1. Introduction
2. Key Definitions
3. Certification of Compliance  Travel
4. Disclosure Review Process
5. Training
6. Responsibilities
   1. Institution
      1. Institutional Official
      2. The Conflict of Interest Committee
      3. Additional Research Program Responsibilities
   2. Center Staff Member/Investigator
   3. Program Directors
7. Awardees and Subrecipients
8. Reporting

Public Health Service (PHS)-Funded Projects
National Science Foundation (NSF)-Funded Projects

9. Record Retention
10. Noncompliance

Additional PHS Requirements

11. Public Accessibility
    1. Required Center SFI Disclosures
12. Additional Resources

I. INTRODUCTION

The Center for Cultural and Technical Interchange Between East and West, Inc. (East-West Center) is committed to maintaining a research environment that promotes attention to the highest ethical standards for all sponsored and non-sponsored research. This commitment includes compliance with regulatory requirements set forth by the Public Health Service (PHS) and the National Science Foundation (NSF). It is the responsibility of the Center to promote objectivity in research through the establishment of a Policy on Financial Conflict of Interest.  This Policy supplements other Conflict of Interest Policies included in Employee Handbooks and East-West Center Policy Manuals.

A conflict of interest might take various forms, but includes any circumstance where personal, professional, financial, or other private interests of a person or institution compromise or have the potential to compromise the exercise of professional judgment or obligations, or may be perceived as doing so. It is important to note that a conflict of interest depends on the situation; not on the character or the actions of the individual.  Members of the Center community should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when apparent conflicts of interest arise.

The purpose of this policy is to educate individuals about situations that generate conflicts of interest, and to provide means for Center staff members and the East-West Center to identify, manage, reduce, and/or eliminate actual or potential conflicts of interest. Every member of the Center community has an obligation to become familiar with, and abide by, the provisions of this policy.

II. KEY DEFINITIONS

• Significant Financial Interest (SFI) – Anything of monetary value, whether the value is readily ascertainable, that 1) is related to the Investigator's professional responsibilities on behalf of the Center; and 2) belongs to the Investigator or the Investigator's family. Additional details regarding what constitutes a Significant Financial Interest are specified in Section III.
• Family - Any member of the Investigator’s immediate family, specifically, spouse or registered domestic partner, and any dependent children.
• Financial Conflict of Interest (FCOI) – A significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.[1] Similarly, if a significant financial interest could reasonably appear to be affected by the research or educational activities, or the interest is in entities whose financial interests would reasonably appear to be affected by such activities,[2] review and elimination or management of the conflict is required.
• Investigator – This policy applies to all Center employees and other Center project investigators who fall under the definition of Investigator. Specifically – the project director or principal investigator, and any other persons, regardless of title or position, who are responsible for the design, conduct, or reporting of research activities funded by PHS or proposed for funding by PHS. Therefore, the policy also applies to subrecipients, collaborators, consultants, post-doctoral fellows, graduate students, and others who meet the threshold for responsibility.
• Institutional Responsibilities – The Investigators' professional responsibilities associated with his or her position at the Center including, but not limited to, research, research consultation, teaching, training, and public service done on behalf of the Center or directly related to the those credentials, expertise and achievements upon which the Investigator’s position at the Center is based.
• Certification/Disclosure Process – All investigators must provide certification of their knowledge of and compliance with this policy on an annual basis. The certification process involves either a certification that no significant financial interest exists or the disclosure of existing significant financial interests to the Center.  In addition to the annual requirement, the acquisition or discovery of any new significant financial interests requires disclosure within 30 days.
• Conflict of Interest Committee (COIC) – The Center may create a COIC to advise the Institutional Official on conflict of interest matters or the Institutional Official may consult with the Director of Administration or his designee, Human Resource Officer, or other Center research staff for advice on matters relating to conflict of interest matters.
• Institutional Official – The individual at the Center responsible for the solicitation and review of disclosures of significant financial interests from each Investigator who is participating in, or is planning on participating in, research. The Institutional Official for the East-West Center is the Director of Research.
• Key Personnel – The individuals including the project director or principal investigator, or any other person considered essential to the work performance and identified as key personnel in the grant application or proposal submitted to the awarding agency.
• Public Health Service (PHS) - The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated, including the National Institutes of Health.

