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Conflict of Interest

Effective Date: April 30, 2019

Revision Date: April 30, 2019

 

Definitions

A potential conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the university such that an independent observer might reasonably question whether the individual's professional actions and decisions are determined by consideration of personal gain, financial or otherwise.  A conflict of interest depends on the situation, not on the character or actions of the individual.  For purposes of this policy, a conflict of interest exists when the university, through procedures described herein, determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of sponsored projects.

 

Investigator

Investigator means the principal investigator/project director, co-principal investigators, and any other person who is responsible for the design, conduct, or reporting of the sponsored project. For reporting of Significant Financial Interest, "investigator" includes the investigator's spouse and dependent children.

 

Significant Financial Interest

Significant Financial Interest means anything of monetary value, including, but not limited to:

  • salary or other payments for services (e.g., consulting fees or honoraria)
  • equity interests (e.g., stocks, stock options or other ownership interests)
  • intellectual property rights (e.g., patents, copyrights and royalties from such rights)

The term does not include:

  • Salary, royalties, or other remuneration from the university;
  • Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
  • Income from service on advisory committees or review panels for public or nonprofit entities;
  • An equity interest that, when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests:
    • does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and
    • does not represent more than a five percent ownership interest in any single entity.
  • Salary, royalties or other payments that, when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $5,000.

 

Sponsors for which Disclosure is Required:

  • National Science Foundation
  • Public Health Service (PHS) Agencies under the Department of Health and Human Services (includes National Institutes of Health)
  • Non-governmental entities

 

Guidelines

 

1A. FEDERAL REQUIREMENTS:  Each investigator who submits a proposal to the National Science Foundation or an agency of the U.S. Department of Health and Human Services must, at the time of submission, complete a Conflict of Interest Disclosure Form and disclose the following:

  1. Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the funded project;
  2. Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the funded project.

1.B.  STATE REQUIREMENTS:  All persons employed by UC or CSU who have principal responsibility for a research project funded or supported, in whole or in part, by a contract or grant (or other funds earmarked by the donor for a specific research project or for a specific researcher) from a nongovernmental entity, must complete CSU Form 700U “Statement of Economic Interests form” and disclose any financial interest. 

 

Research funding by certain nonprofit entities will not trigger disclosure on the Form 700-U. For a list of these exempt nonprofits, refer to http://www.ucop.edu/research/exempt.html.

 

Failure to file the required Statement of Economic Interests form or failure to report a financial interest may subject a principal investigator to civil liability, including fines, as well as University discipline. (Government Code sections 81000-91014)

 

  1. The NSF/DHHS Conflict of Interest Disclosure Form or CSU Form 700-U (as appropriate) must accompany the internal Proposal Routing Form submitted to the Office of Research and Sponsored Programs. Supporting documentation that identifies the business interest or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked "Confidential - Conflict of Interest Disclosure."

 

  1. As required by Federal regulation, all Significant Financial Interests must be disclosed to the university prior to submission of the proposal to the federal agency. If an award is made, financial disclosures must be updated by Investigators during the period of the award as new reportable Significant Financial Interests are obtained or annually.

 

  1. The Associate Vice President (AVP) of Research and Sponsored Programs shall conduct an initial review of each financial disclosure. If the review reveals a potential for conflict of interest covered by this policy, the AVP of Research and Sponsored Programs shall, in consultation with the Investigator, the Dean of the Investigator's school or equivalent administrative officer, and the Provost and Vice President, Academic Affairs, draft a Resolution Plan that details steps that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a Significant Financial Interest.

 

The Resolution Options may include, but are not limited to:

  • Public disclosure of significant financial interests;
  • Monitoring of the project by independent reviewers:
  • Modification of the project plan;
  • Disqualification from participation in all or a portion of the project;
  • Divestiture of significant financial interests;
  • Severance of relationships that create actual or potential conflicts.

