»Financial Conflict of Interest

Financial Disclosure Policy for All Senior or Key Research Personnel

Conducting Research Funded by Federal Grants

 

The federal government requires that the University establish and administer a financial disclosure policy for investigators and a program for training investigators in that policy.  This is designed to ensure appropriate management of actual or potential conflicts of interest.  The Chapman University policy fulfills the requirements of grantee institutions as put forth in the National Institutes of Health’s guidelines (see http://grants.nih.gov/grants/policy/coi/index.htm) and the National Science Foundation’s conflict of interest policies (see http://www.nsf.gov/pubs/policydocs/pappguide/nsf08_1/aag_4.jsp). 

  1. Disclosure of Significant Financial Interests.  All personnel responsible for the design, conduct or reporting of research under the terms of a federal grant or contract (each, an “Investigator”) are required to disclose to the University’s Conflicts Officer (the “CO”), or designee, all “Significant Financial Interest” of the Investigator and/or the Investigator’s spouse, partner, parents, dependent children, and any other relative or close associate if residing in the same household as the Investigator. 
  1. Significant Financial Interest.” 

1)     Definition.  A significant Financial Interest means one or more of the following interests, if it reasonably appears to be related to the Investigator’s institutional responsibilities, including all research, teaching and/or service to the University: 

  1. 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 the disclosure, when aggregated, exceeds $5,000.  Remuneration includes any salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); equity interest includes any stock, tock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. 
  1. 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 spouse, partner, dependent children) owns any equity interest, regardless of dollar value. 
  1. Intellectual property rights and interests (e.g. patents and copyrights) upon receipt of income related to such rights and interest.  This does not include any income received from Chapman University for intellectual property rights assigned to Chapman University based on agreements to share in the royalties related to such rights in conformity with the University’s Intellectual Property policy.
  1. Any occurrence of reimbursed or sponsored travel related to your institutional responsibilities must also be disclosed, including instruction, research or service to Chapman University, with the exception of any travel 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 center affiliated with an institution of higher education.  Travel that is reimbursed by Chapman University from a sponsored fund account whose sponsor is an entity that is not one of those exempt entities shall be treated as a Significant Financial Interest.  The Investigator must disclosure the purpose of the trip, the identity of the sponsor and/or organizer, the destination and its duration within 30 days of travel.  Additional information, including the estimated cost of travel, may be requested by the CO and must be furnished upon request. 

e. Payment for services.  Any and all salaries and other payments for services (e.g. consulting fees, honoraria, study design, management position, independent contractor, service on advisory committees or review panels of for-profit entities, board membership of for-profit entities, seminars, lectures or teaching engagements for for-profit entities), when totaled together exceed $5,000 during the previous 12 months or are expected to exceed $5,000 over the next 12 months. 

2)     Exclusions.  The term “Significant Financial Interest” does not include : a) salary, royalties, or other remuneration from Chapman University; b) income from investment vehicles such as mutual funds or 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 government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with institutions of higher education; d) income from service on advisory committees or review panels for government agencies, institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with institutions of higher education. 

  1. Timing of Required Disclosures 
  1. Investigators must provide all required financial disclosures at the time a proposal is submitted.
  1. In addition, Investigators must update those financial disclosures:
    1. Within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage or inheritance) any new Significant Financial Interest;
    2. Engaging in activities requiring disclosure and
    3. Annually within the period of the award, coinciding with submission of the University’s annual Conflict of Interest Disclosure Statement.

Definition of Family - A spouse or domestic partner, parents, siblings, children, and any other relative or close associate if residing in the same household as the senior or key employee. 

