Financial Conflict of Interest Policy | Moses Weitzman Health System

Moses/Weitzman Health System, Inc. Financial Conflict of Interest Policy

Purpose and Scope

The Federal Department of Health and Human Services has developed regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. The regulations were first developed in 1995, and in 2011, the regulations were revised. These regulations describe the actions an individual and an organization must take to promote objectivity in PHS-funded research. The regulations apply to all Public Health Service (PHS) (e.g., National Institutes of Health [NIH]) funded grants, cooperative agreements, and research contracts. The regulations do not apply to Phase 1 Small Business Innovation Research or Small Business Technology Transfer applications and/or awards. This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for the Moses-Weitzman Health System, Inc. (“MWHS” or “the Institution”). A copy of the policy is available on the MWHS website (www.MWHS1.com).

Definitions

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.

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

Foreign Financial Interests – Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income over $5,000).

Institutional Responsibilities: The professional activities an Investigator performs on behalf of MWHS. (e.g., administration, research, or consulting).

Investigator means the Project Director/Principal Investigator and any other person, regardless of title or position who is responsible for the design, conduct or reporting of the NIH-funded research (“Covered Individual”), or proposed for such funding, and which may include, for example, collaborators or consultants, includes investigators who plan to participate in or who participate in NIH-funded research. The Principal Investigator (Project Director), will determine who is responsible for the design, conduct or reporting of the research by considering each individual’s role and degree of independence in carrying out the research.

Significant Financial Interest (SFI):

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities performed on behalf of MWHS.

(A) Concerning any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

(B) Concerning any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(C) Concerning intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests.

(2) The term significant financial interest does not include the following types of financial interests:

(A) Salary, royalties, or other remuneration paid by MWHS to the Investigator if the Investigator is currently employed or otherwise appointed by MWHS, including intellectual property rights assigned to MWHS and agreements to share in royalties related to such rights.

(B) Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

(C) Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States (U.S.), a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. Institution of higher education or

(D) Income from service on advisory committees or review panels for a federal, state, or local government agency located in the United States (U.S.), a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. Institution of higher education.

(3) Investigators must disclose the occurrence of any foreign or domestic reimbursed or sponsored travel that exceeds $5,000 (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities. The initial disclosure of reimbursed or sponsored travel should include income received over the previous twelve months. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:

a federal, state, or local government agency located in the United States,
a United States institution of higher education,
an academic teaching hospital,
a medical center, or
a research institute affiliated with a United States Institution of Higher Education.

Training

Each Investigator will be informed about MWHS’s Financial Conflict of Interest Policy and be trained on the Investigator’s responsibility to disclose foreign and domestic SFIs per this policy and of the FCOI regulation at 42 CFR Part 50 Subpart F. FCOI training will occur before an Investigator engaging in PHS/NIH-funded research, at least every four years and immediately (as defined below) when any of the following circumstances apply:

MWHS revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators;
An Investigator is new to MWHS research under an NIH award (training is to be completed before his/her participation in the research); or
MWHS finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the designated official).

In fulfillment of the FCOI training requirement of the FCOI regulation, MWHS requires its Investigators to complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html in accordance with the requirements and expectations of this Policy. All Investigators must print a certification of completion at the end of training and retain it for audit purposes.

Disclosure Requirements

No later than the time of application, the Principal Investigator and all other individuals who meet the definition of “Investigator” must disclose their SFIs to MWHS. Any new Investigator who, after applying to NIH for funding from NIH or during the research project, plans to participate in the project must similarly disclose their SFI(s) to the MWHS promptly and before participation in the project.

Each Investigator who is participating in research under an NIH award must submit an updated disclosure of SFI at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to MWHS according to this Policy or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on an NIH-funded project directly as an NIH Grantee and/or indirectly through a sub-award) that was transferred from another Institution), and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

Each Investigator participating in PHS/NIH-funded research must submit an updated disclosure of SFI within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). In addition, Investigators must submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.

