The California State University, Long Beach Financial Conflict of Interest Policy establishes guidelines for the disclosure, identification, and management of financial conflict of interests (FCOI) for investigators responsible for the design, conduct, or reporting of research under a sponsored research project or when proposing a sponsored project. CSULB ORSP and the CSULB Research Foundation follow all federal, state, and California State University regulations for reviewing, identifying, and managing FCOI disclosures.
The CSULB Office of Research and Sponsored Programs (ORSP) actively encourages involvement of academic researchers and educators with industry and private entrepreneurial ventures. Such involvements, however, can create an increased risk of financial conflict between the private interests of individuals, the entities with which they are involved, and the public interest that governmental funding serves.
This policy is set in place to ensure that investigators involved in a sponsored research project that is externally funded by contracts or grants from non-governmental sponsors, the National Science Foundation, or the Public Health Service disclose all significant financial interests (SFI) related to the proposed research. Prior to proposal submission CSULB Grants and Contracts Administrators (GCA's) review FCOI disclosures to determine if investigators have potential significant financial conflicts of interests. Any significant financial conflicts of interest are further reviewed by the CSULB Director for Research Compliance (DRC) and a management plan is implemented to manage, reduce, or eliminate the FCOI. Records of financial disclosures and all actions taken to resolve conflicts of interest are maintained for three years beyond the termination or completion of the grant to which they relate or until the resolution of any sponsor action involving those records, whichever is longer.
Investigators are required to disclose Significant Financial Interests (SFI) whenever an investigator applies for funding from the National Science Foundation, Public Health Service, from non-governmental contract or grant sources, or from a governmental entity with a contractual conflict of interest requirement. In addition investigators must disclose significant financial interests annually during the life of a sponsored research project, and within 30 days of discovering or acquiring a new SFI.
Significant financial disclosures are defined as follows:
"(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:
(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. 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;
(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) PHS funded investigators also must disclose the occurrence of any reimbursed or sponsored travel (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 their institutional responsibilities; provided, however, 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 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. Travel disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The CSULB DRC will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by an Investigator's 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; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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; 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 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."
Investigator is defined as the Principal Investigator (PI) or Project Director (PD), the Co-PI or Co-PD, and any other person, regardless of title or position, who would be responsible for the design, conduct, or reporting of research funded by the PHS or proposed for such funding, including non-CSULB investigators, consultants, and unpaid collaborators. CSULB DRC is required to consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work.
Sponsored program funders for which FCOI disclosure is required by investigators before a proposal is submitted or an award is accepted include the following:
An investigator must make a financial disclosure using a specific financial conflict of interest disclosure form.
For all proposal submissions for a non-governmental contract or grant, or for funding from the National Science Foundation or Public Health Service funds, GCA's will provide the Conflict of Interest Form or 700u Form and guidelines for completion to each investigator before proposal submittal.
Investigators will also submit FCOI forms annually and when SFI status changes.
Upon receipt of a COI disclosure form from an investigator, the Sponsored Programs
Manager will ensure the form is completed and signed by the investigator.
The GCA's will include the FCOI disclosure form in the proposal routing package for review by DRC and campus administrators or if subsequent to proposal submittal will forward the FCOI disclosure form to the DRC for review.
When an investigator discloses a significant financial interest the CSULB chair, dean, and AVP will review the disclosure to determine whether the SFI is related to the sponsored research and whether the SFI is an FCOI. The CSULB chair, dean, and AVP R&EP work with the Investigator to create a management plan to mitigate and manage the potential conflict of interest and will provide a copy of the approved mitigation and management plan to the CSULBORSP GCA's for inclusion in an FCOI file within the proposal file.
Prior to transmitting an award file to the post-award GCA, the pre- award GCA will ensure that each investigator receiving an award for funding from the National Science Foundation, a Public Health Service-funded agency, a non-governmental contract or grant sources, or from a governmental entity with a contractual conflict of interest requirement has an unexpired disclosure form (Conflict of Interest Form or 700u Form) in place.
When an investigator has disclosed a significant financial interest on a disclosure form the GCA will confirm that the form has been countersigned by the Associate Vice President R&ES to indicate acknowledgement of the disclosure, and that a copy of an approved FCOI management plan accompanies the disclosure form signed by the investigator and the AVP R&ES, and that a training completion certificate is on file for any investigator subject to mandatory FCOI training (PHS funded research projects).
Investigators must complete mandatory FCOI training before engaging in research funded by Public Health Service (PHS), and must also complete refresher training every four (4) years thereafter; when CSULB ORSP or CSULB FCOI policy, procedures, or forms are revised in any manner that affects the requirements of investigators; when the investigator is new to a university; and when CSULB or CSULB ORSP finds that an investigator is not in compliance with the FCOI regulations or management plan.
CSULB ORSP DRC provides the CITI Tutorial link to investigators when research projects are being proposed for PHS-funding.
Once investigators complete the mandatory training they request the issuance of the training completion certificate and provide a copy of the certificate to their designated CSULB GCA.
Prior to the expenditure of awarded funds, the CSULB DRC reviews all Investigator disclosures of significant financial interests, determines whether any significant financial interests relate to the funded award, determines whether a financial conflict of interest exists, and if so, creates and implements a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.
