Policy on Investigator Financial Conflicts of Interest in Research

I. Purpose

“ADVAITA CORPORATION” acknowledges the significance of collaborations with industry, government, academia, and other entities and aims to promote such associations. However, it is crucial to ensure that any financial incentives associated with these collaborations do not lead to conflicts of interest that could compromise the integrity of research or the safety of human research subjects. Such conflicts have the potential to introduce actual or perceived bias in research and may erode public confidence in the research endeavors.

To address these concerns, ADVAITA CORPORATION has formulated the following Policy on Investigator Financial Conflicts of Interest for Research. The primary objective of this policy is to uphold the highest ethical standards of research objectivity by identifying and assessing financial conflicts of interest (“FCOI”) that could influence research decisions, transactions, and operations at ADVAITA CORPORATION. The policy is designed to comply with the federal regulations outlined in 42 CFR Part 50 and 45 CFR Part 94 concerning research funded through the Public Health Service (PHS). Any requirements not explicitly stated in this policy but specified in those regulations shall also be considered part of this policy.

II. Covered Parties

This policy applies to all individuals, regardless of their titles or positions, who are involved in the design, conduct, or reporting of PHS-Funded and Non-PHS Research for ADVAITA CORPORATION.

III. Policy on Investigator Financial Conflicts of Interest for Research

Each individual responsible for designing, conducting, or reporting research at ADVAITA CORPORATION must disclose all Significant Financial Interests (SFIs) for themselves, their spouse, and dependent children that reasonably appear to be related to their Institutional Responsibilities. It is not the Investigator’s responsibility to determine whether the SFI constitutes a conflict of interest or could influence the research’s design, conduct, or reporting. This determination will be made by the Designated Official, as further described below.

Significant Financial Interest (“SFI”) Defined: An SFI refers to any financial interests (monetary value) of the Investigator, their spouse, and dependent children within the past 12 months that reasonably appear to be related to their Institutional Responsibilities, as follows:

1. For all Publicly Traded Entities:

Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship, or any payment) from an Entity exceeding $5,000;
Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity exceeding $5,000; or
The combined value of remaining remuneration and equity from an Entity exceeding $5,000.

2. For all Non-Publicly Traded Entities:

Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship, or any payment) from an Entity exceeding $5,000;
Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity, regardless of value; or
The combined value of remaining remuneration and equity from an Entity exceeding $5,000.

3. Intellectual Property (IP) Rights and Interests:

Intellectual property rights and interests (e.g., patents, copyrights) that generate income.

4. For PHS-Funded Research Investigators Only: Reimbursed or Sponsored Travel:

Travel expenses reimbursed or sponsored by an Entity other than the Investigator’s current institution, related to their Institutional Responsibilities, exceeding $5,000 in aggregate for a single Entity.

Exclusions: SFIs do not include the following financial interests:

Salary, royalties, or other remuneration paid by ADVAITA CORPORATION to the Investigator, if the Investigator is currently employed or appointed by ADVAITA CORPORATION, including intellectual property rights assigned to ADVAITA CORPORATION and royalty-sharing agreements related to such rights.
Income from investment vehicles like mutual funds and retirement accounts, as long as the Investigator does not have direct control over the investment decisions made in these vehicles.
Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by certain government agencies, US Institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with US Institutions of higher education.

Before releasing any funds for research, ADVAITA CORPORATION will assess whether an Investigator’s SFI disclosure is related to the research and, if so, whether it constitutes a Financial Conflict of Interest (FCOI). An Investigator’s SFI is deemed related when the Designated Official reasonably determines that the SFI could be influenced by the research or is held in an Entity whose financial interests could be affected by the research.

An FCOI exists when ADVAITA CORPORATION reasonably determines that the SFI could directly and significantly affect the research’s design, conduct, or reporting. In the event of identifying an FCOI, ADVAITA CORPORATION will manage it as necessary, including the development and implementation of a management plan.

Requirements for Disclosure of Significant Financial Interests (SFI) in Research

Before Application for Funding: All Investigators intending to participate in research must disclose SFIs at the time of application or formal proposal submission, if applicable.
When Executing a Contract with an Entity: Investigators planning to participate in research must disclose SFIs before expending any funds when entering into a contract that does not require an application or proposal.
Upon Discovery or Acquisition of New SFIs: Investigators must submit a disclosure within thirty (30) days of discovering or acquiring any new SFIs, such as through purchase, marriage, or inheritance.
For Active Awards: Investigators participating in research must update their SFI disclosure annually during the award period. This updated disclosure should include any new information not previously disclosed and any updates to previously disclosed SFIs (e.g., updated value of previously disclosed equity interest).

Details Required in SFI Disclosures: Investigators must disclose:

The individuals holding the interest.
The Investigator’s relationship to those individuals.
The name of the Entity with which the Investigator has the SFI.
The nature and approximate monetary value of the SFI.

