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PHS/NIH Specific Reporting Requirements

Prior to spending any funds under an PHS/NIH award, (only applies to PHS/NIH) Tufts must report to the PHS awarding component the existence of a conflicting financial interests that is reasonably determined to be a COI that is significant to the point that it could directly and significantly affect the design, conduct and reporting of the funded research. In these cases, Tufts will ensure the interest has been managed, reduced, or eliminated in accordance with the regulation. The regulation does not require Tufts to report to NIH officials the nature or other details of a reported FCOI; however, Tufts is required to make information available, upon request, to the NIH regarding all Financial Conflicts of Interest (FCOI) identified by Tufts and how those interests have been managed, reduced, or eliminated to protect the research from bias.

For any significant financial interest that Tufts identifies as conflicting subsequent to the its initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the University will provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that Tufts has implemented a management plan in accordance with the regulation. Where such a FCOI report involves a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by Tufts (e.g., was not timely reviewed or reported by a subrecipient), the University is also required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, the University is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

The FCOI Conflict of Interest Report Specific to the PHS/NIH

Any FCOI report required by the regulation shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the University’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:

  • Project number;
  • PD/PI or Contact PD/PI if a multiple PD/PI model is used;
  • Name of the Investigator with the financial conflict of interest;
  • Name of the entity with which the Investigator has a financial conflict of interest;
  • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
  • Value of the financial interest (dollar ranges are: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;
  • A description of how the financial interest relates to the PHS-funded research and the basis for the University’s determination that the financial interest conflicts with such research; and
  • A description of the key elements of the University’s management plan, including:
  • Role and principal duties of the conflicted Investigator in the research project;
  • Conditions of the management plan;
  • How the management plan is designed to safeguard objectivity in the research project;
  • Confirmation of the Investigator’s agreement to the management plan;
  • How the management plan will be monitored to ensure Investigator compliance; and
  • Other information as needed.
Annual FCOI Report to the PHS Awarding Component

For any financial conflict of interest previously reported by the University with regard to an ongoing PHS-funded research project, Tufts will provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report will specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. The University will provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

PHS/NIH Mitigation Report if Bias is Found During Retrospective Review

Based on the results of the retrospective review, if appropriate, the University will update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the University is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the University’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the University will submit FCOI reports annually. Depending on the nature of the financial conflict of interest, the University may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator’s noncompliance is determined and the completion of the University’s retrospective review.

Subrecipient Special Reporting for PHS/NIH Projects: The University is responsible for providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this policy, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

Other Reporting

In addition to the types of financial conflicts of interest as defined in this policy that must be reported pursuant to the regulation, the University may require the reporting of other financial conflicts of interest in its policy on non-federal financial conflicts of interest, as it deems appropriate.