Financial Conflict of Interest (FCOI) Policy

1) Introduction

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 agreements, and research contracts, respectively. The regulations do not apply to SBIR or STTR Phase I applications or awards. This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements.

ZwiCoat Materials Innovations, LLC ("ZCMI," "the Company," "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.

2) Applicability

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.

3) Definitions

Financial Conflict of Interest (FCOI): A significant financial interest that 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 PHS-funded 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 ZCMI, which may include activities such as research, research consultation and collaboration, coatings formulation, materials characterization, substrate testing, product development, product testing and validation, manufacturing process development, development of datasets, models, or systems, customer technical support, collaboration with device manufacturers, intellectual property and patent development, fundraising, publication and communication of research results, and other professional services performed on behalf of ZCMI.

Designated Official (DO): The individual appointed by ZCMI 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. The President and Chief Technology Officer serves as the Designated Official. In cases where the DO has a disclosed SFI related to the research under review, or where additional independence is warranted, the DO will recuse themselves and an alternate qualified designee or external advisor may be appointed. The use of such alternative review arrangements will be documented.

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 will consider the individual's role, rather than their title, and degree of independence in carrying out the work when making this determination.

Manage: 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: 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 and product development, and includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or other statutory authority.

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 described in Section 9.

Significant Financial Interest (SFI):

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

• Publicly traded entity: An SFI exists if the total of remuneration received in the previous 12 months and the value of any equity interest on the disclosure date exceeds $5,000. Remuneration includes salary and payments for services (e.g., consulting fees, honoraria, paid authorship). Equity interest includes stock, stock options, or other ownership interests.
• Non-publicly traded entity: An SFI exists if the aggregated value of remuneration received in the 12 months preceding disclosure exceeds $5,000, or if the Investigator (or their spouse or dependent children) holds any equity interest.
• Intellectual property: An SFI exists if receipt of income related to intellectual property rights or interests (e.g., patents, copyrights) exceeds $5,000 during the 12 months preceding disclosure.

2) Investigators must disclose any reimbursed or sponsored travel related to their institutional responsibilities in excess of $5,000 in the previous 12 months, including at minimum the purpose, sponsor or organizer, destination, and duration of each trip. This requirement does not apply to travel reimbursed or sponsored by a U.S. federal, state, or local government agency; a U.S. Institution of Higher Education; an academic teaching hospital; a medical center; or a research institute affiliated with a U.S. Institution of Higher Education.

3) SFI does not include, and investigators are not required to disclose:

• Salary, royalties, or other remuneration paid by ZCMI to the Investigator if currently employed or appointed by ZCMI, including intellectual property rights assigned to ZCMI and agreements to share royalties related to those rights.
• Any ownership interest in ZCMI held by the Investigator, since ZCMI is a commercial or for-profit organization.
• Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions for those vehicles.
• Income from seminars, lectures, or teaching engagements, or service on advisory committees or review panels, sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education.

4) Significant Financial Interest (SFI) Disclosure Requirements

Investigators will disclose their SFIs that are related to their institutional responsibilities as defined in this 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. Investigator SFI Disclosures will be retained by the Institution as part of the record maintenance requirements.

Investigators are required to disclose SFIs at the following times:

• At the time of application: The PI and all other Investigators must disclose their SFIs to the DO. Any new Investigator who joins the project after the NIH application has been submitted or during the course of the research must also disclose promptly and before participating, using the SFI Disclosure Form.
• Annual disclosure during the award: Each Investigator must submit an updated SFI disclosure at least annually (on or before May 1) during the award period, including any new information not previously disclosed and updated details for any previously disclosed SFI.
• Ad hoc during the award: Each Investigator must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

5) Review of SFI Disclosures

The President and Chief Technology Officer serves as the Designated Official (DO) responsible for reviewing all SFI disclosures. In cases where the DO has a disclosed SFI related to the research under review, the DO will recuse themselves, and an alternate qualified designee or external advisor may be appointed. Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible.

