Financial Conflict of Interest in PHS-Funded Projects Policy

I. Policy

Radiopharmaceutical Imaging and Dosimetry, LLC (Rapid) strives to create a research climate that promotes objectivity in research by establishing standards such that the design, conduct and reporting of Public Health Service (PHS, which includes NIH) funded research is free from bias resulting from financial conflict of interest (FCOI).

Rapid FCOI policy consists of:

1. Policy and procedure: Financial Conflict of Interest in PHS-Funded Projects.
2. Protocol: Protocol for Handling Financial Conflict of Interest.

This policy is applicable to each employee who is planning to or is participating in research activity that is either partially or wholly supported by PHS funds. Each such employee must:

1. Disclose his/her significant financial interests (SFI) in non-Rapid entities that would appear to be related to the employee’s professional responsibilities on behalf of Rapid;
2. Comply with a FCOI management plan, if a FCOI is identified; and 3. Undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for Rapid to determine if a FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the employee to employment discipline including, without limitation, suspension or termination of employment.

II. Definitions

A. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS funded research.

B. Significant Financial Interest (SFI) exists if the value of remuneration received by the employee, employee’s immediate family (spouse or partner and dependent children) that reasonably appear to be related to the employee’s Rapid responsibilities exceeds $5000; including:

  • Remuneration received from a publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $5,000. For the purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary; equity interest includes stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value

  • Remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000 or any equity interest in such entity.

  • Intellectual property rights and interests (e.g., patents, copyrights, trademarks) upon receipt of income related to such rights and interests.

  • Any reimbursed or sponsored travel expenses.

C. Employee’s professional responsibilities on behalf of Rapid means conducting research, submitting patent applications, publication, technical committee membership and, teaching as adjunct faculty at an Institute of higher education.

III. Procedure

Employees who are planning to or participating in research activity that is either partially or wholly supported by PHS funds must disclose their SFI in a timely fashion, either to a member of the Rapid Management Team (Rapid MT) or the designated Rapid FCOI official. The designated Rapid FCOI official will determine whether the SFI constitutes an FCOI, based on guidance set by the Rapid MT. Consistent with the attached, Protocol for Handling Financial Conflict of Interest, if the SFI is determined to be an FCOI, the Rapid MT will take actions to discuss and approve the implementation of an FCOI management plan consistent with government regulation and, furthermore, to promptly notify the PHS funding component (e.g., NIH) via a FCOI report.

As a part of the FCOI management plan, the Rapid MT will decide one or more actions depending upon the situation, including requiring certain disclosure in public presentations, employee role reassignment, reduction or elimination of the financial interest sanctions (e.g., sale of an equity interest) or severance of relationships that create financial conflicts. Employees with an identified FCOI must comply with the FCOI management plan.

IV. Related Policies and Procedures
Procedures for Handling Financial Conflicts of Interest

As a part of the FCOI management plan, the Rapid MT will decide one or more actions depending upon the situation, including requiring certain disclosure in public presentations, employee role reassignment, reduction or elimination of the financial interest sanctions (e.g., sale of an equity interest) or severance of relationships that create financial conflicts. Employees with an identified FCOI must comply with the FCOI management plan.

V. Administration

The designated Rapid FCOI official is responsible for administration of this policy.

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Financial Conflict of Interest in PHS-Funded Projects Policy
I. Policy

Radiopharmaceutical Imaging and Dosimetry, LLC (Rapid) strives to create a research climate that promotes objectivity in research by establishing standards such that the design, conduct and reporting of Public Health Service (PHS, which includes NIH) funded research is free from bias resulting from financial conflict of interest (FCOI).

Rapid FCOI policy consists of:

1. Policy and procedure: Financial Conflict of Interest in PHS-Funded Projects.
2. Protocol: Protocol for Handling Financial Conflict of Interest.

This policy is applicable to each employee who is planning to or is participating in research activity that is either partially or wholly supported by PHS funds. Each such employee must:

1. Disclose his/her significant financial interests (SFI) in non-Rapid entities that would appear to be related to the employee’s professional responsibilities on behalf of Rapid;
2. Comply with a FCOI management plan, if a FCOI is identified; and 3. Undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for Rapid to determine if a FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the employee to employment discipline including, without limitation, suspension or termination of employment.

Financial Conflict of Interest in PHS-Funded Projects Policy
I. Policy

Radiopharmaceutical Imaging and Dosimetry, LLC (Rapid) strives to create a research climate that promotes objectivity in research by establishing standards such that the design, conduct and reporting of Public Health Service (PHS, which includes NIH) funded research is free from bias resulting from financial conflict of interest (FCOI).

Rapid FCOI policy consists of:

1. Policy and procedure: Financial Conflict of Interest in PHS-Funded Projects.
2. Protocol: Protocol for Handling Financial Conflict of Interest.

This policy is applicable to each employee who is planning to or is participating in research activity that is either partially or wholly supported by PHS funds. Each such employee must:

1. Disclose his/her significant financial interests (SFI) in non-Rapid entities that would appear to be related to the employee’s professional responsibilities on behalf of Rapid;
2. Comply with a FCOI management plan, if a FCOI is identified; and 3. Undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for Rapid to determine if a FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the employee to employment discipline including, without limitation, suspension or termination of employment.