 

  1. The Resolution Plan shall be incorporated into a Memorandum of Understanding between the university and the Investigator that details the conditions or restrictions imposed upon the Investigator in the conduct of the project or in the relationship with the Business Enterprise or Entity. The Memorandum of Understanding shall be signed by the Investigator and, on behalf of the university, by the Provost and Vice President, Academic Affairs.  Actual or potential conflicts of interests will be satisfactorily managed, reduced or eliminated in accordance with the Memorandum of Understanding and these Guidelines prior to expenditure of any funds under this award.

 

  1. Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest shall be retained by the Office of Research and Sponsored Programs until 3 years after the date of the termination or completion of the award to which they relate, or the resolution of any government action involving these records, whichever occurs later.

 

  1. Alleged violations of this policy or of the Memorandum of Understanding will be reported to the AVP, Office of Research and Sponsored Programs. The AVP, Office of Research and Sponsored Programs will conduct a review to determine whether the allegations warrant submission of the matter to the Provost and Vice President, Academic Affairs.  Upon submission, the Provost and Vice President, Academic Affairs will establish a Review Committee to review the matter and recommend sanctions to the Provost and Vice President, Academic Affairs.  Such sanctions may range from a formal reprimand to the imposition of disciplinary action as defined in Article 19 of the Memorandum of Understanding (MOU) between The California State University and the California Faculty Association.

 

  1. Collaborators, sub-recipients, and subcontractors from other academic or not-for profit institutions must either comply with this policy or provide a certification from their institution that they are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policy. Subcontractors from commercial firms need not make a certification, except when the prime award is from the Public Health Service. The PHS requires a certification from any subcontractor, including commercial firms, stating that it is in compliance with Federal policies regarding investigator significant financial interest disclosure and that its portion of the project is in compliance with company policy.

 

Update on NIH COI policy

 

Update regarding NIH Financial Conflict of Interest Policy:

Pursuant to 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94, as revised on August 25, 2011 along with CSUEB's policy governing financial interest.  Financial interest means anything of monetary value, whether or not the value is readily ascertainable.  A Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of the NIH-Funded research.  To determine if an investigator has an SFI please reference 42 C.F.R. 50 Subpart-F definition.  NIH has revised its FCOI policy which has an effective date of August 24, 2012.  The policy revision is designed to promote the objectivity of NIH-funded research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded by NIH grants and cooperative agreements will be free from bias resulting from Investigator FCOIs.   The investigator, the Institution, and the NIH all have responsibilities under this regulation.

 

Investigator Responsibilities:

-Disclosure of SFI (Completing 700-U, NIH or NSF COI Forms)

 

-Ensure compliance with CSUEB policy,

For CSUEB training, which includes certification of completion, please contact ORSP directly.  This training must be completed prior to proposal submission.  Each investigator (Principal Investigator/Project Director, collaborators, consultants and any other person, regardless of title and position, who is responsible for the design, conduct or reporting) that is the Prime/Subrecipient of a PHS award, must disclosure of all significant financial interests and must complete training regarding FCOI prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply:

  1. CSU East Bay revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
  2. An Investigator is new to CSUEB; or
  3. During the award period on an annual basis
  4. Within 30 days of the acquisition or discovery of new SFIs (e.g., through purchase, marriage, or inheritance)
  5. CSU East Bay finds that an Investigator is not in compliance with the financial conflict of interest policy or management plan.

 

Impact on Subrecipients:

If CSUEB carries out PHS-funded research and establishes a subrecipient agreement, CSUEB investigators along with subrecipient investigators are required to be in compliance with CSUEB's FCOI policy by:

  1. Certifying subrecipient's FCOI policy complies with 42 CFR 50.604 within the specified time period(s) or
  2. If subrecipient cannot provide the certification, they must agree to CSUEB's FCOI policy for disclosing SFI that are directly related to the subrecipients work for CSUEB within the specified time period.

CSUEB Summary of Statement of Economic Interest and Online Ethics Training: http://www20.csueastbay.edu/af/departments/risk-management/risk/training.html

Regulations

 

Forms:

  • 700U – General Conflict of Interest Form
  • NSF COI Form
  • NIH COI Form
  • Disclosure Chart
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