Review of SFI Disclosures

The MWHS COI Committee (or an individual designated by the Committee) will review any SFI that has been identified in a disclosure; these interests will be compared to each PHS/NIH research application and/or award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the PHS/NIH-funded research and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that research award.

Guidelines for Determining “Relatedness” of SFI to PHS/NIH-Funded Research and a Financial Conflict of Interest

The MWHS COI Committee will determine whether an Investigator’s SFI is related to the research under an NIH award and, if so, whether the SFI is a financial conflict of interest.

An Investigator’s SFI is related to the research when the Committee reasonably determines the SFI:

could be affected by the PHS/NIH-funded research; or
is in an entity whose financial interest could be affected by the PHS/NIH-funded research.

The Committee may involve the Investigator in determining whether an SFI is related to the research supported by the award.

A financial conflict of interest exists when the Committee reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. (“Significantly” means that the financial interest would have a material effect on the research).

Management of SFIs that are FCOIs

If a FCOI is identified, the Committee will work with the individual to develop and implement a management plan to address the conflict. Management plans may include, but are not limited to:

Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to research personnel working on the study, to the Institution’s Institutional Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.);
For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants in the informed consent document;
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
Modification of the research plan;
Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
Reduction or elimination of the financial interest (e.g., sale of an equity interest);
Severance of relationships that create financial conflicts;

If the Committee determines that a conflict exists, it will communicate its determination and the means it has developed for managing the FCOI in writing to the individual, to the relevant Principal Investigator/Project Director, and to the appropriate direct supervisor.

No expenditures on an NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the Financial Conflict of Interest. The designated FCOI grant manager will submit the FCOI report to NIH via the eRA Commons FCOI Module.

Reporting of Financial Conflicts of Interest

Before the expenditure of any funds under an award funded by NIH, MWHS will provide NIH a FCOI report compliant with NIH regulations regarding any Investigator’s Significant Financial Interest found to be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding management plan.

MWHS will assign a designee to serve as the FCOI SO within the eRA Commons FCOI Module. The FCOI SO has the authority to submit FCOI reports to the NIH. The FCOI Module User Guide is available at Financial Conflict of lnterest User Guide (nih.gov).

While the award is ongoing (including any extensions with or without funds), MWHS will provide NIH with an annual FCOI report that addresses the status of the FCOI (i.e., an indication whether the FCOI is still being managed or if it no longer exists) and any changes in the management plan, if applicable.

For any Significant Financial Interest that is identified as conflicting after an initial FCOI report during an ongoing NIH-funded research project ( e.g., a new SFI is identified for an Investigator who is participating in the NIH-funded research, upon the participation of an Investigator who is new to the research project, etc.), MWHS will provide to NIH within 60 days of identifying an FCOI, an FCOI report regarding the financial conflict of interest and ensure that MWHS has implemented a management plan and the Investigator has agreed to the relevant management plan.

The Original (initial) FCOI report will include the information required in the regulation at 42 CFR Part 50.605(b)(3) or as outlined in NIH’s FAQ H.5. at Frequently Asked Questions (FAQs) | grants.nih.gov.

Maintenance of Records

The Institution will keep all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of lnterest), and all actions under the Institution’s policy or retrospective review, if applicable, that meet the regulatory requirements. Records of financial disclosures and any resulting action will be maintained by the Institution for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations. MWHS will retain records for each competitive segment as provided in the regulation.

Failure to Comply with MWHS’s Conflict of Interest Policy

When an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a FCOI, failure by the Institution to review or manage such an FCOI; and failure by the Investigator to comply with a management plan; MWHS will within 120 days:

Complete a retrospective review of the Investigator’s activities and the PHS/NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the period of the noncompliance was biased in the design, conduct, or reporting of research;
Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B) or as described in NIH’s FAQ 1.2. at Frequently Asked Questions (FAQs) I grants.nih.gov;

If bias is found MWHS shall notify NIH promptly and submit a mitigation report to NIH via the eRA Commons FCOI Module that shall address the following:

Impact of the bias on the research project, and
MWHS’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

Thereafter MWHS shall submit FCOI reports annually to NIH in accordance with the regulations and terms and conditions of the award agreement. Depending on the nature of the Financial Conflict of Interest, MWHS may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the Financial Conflict of lnterest is identified and the completion of MWHS’s independent retrospective review. If bias is not found, no further action is required.

