Financial Conflicts of Interest in Funded Research Policy

Responsible Unit: Office of Scholarly Activity | Executive lead: Provost 
Created: 08/21/2021 | Reviewed/Revised: 06/28/2022 | Effective: 06/28/2022 
Compliance: CFR Title 42, Chapter I, Subchapter D, Part 50, Subpart F AUTHORITY: 42 U.S.C. 216, 289b-1, 299c-4; Sec. 219, Tit. II, Div. D, Pub. L. 111-117, 123 Stat. 3034. SOURCE: 76 FR 53283, August 25, 2011, unless otherwise noted. NIH Financial Conflict of Interest, NWCCU 2.D.3
Approving Body: PAC | Classification: Institution-wide 

Policy:  
1. POLICY PURPOSE  
The Purpose of this Policy is to promote integrity and objectivity in research at Pacific Northwest University (University) by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded by U.S. Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from any financial interest of an investigator, as defined and set forth below. This policy is specifically designed to meet the requirements of the U.S. Public Health Service (PHS) regulations regarding Financial Conflicts of Interest.  

2. POLICY SCOPE AND IMPLEMENTATION 
This policy applies to all University employees, collaborators, and subrecipients (subcontractors, subgrantees) who are responsible for the design, conduct, or reporting of research. These individuals must comply with this University policy to disclose financial interests, cooperate with the University processes, and abide by any management plan adopted to manage financial conflicts of interest (FCOI).  

The provost is primarily responsible for the implementation of this University policy. 

3. Applicable regulatory PROVISIONS  
Before applying for or using funding from a PHS funding component, the University must fully satisfy the provisions of the PHS COI regulations. PHS funding components include, among others, the National Institutes of Health, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention.1 