III. CERTIFICATION OF COMPLIANCE

All Investigators as defined in this policy are required to complete the appropriate Financial Disclosure Form (Form 1) to disclose their outside financial interests as defined above to the Center on an annual and on an ad hoc basis, as described below. The Institutional Official (Director of Research) is responsible for the distribution, receipt, processing, review and retention of disclosure forms.  The Director of Research will take appropriate action for Forms indicating possible conflicts including, when necessary, consulting the COIC for review and other appropriate actions.  The completed certifications will be retained in the project grant file or, when applicable, the investigator’s Human Resource personnel file.

1. Annual Disclosure

On an annual basis, all Center staff members and other collaborators meeting the definition of an Investigator must certify their knowledge of and compliance with this policy by completing the applicable Financial Disclosure Form for review by the fiscal staff by October 1^st of each fiscal year during the award period.

2. Other Ad Hoc Disclosures

In addition to the annual disclosure, all Investigators must update or disclose their Significant Financial Interests in the following situations:

• Within 30 days of their initial appointment or employment;
• Prior to entering into PHS-sponsored projects or applications for PHS-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirm the currency of the annual disclosure or submit to an updated disclosure form.  The Center will not submit a research proposal unless the Investigator(s) have submitted such disclosures.
• Within thirty (30) days of discovering or acquiring a Significant Financial Interest all Investigators a new form for disclosure of any Significant Financial Interest they acquire or discover during the course of the year.

The financial disclosure form requires that Center staff members indicate "yes" or “no" to a series of questions applicable to both themselves and immediate family members.  The following forms will be completed by Investigators for the respective PHS or NSF funded projects on an annual basis or as required for other ad hoc disclosures:

PHS Financial Disclosure (Form 1) - (download PDF and open in Adobe Reader)

NSF Project Financial Disclosure (Form 1) - (download PDF and open in Adobe Reader)

In answering the questions, if a reasonable, disinterested person would question the relationship, it should be disclosed and approval sought for the proposed arrangement. A Significant Financial Interest (SFI), which requires disclosure includes:

• Income in excess of $5,000 ($10,000 for NSF-funded Investigators) from a publicly-traded entity[3] during the last 12 months,
• Stock in a publicly traded company valued in excess of $5,000 ($10,000 for NSF-funded Investigators) at the time of disclosure,
• A combination of the above two items (stock and income) that exceeds $5,000 ($10,000 for NSF- funded Investigators),
• Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity, such as a start-up company,
• Compensation that exceeds $5,000 from a non-publicly traded entity in the past 12 months, or
• Income related to intellectual property rights paid by any source other than the Center.
• Certain travel reimbursements or sponsored travel by an entity not excluded below that is for travel related to your institutional responsibilities.

The following DO NOT require disclosure:

• Salary, royalties, or other remuneration paid to the Investigator from the Center or the University of Hawaii as an authorized EWC or UH joint appointee.
• Income from investments in mutual funds or retirement accounts, as long as the Investigator does not directly control the investment decisions, e.g., TIAA/CREF, Merrill Lynch, Charles Schwab.
• Income for services (e.g., honoraria, advisory committees, and review panels) paid by a U.S. federal, state, or local government agency; a U.S. institution of higher education, research institutes affiliated with U.S. institutions of higher education, a U.S. medical center, or a U.S. academic teaching hospital.
• Travel expenses when paid by the Center; or a U.S. federal, state, or local government agency; a U.S. institution of higher education, research institutes affiliated with institutions of higher education, a U.S. medical center, or a U.S. academic teaching hospital.
• Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Program Phase I applications and awards.

PHS Additional Financial Disclosure

When a PHS Financial Disclosure indicates any Yes (Significant Financial Interest) response, the Investigator MUST complete PHS Additional Financial Disclosure (Form 2) - (download PDF and open in Adobe Reader).  The Form will be forwarded to the Director of Research for review and necessary actions then retained by the Human Resource Office for record retention.  Form 2 will require the investigator to provide the following information including:

• The individual's current or pending relationship including past and planned travel costs with the outside enterprise or entity in which the Center staff member has a significant financial interest;
• The relationship of the proposed Center activity to the enterprise or entity,
• The means by which the Center staff member proposes to address actual or potential conflicts of interest that arise from his/her (or immediate family members) dual Center and enterprise or entity roles, and
• The dollar amount of the financial interest in specified ranges.

