Fizz Studio LLC 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.

Fizz Studio LLC (“Fizz Studio,” “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 rights and welfare of human participants where applicable, 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.

This policy applies regardless of whether the Investigator is an employee, officer, contractor, consultant, collaborator, subrecipient personnel member, or other individual acting on behalf of Fizz Studio.

3. Definitions

For the purpose of these policies and procedures, the following definitions apply:

Financial Conflict of Interest (FCOI): A significant financial interest that is related to the PHS/NIH-funded research, meaning 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 Fizz Studio, which may include activities such as research, research consultation and collaboration, software design and development, accessibility research, usability testing, human-subjects evaluation, educational or assistive-technology evaluation, product evaluation, data visualization research, development of datasets, models, prototypes, systems, and related documentation, publication and communication of research results, and other professional services performed on behalf of Fizz Studio.

Designated Official (DO): The individual appointed by Fizz Studio 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 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 title, 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: 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. 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 or cooperative agreement, whether authorized under the PHS Act or other statutory authority. For Fizz Studio, PHS/NIH-funded research may include accessibility-focused software development, assistive-technology evaluation, data visualization research, usability testing, user-experience research, educational-validity review, and related product-development activities where supported by PHS/NIH funding.

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):

A domestic or foreign financial interest consisting of one or more of the following interests 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 performed on behalf of Fizz Studio, and that consists of one or more of the following:

• Publicly traded entity: An SFI exists if the total of remuneration received from the entity in the previous 12 months and the value of any equity interest in the entity on the disclosure date exceeds $5,000. Remuneration includes salary and payments for services, such as consulting fees, honoraria, and paid authorship. Equity interest includes stock, stock options, or other ownership interests measured by public prices or other reasonable market value.
• Non-publicly traded entity: An SFI exists if the aggregated value of remuneration received from the entity in the 12 months preceding the disclosure exceeds $5,000, or if the Investigator, or the Investigator’s spouse, domestic partner, or dependent children, holds any equity interest in the entity, such as stock, stock options, or other ownership interest.
• Intellectual property: An SFI exists if receipt of income related to intellectual property rights or interests, such as patents or copyrights, exceeds $5,000 during the 12 months preceding the disclosure, related to such rights and interests.

Investigators must disclose any reimbursed or sponsored travel related to their institutional responsibilities in excess of $5,000. 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:

• A federal, state, or local government agency located in the United States
• A United States institution of higher education
• An academic teaching hospital
• A medical center
• A research institute affiliated with a United States institution of higher education

The term “significant financial interest” does not include, and therefore Investigators are not required to disclose, the following types of financial interests:

• Salary, royalties, or other remuneration paid by Fizz Studio to the Investigator if the Investigator is currently employed or otherwise appointed by Fizz Studio, including intellectual property rights assigned to Fizz Studio and any agreements to share royalties related to those rights.
• Any ownership interest in Fizz Studio held by the Investigator, since Fizz Studio is a commercial or for-profit organization. This exclusion applies only if the applicant or recipient, including a subrecipient, is a for-profit or commercial institution.
• 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 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.
• Income from service on advisory committees or review panels for 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.

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, such as income in excess of $5,000.

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 funded research, because this is too narrow in scope and not consistent with the 2011 regulation.

The 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 individuals who meet the definition of “Investigator” 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 their SFIs to the DO promptly and before participating in the project, using the SFI Disclosure Form.

Annual disclosure during the award: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure at least annually during the award period. Fizz Studio will collect annual SFI disclosures from Investigators by January 31 of each year, unless another annual disclosure date is designated by Fizz Studio’s Designated Official. Annual disclosures must include: (1) any new information that was not previously disclosed to the Designated Official under this policy, including SFIs associated with PHS/NIH-funded projects transferred from another institution; and (2) updated details for any previously disclosed SFI, such as changes in the value of an equity interest.

Ad hoc basis during the award: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI, such as 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

Doug Schepers, Founder, CEO, and Institutional Official, serves as the Designated Official responsible for reviewing all SFI disclosures. 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 from the review and determination. In such cases, an alternate qualified designee or external advisor may be appointed to perform the review. The use of such alternative review arrangements will be documented.

For disclosures involving Doug Schepers, Fizz Studio may use Tim Podkul, Director of Education & Learning Strategy, Fizz Studio, as the reviewer, provided that Tim Podkul does not have the same or a related financial interest. If Tim Podkul has the same or a related financial interest, Fizz Studio will use another qualified non-conflicted reviewer, such as outside counsel, an accountant, an external compliance advisor, or another qualified person.

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 an FCOI.