4. MANAGEMENT OF FCOI 

  1. Disclosure of SIGNIFICANT Financial INTERESTS 
    • When applying for or using PHS funding, an investigator must disclose any Significant Financial Interest (SFI) which reasonably appears to be related to the investigator’s PNWU responsibilities. The University must receive all disclosures before a funding proposal is submitted to PHS. 
    • When applying for or using PHS funding, an investigator must disclose the following financial interests of the investigator or the investigator’s family that reasonably appear to be related to the investigator’s institutional responsibilities: 
      • The value of remuneration received by an investigator or their family from a publicly-traded entity in the 12 months preceding the disclosure.   
      • The value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.  For purposes of this policy, 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. 
      • The value of remuneration received from a non-publicly-traded entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator and/or the investigator’s family holds any equity interest in a non-publicly-traded entity. 
      • The values above should include any intellectual property rights and interests (e.g., patents, copyrights), held by the investigator and/or the investigator’s family upon receipt of income related to those rights and interests. 
      • Any travel reimbursed or sponsored (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 the investigator’s PNWU responsibilities; except travel that is reimbursed or sponsored by a nonconflicting institution as defined above. 
      • All gifts received from an entity other than a nonconflicting institution during the 12 months preceding the disclosure if the aggregate value of the gifts exceeds $50.  
    • Note: Do not include salary, royalties, or other remuneration paid by the University if the investigator is currently employed or appointed by the University; 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 nonconflicting institution; or income from service on advisory committees or review panels for a nonconflicting institution or a research institute that is affiliated with an institution of higher education. As noted above, the term “nonconflicting institution” does NOT include foreign institutions or foreign government entities. 
    • Each investigator who is participating in the PHS-funded research must submit an updated disclosure of significant financial interests at least annually during the period of the award. Such disclosure shall include any information that was not disclosed initially to the Institution, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest). 
    • Each investigator who is participating in the PHS-funded research mush submit an updated disclosure of significant financial interest within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest. 
    • Investigators shall submit all disclosures required by this policy to the PNWY Office of Scholarly Activities (OSA) using such forms or though such means as OSA may require. 
  2. FINANCIAL CONFLICT OF INTEREST REVIEW of Disclosure Form Process 
    • The provost and/or the provost’s designees shall review all pertinent documentation, disclosures of significant financial interests, and FCOI resolution plans for potential or actual FCOI cases, based on applicable law and University policy. The provost and/or the provost’s designees have the responsibility and authority to (1) assess whether an actual or potential FCOI exists, (2) assess the extent of the FCOI, and (3) develop a plan to manage, reduce or eliminate the actual or potential FCOI before approving the research, or at any later date when an actual or potential FCOI is disclosed or discovered. 
    • The investigator or research employee, in collaboration with the provost and/or the provost’s designees, must develop a suitable management strategy for an identified FCOI, subject to the provost’s approval. If the investigator or research employee disagrees with the decisions of a provostial designee, they may ask the provost to review the decision. 
    • The management plan may include monitoring of the plan until the completion of the research project and/or a retrospective review and a mitigation report pursuant to PHS regulations.  
    • The provost may establish additional procedures related to the FCOI review and the FCOI management process, as appropriate, consistent with applicable law.  
  3. CONFLICT OF INTEREST MANAGEMENT PLAN PROVISIONS 
    The provisions of a conflict management plan may include, but are not limited to: Public disclosure of the FCOI; 
    • For human subjects research, disclosure of FCOIs directly to participants; 
    • Independent monitoring to protect the research against potential bias; 
    • Modification of the research plan; 
    • Change of personnel or responsibilities, or disqualification of personnel from participation in all or a portion of the research; 
    • Reduction or elimination of the conflicting financial interest (e.g., sale of an equity interest); and/or 
    • Severance of relationships that create FCOI. 
  4. CONFLICTS THAT MUST BE ELIMINATED 
    • Some FCOI are not allowable in a management plan. In sections 2 and 3 below, the term “participate” means the actions of approving, disapproving, making decisions regarding, or making recommendations of contract terms. 
    • Honorariums are not permitted when: 
      • The person offering the honorarium is seeking or is reasonably expected to seek a contract or subcontract with the University and the University employee who is offered the honorarium is in a position to participate in the terms of that contract or subcontract. An investigator is presumed to participate in a contract or subcontract related to their research, as is anyone negotiating, managing, or substantially performing the agreement, contract, or subcontract. 
      • The person offering the honorarium is regulated by the University and the University employee is in a position to participate in that regulation. 
      • The person offering the honorarium is seeking or opposing or is reasonably likely to seek or oppose enactment of administrative rules or actions or policy changes by the University and the University employee may participate in that process. 
    • FCOIs may not be managed if the investigator or research employee participates on the University side of a contract or subcontract and also participates for the other party. A principal investigator is presumed to participate in a contract or subcontract related to their research, as is anyone negotiating, managing, or substantially performing the contract or subcontract. 
    • FCOI which violate federal or state law or professional ethical standards may not be managed unless the violation of law can be entirely eliminated. 

5. FAILURE TO COMPLY BY INVESTIGATORS 
Failure to comply fully with this policy and any management plan adopted under this policy may result in action under federal and/or University policy against the investigator or research employee, including disciplinary action pursuant to PNWU policy, up to and including termination.  

6. RETROSPECTIVE REVIEW PROCESS 

  1. If during an ongoing PHS-funded research project, the University finds that a SFI has not been disclosed timely or was not previously reviewed by the COIC, the University’s designated official(s) are to, within sixty days, determine whether the SFI is related to PHS-funded research and/or determine whether a FCOI exists, and, if so: 
    • Implement a management plan to manage the COI going forward; 
    • Determine if the untimely disclosure was due to investigator noncompliance, and if so: 
    • Complete a retrospective review within 120 days, including a determination whether the COI biased the PHS-funded research project. 
    • Create a review report is to include, at minimum: 
      • PNWU/PHS Project numbers; 
      • Project title; 
      • PD/PI or contact PD/PI if a multiple PD/PI model is used; 
      • Name of the investigator with the COI; 
      • Name of the entity with which the investigator has a financial conflict of interest; 
      • Reason(s) for the retrospective review; 
      • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); 
      • Findings of the review; and 
      • Conclusions of the review. 
    • If appropriate, the University amends any previously submitted COI report and specifies the actions that are to be taken to manage the COI. 
    • If bias is found, the University must notify the PHS awarding component promptly and submit a mitigation report that includes the review report, a description of the impact of the bias on the research project, and the plan of action to eliminate or mitigate the effect of the bias. 
    • The University may impose reasonable interim measures to the investigator’s participation in the PHS-funded research project between the time the University discovers there is undisclosed SFI or COI and the completion of the retrospective review, as the University deems necessary. 
    • Whenever the University implements a management plan based on noncompliance that requires a retrospective review, the University monitors compliance with the management plan until the completion of the PHS-funded research project. 