The Additional Financial Disclosure form must be attached to the contract or grant Proposal and Financial Disclosure Form (Form 1) and provided to the Institutional Official before routing the proposal for review or submission to the funding agency.

Disclosure forms on file must be updated within 30 days in the case of any new acquisitions or discovery of new significant financial interests.  Complete the appropriate PHS or NSF Form 1.

The Institutional Official or the COIC may contact the Investigator to provide more information regarding the information presented in Form 2.  The Investigator will be asked to complete PHS Financial Disclosure (Form 3) to provide additional information to enable them to make a determination whether a FCOI exists.

PHS Financial Disclosure (Form 3) - Additional Information Requested by ICOI - (download PDF and open in Adobe Reader)

Investigators required to sign the Forms are encouraged to provide input with regard to additional factual information, concerns, or any conditions or restrictions that might be imposed by the Center to manage, reduce, or eliminate such conflict of interest.  This information will be made available to the Institutional Official and COIC for consideration. Examples of conditions or restrictions that might be imposed to manage, reduce, or eliminate actual or potential conflicts of interest can include, but are not limited to:

• Public disclosure of the conflict in publications and presentations
• Disclosure to other research team members
• Appointment of an independent third party to monitor the research
• Modification of the research plan, with approval by the sponsor
• Change of personnel or personnel roles so that the individual in conflict does not participate in the part of the research that could be affected
• Reducing or eliminating the financial interest (e.g., sale of an equity interest)
• Severance of relationships that create financial conflicts

TRAVEL

All PHS-funded project investigators as defined in this policy reimbursed or sponsored travel paid by a third-party entity, including non-profit organizations or other entities not specifically excluded below must be disclosed on Form 2 if it is related to your institutional responsibilities. However, disclosure is not required for travel sponsored by or reimbursed by a U.S. federal, state, or local government agency, a U.S. Institution of higher education, research institutes affiliated with institutions of higher education, a U.S. medical center, or a U.S. academic teaching hospital.

Travel disclosures must include, at a minimum: the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  The Director of Research or the COIC will determine if additional information is required, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI for the investigator and the PHS-funded project.

IV. DISCLOSURE REVIEW PROCESS

All certifications in which a Significant Financial Interest is indicated, their associated disclosures, and any recommended arrangements by or concerns of the signatories will be reviewed by the Director of Research. If necessary, the Director may organize and consult with the Center's Conflict of Interest Committee.

An actual or potential conflict of interest exists when the Director of Research or the Committee reasonably determines that the Significant Financial Interest could affect the design, conduct, or reporting of the research or educational activities in question.  Additional information might be requested by the Director of Research or the Committee to make this determination, and the Investigator must comply with this request.

If it is determined that a conflict exists, a final written agreement to manage the conflict will be reached by the Investigator, the Director of Research, and the Center’s President.  Program Directors are responsible for ensuring that required management plans are carried out and monitored until the completion of the research.  Should an Investigator wish to appeal a decision made by the Director of Research or the COIC, he or she may present the appeal in writing. The Investigator will be made aware of all appeals by the Director of Research.  The Center’s President will be kept informed by the Director of Research whenever a FCOI is disclosed, discovered, or reported and the status of the ongoing conflict management plan.

V. TRAINING

All NSF or PHS-funded project investigators must complete training on this Policy and the investigator’s responsibilities regarding disclosure. All PHS-funded project investigators must also complete training on the PHS regulations (42 CFR Part 50 Subpart F) prior to engaging in research and must complete the Center recognized National Institute of Health (NIH) Financial Conflict of Interest tutorial training at https://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or an acceptable PHS FCOI training course equivalent at a U.S. institution of higher education.

• Before utilizing PHS funds;
• At least once every four years; and
• Whenever an investigator is found to be out of compliance with these procedures, their governing policy, or an applicable management plan.

A copy of the Investigator(s) NIH Certificate of Completion or equivalent training course certificate must be retained in the related project contract or grant file.

