Hummingbird Precision Machine Co. (“HPM”) is dedicated to maintaining public trust in the integrity of our research-related activities. The identification and responsible management of financial conflicts of interest (FCOI) are crucial both for safeguarding research objectivity and for compliance with federal regulations and HPM policies.

HPM seeks to ensure the integrity of its research and to comply with the federal National Institute of Health (NIH) requirements for institutions that seek research funding. The NIH has implemented regulations (Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which NIH Funding is Sought) (“FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest. The FCOI Regulations are applicable to institutions that apply for or receive NIH grants or cooperative agreements for research and to each investigator (as defined below) planning to participate in or participating in such research. This policy (the “FCOI Policy”) is implemented to fulfill HPM’s obligation under the FCOI Regulations to maintain an up-to-date, written, enforced policy and process on investigator conflicts of interest.

The Director of Research is the person responsible for the procedures under this FCOI Policy but may designate one or more individuals to assist in any or all of these responsibilities and/or may delegate any or all of these responsibilities to one or more individuals.

 

1. Researchers Covered and Financial Interests That Must Be Disclosed

All “investigators” planning to or participating in NIH-funded “research” are required to disclose to HPM his/her known “significant financial interests” (and those of his/her spouse and dependent children) that reasonably appear to be related to the investigator’s “institutional responsibilities”.

The term “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 consultants.

The term “research” means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from an NIH Awarding Component2 through a grant or cooperative agreement.

The term “institutional responsibilities” means an investigator’s professional responsibilities on behalf of HPM, including research, research consultation, clinical or other professional practice, participation in scholarly events, institutional committee memberships; and service on panels.

The term “significant financial interest” means a financial interest – defined as anything of monetary value, whether or not readily ascertainable – 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.

Publicly Traded Entities – 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.

Privately Held Entities – 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 and dependent children) holds any equity interest (e.g., stock, stock option or other ownership interest).

Intellectual Property – Intellectual property rights and interests (e.g., patents, copyrights), must be disclosed upon receipt of income (e.g., royalties) related to such rights and interests. The filing of any patent application also should be disclosed.

Travel Expenses – 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 in the twelve months preceding the disclosure if the value of such travel, when aggregated from all sources, exceeds $5,000; 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. Disclosures relating to travel expenses must specify at a minimum the purpose and duration of the trip, the identity of the sponsor/organizer, and the destination.

Not included are the following types of financial interests: salary, royalties, or other remuneration paid by HPM to the investigator if the investigator is currently employed or otherwise appointed by HPM, including intellectual property rights assigned to HPM and agreements to share in royalties related to such rights; 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; and income from seminars, lectures or teaching engagements sponsored by, and 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.

 

2. Mandatory Investigator Training Requirements

The Director of Research is responsible for ensuring that each investigator is informed about (i) this FCOI Policy, (ii) the investigator’s responsibilities regarding disclosure of significant financial interests relating to the investigator’s institutional responsibilities, and (iii) the FCOI Regulations.

The Signing Official shall ensure that each investigator completes training regarding items (i)–(iii) prior to engaging in research related to any NIH-funded grant or cooperative agreement, immediately upon being hired and at least every four (4) years. Investigators are required to complete the FCOI training module prior to engaged in NIH-supported research at least every four years, and immediately under the designated circumstances: (1) HPM FCOI policies change in a manner that affects investigator requirements, (2) an investigator is new to HPM, or (3) HPM finds an investigator noncompliant with HPM’s FCOI policy.

All investigators must complete FCOI training required under the policy. Training can either be completed using the NIH FCOI tutorial found at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html, or by reviewing their responsibilities related to this policy with the Director of Research. Either way, confirmation of understanding of the investigator’s responsibilities under this policy will be recorded after training.

The Director of Research also shall ensure that each investigator completes training immediately when any of the following applies: (1) this FCOI Policy or procedures are revised in any manner that affects the requirements of the investigators or (2) HPM finds that an investigator is not in compliance with this FCOI Policy or a management plan.

