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Financial conflicts of interest (FCOI) policy
The purpose of this policy is to outline the requirements and responsibilities of XenoBiotic Laboratories (XBL) employees that are necessary to comply with 42 CFR part 50 subpart F: Promoting Objectivity in Research (2011 Revised Financial Conflict of Interest Regulation). As an applicant for, and recipient of, federal U.S. Public Health Service (PHS) research funds XBL is required to establish standards that ensure a reasonable expectation that the design, conduct, and reporting of federally sponsored research is free from bias that could arise due to financial conflicts of interest.
Investigator or Key Personnel – Are any personnel, regardless of title or position, with design, conduct, or reporting of research responsibilities, including administrative staff.
Significant financial interest – Includes, but is not limited to:
The Company – XenoBiotic Laboratories, Inc. (XBL)
All new Investigators and Key Personnel (including administrative staff as noted above) and any Investigator and Key Personnel applying for, or receiving funding from, the PHS, must be provided with a copy of this policy and disclose any significant financial interest prior to initiating work on any federally sponsored project, and update any disclosed information (e.g. a change in value of a previously disclosed interest) at least annually and:
- Within 30 days of the discovery or acquisition of a new significant financial interest; and
- Prior to:
If, after the submission of an annual disclosure, there is a material change in an employee's financial interests, they should update their disclosure in writing to reflect the change as soon as possible.
All disclosures will be reviewed by the designated FCOI Management representative, and in the event that it is determined that a financial conflict of interest exists, the Company will appoint a committee to verify the determination of the FCOI Management representative, and then provide a written plan to address the FCOI.
In the event that it is determined that a financial conflict of interest exists, the Company must respond by eliminating, reducing, or managing the conflict. The Company must generate a written record of its response. A written copy of the plan must be provided to the relevant employee, and the employee should sign the plan indicating receipt, comprehension, and willingness to fully comply with the plan. The plan to eliminate, reduce, or manage the FCOI must be reviewed at least annually to determine if it needs updating and to verify compliance of the relevant employee with the plan. This review must be documented.
A conflict can be eliminated by requiring that the employee divest the conflicting financial interest, or not participate in the conflicted activity. It may be determined that it should be acceptable to reduce his or her financial interest to a level that the Company determines is acceptable for the activity in question. In some case a conflicted activity may be allowed to proceed with a credible plan to manage the conflict in a way that acceptably minimizes the associated risks (e.g., by a change of personnel, a change of a person's role and responsibilities related to certain activities, modification of the research plan, having a person refrain from participation in all or part of the activity).
Willful failure of employees to fully comply with this policy (including willfully providing materially incomplete or inaccurate disclosures, and failure to adhere to conflict management plans), and/or failure to provide disclosure in a timely manner can result in disciplinary action up to, and including, immediate termination.
As required by the applicable regulation, this policy will be made publically accessible on XBL's Website.
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