VI. RESPONSIBILITIES

1. Institution

The East-West Center is responsible for maintaining a Financial Conflict of Interest Policy for PHS and NSF funded research projects. The Center will adhere to any updated federal regulations and update its policy to comply with the federal requirements when it becomes aware of such differences. Additional resources are included as below:

National Institutes of Health

National Science Foundation Award and Administration Guide. Chapter IV
 

1. Institutional Official (IO)

The East-West Center Institutional Official for purposes of this policy is the Director for Research. The Institutional Official is responsible for the solicitation and review of disclosures of significant financial interests from each Investigator at the Center. The Institutional Official is the final signing official for all management plans put in place when it is determined that a Financial Conflict of Interest exists.

2. The Conflict of Interest Committee (COIC)

A Conflict of Interest Committee may be organized to consult with the Director of Research to review SFI disclosures and annual certifications with SFI disclosures for PHS or NSF sponsored projects.  The Committee may be comprised of the Director of Research as chairperson, Director of Administration or a designee, and a member from the Human Resource Office.  A member from the research staff may also be added or consulted by the Director of Research.

The Director of Research or COIC will determine within 60 days for PHS funded projects whether an Investigator's submitted Significant Financial Interest could directly and significantly affect the research or is in an entity whose financial interest could be affected by the research. If it is determined that either of these conditions is valid, a Financial Conflict of Interest exists. In the case of a Financial Conflict of Interest and prior to the expenditure of any research funds, the Director of Research or COIC will work with the Investigator to develop a plan to manage or eliminate the conflict, and to ensure to the extent possible that the research is free of bias.

3. Additional Research Program Responsibilities

• Maintenance of an up-to-date, written, enforced policy on FCOI, made available through a publicly accessible website. This policy is available on the East-West Center Research Program website.
• Notification to Investigators of new regulations and revised Center policy/Investigator responsibilities.
• Reporting all required information regarding Financial Conflicts of Interest to federal sponsors.
• Making information regarding FCOIs of senior/key personnel on PHS funded projects publicly available.
• Maintenance/retention of all required FCOI records as per funding agency requirements.

B. Center Staff Member/Investigator

• Being familiar with and abiding by federal regulations and Center’s Policy regarding FCOI.
• Ensuring that FCOI training is completed prior to utilizing PHS funds and at least once every four years, as outlined in section V.
• Filing an FCOI Certification and disclosure (if appropriate) to the Center annually and within 30 days of discovering or acquiring a new significant financial interest.
• Confirming agreement to and complying with any management plan issued by the Center; retaining documentation that demonstrates compliance with the management plan, such as notices to journal editors or conference audiences.

C. Program Directors

• All Program Directors who have program staff members receiving PHS or NSF funded projects are responsible for ensuring that their investigators submit annual certifications and disclosures.
• As indicated in Section III, the Director of Research and Investigators are encouraged to provide input with regard to additional factual information, concerns, or any conditions or restrictions that might be imposed by the Center to manage, reduce, or eliminate such conflict of interest.  They will also be actively involved in the final review of plans to manage or eliminate conflicts.
• Respective Program Directors are responsible for ensuring that required management plans are carried out and monitored until the completion of the research.

VII. AWARDEES AND SUBRECIPIENTS

When the East-West Center is the primary awardee of a collaborative PHS or NSF funded project, it must assure that the financial interests of all subrecipients are reviewed and eliminated or managed properly. During the proposal stage and during the negotiation of a subaward, all subrecipients/potential subrecipients of PHS funding will be required to certify the following in writing via a Letter of Compliance:

• The subrecipient Institution has a policy in place to review and manage Significant Financial Conflicts of Interest that meets regulatory requirements.
• The subrecipient's policy applies to the subaward portion of the research project, and
• The subrecipient must agree that the identification of and management plan of any FCOI identified will be submitted to the awardee Center for required reporting purposes.

If the Institution does not have a compliant FCOI program in place, the subaward agreement must indicate that the subrecipient will follow Center FCOI policy, including the pre-award and annual submission of a Certification (Form 4) to the Center Institutional Official/COIC within 30 days of the submission of the proposal.