Disclosure Obligations in Publications or Presentations: Investigators must disclose their financial interests related to any presentation or publication of research results. This includes financial interests in Entities supporting or connected to the research, provision of legal consulting on the research topic, and any other interests that could be material to the audience or readers assessing the work presented.

Training Requirements for PHS-Funded Research Investigators: Investigators engaged in or planning to engage in PHS-Funded Research at ADVAITA CORPORATION must undergo financial conflict of interest training on Investigator responsibilities before starting PHS-Funded Research and at least once every four (4) years while still engaged in PHS-Funded Research. Training is also required in specific circumstances, such as policy revisions, new Investigators joining ADVAITA CORPORATION, or instances of non-compliance.

Review Process for SFI Disclosures: The Designated Official evaluates all disclosures and relevant information to determine whether the Investigator’s SFI is related to the Research and, if so, whether it constitutes a Financial Conflict of Interest (FCOI). The Designated Official recommends a management plan to the CEO for any identified FCOIs.

Notification and Compliance: The Designated Official provides copies of the final determination and management plan to the conflicted Investigator. The Investigator must comply with the imposed management plan, and funding will be withheld until the Investigator agrees to comply.

Management of Financial Conflicts of Interest (FCOIs

When a Financial Conflict of Interest (FCOI) is identified, a management plan will be developed, specifying actions to be taken to address and control the FCOI. Examples of conditions or restrictions that may be imposed to manage an FCOI include, but are not limited to:

Making the FCOI publicly known (e.g., during research presentations or publications).
For research involving human subjects, disclosing the FCOI directly to the human subjects, as approved by the Institutional Review Board.
Appointing an independent monitor with the authority to safeguard the research’s design, conduct, and reporting against bias resulting from the FCOI.
Modifying the research plan or protocol.
Reassigning personnel roles or excluding certain personnel from participating in all or part of the research. • Reducing or eliminating the financial interest (e.g., divesting from equity holdings).
Severing relationships that lead to the FCOI.

Appealing a Management Plan: The Investigator has ten (10) business days from receiving the Designated Official’s final decision to submit a written appeal. The appeal must specify the challenged provisions, reasons for the appeal, and justifications for a different outcome. The Investigator may also propose an alternative management plan and provide supplemental information to support the appeal. After a secondary review, the decision will be considered final and cannot be further appealed.

Monitoring Compliance with the Management Plan: The Designated Official will conduct ongoing audits and monitoring of compliance with the management plan throughout the course of the research.

Consequences of Non-Compliance: Investigators are obligated to adhere to the final decision of the Designated Official and the management plan. Failure to comply may result in corrective action plans developed by the Designated Official in consultation with the CEO. Sanctions for non-compliance may include suspension, denial of eligibility for research participation, or other appropriate penalties. In some cases, professional bodies, journals, or the public may be notified of sanctions.

New SFIs During Ongoing Research: If a new significant financial interest is disclosed during an ongoing research project or if ADVAITA CORPORATION identifies a previously undisclosed interest not reviewed in a timely manner, the Designated Official, in collaboration with the CEO, will:

Determine whether an FCOI exists, and if so, implement a management plan that outlines actions to address the FCOI in accordance with the policy.

Consequences of Unidentified or Mismanaged FCOIs: If an FCOI is not identified or managed in a timely manner, including Investigator’s failure to disclose an SFI that is later deemed an FCOI or ADVAITA CORPORATION’s failure to review or manage the FCOI, ADVAITA CORPORATION will conduct a retrospective review of the Investigator’s activities on the project(s) within 120 days of determining noncompliance. The review will assess whether bias was present in the design, conduct, or reporting of the research during the period of noncompliance. The findings of this review, including key details, methodology used, and conclusions, will be documented.

For PHS-Funded Research: ADVAITA CORPORATION will submit FCOI reports annually to the PHS awarding agency until the project’s completion, detailing actions taken to manage the financial conflict of interest. If the retrospective review indicates bias in the PHS-funded research, ADVAITA CORPORATION will promptly notify the PHS awarding agency and submit a mitigation report, including the retrospective review’s key elements, the impact of the bias on the research, and actions taken to eliminate or mitigate the bias’s effect

PHS-Funded Clinical Research: In the event that the Department of Health and Human Services determines that a PHS-funded Clinical Research project, aimed at assessing the safety or effectiveness of a drug, medical device, or treatment, was designed, conducted, or reported by an Investigator with an FCOI, and the Institution failed to manage or report it as required by policies, ADVAITA CORPORATION will mandate the involved Investigator to disclose the FCOI in all public presentations of the Clinical Research results. Additionally, the Investigator will be required to request an addendum to previously published presentations.

NSF-Sponsored Research:
For NSF-Sponsored Research, if the Designated Official finds that the Institution cannot adequately manage an FCOI, notice will be provided to the NSF Office of General Counsel.

Interim Measures: The Designated Official has the authority to implement interim measures concerning the Investigator’s involvement in affected PHS or NSF-Funded Research at any time.