The SFI disclosures will be reviewed as described below:

Prior to the issuance of a new award or before any expenditure of awarded funds: The DO will review the Investigator’s 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: As part of the annual disclosure process, Investigators must provide updated information on any previously disclosed SFIs. The DO will review these 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, if applicable.

Ad hoc basis during award period: If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days:

• Review the disclosure
• Determine whether the SFI is related to the PHS/NIH-funded research
• Determine whether an FCOI exists
• If an FCOI exists, implement, on at least an interim basis, a 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: The DO determines whether an Investigator’s SFI is related to research under an NIH award. 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.

Investigator Involvement: The DO may consult with the Investigator when assessing whether an SFI is related to the research.

Designated Official 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, with “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:

• Public disclosure of the FCOI, such as in publications or presentations, to study personnel, to the IRB, independent monitor, advisory board, data safety or privacy reviewer, or other oversight body, as applicable. 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.
• For human subjects research, disclosure of the FCOI to participants in the informed consent document.
• Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research.
• Modification of the research plan.
• Change of personnel roles or removal from portions of the research.
• Reduction or elimination of the financial interest, such as divesting equity.
• 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, if applicable.

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 or FCOI Signing Official will submit an FCOI report to NIH via the eRA Commons FCOI Module.

In addition to Investigator FCOI, Fizz Studio recognizes that certain financial interests at the institutional level, including company equity, intellectual property interests, licensing arrangements, commercialization plans, customer or partner relationships, paid pilots, data-access agreements, financial relationships of senior leadership, or other business relationships, 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

Fizz Studio will monitor Investigator compliance with the management plan for the duration of the NIH award.

When an FCOI management plan requires disclosure in publications, presentations, or other communications, Investigators must provide such disclosures as required by the management plan. Investigators must also disclose the FCOI in writing to study personnel when required by the management plan 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 will be available on Fizz Studio’s public website at https://fizz.studio/legal/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, Fizz Studio 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, meaning the PD/PI and any other individual identified by Fizz Studio as senior/key personnel in the application, progress report, or other NIH submission.
• Fizz Studio has determined that the SFI is related to the NIH-funded research.
• Fizz Studio has determined that the SFI constitutes an FCOI.

When applicable, Fizz Studio will make available at least the following information:

• Investigator’s name
• Investigator’s 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 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 Fizz Studio uses a publicly accessible website to meet this requirement, the information will be updated at least annually and within 60 days of:

• Receiving or identifying an additional SFI of Senior/Key Personnel related to the NIH-funded research that was not previously disclosed, or
• A new SFI being disclosed by Senior/Key Personnel joining the project and determined by the DO to be related and an FCOI.

Information on SFIs subject to public accessibility 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, Fizz Studio will submit an identified FCOI report to NIH, in accordance with the FCOI regulations, for any Investigator’s SFI determined to be an FCOI. Fizz Studio will also ensure that the Investigator has agreed to and begun implementing the associated management plan.

Fizz Studio 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, meaning no award means no FCOI report, and no FCOI means no FCOI report.

The NIH eRA Commons FCOI Module User Guide provides instructions for preparing and submitting FCOI reports: NIH eRA Commons FCOI Module User Guide

Initial (Original) FCOI Reports: The report must include all information required under 42 CFR 50.605(b)(3) or as outlined in NIH guidance.

• Prior to the expenditure of funds: If an FCOI is identified at the time a new NIH award is issued, the FCOI SO will submit an Original FCOI report through the eRA Commons FCOI Module before any funds are spent.
• Within 60 days during the award: If an FCOI is identified during the award period, such as when a new SFI is disclosed or a new Investigator joins the project, the Institution must submit an Original FCOI report within 60 days of identifying the FCOI.

Annual FCOI Reports: For the duration of an award, including any extensions with or without funds, the Institution must submit an annual FCOI report to NIH. This report will indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable.

The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report, and at the time of any grant extension, following NIH guidance. NIH creates the opportunity for the FCOI SO to submit the Annual report 75 days prior to the next budget period start date for continuation awards. NIH will notify the Institution by email when an annual report is due.

Annual FCOI reports are not required at grant closeout.

Revision or Mitigation FCOI Reports: After completing a retrospective review, the Institution will submit a Revision report to NIH if new information about the FCOI is discovered, or a Mitigation report if the review finds that bias has occurred.

Types of FCOI Reports Summary Chart for NIH:

11. Training Requirements for Investigators

Each Investigator will be informed of Fizz Studio’s 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 when any of the following occur:

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

To meet the NIH training requirement, Fizz Studio requires Investigators to complete the NIH FCOI Training Tutorial. Fizz Studio also requires Investigators to review the NIH Virtual Seminar presentation on FCOI compliance. Investigators must send the DO the date of completion by email for audit purposes.