If HHS determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a Financial Conflict of lnterest that was not managed or reported by MWHS, MWHS shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Subrecipients and Other Collaborators

A subrecipient relationship is established when federal funds flow down from or through MWHS to another individual or entity, and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to MWHS for programmatic outcomes and compliance matters. Subrecipients, who include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to MWHS’s terms and conditions, and as such, MWHS will take reasonable steps to ensure that any subrecipient Investigator complies with the federal FCOI regulation at 42 CFR Part 50 Subpart F.

MWHS will incorporate, as part of a written agreement with the subrecipient, terms that establish whether MWHS’s FCOI Policy or that of the subrecipient’s institution will apply to the subrecipient Investigator(s). See the NIH Grants Policy Statement Section 15.2.1 Written Agreement at 15.2 Administrative and Other Requirements (nib.gov).

If the subrecipient’s FCOI policy applies to the subrecipient Investigator, the subrecipient institution will certify as part of the agreement with MWHS that its policy complies with the federal FCOI regulation. In this situation, the agreement shall specify the period for the subrecipient to report all identified FCO is to MWHS in sufficient time to enable MWHS to provide timely FCOI reports, as necessary, to the PHS/NIH as required by the regulation (i.e., before the subrecipient’s expenditure of funds and within 60 days of the subrecipient’s identification of an FCOI during the period of an award). Therefore, the written agreement may establish a reporting requirement of FCOIs identified during the period of an award to be submitted to MWHS within 50 or 55 days of the subrecipient’s identification of an FCOI to allow MWHS to report the FCOI within the 60 days. The MWHS assigned FCOI SO will submit the FCOI report (subrecipient report) to the NIH via the eRA Commons FCOI Module.

If the subrecipient cannot provide the certification of compliance with the FCOI regulation, the agreement shall state that the subrecipient Investigator is subject to MWHS’s FCOI Policy for disclosing SFI(s) that are directly related to the subrecipient’s work for MWHS Therefore, MWHS will require the submission of all Investigator disclosures of SFIs to MWHS The agreement will include sufficient period (s) to enable MWHS to comply timely with its review, management, and reporting obligations under the regulation. When an FCOI is identified, MWHS will develop a management plan, monitor subrecipient Investigator compliance with the plan, and submit an FCOI report (subrecipient report) to the NIH through the eRA Commons FCOI Module for any FCOIs identified for a subrecipient Investigator.

Public Access

Information regarding FCOIs will be made available to the public within five business days of a request, for information concerning any SFI disclosed that meets the following three criteria:

(A) The SFI was disclosed and is still held by the senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel. in the award application, progress report, or any other report submitted to the NIH Grantee;

(B) MWHS has determined that the SFI is related to the research funded through an award; and

The information that MWHS will make available in a written response to any requestor within five days of request will include, at a minimum, the following:

(A) The Investigator’s name;

(B) The Investigator’s title and role with respect to the research project;

(D) The nature of the Significant Financial Interest; and

(E) The approximate dollar value of the Significant Financial Interest in the following ranges: $0-$4,999; $5,000-9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

Contact [email protected] or [email protected]. MWHS’s FCOI policy is publicly available at MWHS1.com.

Contact Information

Office of Research Administration: For questions or additional information regarding this policy, please contact the MWHS Office of Research Administration at [email protected] or [email protected].

Effective Date: 9.13.24 Revised: 10.9.24 Approved By: Margaret Flinter, Sr. Vice President and Clinical Director, Moses Weitzman Health System Policy Version: 24-02