict of Interest (FCOI): A situation where an investigator’s significant financial interest is related to the NIH-funded research and could directly and significantly affect the research. The FCOI determination is made when the financial interest may influence the objectivity or integrity of the research.
4. Investigator Responsibilities
- Disclosure of Financial Interests: Investigators must disclose any Significant Financial Interests (SFIs) that are related to their institutional responsibilities, including but not limited to income from consulting, equity interests, royalties, and sponsored or reimbursed travel. This disclosure should include both domestic and foreign financial interests.
- Foreign Financial Interests: Investigators must disclose any foreign financial interests when income from foreign entities or foreign governments exceeds $5,000. This includes, but is not limited to, income from foreign institutions, governments, and advisory panels.
- Timing of Disclosures: Investigators are required to disclose SFIs at the time of application for NIH funding, at the time of annual updates, and whenever a new financial interest arises that could impact the research.
5. Institutional Responsibilities
- Review of Disclosures: The institution’s designated officials (e.g., Conflict of Interest Committee) are responsible for reviewing all disclosures of SFIs to determine whether an FCOI exists. This review will assess whether the financial interest could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
- Management of FCOIs: When an FCOI is identified, the institution will implement a management plan to address and mitigate the conflict. Management strategies may include modifying the research plan, changing the investigator’s role, monitoring the research, or other actions that ensure objectivity in the research.
- Training: All investigators and key personnel involved in NIH-funded research must undergo training on the FCOI policy and regulations. The institution will provide training and resources to ensure understanding of the responsibilities regarding financial disclosures and FCOI management.
- Subrecipient Compliance: If the institution collaborates with subrecipients (e.g., subcontractors or consortium members) for NIH-funded research, the institution will ensure that the subrecipient complies with the FCOI regulations. Subrecipients must disclose any financial conflicts of interest related to the research in accordance with this policy.
6. FCOI Reporting
- Reporting to NIH: The institution will report any identified FCOI to the NIH through the eRA Commons FCOI Module. The following information will be included in the report:
- The name of the investigator with the FCOI.
- The name of the entity with which the investigator has the financial interest.
- A description of the nature of the financial interest.
- The value of the financial interest.
- A description of how the financial interest relates to the NIH-funded research and why it is a conflict.
- A description of the management plan for the identified conflict.
- Annual Updates: The institution will submit an annual update to the NIH regarding the status of any ongoing FCOIs and the management strategies in place to mitigate them.
7. Maintenance of Records
The institution will maintain records of all financial interest disclosures, FCOI determinations, and management plans for at least three years after the completion of the related research. These records will be made available to the NIH upon request and will be retained in accordance with applicable regulations.
8. Enforcement
Failure to comply with this policy may result in disciplinary action, which may include removal from the research project, suspension, or termination of the investigator's participation, or other actions deemed appropriate by the institution. Investigators who fail to disclose financial interests or who violate the terms of an FCOI management plan may be subject to institutional disciplinary procedures.
9. Policy Accessibility
This FCOI policy will be posted on the organization’s publicly accessible website. All investigators and personnel involved in research will be informed of this policy and must acknowledge receipt and understanding of the policy before engaging in NIH-funded research.
10. Amendments
This policy will be reviewed periodically and updated as necessary to ensure compliance with the most current NIH regulations and to reflect any changes in institutional practices. The organization will notify all relevant stakeholders of any amendments to the policy.