“Immediately” shall mean the training is provided or made accessible and the investigators participate in the training expeditiously following the event that triggers the training requirement.

 

3. Disclosure Requirements

Prior to submission to NIH of an application for a research grant, the principal investigator shall identify to the Signing Official (1) all investigators (as defined above) anticipated to be participating in the research, (2) those who are senior/key personnel (as defined below) and (3) those who are sub-recipients and the institution(s) employing them.

The term “senior/key personnel” means the project director or principal investigator and any other person identified as senior/key personnel in the grant application, progress report or any other report submitted to the NIH.

Also prior to submission of the application, the Signing Official shall ensure that each investigator submits a listing of his/her known significant financial interests (as described above) and those of his/her spouse and dependent children that reasonably appear to be related to the investigator’s institutional responsibilities, if any. In accordance with Section 7, the Director of Research shall ensure that sub-recipient investigators either comply with this FCOI Policy or that their institution(s) provides assurances to enable HPM to fulfill the requirements of this FCOI Policy. In either case, the Director of Research shall ensure that the proper documentation as required under the FCOI Regulations is executed, also in accordance with Section 7.

All disclosures must be updated annually during the period of the award or within 30 days of discovering or acquiring (e.g., through purchase, marriage, inheritance or expansion of responsibilities) a new significant financial interest. The Director of Research shall ensure that annual update forms are sent to and promptly returned by each investigator. (One annual disclosure is sufficient to cover all ongoing NIH awards.) Each investigator is responsible for submitting disclosure forms within 30 days of discovering or acquiring a new significant financial interest. Disclosures shall be provided by an investigator at any other time upon request.

 

4. Review of Disclosures and Monitoring and Reporting FCOI

The Director of Research shall be responsible for reviewing all forms disclosing a significant financial interest, making the requisite determinations, and taking any subsequent action.

Prior to the expenditure of funds or, with respect to an ongoing NIH-funded project, within 60 days of the disclosure or discovery of a significant financial interest, the Director of Research shall:

(1) review all disclosure forms and determine whether (a) an investigator’s significant financial interest is related to NIH-funded research and (b) if so related, whether the significant financial interest is a financial conflict of interest (FCOI); and

(2) in the case of an FCOI, develop and implement a management plan specifying actions that have been and shall be taken to manage the FCOI; and

(3) submit initial and ongoing FCOI reports to the NIH Awarding Component as required under the FCOI Regulations [§50.605(b)(3), (4)].

An investigator’s significant financial interest is related to NIH-funded research when the Director of Research reasonably determines that the significant financial interest could be affected by the NIH-funded research or is in an entity whose financial interest could be affected by the research. In determining whether an investigator’s significant financial interest is related to NIH-funded research the Director of Research will consider all relevant factors and information, including but not limited to whether there is an ongoing relationship between the investigator and the payer.

A financial conflict of interest (FCOI) exists when the Director of Research reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. In determining whether there is an FCOI, the Director of Research will consider all relevant factors and information, including but not limited to the nature of the research, the magnitude of the financial interest and degree to which it is related to the research, the extent to which the interest could be directly and substantially impacted by the research, and the degree of risk to the human subjects, if any, that is inherent in the research protocol.

Prior to making the decision whether an FCOI exists, the Director of Research may impose interim measures, may ask the investigator to submit additional information, and may meet or communicate with the investigator. The investigator may be encouraged to suggest procedures, protocols, or other measures designed to manage the FCOI.

“Manage” means taking action to address an FCOI, which can include reducing or eliminating the financial conflict of interest to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.

Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:

Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

For research involving human subjects, disclosure of financial conflicts to research participants;

Monitoring of the research by independent reviewers;

Modification of the research plan;

Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research;

Reduction or elimination of the financial interest; and/or

Severance of relationships that create such conflicts.

