FINANCIAL CONFLICTS OF INTEREST POLICY
Curadel, LLC
Last Revised September, 2021
Purpose:
The purpose of this policy is to document the requirements and responsibilities of CURADEL 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 we are required to establish standards that provide a reasonable expectation ensuring that the design, conduct, and reporting of federally sponsored research is free from bias that could arise due to financial conflicts of interest.
A key component of the federal policy is its training requirement. 42 CFR 50.604b requires that the institution establish a policy to inform the Investigator of the existence of its FCOI policy, his/her disclosure responsibilities under said policy and the federal regulation underpinning the policy.
The institution must establish a process to require each PHS-supported Investigator to complete training:
- prior to engaging in research related to any PHS-funded grant
- at least every four years
- Immediately, if:
- institution revises its FCOI policy that affects requirements of Investigators
- an Investigator is new to the institution
- an investigator is not in compliance with the policy or management plan
Definitions:
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:
(1) financial compensation outside of that received from CURADEL , from consulting, employment, managerial, and fiduciary relationships (including travel) that, when aggregated over the preceding twelve months, exceeds $5,000
(2) equity and other financial interests above $5,000 (outside of CURADEL)
(3) equity interests of any amount, or entitlement to the same, in a non-publicly traded, for-profit, entity (outside of CURADEL ) and
(4) intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
“Financial compensation” does not include, for example, interests of any amount in diversified financial holdings, or royalties, or other remuneration paid by CURADEL.
The Company – Curadel, LLC
Procedures:
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 SFIs no later than the time of application submission of any federally sponsored project. Disclosed information (e.g., a change in value of a previously disclosed interest) just be updated at least annually and:
- Within 30 days of the discovery or acquisition of a new significant financial interest; and
- Prior to:
- Accepting gifts (above de mimis)
- Submitting an application for a sponsored project
- Initiating a technology licensing agreement
Disclosures must include those of the Investigator’s spouse and dependent children. 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. If the FCOI disclosure was not done in a timely manner, the Institution will within 120 days complete and document a retrospective analysis of the conflict.
All disclosures will be reviewed by the designated FCOI Management representative, and in the event that the determination 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 in accordance with applicable PHS policy.
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).
Reporting to NIH: Per 42 CFR 50.604h, the institutional policy should include a section on reporting initial, annual and revised FCOI reports to the NIH, for both the institution and its subrecipients. Such reporting should occur:
- Prior to the expenditure of funds
- Within 60 days of identification for an Investigator who is newly participating in the project
- Within 60 days for new, or newly identified, FCOIs for existing Investigators
- At least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
All FCOI-related records shall be maintained for at least three years from the date the final expenditure report is submitted to the PHS (NIH), unless otherwise specified.
Sanctions:
Willful failure of employees to fully comply with this policy (including non-disclosure, whether intentional or not; 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.
Where applicable, establish via written agreement confirmation that subrecipients will follow the FCOI policy of the Institution.
Public Disclosure:
As required by the applicable regulation, this policy will be made publicly accessible on CURADEL ’s website.
Additionally, prior to the Institution’s expenditure of any funds under a PHS-funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:
- The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;
- The Institution determines that the significant financial interest is related to the PHS-funded research; and
- The Institution determines that the significant financial interest is a financial conflict of interest.