COI Summary of EWU FCOI policies

Eastern Washington University
Summary of Financial Conflict of Interest Policies

Purpose
Office of Grant and Research Development (OGRD) has the responsibility to promote objectivity in research, to provide oversight and to manage compliance issues regarding all grants and contracts developed, submitted and awarded at Eastern Washington University (EWU). Under the Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards of the Office of Management and Budget (the OMB Uniform Guidance), each Federal agency that awards and administers grants and agreements is subject to the Uniform Guidance and is responsible for implementing standards to ensure that recipients and subrecipients comply with the EWU’s implementation of the guidance. In 2 CFR 200.112, it is specified that the Federal awarding agency must establish conflict of interest (COI) policies for all Federal awards and that the non-Federal entity and pass-through entity must disclose, in writing, any COI in accordance with the Federal awarding agency policy.

Background
Federal regulations, including PHS 42 CFR Part 50 Subpart F (grants and cooperative agreements), along with 2 CFR§215 (Uniform Administrative Requirements for Grants and Agreements) require institutions to have compliant and enforceable policies and procedures in place to ensure that all investigators disclose all Significant Financial Interests (SFI) that may present actual, or potential conflicts of interest in relationship to Public Health Service (PHS), National Science Foundation (NSF) or other federally funded sponsored projects. In addition, effective June 6, 1996, the Federal policies were adopted by the Washington State Legislature as part of the Ethics in Public Service Law. (See http://apps.leg.wa.gov/rcw/default.aspx?cite=42.52)

In addition,

Requirements

INVESTIGATOR DISCLOSURE:
This policy is applicable to all externally funded grants and contracts regardless of funding source. Compliance with these policies is applicable at the date of proposal submission. Disclosure of SFIs must be made prior to the submission of a proposal for funding, and annually upon award. Institutions are required to develop specific mechanisms by which COIs will be satisfactorily managed, reduced or eliminated prior to the expenditure of funds on any subsequent award. If a new reportable SFI develops at any time following the submission of a proposal, but prior to required reporting schedule as indicated by the sponsor, the filing of a new disclosure is also required in addition to updates as indicated by each sponsor.

INVESTIGATOR TRAINING
For federally funded projects, as well as for other sponsors that follow PHS policy, all investigators who are engaged in federally funded research projects or those who follow PHS policy will complete Conflict of Interest training prior to engaging in research. Accessing and participating in the FCOI module available through the Collaborative Institutional Training Initiative (CITI), located at https://about.citiprogram.org, will satisfy this training requirement.

Key Definitions

• Conflict of Interest may exist when an investigator engages in an activity or circumstance that has the potential to bias the design, conduct or reporting of results of research or technology.
• Conflict of Commitment may exist when an individual has difficulty balancing the effort necessary to perform their job duties while engaging in additional activities that may or may not be related to their job.
• 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 the NIH, or proposed for such funding, which may include, for example, collaborators or
• Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by the institution in the grant application, progress report, or any other report submitted to the PHS by the institution under the definitions used by the funding agency.
  • Note: this is a different definition than the NIH Grants Policy Statement.
• Investigator’s Institutional Responsibilities means an investigator's professional responsibilities on behalf of the institution, and as defined by the institution in its policy on financial conflicts of interest, 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.
• Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of NIH-­‐funded research.

Significant Financial Interest (SFI)

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.

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 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;
2. 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 intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

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 excluded sources provided in the regulation.

SFI Exclusions

1. Salary royalties, or other remuneration paid by the Institution to the investigator if the investigator is currently employed or otherwise appointed by the institution;
2. Intellectual property rights assigned to the institution and agreements to share in royalties related to such rights;
3. Any ownership interest in the institution held by the investigator, if the institution is a commercial or for-­profit organization;
4. 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;
5. 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;
6. 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.

For NSF Funded Projects

Significant Financial Interest (SFI): anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

SFI Exclusions

1. Salary, royalties or other remuneration from the applicant organization;
2. Any ownership interests in the organization, if the organization is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;
3. Income from seminars, lectures or teaching engagements sponsored by public or non-profit entities;
4. Income from service on advisory committees or review panels for public or nonprofit entities;
5. An equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests:
6. Does not exceed $10,000* in value as determined through reference to public prices or other reasonable measures of fair market value; and
7. Does not represent more than a 5% ownership interest in any single entity; or
8. Salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $10,000* during the prior twelve-month period.

