Financial Conflict of Interest Policy and Procedures

Subject: Financial Conflict of Interest

Division: Grants Management

Date: March 17, 2021

FINANCIAL CONFLICT OF INTEREST POLICY AND PROCEDURES



Purpose of Policy

The purpose of Lyndra Therapeutics’ Financial Conflict of Interest (FCOI) Policy is to comply with Federal regulation 42 CFR Part 50 Subpart F and to protect its employees, collaborators and research participants from potential or actual risks associated with any financial conflicts of interest related to Public Health Service (PHS) funded research studies conducted by Investigators.

The purpose of this regulation is to promote objectivity in research by establishing standards to minimize the possibility of bias by reporting conflicting financial interests of an Investigator.

Application of Policy

This policy applies to all Investigators (including subrecipient investigators) and key personnel who are planning to participate in or are participating in PHS funded research.

An “Investigator” is defined as 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 PHS (e.g., National Institutes of Health (NIH)), or proposed for such funding, including persons who are subgrantees, contractors, consortium participants, collaborators or consultants. Note, that these responsibilities are not limited to the Project Director, Principal Investigator, or key personnel but rather, apply to all individuals who are responsible for the design, conduct, or reporting of research.

Training Requirements

 Investigators are required to complete FCOI training:

  1. Prior to engaging in research related to any PHS-funded grant,
  2. At least every 4 years, and
  3. Immediately, if:
    • Lyndra Therapeutics revises its FCOI policy and procedures in any manner that affects Investigator requirements;
    • An Investigator is new to Lyndra Therapeutics

Please see FCOI required training at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

Financial Conflict of Interest (FCOI)

An FCOI exists when Lyndra Therapeutics, through its FCOI Officer, reasonably determines that an Investigator (including their spouse and dependent children) has a Significant Financial Interest (SFI) related to a NIH-funded research project that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.

Significant Financial Interest (SFI)

Investigators are required to disclose to Lyndra Therapeutics a listing of SFls (and those of his/her spouse and dependent children) that: (1) would reasonably appear to be affected by the research for which funding is sought, and (2) includes those entities whose financial interests would reasonably appear to be affected by the research.

PHS FCOI regulation defines a “Significant Financial Interest” as follows:

  1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
  2. With regard to any publicly traded entity (U.S. or foreign), 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, 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 etc.); 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;
  3. 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 (g., stock, stock option, or other ownership interest); or
  4. Aggregate value of income related to intellectual property rights and interests (g., patents, copyrights) paid by an entity that exceeds $5,000
  5. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (e., that which is paid on behalf of the Investigator and not reimbursed to the

Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal state, or local government agency, an institution of higher education as defined by 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. Lyndra Therapeutics’ FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with Lyndra’s FCOI policy, the FCOI Officer will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI regarding the PHS-funded research.

Disclosure of a SFI

An Investigator is under a continuing obligation to disclose any SFI (and those of his/her spouse and dependent children), or the appearance of a financial conflict as soon as it is known, or reasonably should have been known.

The SFI must be disclosed to Lyndra Therapeutics: 1) by the time an application is submitted to NIH for funding; 2) within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI; and 3) on an annual basis at intervals determined by Lyndra Therapeutics.

An Investigator shall complete an SFI Disclosure Form in order to fully disclose an SFI. The SFI Disclosure Form shall be completed upon first participation in a PHS award with Lyndra Therapeutics, and shall be updated annually, thereafter, prior to each new PHS award year. An additional SFI Disclosure Form shall be filed to Lyndra therapeutics within 30 days of discovering or acquiring a new SFI.

All disclosures of SFI shall be sent to Lyndra Therapeutics and will be reviewed by Lyndra Therapeutics ‘s FCOI Officer. The Lyndra Therapeutics FCOI Officer shall send his/her personal SFI Disclosure Form to the CEO of Lyndra Therapeutics for review.

Procedures for Review of an Actual or Potential FCOI

When there is reason to believe that an actual or potential FCOI exists, or the appearance of an FCOI exists, between the interests of Lyndra Therapeutics and that of an Investigator, the CEO shall ultimately be responsible for determining the appropriate response. This shall include, but not necessarily be limited to, invoking the procedures described below with respect to a specific proposed action.