At the discretion of CSULB, examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:
CSULB ORSP DRC will submit a report to NIH or other PHS-funded agency regarding any Investigator Significant Financial Interest found by the Institution to be a Financial Conflict of Interest in accordance with the regulation prior to expenditure of any funds under a PHS-funded research project. CSULB ORSP will also provide an FCOI report whenever an Investigator does not timely disclose a Significant Financial Interest or whenever CSULB ORSP, for whatever reason, does not review a disclosed Significant Financial Interest and the Institution then determines that a Financial Conflict of Interest exists.
CSULB ORSP will submit an FCOI report within sixty (60) days after its determination that an FCOI exists for an Investigator who is newly participating in the project or for an existing Investigator who discloses a new Significant Financial Interest to the Institution during the period of award. CSULB will implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage such Financial Conflict of Interest going forward and submit an FCOI report to the NIH or other PHS-funded agency.
CSULB ORSP will also, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator's research activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct or reporting of such research. Based on the results of the retrospective review, if appropriate, CSULB ORSP will update the previously submitted FCOI report, specify the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, CSULB ORSP will notify the NIH promptly and submit a mitigation report that includes the key elements documented in the retrospective review and 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 effects of the bias.
Thereafter CSULB ORSP will submit FCOI Reports to NIH or other PHS-funded agency annually for any Financial Conflict of Interest previously reported. The annual FCOI report shall address the status of the financial interest and any changes to the management plan. Annual FCOI reports shall specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists. Annual FCOI reports will be submitted to the NIH (e.g., through the eRA Commons for grants and cooperative agreements) for the duration of the project period (including extensions with or without funds) at the same time as when the Institution is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension (e.g., submission of an extension notification in the eRA Commons or submission of a NIH prior approval request, whichever is applicable) , but is not to be submitted as part of the annual progress report.
The annual FCOI report will be submitted to NIH separately through the eRA Commons
FCOI Module and will include the following key elements
CSULB ORSP follows all federal, state, and California State University regulations for reviewing SFIs and for identifying, managing, reducing, eliminating, and reporting FCOIs.
As required by PHS regulations, CSULB ORSP will notify the sponsoring agency promptly of the corrective action taken or to be taken for non-compliance by an Investigator and the non- compliance appears to have biased the design, conduct, or reporting of the PHS-funded research. PHS FCOI regulations will be followed for the conduct of retrospective reviews and management and mitigation reports.
As required by PHS regulations, CSULB ORSP will require the Investigator(s) to disclose an FCOI in each public presentation of the research results and to request and addendum to previously published presentations for any clinical research projects supported by the PHS, should the Department of Health and Human Services determine that the PHS-funded project of clinical research, whose purpose is to evaluate that safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with a FCOI that was not properly disclosed or managed.
CSULB ORSP will complete and document retrospective reviews within 120 days of a determination of noncompliance for SFIs not disclosed timely by the investigator, not initially identified when previously reviewed, or whenever an FCOI is not identified or managed in a timely manner, and will document the reviews as required by the regulation.
Prior to including a subrecipient in a PHS-funded research proposal, the CSULB ORSP Sponsored Programs Manager will confirm, through use of the written subrecipient information form, that all proposed subrecipients have a FCOI interest policy that complies with FCOI regulations and that the subrecipient will report identified FCOIs for its investigators in a timeframe that allows CSULB ORSP to report identified FCOIs as required by the regulation.
CSULB ORSP will report to the PHS-funding agency any FCOI that is identified by any subrecipient, subcontractor, collaborator, or consultant in the manner required under FCOI regulations prior to expenditure of funds and within sixty (60) days of any subsequently identified FCOI.
|Form||Description of Use|
|700u Form||Must be completed by Investigator for financial disclosure when Investigator is proposing to or receiving sponsored funding from a non-governmental entity.|
|Conflict of Interest Form||Must be completed by Investigator for financial disclosure when Investigator is proposing to or receiving sponsored funding from a government agency that requires disclosure of Significant Financial Interests such as NSF and PHS-funded research.|
|Subrecipient Information Form(under construction)||Must be completed by potential subrecipients or subcontractors to provide contact and regulatory compliance information and disclosures.|
|FCOI disclosure forms and all documents related to the management of an FCOI||Three years|
|Term or Acronym/Abbreviation||Description|
|Financial Conflict of Interest||A Financial Conflict of Interest (FCOI) exists when the Institution, through its designated official(s), reasonably determines that an Investigator's Significant Financial Interest is related to an NSF-, PHS-, or other funded research project and could directly and significantly affect the design, conduct, or reporting of the NSF-, PHS- or other- funded research.|
|Institutional Responsibilities||Institutional responsibilities are defined by the 2011 revised PHS regulation as an Investigator's professional responsibilities on behalf of the Institution, and as defined by the institution in FCOI policy, which may include, for example, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards, or Data and Safety Monitoring Boards.|
|Investigator||In this policy investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by NSF, PHS, or proposed for such funding, which may include, for example, collaborators or consultants. For sponsored projects funded by non-governmental agencies or government agencies with contractual conflict of interest clauses the institution officials may determine that investigators are limited to the PI or Co-PIs of the sponsored program.|
|Significant Financial Interest||Interest that would create a conflict of interest is defined as any financial interest that a principal investigator would have that would reasonably appear to be directly and significantly affected by sponsored activities or any interest that a principal investigator would have in entities whose financial interest would reasonably appear to be directly and significantly affected by sponsored activities.|
|Sponsored Travel||Travel that is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available.|
These are the referenced or related documents for the Conflict of Interest