 *While current NSF regulations designate a higher threshold of ($10,000) for SFIs than the PHS (NIH) policy, EWU identifies $5,000 as the standard monetary threshold in determining SFI for all funding sources.

INVESTIGATOR RESPONSIBILITIES

Each investigator is responsible to regularly update their disclosure status to ensure regulatory compliance. The schedule is as follows:

1. At the time of application:
2. If the investigator discloses known SFI’s to the institution; the designated official will review the disclosure to make a determination of FCOI’s and report to the PHS/NIH, NSF Office of General Council (OGC) or other funding agency as indicated in the regulation or policy.
3. Annually, each investigator will submit an updated Financial Conflict of Interest Disclosure form in accordance with university policy or;
4. Within 30 days of discovering or acquiring a new SFI;
5. Within the specific time period designated by the institution, during the period of award, or as indicated by the sponsor.

INSTITUTIONAL RESPONSIBILITIES

The University must:

• Establish standards that provide a reasonable expectation that the design, conduct and reporting of NIH-funded research will be free from bias resulting from investigator FCOIs.
• Maintain an up-to-date, written, enforced policy that complies with the FCOI regulation and make available via a publicly accessible website.
• Maintain records of all investigator disclosures of financial interests and the institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the institution’s determination of FCOI) and all actions under the institution’s policy or retrospective review, if applicable. Records must be maintained at least six years from the date of submission of the final expenditure report for the project.
• Certify in each application for funding that the institution:
  • Agrees to make information available upon request relating to any investigator disclosure of financial interest and the institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the institution’s determination of an FCOI.
  • Fully comply with the requirements of the regulation.
  • Designate Institutional Official(s) to solicit and review disclosure statements from each investigator planning to participate in, or who is participating in, PHS/NIH or other sponsor specific funded research.
  • Provide guidelines to identify conflicting interests related to proposed or PHS/NIH or other sponsor specific funded research.
  • Develop management plans that specify the actions that have been, and shall be, taken to manage FCOI.
• Designate an institutional official(s) to solicit, review disclosure statements, provide guidelines to identify conflicting interests related to sponsor funded research, develop management plans that specify the actions that have been and shall be taken to manage FCOI’s.
• Inform each investigator of the:
  • Regulation;
  • Institution’s policy on FCOI; and
  • Investigator’s responsibilities regarding disclosure of SFIs;
  • Require that each investigator complete FCOI training:
  • Prior to engaging in research related to any federally funded project; or sponsor who follows PHS policy;
  • At least every four years, and
  • Immediately when any of the following circumstances apply:
  • The institution revises its policy in a manner that affects the investigator;
  • When an investigator is new to the institution; or
  • When the institution finds an investigator does not comply with the institution’s policy and/or management plan.
• Manage investigator disclosures of SFI’s at time of application, annually and within 30 days of discovering or acquiring a new SFI.
• Management of FCOI’s by taking the necessary actions, development of management plans, and in cases of non compliance, complete a retrospective review and submit a mitigation report if bias is found.
• Provide FCOI reports as required.
• Manage Subrecipients:
  • Awardee institutions are responsible for monitoring subrecipient’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest to the NIH.
  • Incorporate as part of a written agreement terms that establish whether the FCOI policy of the awardee institution or that of the subrecipient will apply to subrecipient investigators and include time periods to meet SFI disclosure, if applicable, and FCOI reporting requirements.
  • Subrecipient institutions who rely on their FCOI policy must report identified FCOIs to the awardee institution in sufficient time to allow the awardee institution to report the FCOI to the PHS/NIH Awarding Component (or sponsor who follows PHS policy) to meet FCOI reporting
• Prior to expenditure of funds make certain information concerning FCOI’s held by senior/key personnel is made publicly accessible on the university’s website or provide written response within five business days of a request, and update information annually and within 60 days of identification of a new FCOI, and retain information for three years.
• Implement retrospective reviews if a new or non-reported SFI has been identified.
• Notify the sponsor if bias is found through a retrospective review, and submit a mitigation report as necessary.
• Develop adequate enforcement mechanisms and provide employee sanctions or other administrative actions to ensure investigator compliance.

