Effective: July 30, 2026
Effective: July 30, 2026
The purpose of this policy is to ensure that research funded by the National Institutes of Health
(NIH) is designed, conducted, and reported objectively and without bias resulting from
Investigator financial conflicts of interest (FCOI). The 2011 revised regulations are 42 CFR Part
50 Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible
Prospective Contractors”, which set requirements for promoting objectivity in Public Health Service (PHS)–funded research for grants, cooperative agreement, and research contracts, respectively. The regulations and this policy do not apply to SBIR or STTR Phase I applications or awards.
This policy is intended to implement the regulatory requirements for PHS/NIH grants and cooperative agreements per the regulation at 42 CFR Part 50 Subpart F and NIH’s guidance. Kano Therapeutics (“The Institution”) adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research. It establishes processes to identify, disclose, and manage Investigator financial conflicts of interest to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH-supported research.
This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the NIH. This policy applies to individuals who meet the regulatory definition of “Investigator” (as defined below) who are planning to participate in or who participate in PHS/NIH-funded research.
For the purpose of these policies and procedures, the following definitions apply:
Financial Conflict Of Interest (FCOI): A significant financial interest (SFI) that the Institution’s designated official(s) determines is related to the PHS/NIH-funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHSfunded research.
Financial Interest: Anything of monetary value, whether or not its value is readily ascertainable.
Institutional Responsibilities: The professional responsibilities of an Investigator on behalf of Kano Therapeutics, which may include activities such as research, research consultation and collaboration, product development (e.g., developing therapeutic circular single-stranded DNA), product testing and validation, development of datasets, models, or systems, publication and communication of research results, and other professional services performed on behalf of Kano Therapeutics. These responsibilities also extend to institutional committee memberships and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards and those holding fiduciary responsibility for the company.
Designated Official (DO): The individual appointed by Kano Therapeutics to solicit and review disclosures of significant financial interests, determine FCOIs in accordance with 42 CFR 50.604(f) and this policy, and develop management plans for identified FCOIs.
Institution: Any public or private organization, domestic or foreign (excluding a federal agency) that is applying for or receives, PHS/NIH research funding.
Investigator: The Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH or proposed for such funding, which may include, for example, collaborators or consultants. The institution determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research. The Institution will consider the individual’s role, rather than the title (e.g., senior/key personnel, faculty, MD, PHD, etc.), of those individuals involved in the research and the degree of independence in carrying out the work when determining who is responsible for the design, conduct, or reporting of the PHS/NIH-funded research.
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.
Research: Refers to 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., developing therapeutic monoclonal antibodies). As used in the regulation, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, 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.
PHS-Funded Research: Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority.
PHS: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
NIH: The biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge.
Senior/Key Personnel: The PD/PI and any other individual identified as senior/key personnel by the Institution in a grant application, progress report, or other submission to PHS/NIH. For this policy, the term applies specifically to the public accessibility requirement, which mandates disclosure only of financial conflicts of interest held by these senior/key personnel, as described in Section 9.
Significant Financial Interest (SFI):
Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact cost may not be known. The disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip.
The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
Exclusions Related to Foreign Financial Interests: Investigators must disclose all financial interests originating outside the United States, including income from seminars, lectures, teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel, received from any foreign entity. This includes foreign institutions of higher education and foreign governments (including local or provincial governments). Disclosure is required when the aggregated amount of such income meets the threshold for disclosure (e.g., income in excess of $5,000).
Investigators will disclose their SFIs that are related to their “institutional responsibilities” as defined in the policy. The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the 2011 regulation. The Investigator SFI Disclosures will be retained by Kano Therapeutics as part of the record maintenance requirements.
Investigators are required to disclose SFIs at the following times:
The Kano Therapeutics Executive Team, which consists of its Chief Executive Officer and Chief Business Officer will serve as the Designated Officials (DOs) responsible for reviewing all SFI disclosures and making determinations of FCOI. In cases where it is determined that one of the members of the Executive Team has a disclosed SFI related to the research under review, or where additional independence is warranted, the DO team member will recuse themselves from the review and determination. In such cases, the remaining members of the Executive Team will serve as the DOs.
Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible for the design, conduct, or reporting of research, to determine whether the SFI is related to the funded research and, if so, whether it constitutes a Financial Conflict of Interest (FCOI).
The SFI disclosures will be reviewed as described below:
An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.
The DOs are responsible for assessing whether an Investigator’s SFI is related to the PHS/NIHfunded research, and if so, whether the SFI is an FCOI. The DOs will utilize the following criteria per 42 CFR 50.604(f), at a minimum, to make determinations of FCOI.
