Financial Conflict of Interest (FCOI) Policy

Financial Conflict of Interest (FCOI) Policy ,
Yama Services Private Limited DBA Mankaa Kura

Effective Date: 06/01/2024
Last Updated: 09/29/2024

I. Purpose

The purpose of this policy is to ensure that research funded by the Public Health Service (PHS), including the National Institutes of Health (NIH), is free from bias that may arise from financial conflicts of interest (FCOI). This policy promotes objectivity in research conducted by Yama Services Private Limited DBA Mankaa Kura and complies with federal regulations (42 CFR Part 50 Subpart F).

II. Scope

This policy applies to all Investigators who are responsible for the design, conduct, or reporting of research funded by PHS. Investigators include employees, consultants, collaborators, and any individuals involved in PHS-funded research.

III. Investigator Responsibilities

All Investigators must:

1. Disclose any significant financial interests (SFI) related to their institutional responsibilities at the time of applying for PHS funding.
2. Update disclosures annually during the period of the award.
3. Disclose new SFIs within 30 days of acquiring them (e.g., through purchase, inheritance, or new consulting arrangements).
4. Complete FCOI training at least once every four years, or when the policy or regulations change.

IV. FCOI Training

Each Investigator must complete FCOI training before engaging in PHS-funded research and every four years thereafter. Training is also required immediately when:

• There are revisions to the FCOI policy that affect Investigator responsibilities.
• A new Investigator joins a PHS-funded research project.
• An Investigator is found to be non-compliant with this policy or an FCOI management plan.

Training will be based on the NIH’s FCOI tutorial, and Investigators must submit certificates of completion.

V. Disclosure of Significant Financial Interests (SFI)

Investigators are required to disclose SFIs that:

• Exceed $5,000, including salary, royalties, equity interests, or intellectual property rights related to their institutional responsibilities.
• Include reimbursed or sponsored travel (excluding government and non-profit organizations), with disclosure including the purpose, sponsor, destination, and monetary value.

Disclosures must be submitted:

• Initially, prior to applying for PHS funding.
• Annually, during the project period.
• Within 30 days of discovering or acquiring a new SFI.

VI. Review of SFI Disclosures

The designated FCOI Officer will review all SFI disclosures to determine if they are related to PHS-funded research and whether they constitute a financial conflict of interest. If an FCOI is identified, the FCOI Officer will develop a management plan to ensure research objectivity, which may include:

• Public disclosure of the FCOI in publications or presentations.
• Appointment of an independent monitor.
• Modification of the research plan to eliminate bias.
• Reduction or elimination of the financial interest.
• Severance of relationships that create conflicts.

VII. FCOI Reporting to PHS

Prior to the expenditure of funds under any PHS-funded project, Yama Services Private Limited DBA Mankaa Kurawill submit a report to the PHS Awarding Component (e.g., NIH) identifying any FCOI and the management plan in place to mitigate the conflict. If an FCOI is identified after funding has started, the report must be submitted within 60 days of the disclosure.

The report will include:

• Project number, PI name, and the name of the Investigator with the FCOI.
• The entity with which the Investigator has a financial conflict.
• Nature of the financial interest and its approximate value.
• How the financial interest relates to the PHS-funded research.
• A description of the management plan to address the conflict.

VIII. Non-Compliance and Retrospective Review

If an FCOI is not managed in a timely manner, Yama Services Private Limited DBA Mankaa Kura will conduct a retrospective review of the research to determine if bias occurred. If bias is identified, a mitigation report will be submitted to the PHS Awarding Component, detailing the impact of the bias and corrective actions taken.

IX. Subrecipient Requirements

When working with subrecipients on PHS-funded research, Yama Services Private Limited DBA Mankaa Kura will ensure that subrecipients either:

• Have an FCOI policy that complies with federal regulations, or
• Follow Yama Services Private Limited DBA Mankaa Kura’s FCOI policy.

Subrecipients must report any FCOI to Yama Services Private Limited DBA Mankaa Kura, who will then report it to the PHS Awarding Component.

X. Record Retention and Public Access

Yama Services Private Limited DBA Mankaa Kura will retain all records related to FCOI disclosures and management plans for at least three years from the submission of the final expenditure report to the PHS. This policy is publicly accessible on the company’s website. Upon request, details regarding any FCOI will be provided within five business days.

Contact Information

For any inquiries or submissions related to this FCOI policy, please contact:

FCOI Officer
Yama Services Private Limited DBA Mankaa Kura
contact@mankaakura.com
+977-9864067676