EASTERN WASHINGTON UNIVERSITY STATEMENT OF POLICY

How Disclosure Is Made

1. Each university-affiliated individual who meets the definition of an investigator (See Key Definitions above) who is listed on a sponsored project will complete Financial Conflict of Interest Disclosure form.
2. Each university-affiliated investigator must complete the Financial Conflict of Interest Disclosure form. If the investigator answers yes to any question, supporting documentation outlining nature of the interest should be placed in an envelope marked CONFIDENTIAL, and submitted with the Financial Conflict of Interest Disclosure form for acknowledgement by the investigator's department chair or Dean.
3. The completed Disclosure form (and attachments, if applicable) must be submitted by the investigator to the OGRD whether or not there is an SFI being disclosed prior to the submission of the proposal.
   1. If an SFI is being disclosed, the confidential information will remain sealed until a notification of award from the funding agency is received. If a conflict is identified, it must be resolved prior to research beginning or the expenditure of any funds. Confidential information submitted for projects that are not funded will be returned to the investigator unopened or destroyed as requested by the investigator.

Evaluation of Financial Interests

The Office of Grant and Research Development will review the financial interest documentation that was completed at the time of proposal submission after notification of award to determine if a potential conflict of interest may exist that could directly and significantly affect the design conduct or reporting of the proposed project. The investigator is free to submit updated information that could potentially affect the SFI determination if applicable. If an initial judgement is made that an actual or potential conflict of interest may exist, the Provost’s Office will be notified.

The Provost has the ultimate responsibility for reviewing significant financial interest disclosures, determining whether or not an actual or potential conflict of interest exists, and for determining what action should be taken by the University to manage any conflict of interest.

Conflict of Interest Review Committee

When the Provost concurs with the judgment that an actual or potential conflict of interest exists, the case will be referred to the Conflict of Interest Review Committee. This three-member Committee, of which one member serves as chair, will be appointed by the President with nominations submitted by the EWU Academic Senate for a two-year term.  The Vice Provost or designee will serve as an additional non-voting member.

Reporting directly to the Provost, the Committee shall review all pertinent documentation including, but not limited to, the grant proposal, the Financial Conflict of Interest Disclosure form, the supporting documentation as required by Section B of the Financial Conflict of Interest Disclosure form, and the conflict of interest resolution plan developed and presented by the investigator in consultation with the unit chair or program director and dean.  At its discretion, the Committee may request additional information from and/or an interview with the investigator whose significant financial interest is under review.

The Committee will develop a resolution plan with the investigator.  The resolution plan shall not include any reduction in an employee’s salary unless the plan also includes a leave of absence from the University. Furthermore, in setting the salary of an employee, no account shall be taken of any payments received by any employee from outside sources that are disclosed in connection with the employee’s disclosure of any conflict of interest.

The Committee may endorse the resolution plan without change or propose alternative conditions which may be either more or less stringent or restrictive. The investigator may propose or the Committee may require one or more of the following as part of the resolution plan:

1. No action beyond disclosure to the University, sponsor, and/or competitor, as appropriate;
2. Disclosure of significant financial interests to:
   (i) the academic and professional communities in presentations and publications,

(ii) the sponsor through written notification, and
(iii) the participants through informed consent documents when human subjects are involved. In determining an appropriate means of disclosure, consideration should be given to whether it should be written and/or oral and to the level of detail;

3. Monitoring of research by independent reviewers — either through an in-house quality assurance program or through an outside referee or coordinating center;
4. Modification of the research plan to manage concerns of bias by establishing protocols that include actions such as blinding, modifying the scope of the project, and setting timetables for the delivery of the product. These modifications would require the approval and cooperation of the sponsor and perhaps collaborating investigators at the University and elsewhere;
5. Disqualification of the investigator from participation in all or a portion of the research when no other resolution is acceptable to the investigator and the Conflict of Interest Review Committee;
6. Designation of a co-investigator (peer or superior) who has no significant financial interest in the project to assume the lead role on the project;
7. The sale or other divestiture of the significant financial interest in a sponsor or competitor and restrictions on re-investment after the project is completed for an appropriate period to provide for publication and critique of the project;
8. Placing interest in escrow for the term of the project and perhaps a period beyond the end of the project to provide for publication and critique of the project;
9. Severance of other relationships with the sponsor or competitor that create actual or potential conflicts of interests.
10. Other strategies that may include variations of options presented, combinations of options, and/or new options not identified herein.

