Financial Conflicts of Interest
As applied research is fundamental to our business, Honeycomb Biotechnologies is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. Honeycomb Biotechnologies has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest.
The procedures described in this policy were created and designed primarily to comply with the specific regulatory requirements for U.S. Public Health Service (PHS)-sponsored research but are also intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to Honeycomb Biotechnologies other research activities. For non-PHS research, the specific steps, timing, determinations, documentation, and notifications may be tailored as appropriate but will remain focused on maintaining Honeycomb Biotechnologies high standards for research integrity and effectively eliminating or managing actual or potential financial conflicts of interest.
Effective December 1st, 2020, Honeycomb Biotechnologies policy requires that each investigator, subrecipient, subgrantees and collaborators affiliated with Honeycomb Biotechnologies, by NIH or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). In addition, this legislation spells out NIH’s commitment to preserving the public’s trust that the research support by them is conducted without bias and with the highest scientific and ethical standards. Honeycomb Biotechnologies intends to use this same FCOI standard for all other Federal agency grant and contract efforts, as amended accordingly
For purposes of this policy, the following definitions shall apply to principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Honeycomb Biotechnologies. This policy and all FCOI guidance are also available at www.honeycomb.bio so that all interested parties, including the general public, have access to the Company Policy.
Designated Officials are the individuals designated by Honeycomb Biotechnologies to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.
Disclosure refers to the investigator’s disclosure of Significant Financial Interest (SFIs) to Honeycomb Biotechnologies designated official(s) who will review all “disclosure” and evaluate whether they contain any FCOI. If no FCOI is found the “disclosure forms” will be filed electronically in the SFI Disclosures Folder. Information to include in the disclosure are:
- The project number
- The PD/PI or Contact PD/PI if there are multiple PD/PIs
- The name of the investigator with the FCOI
- The name of the entity with which the investigator has an FCOI
- The nature of the financial interest, for example equity interest, consulting fee, travel reimbursement, honorarium
- The value of the financial interest 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
- A description of how the financial interest relates to the research and the basis for the institution’s determination that the financial interest conflicts with such research
If any interests are identified as conflicting subsequent to the initial report, they must be reported to Honeycomb Biotechnologies within 30 days. Each investigator must submit an updated disclosure of an SFI not less than annually. If a PHS-funded project is conducted by an investigator or SO with a conflict that was not disclosed or managed, Honeycomb Biotechnologies is required to disclose the conflict in each public presentation related to the results of the research.
Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.
Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research as determined by Honeycomb Biotechnologies through the Designated Official.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Immediate family refers to an Investigator’s spouse and dependent children.
Investigator refers to the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH-funded research, including subgrantees, contractors, consortium participants, collaborators, or consultants.
Institution refers to any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, NIH research funding.
Management of a FCOI refers to the action taken 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 will be free from bias. Honeycomb Biotechnologies management plan will include:
- The role and principal duties of the conflicted investigator in the research project
- The conditions of the management plan
- How the management plan is designed to safeguard objectivity in the research project
- Confirmation of the investigator’s agreement to the management plan
- How the management plan will be monitored to ensure investigator compliance
- Other information as needed
PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.
PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.
Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Regulation or FCOI regulation refers to 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements.
Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
Report refers to the institution’s report of identified FCOIs to the NIH. If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds. For any interests identified as conflicting subsequent to the initial report, Honeycomb Biotechnologies will report any new disclosures to the PHS awarding component that has issued the award within 60 days.
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). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s Honeycomb Biotechnologies project responsibilities, as defined by the following regulation:
- 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
- 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 the 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;
- With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest) or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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 institute of higher education. At minimum to be disclosed are as follows: the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Honeycomb Biotechnologies 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.
The term Significant Financial Interest does not include the following types of financial interest:
- 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 Honeycomb Biotechnologies (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);
- 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 the 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.
Responsibilities of Honeycomb Biotechnologies Designated Official
The Designated Official or his/her designee shall be responsible for the following:
- Informing Honeycomb Biotechnologies Investigators of their obligations under this policy and any related regulations;
- Reviewing disclosures of significant financial interest with Honeycomb Biotechnologies Administrator to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest;
- Screening and managing potential financial conflicts of interest;
- Maintaining all records relating to disclosures of financial interests, Honeycomb Biotechnologies review of and response to such disclosures, and any related actions under this policy;
- Ensuring inclusion of any required certifications in applications for funding or contract proposals; and
- Reporting and disclosure as required under this policy and applicable regulations.
For PHS-funded research, the Designated Official shall also have the following responsibility:
- Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide Honeycomb Biotechnologies with sufficient assurances to enable Honeycomb Biotechnologies compliance with all applicable laws or regulations. To this end, the written agreement between Honeycomb Biotechnologies and the subrecipient will specify whether Honeycomb Biotechnologies or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
- Obtain certification from the subrecipient that its policy complies with Honeycomb Biotechnologies policy and the applicable regulations (absent such certification, Honeycomb Biotechnologies policy will apply to the subrecipient’s Investigators, and
- Establish time periods for subrecipient reporting of financial conflicts of interest to Honeycomb Biotechnologies that enable Honeycomb Biotechnologies to report such conflicts in a timely manner, as required under its policy and the applicable regulations.
If Honeycomb Biotechnologies policy will apply to the subrecipient Investigators, Honeycomb Biotechnologies will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.