12. Noncompliance With FCOI Policy and Corrective Actions

If Fizz Studio 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 describing actions that have been and will be taken to manage the FCOI going forward. Fizz Studio 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 that is later determined to constitute an FCOI.
• Failure by the Institution to review or manage an FCOI.
• Failure by the Investigator to comply with an established management plan.

Fizz Studio will, within 120 days of identifying noncompliance:

• 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.
• Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or NIH guidance.

If bias is found, Fizz Studio will promptly notify NIH and submit a mitigation report as required by 42 CFR 50.605(a)(3)(iii) to NIH via the FCOI Module. The report will include:

• 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.

Fizz Studio will thereafter submit FCOI reports annually to NIH as required by the regulations and the terms and conditions of the award. Depending on the circumstances, Fizz Studio 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 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 following the completion of the retrospective review.

If the failure of an Investigator to comply with an Institution’s FCOI policy or an 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.

13. Clinical Research Requirements, If Applicable

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, Fizz Studio 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 Fizz Studio to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to Fizz Studio for programmatic outcomes and compliance.

Subrecipients, such as collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to Fizz Studio’s terms and conditions. Fizz Studio will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. Fizz Studio will include in each written agreement with a subrecipient terms specifying whether Fizz Studio’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators.

If the subrecipient’s FCOI policy applies: The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to Fizz Studio in time for Fizz Studio to meet NIH reporting deadlines, meaning before funds are spent and within 60 days of the subrecipient identifying an FCOI. Typically, this means requiring subrecipients to report FCOIs to Fizz Studio within 50-55 days of identification. Fizz Studio’s DO or FCOI SO will then submit the subrecipient FCOI report to NIH through the eRA Commons FCOI Module.

If the subrecipient cannot certify compliance: The agreement will specify that Fizz Studio’s FCOI Policy applies. In this case, subrecipient Investigators must disclose their SFIs to Fizz Studio. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for Fizz Studio. The agreement will allow sufficient time for Fizz Studio to review, manage, and report any resulting FCOIs. When an FCOI is identified, Fizz Studio will implement a management plan, monitor compliance by the subrecipient Investigator, and submit the required FCOI report to NIH via the eRA Commons FCOI Module.

15. Maintenance of Records

Fizz Studio will maintain records of all Investigator financial interest disclosures, Fizz Studio’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 for specific situations. Fizz Studio 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 participation in PHS/NIH-funded research conducted by or on behalf of Fizz Studio LLC. Failure to comply with this policy may result in corrective or disciplinary action, depending on the nature, severity, duration, and impact of the noncompliance.

Examples of noncompliance include, but are not limited to:

• Failure to complete required FCOI training;
• Failure to submit a required Significant Financial Interest disclosure;
• Failure to update a disclosure within the required timeframe;
• Submission of incomplete, inaccurate, or misleading disclosure information;
• Failure to comply with an FCOI management plan;
• Failure to cooperate with Fizz Studio’s review, monitoring, retrospective review, or mitigation activities under this policy.

Fizz Studio may impose one or more corrective or disciplinary actions, as appropriate. Such actions may include, but are not limited to:

1. Written notice of noncompliance and requirement to cure the deficiency;
2. Required completion or repetition of FCOI training;
3. Required submission or correction of an SFI disclosure;
4. Temporary suspension of participation in PHS/NIH-funded research activities;
5. Restriction or modification of the Investigator’s role in the research;
6. Suspension of access to study data, participants, systems, research funds, or project materials;
7. Removal from responsibility for the design, conduct, or reporting of the affected research;
8. Replacement on the project or removal from the PHS/NIH-funded project;
9. Suspension or termination of consulting, contractor, collaborator, employment, or other working relationship, as applicable;
10. Any additional actions required by NIH, PHS, HHS, or other applicable sponsor or regulatory authority.

Fizz Studio will also take any actions required under applicable federal regulations and sponsor requirements, including retrospective review, mitigation measures, management-plan revision, and notification to NIH or the PHS Awarding Component when required.

Corrective or disciplinary actions will be documented and retained in accordance with this policy’s record-maintenance requirements.

17. Useful FCOI and NIH Resources

• NIH email address for FCOI-related inquiries
• FCOI Regulation 42 CFR Part 50 Subpart F - Promoting Objectivity in Research
• NIH Financial Conflict of Interest
• NIH FCOI Training
• NIH eRA Commons FCOI Module User Guide

18. Point of Contact

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