Committee Recommendation

The committee shall recommend to the Vice Provost or designee the conditions and restrictions, if any, to be imposed by the university to reasonably manage the actual or potential conflict of interest. The resolution plan shall not include any reduction in an employee’s base salary unless the plan also includes a leave of absence from the university. The final decision regarding management of the conflict of interest will be made by the Vice Provost or designee with due regard for the committee’s recommendations. The investigator shall indicate in writing acceptance of the resolution plan prior to acceptance and expenditure of any funds under the award.

For National Science Foundation (NSF) funded projects only: If the Vice Provost or designee determines the imposition of conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health or welfare, the university may allow the NSF-supported research, educational, or service activities to go forward without imposing such conditions or restrictions when permitted by applicable regulations.

Appeals

The Provost or designee has the ultimate responsibility for reviewing significant financial interest disclosures, determining whether an actual or potential conflict of interest exists, and for determining what actions should be taken by the university to manage any conflict of interest.

Investigators may appeal decisions of the Vice Provost or designee to the Provost. The appeal must be filed in writing and received by the Provost's office within 14 calendar days of the date the Vice Provost or designee issues a written decision. The Provost or designee should respond to the appeal within 14 calendar days of receipt. The Provost or designee may affirm, modify, or reverse the Vice Provost or designee’s determination. The Provost or designee’s decision is final and no further appeal is available.

Withdrawal due to Non-compliance

The University reserves the right to withdraw applications for funding in cases where an investigator, after the process of appeal, chooses not to comply with the resolution plan adopted in accordance with university policy and procedures, and if the project cannot otherwise be completed by the services of the investigator. In addition, violations of this policy may result in one or more university actions due to non-compliance.

Record Retention

The OGRD will maintain all records related to this policy. If a proposal is not funded, all information shall be returned to the investigator unopened or at the direction of the investigator will be destroyed. Records for funded projects will be maintained for six years after the conclusion of the project.

Reporting

Should the FCOI necessitate reporting to PHS or to a sponsor who follows PHS policy, EWU is required to provide the following information:

1. Name and address of organization, company, foundation, society, etc.;
2. Disclosure of the financial interest and indication that the activity is that of self, spouse, domestic partner or child;
3. Description of activity/financial interest;
4. Description of activities such as board of directors’ membership, executive or other employee relationship with said company, consulting, payment for lectures, papers, reports, evaluation, ownership of stock or stock options or other ownership interests (excluding investments that you do not directory control investment decisions such as mutual funds), licensing of your intellectual property, payment for royalties etc.;
5. Total amount of the financial interest;
6. Whether or not the company or organization is publicly traded or privately held.

In addition, all identified FCOI’s held by senior/key personnel will be made public on EWU’s website or by written response to any requester within five (5) business days of request and such information will be updated as specified by the regulation.

EWU will submit all reports as required to the relevant sponsor.                                                                                                                                                          

Retrospective Review

When it has been determined that a FCOI has not been identified or managed in a timely manner, there has been a failure of the investigator to disclose an SFI, or an investigator has failed to comply with a management plan, the institution shall within 120 days of the determination of noncompliance, compete a retrospective review of the investigator’s activities and the project to determine bias in the design conduct or reporting of such research. If bias is found through a retrospective review, EWU will notify the NIH or any other awarding component promptly and submit a revised FCOI report containing new information as necessary.

Responsibilities for Subrecipients

• All subrecipients, subcontractors, consultants, and consortium members that are identified as investigators on a proposal submission at EWU will provide assurance that their institution complies with FCOI regulations prior to submission.
• If the investigator or investigator’s institution does not have a PHS FCOI compliant policy, the subrecipient will be subject to EWU’s policies regarding Financial Conflict of Interests, which will be specified in the written agreement between the subrecipient and EWU. In addition, the subrecipient will follow the required deadline for disclosure of identified financial conflicts of interest as necessary to ensure that EWU can submit the required reports to the relevant federal agency in a timely manner. Prior approval is required to use EWU’s FCOI policy.
• The subrecipient investigator will provide assurance and documentation of completion of the required FCOI training prior to any funds being expended.
• The subrecipient will provide FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

For Additional Information, contact the Office of Grant and Research Development (ext. 6567), ogrd@ewu.edu, visit https://staging-inside.ewu.edu/ogrd/ or https://staging-inside.ewu.edu/policies/policies-and-procedures/.