Where the appearance of a SFI or an actual or potential SFI involves an Investigator, the FCOI Officer shall review the matter and determine whether an Investigator’s SFI is related to PHS­ funded research and if so related, whether the SFI is an FCOI. The FCOI Officer will notify the CEO, who will take appropriate action to protect the interests of Lyndra Therapeutics, its employees, and its clients and research participants. The FCOI Officer shall report his/her determinations and suggestions for management of the conflict to the CEO for review and adjudication. The CEO shall, at his/her discretion, report his/her determination to the Chairman of the Board of Directors, who in consultation with the Executive Committee of the Board of Directors, shall determine if any further Board review or action is required.

In addition, the CEO will present a report of all FCOI cases at Executive Committee meetings and Board of Directors’ meetings.

The CEO of Lyndra Therapeutics shall serve as the FCOI Officer in reviewing actual or potential conflicts of interest in those cases in which the Lyndra Therapeutics FCOI Officer has a potential FCOI or there exists the appearance of an FCOI.

Procedures for Addressing an FCOI

Where an actual or potential FCOI exists or the appearance of an FCOI exists, Lyndra Therapeutics shall refrain from making any decisions concerning the FCOI until the CEO has reviewed the FCOI and approved the action, or has presented the FCOI to the Board of Directors. The following procedures shall also apply:

  • An Investigator who has an actual or potential FCOI or the appearance of an FCOI shall not participate in, or be present during, the deliberations and decision-making with respect to this action unless requested by the CEO or Board of Directors, and then will be present only to answer questions, provide information about the alleged FCOI, or respond to proposed Lyndra Therapeutics acti
  • The CEO may approve the proposed actions for remediation or amelioration of the FCOI upon a finding that these actions are in the best interests of Lyndra Therapeutics, its employees, clients, and/or research parti
  • If a finding of an FCOI, or a decision about an FCOI, is to be determined by the Board of Directors, determination and/or approval by the members of the Board shall be by a majority vote, at a convened meeting, at which a quorum is The Investigator who is the subject of the FCOI shall not be present during the vote.
  • The meeting minutes shall reflect that the FCOI was discussed, the nature of the Board’s decision, and that a vote was taken regarding that
  • Members of the Board of Directors must recuse themselves from any discussion and vote on issues in which they have an FCOI or appear to have an

Management of FCOIs

Lyndra Therapeutics will make every effort to ensure that FCOls do not bias research conducted by Investigators and that do not place clients, research participants, or others at risk.

If the CEO determines that an FCOI exists or has the potential to exist, he shall determine what conditions or restrictions, if any, should be imposed by Lyndra Therapeutics to manage these actual or potential conflicts.

Examples of conditions or restrictions that might be imposed by the CEO of Lyndra Therapeutics to manage FCOls include, but are not limited to: 1) Public disclosure of SFls; 2) Monitoring and Management of the FCOI by the Lyndra Therapeutics FCOI Officer; 3) Review of the research protocol by independent reviewers; 4) Monitoring of the research by independent reviewers; 5) Modifications of the research plan; 6) Disqualification of the Investigator from participation in all or a portion of the research funded by PHS or NIH; 7) Divestiture of significant financial interests; and/or 8) Severance of relationships that create actual or potential conflicts of interest.

If the CEO of Lyndra Therapeutics does impose conditions or restrictions upon an Investigator with respect to managing an FCOI, a management plan shall be prepared that details the conditions or restrictions imposed upon the Investigator in the conduct of the project or regarding their relationship with Lyndra Therapeutics. The management plan shall be signed by the Investigator and the CEO of Lyndra Therapeutics. Actual or potential conflicts of interests will be satisfactorily managed, reduced, or eliminated, and/or they will be disclosed to the sponsoring agency for action.

If the CEO of Lyndra Therapeutics determines that imposing the above-referenced conditions or restrictions would be inequitable, or that the potential negative impacts that may arise from a SFI are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the CEO of Lyndra Therapeutics may determine that the research should go forward without imposing such conditions or restrictions, although an Investigator would still need to disclose the nature of the conflict on a yearly basis (see Disclosure of Actual or Potential FCOI, above).