7. REQUIRED Notification to PHS 

  1. If the failure of an investigator to comply with the disclosures required by this policy or with a management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the University promptly notifies the PHS awarding component of the corrective action taken or to be taken. 
  2. The PHS may ask for records created under this policy at any time, regardless of whether or not a disclosure resulted in the University’s determination of a financial conflict of interest. The University is required to submit, or permit on site review of, all records pertinent to compliance with this part. The PHS awarding component has the authority to issue a stop work order via the contracting officer or take other enforcement action based on its review of those records. 
  3. In any case in which the Department of Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with a financial conflict of interest that was not managed or reported by the University as required by this part, the University is to require the investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations. 

8. REQUIRED REPORT TO PHS FUNDING COMPONENT 

  • Reporting of FCOI: Before spending any funds under a PHS-funded research project, the University must provide to the PHS awarding component a FCOI report on any investigator’s SFI that the University determines to be a FCOI and ensure PHS that a management plan for that COI has been implemented. If the FCOI has been eliminated prior to the expenditure of PHS-awarded funds, the University is not required to submit a COI report to PHS. 
  • The report must include sufficient information to enable PHS to understand the nature and extent of the financial conflict, and to assess the appropriateness of the University’s management plan. The report is to include, at minimum: 
    • Project/contract number; 
    • PD/PI or contact PD/PI if a multiple PD/PI model is used; 
    • Name of the investigator with the financial conflict of interest; 
    • Name of the entity with which the investigator has a financial conflict of interest; 
    • Nature of the financial interest (e.g.,equity, consulting fee, travel reimbursement, honorarium); 
    • Value of the financial interest in dollar ranges: $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 by increments of $50,000; or a statement that the interest’s value cannot be readily determined through reasonable measures of fair market value; 
    • A description of how the financial interest relates to the PHS-funded research and the basis for the University’s determination that the financial interest conflicts with such research; and 
    • A description of the key elements of the management plan, including: 
      • Role and principal duties of the conflicted investigator in the research project; 
      • Conditions of the management plan; 
      • How the management plan is designed to safeguard objectivity in the research project; 
      • Confirmation that the investigator agrees to comply with the management plan; 
      • Monitoring of the management plan to ensure investigator compliance; and 
      • Other information as needed. 
    • For any COI previously reported regarding an ongoing PHS-funded research project, the University must provide an annual COI report that addresses the status of the financial conflict of interest and any changes to the management plan. 
  • If HHS determines that a PHS-funded project to evaluate a drug, medical device, or treatment was conducted by an investigator with a COI that was not disclosed or managed, HHS may require the investigator to disclose the conflict in each public presentation of the results of the research. 