Relatedness Test: An SFI is “related” to the research when the DOs reasonably determine that:
INVESTIGATOR INVOLVEMENT: The DOs may consult with the Investigator when assessing whether an SFI is related to the research.
Designated Officials FCOI Determination: An FCOI exists when the DOs reasonably determine that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH- funded research (“significantly” meaning that the financial interest would have a material effect on the research).
When an FCOI is identified, the DO will determine and implement management strategies to ensure the research is conducted objectively. Examples of management conditions include, but are not limited to:
The DOs will communicate the determination and the management plan in writing to the Investigator and will require the Investigator to certify compliance with the management plan. No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DOs will submit an FCOI report to NIH via the eRA Commons FCOI Module.
Kano Therapeutics will monitor Investigator compliance with the management plan for the duration of the NIH award. When the Institution’s FCOI policy applies to subrecipient Investigators, the Institution will monitor subrecipient Investigator compliance with the management plan. As part of this monitoring process, the DO may request and review documentation demonstrating compliance with required FCOI disclosures, including publications, presentation materials, abstracts, posters, and written communications to study personnel. Investigators must provide copies of such materials, including relevant emails or other written disclosures, to the DO for recordkeeping. These records will be maintained to document compliance with the management plan and to support institutional review and audit activities.
FCOI Policy: A copy of this FCOI policy is available on Kano Therapeutics’ public website at https://kanotherapeutics.com/news/kano-fcoi-policy/ as required by Section 4.1.10 Financial Conflict of Interest of the NIH Grants Policy Statement.
Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH award, Kano Therapeutics will ensure public accessibility, by providing a written response within five business days to requests for information about any SFI that meets all three of the following criteria:
When applicable, Kano Therapeutics will make available at least the following information:
$0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the value cannot be readily determined by public prices or reasonable fair market value measures.
The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the institution’s identification of a new FCOI, which should be requested subsequently by the requestor.
If Kano Therapeutics uses a publicly accessible website to meet this requirement, the information will be updated at least annually and within 60 days of:
Prior to spending any funds under an NIH-funded award, Kano Therapeutics will submit an identified FCOI report to NIH, in accordance with the FCOI regulations, for any Investigator’s SFI determined to be an FCOI. Kano Therapeutics will also ensure that the Investigator has agreed to and begun implementing the associated management plan.
Kano Therapeutics will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified (i.e., no award means no FCOI report, and no FCOI means no FCOI report).
The NIH eRA Commons FCOI Module User Guide, available at the following location, provides instructions for preparing and submitting FCOI reports. https://www.era.nih.gov/files/fcoi_user_guide.pdf.
The institution will submit the following types of reports as explained below:
When an FCOI is identified, the Original Report will be submitted as described below:
Types of FCOI Reports Summary Chart for NIH:
| Required FCOI Reports to NIH via eRA Commons FCOI Module | ||
| REPORT | CONTENT | REQUIRED WHEN |
| New FCOI Report
(Initial Submission) |
Grant number; PI; name of entity with FCOI; nature of FCOI; value of the financial interest (in required increments); description of how the financial interest
relates to the research; key elements of the management plan |
1) Prior to the expenditure of funds on a new award; or
2) Within 60 days of identifying any new FCOI during the award period |
| Annual
FCOI Report |
Status of the FCOI (whether it is still being managed or no longer exists) and any changes to the management plan, if applicable. | Submitted annually at the same time as the annual progress report, multi-year progress report, or at the time of a grant extension. |
| Revised FCOI Report | If applicable, updates to a previously submitted FCOI report to describe actions that will be taken to manage the FCOI going forward or to revise the original report. | Following a retrospective review
when noncompliance with the regulation is identified, if applicable. |
| Mitigation Report | Project number; project title; contact PI/PD; name of Investigator with FCOI; name of entity with FCOI; reason for review; detailed methodology, findings, and conclusions. | After a retrospective review when bias is found. |
Each Investigator will be informed of Kano Therapeutics’ FCOI Policy and trained on their responsibility to disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training must be completed before an Investigator engages in PHS/NIH-funded research, at least once every four years, and promptly (as described below) when any of the following occur:
To supplement the regulatory training requirements, Kano Therapeutics will utilize NIH’s training programs to train Investigators on the FCOI regulation. Kano Therapeutics requires Investigators to complete either:
Certificate should be shared with the DO, OR
If Kano Therapeutics identifies an SFI that was not disclosed, reviewed, or managed in a timely manner, the DO will, within 60 days: review the SFI; determine whether it is related to NIHfunded research; determine whether it constitutes an FCOI; and, if so, implement an interim management plan describing actions that have been and will be taken to manage the FCOI going forward. Kano Therapeutics will also submit an FCOI report to NIH via the eRA Commons FCOI Module.