Maintenance of Records: ADVAITA CORPORATION will retain records related to all Investigator Significant Financial Interest (SFI) disclosures, including the review and response to the disclosures (whether resulting in an FCOI finding or not), and any actions taken under this policy. For Non-PHS-Funded Research, these records will be kept for a minimum of three (3) years. For PHS or NSF-funded Research, the records will be maintained from the date the final expenditures report is submitted to the respective funding agency, or as specified in 45 CFR 74.53(b), 92.42(b), or the National Science Foundation, Grant Policy Manual, Ch. 510, Conflict of Interests Policy (“NSF 510”) regarding records retention.

Accessibility of the Policy:
This policy and all related forms will be made publicly available on ADVAITA CORPORATION’s website.

IV. Responsible Parties:

Compliance with this policy is the responsibility of Investigators. The Designated Official is accountable for overseeing the implementation and adherence to this policy.

V. Defined Terms:

Designated Official: An institutional official designated to solicit and review disclosures of Significant Financial Interests from Investigators. The Designated Official shall be Advaita’s controller, bookkeeper, or any other individual(s) designated in writing by the Institution.

Entity: Any business or legal entity, including corporations (profit or non-profit), partnerships, limited partnerships, joint ventures, voluntary associations, sole proprietorships, or trusts.

Equity Interest: Any form of ownership interest in an Entity, such as owning stock or stock options (vested and unvested), excluding interests from investments like mutual funds and retirement accounts if the Investigator does not directly control investment decisions.

Financial Conflict of Interest (“FCOI”): A Significant Financial Interest that could significantly and directly affect the design, conduct, or reporting of the Research.

Independent Monitor: An individual with expertise in the research area, having no Significant Financial Interest or role in the Research, and not reporting to the conflicted Investigator.

Institutional Responsibilities: An Investigator’s professional duties on behalf of ADVAITA CORPORATION, including but not limited to research, teaching, professional practice, and administration (e.g., service on committees, boards, and panels).

Investigator: The Project director, principal investigator, or any other person, regardless of title or position, responsible for the design, conduct, or reporting of the Research, considering the degree of independence with which the person works. This may include graduate students, post-doctoral fellows, technicians, collaborators, or consultants.

Non-PHS Research: A systematic investigation, study, or experiment aimed at contributing to generalizable knowledge broadly related to public health, including behavioral and social-sciences research. This research is not funded by a PHS awarding component or any other entity or organization that has incorporated the PHS rules regarding FCOIs. The term encompasses educational activities funded or proposed for funding by NSF. Participate: To have responsibility for the design, conduct, or reporting of Research, irrespective of title or position.

PHS-Funded Research: Research funded or proposed to be funded by the Public Health Service of the U.S. Department of Health and Human Services, including the NIH and any components to which the authority may be delegated. This also includes any entity or organization that has incorporated the PHS rules concerning FCOIs. It encompasses research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects, and research resources awards.

Research: A systematic investigation, study, or experiment aimed at developing or contributing to generalizable knowledge broadly related to public health, including behavioral and social sciences research, regardless of funding source. The term includes basic, sponsored, and clinical research, as well as applied research and product development.

Senior/Key Personnel: The project director or principal investigator and any other person identified as senior/key personnel in the grant application, contract proposal, contract, progress report, or any other report submitted to the sponsor for PHS-Funded or Non PHS-Funded Research.

Significant Financial Interest (“SFI”): Any financial interest (i.e., anything of monetary value) consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children), within the previous 12 months, that reasonably appears to be related to the Investigator’s Institutional responsibilities:

1. For all Publicly Traded Entities:

Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship, or any other payment) from an Entity that exceeds $5,000;
Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity that exceeds $5,000; or
Any remaining remuneration and equity from an Entity that, when added together, exceeds $5,000 in value.

2. For all Non-Publicly Traded Entities:

Remuneration (e.g., salary, income, consulting fees, honoraria, paid authorship, or any other payment) from an Entity that exceeds $5,000;
Any equity interest (e.g., stock, stock option, or other ownership interest) in the Entity regardless of value; or
Any remaining remuneration and equity from an Entity that, when added together, exceeds $5,000 in value.

3. Intellectual Property (IP) Right and Interests:

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

4. For PHS-Funded Research Investigators Only: Reimbursed or Sponsored Travel:

Travel reimbursed or sponsored by an Entity other than the Investigator’s current institution (i.e., paid on behalf of the Investigator and not reimbursed to the Investigator, making the exact monetary value not readily available), related to their Institutional Responsibilities, and exceeding $5,000 in value (in aggregate for a single Entity).

Exclusions: The following types of financial interests are not considered SFIs:

Salary, royalties, or other remuneration paid by ADVAITA CORPORATION to the Investigator if the Investigator is currently employed or appointed by ADVAITA CORPORATION. This includes intellectual property rights assigned to ADVAITA CORPORATION and agreements to share in royalties related to such rights.
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels that are sponsored by a federal, state, or local government agency, a United States Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with a United States Institution of higher education.