Compliance monitoring of the SFI will occur through a yearly review of the management plan by the FCOI Officer, resulting in subsequent recommendations to the CEO. Based on Investigator compliance, the CEO may decide to maintain, reduce, or eliminate the ongoing compliance monitoring plan. Or, the CEO may impose additional conditions or restrictions upon an Investigator, as outlined above.

Procedures for Review of an Actual or Potential FCOI by the IRB

When there is reason to believe that an actual or potential FCOI exists, or the appearance of an FCOI exists, between the interests of Lyndra Therapeutics and that of an Investigator, and involves research reviewed by the Institutional Review Board (IRB), the IRB will be notified. The FCOI Officer will send the IRB a report of his/her assessment of the real or perceived FCOI. He/she will send a remediation plan regarding any FCOI to the IRB.

Investigators should disclose any FCOI to the Lyndra Therapeutics IRB at the time of the Initial Application for a research protocol review, at the time of Continuing Review, or whenever the status of the FCOI changes. The IRB Administrator shall report any new or modified FCOI issues to the Lyndra Therapeutics FCOI Officer, who will share that report with the CEO.

The IRB will review Investigator disclosures and the FCOI Officer’s assessment of any FCOI, taking particular note of the impact of the FCOI on research integrity and risks to research participants.   The IRB will make the final decision about the FCOI at a convened meeting and may require the following:

  1. Prohibition of Investigators’ participation in the research;
  2. Management of the FCOI through:
  • Disclosure to research participants or others regarding the FCOI, as part of the consenting process;
  • Public disclosure in published articles, forums and presentations;
  • Limiting the role of the Investigators;
  • External oversight of the study by an oversight entity outside of Lyndra Therapeutics;
  • Investigators deciding to sever relationships with those organizations, persons, entities, or interests that present an FCOI, or appear to present an FCOI;
  • Other remediation, as

Reporting Requirements to NIH

 Prior to Lyndra Therapeutics ‘s expenditure of any funds under a NIH-funded research project, Lyndra Therapeutics will provide to NIH an FCOI report regarding any Investigator SFI found by Lyndra Therapeutics to be an FCOI, in accordance with the regulation. Lyndra Therapeutics will also provide an FCOI report to NIH whenever an Investigator fails to timely disclose a SFI or whenever Lyndra Therapeutics designated staff, for whatever reason, fail to timely review and/or properly identify a disclosed SFI but then subsequently review and determine that an FCOI exists. Lyndra Therapeutics must report all identified FCOls to NIH.

Lyndra Therapeutics will submit an FCOI report to NIH 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 SFI to the Institution during the award period.

Whenever an Investigator does not timely disclose a previously existing SFI or Lyndra Therapeutics designated staff fail to timely review and/or properly identify a previously existing SFI regarding an ongoing NIH-funded project, Lyndra’s designated staff shall, within sixty (60) days: 1) review the SFI; 2) determine whether it is related to the NIH-funded research; and 3) determine whether an FCOI exists. And, if so, Lyndra Therapeutics will implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be, taken to manage such an FCOI going forward and submit an FCOI report to NIH.

In addition to the FCOI report, the Institution will, within 120 days of Lyndra Therapeutics’ determination of noncompliance, complete a retrospective review of the Investigator’s research activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of noncompliance, was biased in the design, conduct or reporting of such research.

Based on the results of the retrospective review, if appropriate, Lyndra Therapeutics designated staff will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward.

If bias is found, Lyndra Therapeutics designated staff will notify NIH officials promptly and submit a mitigation report that includes the key elements documented in the retrospective review and a description of the impact of the bias on the research project and FRl’s action plan or actions taken to eliminate or mitigate the effects of the bias. Thereafter Lyndra Therapeutics will submit FCOI reports annually.

Lyndra Therapeutics will notify NIH promptly if an Investigator fails to comply with Lyndra Therapeutics’ FCOI policy or if the FCOI management plan appears to have biased the design, conduct or reporting of the NIH-funded research.

For any FCOI previously reported by Lyndra Therapeutics, Lyndra Therapeutics shall provide an annual FCOI report to NIH that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports shall specify whether the FCOI is still being managed or explain why the FCOI no longer exists. Annual FCOI reports will be submitted to NIH for the duration of the project period (including extensions with or without funds) at the same time as when Lyndra Therapeutics is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension (e.g., submission of an extension notification in eRA Commons or submission of a NIH prior approval request, whichever is applicable.) An annual FCOI report is not to be submitted as part of the annual progress report. The annual FCOI report is submitted to NIH separately through the eRA Commons FCOI Module at the same time the annual progress report is submitted.

