Philips Research North America 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)A.
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. This policy is in addition to Philips’ General Business Principles and Directives (collectively, the “GBPs”) which govern Philips’ business decisions and actions throughout the world and apply equally to corporate actions and to the behavior of individual employees in conducting Philips’ business. If there is a conflict between this policy and the GBPs, the GBPs will govern. Each such employee must:
- disclose his or her significant financial interests (SFI)B in non-Philips entities that would appear to be related to the employee’s professional responsibilities on behalf of PRNAC;
- comply with a FCOI management plan, if a FCOI is identified; and
- undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for PRNA 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.
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 spouse or dependent children that reasonably appear to be related to the employee’s PRNA responsibilities exceeds $5000;
- Salary or other payments for services (e.g., consulting fees or honoraria) received in the twelve months preceding disclosure;
- Equity interests (e.g., stocks, stock options or other ownership interests)l however, equity interest in a non-publicly traded entity, no matter the amount, constitutes an SFI; and,
- Income from intellectual property rights owned by the employee.
- Salary, royalties, stock options or other remuneration from Philips;
- Income from seminars, lectures, teaching engagements, service on advisory committees or review panels, derived from excluded sourcesD;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the employee does not directly control the investment decisions; and,
- Unlicensed intellectual property owned by the employee that does not generate income. Note that Intellectual property owned by Philips is excluded.
3. SFI disclosure also includes travel. Specifically, externally funded reimbursed or sponsored travel that would appear to be related to employee’s PRNA responsibilities, however, that is not funded by Philips. Such travel must be disclosed, no matter the amount, except when the expenses are covered by any of the excluded sourcesD.
Note that the threshold of $5000 is applied to the aggregation of 1a and 1b, or to 1c.
C. Employee’s professional responsibilities on behalf of PRNA means conducting research, submitting patent applications, publication, technical committee membership and, teaching as adjunct faculty at an Institute of higher education.
D. An excluded source means a source of remuneration that is excluded from disclosure. With reference to the SFI (2b and 3), excluded sources are – federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
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 PRNA Management Team (PRNA MT) or the designated PRNA FCOI official. The designated PRNA FCOI official will determine whether the SFI constitutes an FCOI, based on guidance set by the PRNA MT. Consistent with the attached, Protocol for Handling Financial Conflict of Interest, if the SFI is determined to be an FCOI, the PRNA 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 PRNA 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
Protocol for Handling Financial Conflict of Interest
The designated PRNA FCOI official is responsible for administration of this policy.