SFI disclosures will be reviewed at the following times:

• Prior to a new award (e.g., Just-in-Time stage): The DO will review Investigator SFIs before NIH issues a new award. If an FCOI is identified, an FCOI report will be submitted to NIH via the eRA Commons FCOI Module prior to any expenditure of funds.
• Annual SFI disclosure: The DO will review annual updates to determine whether changes to an existing management plan are needed. Any modifications will be reflected in the next Annual FCOI report submitted to NIH.
• Ad hoc basis during the award: If a new Investigator joins a project or an existing Investigator acquires a new SFI, the DO will, within 60 days: (1) review the disclosure; (2) determine whether it is related to the PHS/NIH-funded research; (3) determine whether an FCOI exists; and if so, (4) implement at least an interim management plan. An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.

6) Relatedness of SFIs to PHS/NIH-Funded Research and FCOI

The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute an FCOI.

Relatedness Test: An SFI is considered "related" when the DO reasonably determines that the SFI could be affected by the PHS/NIH-funded research, or the SFI is in an entity whose financial interests could be affected by the PHS/NIH-funded research. The DO may consult with the Investigator when making this assessment.

FCOI Determination: An FCOI exists when the DO reasonably determines 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).

7) Management of SFIs that Pose an FCOI

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:

1. Public disclosure of the FCOI (e.g., in publications, presentations, to study personnel, to the IRB, IACUC, or Data Safety Monitoring Board). While public posting of FCOIs is required only for senior/key personnel, the DO may require disclosure of any Investigator's FCOI as a condition of a management plan.
2. For human subjects research, disclosure of the FCOI to participants in the informed consent document.
3. Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research.
4. Modification of the research plan.
5. Change of personnel roles or removal from portions of the research.
6. Reduction or elimination of the financial interest (e.g., divesting equity).
7. Severance of relationships creating the conflict.

The DO will communicate the determination and the management plan in writing to the Investigator and the appropriate supervisor. 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 DO will submit an FCOI report to NIH via the eRA Commons FCOI Module.

In addition to Investigator FCOIs, ZCMI recognizes that certain financial interests at the institutional level — including company equity, intellectual property interests, or financial relationships of senior leadership — may present potential conflicts related to PHS/NIH-funded research. Such interests will be evaluated and managed as appropriate to ensure the objectivity of the research.

8) Monitoring Investigator Compliance

ZCMI will monitor Investigator compliance with the management plan for the duration of the NIH award. FCOIs must be disclosed in publications, presentations, and other communications. Investigators must also disclose the FCOI in writing to study personnel and provide a copy of this disclosure to the DO for recordkeeping.

9) Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

FCOI Policy: A copy of this FCOI policy is available on ZCMI's public website atzwicoat.com/fcoi, as required by Section 4.1.10 of the NIH Grants Policy Statement. A copy of this policy has also been submitted to the NIH via the eRA Commons Institution Profile (IPF) Module.

Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH award, ZCMI 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:

• The SFI was disclosed and is still held by Senior/Key Personnel.
• ZCMI has determined that the SFI is related to the NIH-funded research.
• ZCMI has determined that the SFI constitutes an FCOI.

When applicable, ZCMI will make available at minimum:

• Investigator's name, title, and role with respect to the research project
• Name of the entity in which the SFI is held
• Nature of the SFI
• Approximate dollar value of the SFI in the following ranges: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the value cannot be readily determined.

This information will be updated at least annually and within 60 days of the institution's identification of a new FCOI, and will remain available for at least three years from the most recent update.

10) Reporting Identified Financial Conflicts of Interest

Prior to spending any funds under an NIH-funded award, ZCMI will submit an identified FCOI report to NIH for any Investigator's SFI determined to be an FCOI, and will ensure that the Investigator has agreed to and begun implementing the associated management plan.

ZCMI will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. FCOI reports are submitted only when an award is active and an FCOI has been identified. Instructions for preparing and submitting FCOI reports are available in theNIH eRA Commons FCOI Module User Guide.