Internal Reporting Requirements
For PHS-funded research in particular, as part of the funding application or proposal and prior to performing any work on the research, each Investigator who is planning to participate in the research is required by regulation to complete a Significant Financial Interest Disclosure (SFID) Form and submit the SFID Form to Honeycomb Biotechnologies Administrator. This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. SFID Forms will be provided to Investigators in conjunction with the annual training and will be otherwise made available. Honeycomb Biotechnologies Administrator will review SFID submissions with the Designated Official. The information reported on the SFID Form includes a listing of the Investigator’s known significant financial interests and those of his/her immediate family that reasonably appear to be related to the research or that are in entities whose financial interests could be affected by the research.
Honeycomb Biotechnologies Investigators in non-PHS-funded research who have any significant financial interest that may reasonably appear to be affected by the research are also expected to complete the SFID Form and submit it to Honeycomb Biotechnologies Administrator.
Investigators are expected to submit an updated SFID Form during the period of the award as necessary (at least annually for PHS-funded research). The annual update will typically be done in conjunction with completion of the annual training. Such disclosures shall include any information that was not previously disclosed; any change in information regarding any previously disclosed significant financial interest; or, within 30 days of discovery or acquisition, any new significant financial interest (e.g., an interest acquired through purchase, marriage, or inheritance).
Determination and Management of Financial Conflicts of Interest
Upon receipt of a completed SFID Form, the Designated Official shall determine whether an Investigator’s significant financial interest is related to the subject research and, if so, whether the interest constitutes a financial conflict of interest under this policy and any applicable regulations. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
If Honeycomb Biotechnologies determines that a financial conflict of interest exists, a financial conflicts of interest management plan will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:
- Disclosure to research participants or the public of significant financial interests (e.g., when presenting or publishing the research);
- Monitoring of research by independent reviewers;
- Modification of the research plan;
- Disqualification of staff from participation in all or a portion of the research;
- Reduction or divestiture of a financial interest; or
- Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, Honeycomb Biotechnologies may require the management of conflicting financial interests in other ways as it deems appropriate.
External Reporting Requirements
Honeycomb Biotechnologies will disclose financial conflicts of interest as required by applicable laws or regulations. Before expending any funds under a PHS award, Honeycomb Biotechnologies will ensure public accessibility by posting financial conflicts of interest information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any financial conflict of interest that has not been eliminated and will ensure that Honeycomb Biotechnologies has implemented a plan to manage the conflict.
If a financial conflict of interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, Honeycomb Biotechnologies will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant financial interest that was not disclosed by an Investigator or not previously reviewed or managed by Honeycomb Biotechnologies (e.g., not reviewed or reported by a subrecipient in a timely manner), Honeycomb Biotechnologies will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, Honeycomb Biotechnologies will promptly notify the PHS Awarding Component and submit a mitigation report. Upon request, Honeycomb Biotechnologies will provide HHS with information relating to any Investigator disclosure of significant financial interests; Honeycomb Biotechnologies review of, and response to, such disclosure; and whether the disclosure resulted in Honeycomb Biotechnologies determination of a financial conflict of interest.
Honeycomb Biotechnologies will, to the extent possible, protect the confidentiality of disclosures. In every instance, Honeycomb Biotechnologies will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to Honeycomb Biotechnologies staff only on a need-to-know basis and will not be disclosed outside of Honeycomb Biotechnologies unless necessary to comply with contractual, legal, or regulatory requirements.
If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential financial conflict of interest), Honeycomb Biotechnologies may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research. In addition, for PHS-funded research, failure to comply with this policy or the applicable regulations shall result in the following:
- If the Investigator’s failure to comply with this policy or a financial conflicts of interest management plan has biased the design, conduct, or reporting of the PHS-funded research, Honeycomb Biotechnologies shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken;
- Honeycomb Biotechnologies will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts.
Compliance and Penalties for Non-Performance
If an investigator fails to comply with Honeycomb Biotechnologies FCOI policy, within 120 days, Honeycomb Biotechnologies shall complete a retrospective review of the investigator’s activities to determine bias. If a bias is found, Honeycomb Biotechnologies shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. Honeycomb Biotechnologies will work with the Investigator to set up an FCOI management plan to mitigate the situation. Company-wide, Honeycomb Biotechnologies is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. The investigator may also lose the right to work on the project or receive any future NIH funding. Non-compliance with Honeycomb Biotechnologies FCOI policy can also result in administrative action and employee sanctions, the nature of which will be determined by Honeycomb Biotechnologies.
Training and Education
Investigators receive training to promote objectivity in research and to ensure Investigator compliance with regard to the applicable regulations and significant financial interest disclosure obligations. The training module and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site. (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm)
Honeycomb Biotechnologies requires Investigators to complete such training annually, and when any of the following occurs:
- Honeycomb Biotechnologies revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations;
- An Investigator is new to Honeycomb Biotechnologies; or
- Honeycomb Biotechnologies finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management plan.
Retention of Records
The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information consistent with Honeycomb Biotechnologies Record Retention policy. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by Honeycomb Biotechnologies with respect to each financial conflict of interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 75.361 (Retention requirements for records) or 48 CFR Part 4, Subpart 4.7 (Contractor Records Retention).
Point of Contact
If you have a conflict of interest or if you have a question to discuss regarding Honeycomb Biotechnologies FCOI policy, contact Honeycomb Biotechnologies Designated Officials James Flanigon and Brian Hutchison.