9. UNIVERSITY RESPONSIBILITIES 

  • PNWU MUST HAVE AND ENFORCE AN FCOI POLICY 
    • The University must make this policy available via a publicly-accessible website; 
    • The University must inform each investigator of this policy, the investigator’s responsibilities under this policy, and of the PHS regulations; and 
    • The University must require each investigator to complete training regarding the same before participating in PHS-funded research and at least every four years, and immediately when: 
      • The University revises its policy or procedures in any manner that affects the investigator’s responsibilities under this policy: 
      • An investigator is new to the University; or 
      • The University finds that an investigator violates this policy or management plan 
  • SUBRECIPIENTS 
    • A subrecipient must abide by this policy or a comparable policy of the subrecipient’s own, and take reasonable steps to ensure that any subrecipient investigator complies with FCOI policy. 
    • A subrecipient must be familiar with and comply with the University’s policy to disclose financial interests, cooperate with the University FCOI processes, and abide by any management plan adopted by the University to manage FCOIs. 
    • The subcontract must include terms requiring a subrecipient to comply with this policy or have a policy that is effective in practice and that satisfies PHS FCOI regulations and the regulations of any other federal sponsor. 
    • A subrecipient applying its own policy must certify in the subcontract that its policy complies with FCOI regulations. 
    • If a subrecipient’s investigators must comply with this policy, the subcontract must specify time(s) for the subrecipient to submit disclosures of SFIs to the University. 
    • The University provides FCOI reports to the PHS awarding component regarding all financial FCOIs of all subrecipient investigators prior to the expenditure of funds and/or within 60 days of any subsequently identified FCOI. 
  • CERTIFY TO THE PHS AWARDING COMPONENT 
    • The University has a written and enforced process to identify and manage, reduce, or eliminate conflicting interests; 
    • Before spending any funds under the award, the University reports to the PHS awarding component the existence of FCOI and assures that the FCOI are managed, reduced, or eliminated, as provided in this policy; and 
    • Upon request, the University makes information available to HHS regarding all conflicting interests and how those interests have been managed, reduced, or eliminated. 
    • The Provost or the Provost’s designees review to determine the existence of FCOI and take actions to ensure that the FCOI are managed, reduced, or eliminated; 
    • The University provides for retention of FCOIC review records for at least three years from the date of submission of the research project’s final expenditures report or other dates as specified in 45 CFR 74.53(b) and 45 CFR 75.361.  
    • The University establishes adequate enforcement mechanisms and sanctions where appropriate; and 
    • The University’s written policy includes “A Review of Disclosure Forms” section that provides: 
      • Guidelines for the designated official(s) to identify FCOI and take actions to ensure that they are managed, reduced, or eliminated; and  
      • Examples of conditions or restrictions that might be imposed to manage FCOI. 
  • FCOI REPORTS TO PHS 
    • Prior to spending any funds under a PHS-funded research project, University sends the PHS awarding component an FCOI report that includes any investigator’s FCOI and assurance that a management plan has been implemented. No report is required if any FCOI was eliminated prior to the expenditure of PHS funds. 
    • Any FCOI identified after the University’s initial FCOI report and during an ongoing PHS-funded research project (e.g., upon the participation of an investigator who is new to the research project), must be reported (along with a management plan) within 60 days to the PHS awarding component. If the COI report involves a SFI that was not disclosed timely by an investigator or, for whatever reason, was not previously reviewed or managed by University (e.g., was not timely reviewed or reported by a subrecipient), the University must complete a retrospective review and, if appropriate a mitigation plan. 
    • Any COI report must include sufficient information to enable PHS to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan. The report must include, but is not limited to: 
      • Project number; 
      • PD/PI or contact PD/PI if a multiple PD/PI model is used; 
      • Name of the investigator with the FCOI; 
      • Name of the entity with which the investigator has a FCOI; 
      • Nature of the financial interest; 
      • Value of the financial interest in dollar ranges: $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 by increments of $50,000; or a statement that the interest is one whose value cannot be readily determined through reference to reasonable measures of fair market value; 
      • A description of how the financial interest relates to the PHS-funded research and the basis for University’s determination that the financial interest conflicts with such research; and 
      • The key elements of the management plan, including: 
        • Role and principal duties of the conflicted investigator in the research project; 
        • Conditions of the management plan; 
        • How the management plan is designed to safeguard objectivity in the research project; 
        • Confirmation that the investigator has agreed to the management plan; 
        • The nature of monitoring to ensure investigator compliance with the management plan; and 
        • Other information as needed. 
    • University must provide an annual FCOI report to PHS that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual report must specify whether the financial conflict is still being managed or explain why it no longer exists. 
  • TRANSPARENCY AND PUBLIC ACCESIBILITY
    • Prior to spending PHS funding, University ensures public accessibility, by written response to any requestor within five business days of a request, of information concerning any SFI disclosed to University that: 
    • The investigator previously disclosed and still holds; 
    • The University determined was related to the PHS-funded research; and 
    • The University determined is a FCOI. 
      • The University provides information to the requester within five business days of a request. The information includes the investigator’s name, title, role on the research project; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value of the SFI (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 by increments of $50,000); or a statement that the interest is one whose value cannot be readily determined using reasonable measures of fair market value. 
      • Information concerning the SFIs remain available for responses to written requests for at least three years from the date that the information was most recently updated. 

Definitions:
Clinical Trial means any research that assigns human subjects to intervention and comparison groups to study the relationship between a medical intervention and a health outcome. 