11) Training Requirements for Investigators

Each Investigator will be informed of ZCMI's FCOI Policy and trained on their responsibility to disclose foreign and domestic SFIs. Training must be completed before an Investigator engages in PHS/NIH-funded research, at least once every four years, and promptly when any of the following occur:

• ZCMI revises this policy or related procedures in a way that affects Investigator requirements.
• An Investigator is new to ZCMI research under an NIH award (training must be completed before participating).
• ZCMI determines that an Investigator has not complied with this policy or with a management plan (training must be completed within 30 days as directed by the DO).

To meet the NIH training requirement, ZCMI requires Investigators to complete theNIH FCOI Training Tutorial. ZCMI also requires Investigators to review theNIH Virtual Seminar on FCOI compliance. Send the DO the date of completion by email for audit purposes.

12) Noncompliance With FCOI Policy and Corrective Actions

If ZCMI 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 NIH-funded research; determine whether it constitutes an FCOI; and, if so, implement an interim management plan. ZCMI will also submit an FCOI report to NIH via the eRA Commons FCOI Module.

In cases of noncompliance, including:

• Failure by the Investigator to disclose an SFI later determined to constitute an FCOI,
• Failure by the institution to review or manage an FCOI, or
• Failure by the Investigator to comply with an established management plan,

ZCMI will, within 120 days of identifying noncompliance:

1. Conduct a retrospective review of the Investigator's activities and the NIH-funded research to determine whether the research, or any part of it, was biased in the design, conduct, or reporting.
2. Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or NIH's FAQ I.2.

If bias is found, ZCMI will promptly notify NIH and submit a mitigation report as required by 42 CFR 50.605(a)(3)(iii), including the impact of the bias on the research project and the plan of action or corrective steps taken to eliminate or mitigate the effect of the bias.

If bias is not found following completion of the retrospective review, no further action will be taken unless new information is discovered. If the failure of an Investigator to comply with this policy or a management plan appears to have biased the design, conduct, or reporting of PHS/NIH-funded research, the Institution shall promptly notify the PHS/NIH Awarding Component of the corrective action taken or to be taken.

13) Clinical Research Requirements

If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, ZCMI 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.

14) Subrecipient Requirements

A subrecipient relationship exists when federal funds flow from or through ZCMI to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to ZCMI for programmatic outcomes and compliance. Subrecipients (e.g., collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees) are subject to ZCMI's terms and conditions. ZCMI will include in each written agreement with a subrecipient terms specifying whether ZCMI's FCOI Policy or the subrecipient's own FCOI policy will apply.

If the subrecipient's FCOI policy applies: The subrecipient institution must certify that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to ZCMI (typically within 50–55 days of identification) in time for ZCMI to meet NIH reporting deadlines. ZCMI's DO will then submit the subrecipient FCOI report to NIH.

If the subrecipient cannot certify compliance: The agreement will specify that ZCMI's FCOI Policy applies. Subrecipient Investigators must disclose their SFIs to ZCMI. When an FCOI is identified, ZCMI will implement a management plan, monitor compliance, and submit the required FCOI report to NIH via the eRA Commons FCOI Module.

15) Maintenance of Records

ZCMI will maintain records of all Investigator financial interest disclosures, ZCMI's 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. ZCMI 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.

16) Enforcement Actions for Investigator Noncompliance

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.

In addition, ZCMI will take all actions required under applicable federal regulations and sponsor requirements, including conducting retrospective review, implementing mitigation measures where necessary, and notifying the sponsor when required.

17) Useful FCOI and NIH Resources

• NIH FCOI email:fcoicompliance@mail.nih.gov
• FCOI Regulation:42 CFR Part 50 Subpart F – Promoting Objectivity in Research
• Financial Conflict of Interest:grants.nih.gov/policy-and-compliance/policy-topics/fcoi
• FCOI Training:grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training
• NIH "Welcome Wagon" Letter: Information for New Recipient Organizations

18) Point of Contact

If you have a question related to the FCOI Policy of ZCMI, or would like to disclose a financial interest, contact us using the information below: