a. Investigators are responsible for completing all required training, disclosing all Financial Interests relating to PHS and CMS Research, for mitigating risks associated with Significant Financial Interests, and for assisting with the management of any identified FCOI.
b. The Office of the General Counsel is responsible for reviewing all disclosed Financial Interests to identify any Significant Financial Interests to determine if they may represent an FCOI. All disclosed Financial Interests shall be reviewed by the OGC, and the OGC shall provide guidance to the Investigator and to EZUS LYON management with respect to Significant Financial Interests that may give rise to FCOI. Upon identification of potential FCOI related to a project funded by PHS or CMS, the Office of the General Counsel will work with the Investigator and the relevant research division or corporate manager to manage the FCOI (Section 5.2 below).
c. Division/Corporate Management are responsible for identifying any potential FCOI related to an Investigator's participation in a Research project funded by PHS or CMS. This screening is performed using the "Lookup Conflicts" function within the Screening and Disclosure tool. Division and Corporate management who identify such FCOI will contact OGC, request assistance in managing the FCOI, and assist in such efforts.
d. Contracts & Grant Services is responsible for taking reasonable steps to ensure that subcontractors comply with the Department of Health and Human Services Financial Conflict of Interest regulations.
e. All EZUS LYON Associates will comply with regulatory requirements relating to our Institutional Responsibilities, including certification of compliance, maintenance of records, responses to requests for information, and reporting requirements.
As detailed in Section 3.2 below, all EZUS LYON Investigators must:
a. Disclose all Financial Interests relating to EZUS LYON Research funded by PHS and CMS via the EZUS LYON online conflict of interest screening and disclosure tool (Section 3.2 below), and
b. Complete the related conflict of interest training program at least every four years (Section 3.4 below).
Failure to accurately and timely complete the training and the disclosure and to provide updates as required by this policy could result in disciplinary action, up to and including termination.
3.2 Screening & Disclosure Form
The EZUS LYON online conflict of interest screening and disclosure tool is available on EZUS LYON's Intranet. All Investigators must fully and accurately complete the disclosure within the time allotted depending on the circumstances giving rise to the need for disclosure.
a. Proposals & Projects. Investigators named in a proposal for a project funded by PHS or CMS must complete the training and the online disclosure before the proposal is submitted. Investigators who were not named in a proposal and who participate in the design, conduct, or reporting of PHS- or CMS-funded work must complete the training and the online disclosure before beginning any work on a project funded by PHS or CMS.
b. Continuing Obligation to Update. All Investigators must update and certify the online disclosure form at least annually and within 30 days of receiving, acquiring, or discovering either a new Financial Interest or additional interests from an entity previously disclosed by the Investigator. For example, changes in a Financial Interest could include (but are not limited to) purchase or inheritance of stock or a change in a spouse/domestic partner's employment. All employees covered by the PHS regulations are expected to recognize their continuing obligation to timely disclose relevant Financial Interests to ensure EZUS LYON's compliance with the reporting and certification requirements of the PHS regulations.
3.3 Disclosure Thresholds
EZUS LYON is required to comply with different regulatory and contractual requirements relating to conflicts of interest that require different disclosure thresholds. Because of the variability among the regulatory schemes that apply to EZUS LYON, and because of the potential for enactment of changes in the disclosure thresholds, EZUS LYON has not set a minimum threshold for disclosure. This eliminates the need for staff to resubmit disclosures if thresholds are changed and reduces the potential for confusion about the threshold that applies in a particular situation. Investigators therefore are required to disclose the Financial Interests listed in Section 4.2 below, regardless of the value of such Financial Interests.
3.4 PHS Conflict of Interest Training
As part of completion of the online disclosure, Investigators are required to certify, at least every four years, completion of all training required by the Investigator's work on Department of Health and Human Services projects.