For all management plans, the Director of Research shall (1) monitor ongoing investigator compliance and (2) submit annual updates to the NIH Awarding Component at the time and in the manner specified by the NIH Awarding Component, both until the completion of the NIH-funded research project to which the FCOI relates.

With respect to FCOI related to research sponsored by NIH, annual FCOI reports will be submitted through the eRA Commons FCOI Module for the duration of the project period (including extensions with or without funds) at the same time annual progress reports are required to be submitted and at the time of the extension (if any).

If the FCOI is identified and eliminated prior to the expenditure of any NIH-awarded funds, no FCOI report needs to be submitted.

 

5. Noncompliance and Remedies

If an investigator has failed to comply with a management plan or, for whatever reason, an FCOI is one that was not identified, reviewed, or managed in a timely manner, the Director of Research shall (in addition to the steps required in Section 4 above), within 120 days of the determination of noncompliance, conduct a retrospective review of the investigator’s activities and the research project to determine whether any NIH-funded research or portion thereof conducted during the period of noncompliance was biased in design, conduct or reporting. The review shall be documented consistent with the FCOI Regulations [§60.605(a)(3)(ii)(B)]. If bias is found during the course of the review, the Director of Research will promptly notify the NIH Awarding Component (which may take its own action and/or require further action by HPM and/or the investigator, as it deems appropriate) and submit a mitigation report consistent with the FCOI Regulations [§60.605(a)(3)(iii)]. If appropriate, the Director of Research will update the previously submitted FCOI report. In any event, the Director of Research shall submit FCOI reports annually thereafter.

 

6. Maintenance of Records

The Director of Research shall maintain all disclosure forms and related records of determinations made and actions taken for a period of three years from the date of submission of the final expenditures report to the NIH (or, where applicable, from other dates specified in 45 CFR 74.53(b)).

 

7. Enforcement Mechanism and Sanctions

All researchers to whom this FCOI Policy applies are expected to fully and promptly comply with it. The Director of Research may impose sanctions for non-compliance which may include, but is not limited to, the following:

Failure to make timely, full, or accurate disclosures;

Failure to provide the information requested;

Failure to update a disclosure form as necessary; or

Failure to comply with a management plan.

For HPM employees, sanctions may include suspension or dismissal, denial of eligibility to engage in the research at issue, or other appropriate penalties. Such sanctions may require giving notice of relevant information to funding agencies, professional bodies or journals, or the public. The Director of Research will determine what sanctions, if any, are to be applied.

 

8. Public Accessibility Requirements

This FCOI Policy will be posted on HPM’s publicly accessible website, as required by the FCOI Regulations: https://hummingbirdscientific.com/policy-on-financial-conflict-of-interest-fcoi/

Prior to expending any funds under a NIH-funded grant or cooperative agreement, HPM shall ensure public access to information concerning an FCOI held by a senior/key personnel member by providing a written response to any written request, such response to be postmarked or dated (if replying by electronic means) within five (5) business days of the receipt of the written request. Such information shall consist of that required to be provided under the FCOI Regulations [§50.605(a)(5)(ii), (iii)], shall be updated at least annually and within 60 days of the receipt or identification of information concerning an additional significant financial interest, and shall remain available for three years from the date the information was most recently updated.

 

9. Additional Information

HPM may be asked to provide records related to this FCOI Policy, including disclosure forms, to the Department of Health and Human Services or other federal agencies or entities. HPM will provide the requested information and make any other disclosures necessary to comply with this FCOI Policy or as required by law. Such records may be requested and provided whether or not the disclosure resulted in a determination that an FCOI existed.

 

Contact information:

Daan Hein Alsem

Director of Research

Hummingbird Precision Machine Co.

2610 Willamette Drive NE, Suite A

Lacey WA 98516

Phone: +1 360 252 2737

E-mail: daan_alsem@hummingbirdscientific.com

 

Updated On:  July 16th, 2021

Next Review Date:  July 1st, 2024

Approval Date: July 19th, 2021

Approved By: Norman Salmon