Financial Conflict of
Interest Policy

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

1. Purpose and Scope

The Moses/Weitzman Health System, Inc. (“MWHS” or “the Institution”) is committed to preserving the public’s trust that research is conducted without bias and adheres to the highest ethical and scientific standards. This policy applies to all MWHS Project Directors/Principal Investigators and Covered Individuals involved in PHS-funded research1.

2. 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. 

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 means: 

(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 appears to be related to the Investigator’s institutional responsibilities (e.g., research, research consultation, professional practice, etc.): 

(i) With regard to 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. 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; 

(ii) With regard to 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 

(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. 

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities. That this disclosure requirement does not apply to travel that is reimbursed or 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.  

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

(i) salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;  

(ii) 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;  

(iii) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or  

(iv) income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. 

3. Disclosure Requirements 

Each Investigator and Covered Individual planning to participate in PHS-funded research must disclose to the ORA an updated Disclosure of any Significant Financial Interests (as well as those of their spouse and dependent children) no later than the time of application for the PHS-funded research. 

Each PHS-funded Investigator and Covered Individual must submit an updated Disclosure to the MWHS Office of Research Administration (ORA) annually during the period of the award. 

Disclosures must be updated within 30 days of discovering or acquiring a new SFI. 

4. Review and Management of Financial Conflicts of Interest 

Initial Review: The ORA will review all disclosed SFIs to determine if they constitute a FCOI.  

Management Plans: If a FCOI is identified, the ORA will work with the individual to develop and implement a management plan to address the conflict. Management plans may include disclosure of the FCOI in publications and presentations, modification of the research plan, or other measures deemed appropriate. 

Monitoring: All management plans will be acknowledged by the Covered Individual. MWHS will monitor compliance with management plans annually and take corrective actions if necessary. 

5. Training 

Initial Training: All Covered Individuals must complete training on the MWHS FCOI policy including disclosure responsibilities and NIH regulations before engaging in NIH-funded research. Training is also similarly required for Investigators new to the Institution. 

Refresher Training: Refresher training will be completed every four years or immediately if there is a change in the FCOI policy or relevant regulations that affects the requirements of Investigators. Investigators or Covered Individuals who are not in compliance with the policy or a management plan will be required to undergo immediate retraining. 

6. Recordkeeping 

Records: The ORA will maintain records of all disclosures, reviews, management plans, and related documentation for at least three years from the date of submission of the final expenditures report to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations. 

7. Compliance 

Pursuant to PHS rules, whenever an SFI is not disclosed or reviewed in a timely manner or a Covered Individual fails to comply with a management plan, MWHS will, within 60 days, determine if the SFI is related to PHS funded research and, if so, whether an FCOI exists. If an FCOI exists the Institution will, within 120 days, perform a retrospective review to determine if the PHS-funded research conducted during the period of noncompliance was biased in the design, conduct, or reporting of such research. 

Based on the results of the retrospective review, if appropriate, the Institution shall update any previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, the Institution will notify the applicable PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above, a description of the impact of the bias on the research project, and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually as prescribed by the regulation. 

MWHS will document the retrospective review, which will include at least the following key elements:  

  1. Project number;  
  1. Project title;  
  1. Project Director/Principal Investigator (PD/PI) or contact PD/PI if a multiple PD/PI model is used;  
  1. Name of the Investigator with the FCOI;  
  1. Name of the entity with which the Investigator has an FCOI;  
  1. Reason(s) for the retrospective review;  
  1. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.); 
  1. Findings of the review; and 
  1. Conclusions of the review.  

Based on the results of the retrospective review, if appropriate, MWHS shall update any previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, MWHS will notify the applicable PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above, a description of the 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 (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, MWHS will submit FCOI reports annually as prescribed by the regulation. 

Failure to disclose SFIs or comply with management plans may result in disciplinary action up to and including termination of employment or other contractual relationships. Additionally, any significant non-compliance will be reported to the NIH. 

8. Subrecipients and Other Collaborators 

For PHS -funded research, MWHS will incorporate in a written agreement with any subrecipient terms that establish whether the MWHS Policy or the subrecipient’s COI policy will apply to subrecipient’s Investigator, and will include time periods to meet disclosure and/or COI reporting requirements. If the subrecipient’s Investigator will comply with the subrecipient’s COI policy, the subrecipient must certify as part of the agreement with MWHS that its COI policy complies with the applicable federal regulation(s). If the subrecipient cannot provide such a certification, the agreement between MWHS and the subrecipient will state that subrecipient Investigator is subject to the MWHS Policy, which will apply to research activities that are directly related to the subrecipient’s work for MWHS. MWHS will use the Policy if MWHS will be a subrecipient to another entity on a PHS award, and the prime grantee/contractor asks whether MWHS will use the prime recipient/contractor’s policy 

9. Public Access 

Information Disclosure: Information regarding FCOIs will be made available to the public upon request, consistent with NIH requirements and applicable laws. Contact [email protected] or [email protected].  

10. Reporting of Financial Conflicts of Interest 

Prior to the Institution’s expenditure of any funds under a PHS-funded research project, the Institution shall provide to the PHS Awarding Component an FCOI report regarding any Investigator’s significant financial interest found by the Institution to be conflicting and ensure that a management plan has been implemented.  

While the award is ongoing (including any extensions with or without funds), MWHS will provide to the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes in the management plan. For any SFI that is identified as conflicting subsequent to an initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), MWHS will provide to the PHS Awarding Component, within sixty days, 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. 

11. 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 Approved By: Margaret Flinter, Sr. Vice President and Clinical Director, Moses Weitzman Health System Policy Version: 24-01