Financial Conflict of Interest (COI) means a significant financial interest held by an investigator or research employee and/or specified members of their family which could affect the design, conduct, or reporting of research and scholarship activities. 

Disclosure of Significant Financial Interests means disclosure of significant financial interests to PNWU.  

Equity Interest means stocks, stock options, ownership, partnership or limited liability company, or other ownership interests. Equity interest does not include interest in a mutual fund or other stock management vehicle not under the individual’s control, but does include interest held in a deferred compensation plan that is under the individual’s control. 

Family means the investigator’s or research employee’s spouse/domestic partner, dependent children, and other dependent relatives living in their household (investigator’s/research employee’s financial interest includes the aggregate financial interest of the family). 

Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research. 

Financial Interest means anything of monetary value, whether or not the value is readily ascertainable. 

Gift means anything of received of economic value without giving adequate consideration. A gift of greater than $50 from an outside entity is a significant financial interest and must be disclosed if it is from an entity that may be affected by the recipient’s research. (The law provides exceptions for gifts from persons such as family members.) 

Honorarium means money or thing of value offered for a speech, appearance, article, or similar item or activity in connection with a state employee’s official role. 

Investigator means the project director (PD) or principal investigator (PI), the co-principal investigators (Co-PI), and any other person, regardless of title or position, including the PD/PI and senior/key personnel as defined in this policy, who is responsible for the design, conduct, or reporting of a research project, funding, or proposal. 

Investigator’s PWNU Responsibilities means an investigator’s professional responsibilities on behalf of the University, which may include, for example, activities such as research, research consultation, teaching, professional practice, and institutional committee memberships. 

Manage means taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research is free from bias. 

Nonconflicting Institution means the University, a federal, state, or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. Note well: Pursuant to NIH notice NOT-OD-18-160, Financial Conflicts of Interest: Investigator Disclosures of Foreign Financial Interests, 20 USC 1001(a) refers only to U.S. Institution of higher education or a federal, state, or local government agency within the U.S. investigators and subrecipients must disclose all financial interests received from a foreign institution of higher education or the government of another country or its governmental subdivisions.   

PD/PI means a project director or principal investigator of a research project; the term “investigator” in this policy includes a PD/PI. 

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS, including the National Institutes of Health (NIH). 

PHS Awarding Component is a division of the Public Health Service (PHS), such as NIH, that funds the research. 

Remuneration means 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 reasonable measures of fair market value. 

Research means a systematic scientific investigation designed to develop or contribute to generalizable knowledge including basic and applied research as well as associated instruction, scholarly, creative, public service, product development, and extension activities. When PHS funding is applied for or used, “research” includes any activity for which research funding is available from a PHS awarding component. 

Research Employee: The following may qualify as research employees: 

  • University employees who are responsible for the design, conduct, or reporting of research, including research scientists, postdoctoral research associates, professional staff and graduate students. 
  • Appointees without formal employment status who are obligated to follow University policies and procedures. This may include visiting scientists, scholars and faculty whose responsibilities include contributions via scholarly research. 

Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to the PHS. The term “investigator” in this policy includes senior/key personnel. 

Significant Financial Interest (SFI) means a financial interest of an investigator (and those of the investigator’s family) that reasonably appears to be related to the investigator’s institutional responsibilities. 

Sponsor means the entity which has or will provide financial support for the research, which may include corporate sponsors, state agencies, the University, or agencies of the federal government, including the Public Health Service (PHS). 

Travel Disclosure includes the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. 

Procedure:  
Specific directions for section 4, part B (Financial Conflict of Interest Review of Disclosure form Process) are found in the Financial Conflict of Interest Disclosure Form  

Related Documents: 
National Institutes of Health Central Resource for Grants and Funding, Policy Compliance, Financial Conflict of Interest (https://grants.nih.gov/grants/policy/coi/index.htm)  

Electronic Code of Federal Regulations, Title 42, Chapter I, Subchapter D, Part 50, Subpart F—Promoting Objectivity in Research (https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=992817854207767214895b1fa023755d&rgn=div5&view=text&node=42:1.0.1.4.23&idno=42#sp42.1.50.f) 

Financial Conflict of Interest Disclosure Form 

Policy Resources

For assistance with policies and procedures contact:

Lori Fulton
lfulton@pnwu.edu