4.1 Significant Financial Interests
The Office of the General Counsel will review all disclosed Financial Interests and identify any Significant Financial Interests. Generally, a significant Financial Interest is a Financial Interest that is likely to have a material effect on the Research. In the context of PHS research, Significant Financial Interest means a Financial Interest of an Investigator (including the Investigator's spouse or domestic partner, dependent child, or other member of the Investigator's household) in any Healthcare-Related Entity consisting of one or more of the interests identified in Section 4.2 below (Relevant Financial Interests) if:
1. the Financial Interest reasonably appears to be related to the Investigator's Institutional Responsibilities at EZUS LYON, and
2. the aggregate value of all interests held in a particular Healthcare-Related Entity exceeds $5,000.
4.2 Relevant Financial Interests
The following Financial Interests may potentially qualify as Significant Financial Interests:
a. Remuneration (including salary, wages, consulting fees, honoraria, and any other fee for services)
b. Defined benefit pension payments or other post-employment payments
c. Service in a management position such as a board member, director, officer, partner, or trustee of a Healthcare-Related Entity
d. Ownership of an equity interest (including stock, stock options, bonds, or any other ownership interest)
e. Holdings in a healthcare sector-oriented mutual fund
f. Intellectual property rights (e.g., patents or copyrights) from which income is received
g. Gifts of more than nominal value (more than $20) from clients, vendors, or Healthcare-Related Entities
h. Reimbursed or sponsored travel related to an Investigator's Institutional Responsibilities
Sponsored travel means travel expenses paid on behalf of an Investigator (or relevant family member) rather than paid by reimbursement
Travel reimbursed or sponsored by the following is excluded: federal, state, or local government agencies; institutions of higher education; academic teaching hospitals; medical centers; and research institutes affiliated with institutions of higher education.
Investigators will be required to provide the following information with respect to any reimbursed or sponsored travel: name of entity that sponsored or reimbursed any expenses associated with the trip; purpose of the trip; destination; date and duration of the trip; and amount of reimbursement received.
4.3 Excluded Financial Interests
The following Financial Interests do not give rise to Significant Financial Interests and therefore need not be disclosed:
a. Salary, wages, and remuneration paid by EZUS LYON
b. Travel expenses paid or reimbursed by EZUS LYON
c. Income from mutual funds and retirement accounts (other than healthcare sector-oriented funds, see Section 4.2(e) above), as long as the Investigator does not directly control the investment decisions made by the funds
d. Income from seminars, lectures, or teaching engagements sponsored by a 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
e. Service on advisory committees or review panels for a 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
5.1 Identifying FCOI
A disclosure of a Financial Interest does not, by itself, create an impermissible conflict of interest. Each Financial Interest disclosure will be reviewed by the Office of the General Counsel. The Office of the General Counsel is responsible for determining when an actual or potential conflict of interest exists in a given situation - that is, when a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS- or CMS-funded research - and for taking action as necessary to address and manage such conflicts of interest, including development and implementation of a management plan (see Section 5.2 below). This responsibility will be exercised in cooperation with the relevant research division or corporate manager and with full participation by the Investigator. A variety of criteria may be considered in determining whether a particular Financial Interest creates a conflict of interest with respect to a particular project funded by PHS or CMS.
5.2 Managing FCOI
EZUS LYON will take appropriate steps to address and manage FCOI to ensure that the design, conduct, and reporting of EZUS LYON's research is free from bias or the appearance of bias. As described in the PHS regulations, some examples of how financial conflicts of interest may be addressed and managed include:
a. Public disclosure of an Investigator's Significant Financial Interests; disclosures will only occur after notice to and consultation with the Investigator
b. Disclosure of FCOI directly to participants in Research projects involving human subjects
c. Monitoring of Research projects by reviewers who do not have FCOI and who are capable of implementing measures to protect the design, conduct, or reporting of the Research against bias arising from identified FCOI
d. Modification of the research plan, including, for example, change of personnel or personnel responsibilities with respect to particular tasks
e. Disqualification of personnel from participation in all or a portion of a Research project funded by PHS or CMS
f. Reduction or elimination of a Significant Financial Interest (e.g., sale of stock)
g. Severance of relationships (e.g., consulting activities) that create actual or potential conflicts.
Questions regarding this policy and the Health and Human Services regulations should be directed to Eric BOMEL, Executive Assistant.
Effective: June 14, 2022.
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