Reporting Requirements to the Food and Drug Administration

The Food and Drug Administration (FDA) requires Investigators to certify the absence of and/or disclose the existence of any FCOI.Reporting Requirements to Sponsors

Investigators should contact the sponsors of research in which they are participating to determine their requirements regarding any FCOI.

Violations of the FCOI Policy

 If the CEO has reason to believe that an Investigator has failed to disclose an actual or potential FCOI, or the appearance of an FCOI, the CEO shall inform that Investigator of the basis for this belief and allow him/her an opportunity to respond.

If, after hearing the response of the Investigator, documentation of the response, and after initiating further investigation (as required), the CEO, in determining that the Investigator has failed to disclose an actual or possible FCOI, or the appearance of an FCOI, shall take appropriate administrative, disciplinary and/or corrective actions, such as implementing employee sanctions to ensure Investigator compliance.

In any case in which the Department of Health and Human Services (DHHS) determines that an NIH-funded clinical research project, 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 in which there was a financial conflict of interest that was not managed or reported by the Institution as required by the regulation, Lyndra Therapeutics will require the lnvestigator(s) involved  to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

 

Subrecipient Investigator Requirements

Lyndra Therapeutics will incorporate language, as part of a written agreement with the subrecipient, that the FCOI  Policy of the subrecipient will apply to the subrecipient’s Investigator. The subrecipient must provide Lyndra Therapeutics with certification that the subrecipient Investigator is in compliance with 42 CFR Part 50 Subpart F and must submit all Investigator reported SFls to Lyndra Therapeutics within 30 days of discovering  or acquiring a new SFI or, at the very least, in sufficient time for Lyndra Therapeutics to meet its FCOI reporting obligations. If a subrecipient does not have an FCOI Policy that complies with 42 CFR Part 50 Subpart F, a subrecipient Investigator must follow Lyndra Therapeutics’ FCOI Policy in all aspects.

Maintenance of Records

All FCOl-related records will be retained for at least 3 years from the date the final expenditure report is submitted to PHS. Documents will also be retained from the dates specified in 45 CFR 74.53(b) and 92.42(b), where applicable.

Public Accessibility

The Lyndra Therapeutics FCOI policy is publicly available on Lyndra Therapeutics’ website.

Prior to Lyndra Therapeutics ‘s expenditure of any funds under a NIH-funded research project, Lyndra Therapeutics shall ensure public accessibility, via Lyndra Therapeutics ‘s publicly accessible website located at www.lyndra.com or by a written response to any requester within 5 business days of a request, of information concerning any SFI disclosed to Lyndra Therapeutics that meets the following three criteria:

  1. The SFI was disclosed and is still maintained by Lyndra Therapeutics senior/key personnel regarding a NIH­ funded research project;
  2. Lyndra Therapeutics determines that the SFI is related to the NIH-funded research; and
  3. Lyndra Therapeutics determines that the SFI is an

The information that Lyndra Therapeutics makes available via its publicly accessible website or written response to any requester shall include, at a minimum, the information listed in the PHS regulations at 42 CFR 50.605(a)(5)(ii), including:

  1. Investigator’s name;
  2. Investigator’s title and role with respect to the research project;
  3. Name of the entity in which the SFI is held;
  4. Nature of the SFI; and
  5. 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 through reference to public prices or other reasonable measures of fair market value.

 

 

Lyndra Therapeutics Financial Conflict of Interest OfficerJessica Ballinger

65 Grove Street

Watertown, MA 02472

857-201-5322

Email: [email protected]

50.603   Definitions.

As used in this subpart:

Disclosure of significant financial interests means an Investigator’s disclosure of significant financial interests to an Institution.

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

FCOI report means an Institution’s report of a financial conflict of interest to a PHS Awarding Component.

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

HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.

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 Boards.

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 PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Manage means taking action to address a financial conflict of interest, 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.

PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.

Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

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). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

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 this subpart.

Significant financial interest means:

(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.