In addition, whenever an FCOI is not identified or managed in a timely manner, including:
Kano Therapeutics will, within 120 days of identifying noncompliance:
If bias is found, Kano Therapeutics will promptly notify NIH and submit a mitigation report as required by 42 CFR 50.605(a)(3)(iii) or as described in NIH’s FAQ I.3. at https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52896 to NIH via the FCOI Module. The report will include:
Thereafter, Kano Therapeutics will submit FCOI reports annually to NIH as required by the regulation and terms and conditions of the award.
Depending on the circumstances, Kano Therapeutics may implement additional interim measures regarding the Investigator’s participation in the research until the retrospective review is complete.
If bias is not found following completion of the retrospective review, no further action will be taken unless new information is discovered that needs to be reported to the NIH. If applicable, the Institution will update an existing FCOI report to specify the actions that have been, and will be, taken to manage the FCOI going forward or update a previously submitted report information (e.g., increase in value of the SFI or add any newly identified SFIs) following the completion of the retrospective review.
If the failure of an Investigator to comply with an Institution’s FCOI or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research, the Institution shall promptly notify the PHS/NIH Awarding Component of the corrective action taken or to be taken. The PHS/NIH Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS/NIH-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS/NIH award or when the transfer of a PHS/NIH grant(s) involves such an Investigator.
If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment (such as developing therapeutic monoclonal antibodies) was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, Kano Therapeutics will require the Investigator to disclose the conflict in every public presentation of the research results and to request an addendum to previously published presentations.
A subrecipient relationship exists when federal funds flow from or through Kano Therapeutics to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to Kano Therapeutics for programmatic outcomes and compliance.
Subrecipients (e.g. collaborators or consortium members) are subject to Kano Therapeutics’ terms and conditions. Kano Therapeutics will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. Kano Therapeutics will include in each written agreement with a subrecipient terms specifying whether Kano Therapeutics’ FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators (see NIH Grants Policy Statement Section15.2.1 Written Agreement at https://grants.nih.gov/grants/policy/nihgps/html5/section_15/15.2_administrative_and_other_requirements.html).
Therapeutics in time for Kano Therapeutics to meet NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI). Typically, this means requiring subrecipients to report FCOIs to Kano Therapeutics within 50–55 days of identification. Kano Therapeutics’ DO will then submit the subrecipient FCOI report to NIH through the eRA Commons FCOI Module.
Kano Therapeutics will maintain records of all Investigator financial interest disclosures, Kano Therapeutics’ review and response to those disclosures (whether or not they resulted in a determination of an FCOI), and any actions taken under this policy or through retrospective review. These records will be retained for at least three years from the date of submission of the final expenditures report, or for longer periods as specified in 2 CFR 200.334
(https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-groupECFR4acc10e7e3b676f/section-200.334) for different situations. Kano Therapeutics will retain these records for each competitive segment as required by regulation.
Copies of management plans will be retained as part of the record maintenance requirements and not submitted to the NIH per NIH’s FAQ guidance.
Compliance with this policy is a condition of employment and/or participation for all applicable
Investigators. Failure to comply with this policy, including failure to disclose Significant Financial Interests, failure to comply with a Conflict Management Plan, or failure to complete required training, may result in appropriate corrective or disciplinary actions.
Such actions may include, but are not limited to, formal notification or disciplinary measures, restrictions on participation in research activities or use of research funds, suspension or termination of employment or contractual relationship, and/or disqualification from participation in Government Award–funded research, as appropriate.
In addition, the PHS/NIH Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and the Institution’s review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of an FCOI. The Institution will submit, or permit on site review of, all records pertinent to compliance with the regulation and this policy. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS/NIH Awarding Component may decide that a particular FCOI will bias the objectivity of the PHS/NIH-funded research to such an extent that further corrective action is needed or that the Institution has not managed the FCOI in accordance with the regulation or this policy. The PHS/NIH Awarding Component may determine that imposition of specific award conditions under 2 CFR 200.208 (https://www.ecfr.gov/current/title-2/section-200.208), or suspension of funding or other enforcement action under 2 CFR 200.339
(https://www.ecfr.gov/current/title-2/section-200.339) is necessary until the matter is resolved.
NIH e-mail address for FCOI-related inquiries: fcoicompliance@mail.nih.gov
FCOI regulation 42 CFR 50 Subpart F:
https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F
Financial Conflict of Interest at https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi · FCOI Training at https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training
If you have a question related to the FCOI Policy of Kano Therapeutics, or would like to disclose a financial interest, contact us using the information below:
Contact:
Kano Therapeutics
700 Main St, Cambridge, MA 02139