PHS Financial Disclosure (Form 4) – Financial Interest Directly Related to Work under a Subrecipient Agreement - (download PDF and open in Adobe Reader)

VIII. REPORTING

The Director of Research is responsible for reporting Financial Conflict of Interest Reports to the funding agencies, as applicable:

Public Health Service (PHS)-Funded Projects

Initial Report

• Prior to the expenditure of funds under a PHS-funded research project, the East-West Center must report to the primary recipient or awarding agency any Investigator(s) as defined in this policy Significant Financial Interests that are determined by the Director of Research or the COIC, to constitute a Financial Conflict of Interest.

Interim Reports

• The Center must 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 Center during the period of award.
• A FCOI report is required in cases of noncompliance (when an Investigator does not disclose a previously existing Significant Financial Interest in a timely fashion or the Center fails to review a previously existing Significant Financial Interest during an ongoing PHS-funded project).

Annual Reports

• For any Financial Conflict of Interest previously reported by the Center, the Center shall provide an annual FCOI report to the primary recipient or awarding agency that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports must 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 must be submitted to the awarding agency for the duration of the project period, including extensions with or without additional funds.

National Science Foundation (NSF)-Funded Projects

• The East-West Center must notify the awarding agency if it determines that it is unable to manage a Conflict of Interest related to an NSF-funded project satisfactorily.

IX. RECORD RETENTION

The Investigator training certification and initial Financial Disclosure Form (Form 1 or Form 4) may be retained in the project contract and grant files.  Although all FCOI disclosures are available for public access, the Human Resource Office will be responsible for the maintenance and retention of all personal financial disclosure documentation (PHS Form 2 and Form 3) and of all actions taken to resolve conflicts of interest for at least three years beyond the date of submission of the final expenditures report of the grant to which they relate, or until the resolution of any funding agency action involving those records, whichever is longer. Additional retention might be required under 45 C.F.R. 74.53(b) and 92.42 (b) for different situations.

X. NONCOMPLIANCE

Failure of any Center staff member to comply with this policy shall constitute grounds for disciplinary action. Disciplinary action is based upon a reasonable investigation of the noncompliance and is consistent with the severity of the violation. A range of examples includes, but is not limited to, the requirement for additional training/monitoring for minor violations up to the imposition of restrictions on a Center staff member's participation in sponsored research for severe or continuing violations.

Additional PHS Requirements

• If an investigator fails to disclose a SFI in a timely manner or if for any reason the Center fails to review a SFI, the Center must, within 60 days, determine whether the SFI is related to the research, and whether it rises to the level of a FCOI. If found to be an FCOI, a management plan, even if interim, must be implemented. A FCOI report must be made to the awarding agency at this time.
• In addition, where it is discovered that the East-West Center has failed to manage a FCOI or where a researcher has failed to comply with a management plan, the Center must, within 120 days, complete a retrospective review of research to determine whether the research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research. If bias is identified, a mitigation report must be developed that outlines a plan of action to eliminate or mitigate the effect of the bias. The results of that determination and the mitigation report must be submitted to the awarding agency.

XI. PUBLIC ACCESSIBILITY

The Center is required to make its policy on Financial Conflict of Interest publicly accessible via its website. In addition prior to the expenditure of any PHS funds, the Center will make available on its website or in a written response within five (5) business days required disclosures of Significant Financial Interest. Requests for disclosures can be obtained by contacting the Center’s Human Resource Office or Director of Research. .  The Center is required to disclose information concerning any SFI disclosed to the Center that meets the following three criteria below:

• The SFI was disclosed and is still held by key personnel as defined in this policy;
• The Center determines that the SFI is related to the PHS-funded research, and
• The Center determines that the SFI is a Financial Conflict of Interest.

The information that must be disclosed includes the following:

• Investigator's name;
• Investigator's title and role with respect to the research project;
• Name of the entity in which the Significant Financial Interest is held;
• Nature of the Significant Financial Interest; and
• Approximate dollar value of the Significant Financial Interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 in increments of $50,000) or a statement that the interest is one for which the value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

There are no SFI at the East-West Center to report at this time.Any new SFI disclosures will be posted in accordance with this policy.

XII. ADDITIONAL RESOURCES

Department of Health and Human Services Code of Federal Regulations:

 42 CFR Part 50 / 45 CFR Part 94

Conflict of Interest FAQs 

Effective Date: February 10, 2016