  1. Review of Financial Disclosures.  The following process shall apply to financial disclosures submitted by Investigators.
  1. Determination of Financial Conflicts of Interest.  The CO shall review each disclosed SFI; determine whether such SFI relates to federally-funded research, and, if so related, determine whether a Financial Conflict of Interest (as defined below) exists; and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate such conflict or interest.  The CO, may, depending on the scope of the potential conflict, request that additional staff or faculty serve on an ad hoc review committee to assist in its timely review.  
  1. Financial Conflict of Interest.”  A “Financial Conflict of Interest” exists when the CO reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of federally-funded research or educational activities. 
  1. Management of Financial Conflicts of Interest.  If the CO determines that a Significant Financial Interest constitutes a Financial Conflict of Interest, the CO will convene a committee consisting of faculty, senior staff and/or outside experts.  The COI Committee will review the research, the financial interests in question, and the areas of conflict, and devise a plan for the management of the Financial Conflict of Interest with a combination of elements it deems most conducive to the continued objective pursuit of research.  The Management Plan may include conditions or restrictions to manage, reduce, or eliminate Financial Conflicts of Interest, which may include (but are not limited to): a) monitoring of research by independent reviewers; b) modification of the research plan; c) disqualification from participation in the portion of the federally-funded research that would be affected by Significant Financial Interests; d) divestiture of Significant Financial Interests; e) severance of relationships that create conflicts; or f) public disclosure of Financial Conflicts of Interest.  The Investigator will be consulted as to the implementation of the Management Plan; the Investigator must agree to the plan before the research can proceed.  If the COI Committee and the Investigator cannot agree upon a management plan, the relevant regulatory bodies and funding agencies will be notified. 
  1. Reporting of Financial Conflicts of Interest.
  1. Sponsoring agency.  Significant Financial Interest that are determined by the CO to be Financial Conflicts of Interest will be reported to the sponsoring agency in accordance with its requirements within 60 days of the original disclosure. 
  1. Public request. As required by sponsoring agency regulations, information on the nature of such Conflicts of Interest will be made available to members of the public by the CO in response to inquiries specifying the investigator name and the research project in question within 5 business days of receipt of such requests. 
  1. Enforcement.  The University shall establish appropriate mechanisms for enforcement of this policy, which shall provide for sanctions where appropriate.  Disciplinary proceedings initiated in connection with this policy shall be conducted in accordance with the Chapman University Faculty Handbook, the Chapman University Staff Handbook or the Student Code of Conduct.  All relevant regulatory bodies and funding agencies will be promptly informed of disciplinary sanctions.
  1. Records.  The University shall maintain records of all financial disclosures and of all actions taken to resolve Financial Conflicts of Interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any federal action involving those records, whichever is longer.
  1. Training. 
  • Investigators on NIH/PHS-funded projects.  Each Investigator (including senior/key personnel) on projects funded by or proposed to NIH or other Public Health Service (PHS)-affiliated agencies must complete training in the University’s conflict of interest policy via CITI.
  • New or previously unfunded Investigators.  New and/or previously unfunded Investigators who notify the Office of Research and Sponsored Projects Administration of their intent to submit a research proposal to NIH or another PHS-affiliated agency after  August 24, 2012  will be required to complete training (and make the disclosures described above) prior to submission of their proposal.
  • Investigators on non-NIH/PHS projects.  For Investigators sponsored by or seeking funding from NSF and/or other federal agencies, as well as any Investigators initiating research sponsored by a private, for-profit entity, the activities are optional but strongly recommended. 
  • Repeat training.  Renewal training of active NIH/PHS-funded Investigators will be repeated (i) every four years and (ii) on any occasion when Chapman University revises its Financial Conflict of Interest policies and procedures in any manner that affects the requirements of Investigators. 
  1. Disclosure Statement.   Copies of the University’s Disclosure Statement are available online at (will add website location of disclosure form when approved).  Statement must be completed by all senior personnel who are submitting proposals to a federal funder.  The certification page of a proposal cannot be signed until forms for all Investigators are submitted to the CO.  By signing this form the applicant certifies that he/she has read this and a) does not have potential Financial Conflicts of Interest (“I certify that I have read the Financial Disclosure policy which is effective for all federal proposals submitted through the University.  I certify to the best of my knowledge that neither I nor my spouse, partner, or depends hold any significant financial interest that would reasonably appear to be related to my research, teaching and service responsibilities to Chapman University”) or b) does have potential conflicts (“I have the following relationships, affiliations, activities, or interests (financial or otherwise) which constitute potential conflicts under the Chapman University Conflict of Interest Policy”).  In either case, the applicant also declares that he/she will notify the CO of any change or discovery requiring modification of the above statement. 
  1. Subrecipients.  The University is responsible for ensuring all subrecipients’ compliance with the applicable federal regulations regarding Financial Conflicts of Interest.  To this end, the University shall enter a written agreement with each subrecipient that shall specify whether this policy, or the applicable policy of the subrecipient’s institution, will apply to subrecipient Investigators.  Said agreement will specify the timing for reporting of FCOIs by subrecipients to Chapman University to enable the timely review and reporting of such FCOIs in compliance with funding agency requirements.

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