Financial Conflict of Interest Policy

Briteseed, LLC (“Briteseed”) encourages employees to participate in research activities with the highest ethical standards. We must identify and manage situations in which financial or other personal interests could bias or compromise – or have the appearance of biasing or compromising – objectivity or judgment relative to research. Employees involved in outside consulting or business activities must separate their Briteseed and external obligations to avoid concerns about appropriate use of the company’s resources and contributions by other Briteseed personnel. Each employee must be open about their involvement with and obligations to outside parties.

This Financial Conflict of Interests (FCOI) policy complies with the Federal Public Health Service (PHS) guidelines regarding the Advancement of Neutrality in Research, as found in 42 CFR Part 50 Subpart F and 45 CFR Part 94 and applies to all research endeavors supported by PHS grants, cooperative agreements, and research contracts (excluding Phase I Small Business Innovation or Phase I Small Business Technology Transfer Research Programs).

DEFINITIONS

Financial Conflict of Interest (FCOI): A substantial financial interest that has the potential to directly and significantly influence the planning, execution, or communication of research or other government funded project.

Significant Financial Interest (SFI):

(1) A financial interest consisting of one or more of the following interests of the Investigator (as well as their spouse and dependent children) that reasonably appears to be related to the Investigator’s Responsibilities on behalf of Briteseed:

the value of any remuneration received from a public entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
the value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); OR
intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income exceeding $5,000 related to such rights and interests.

(2) A significant financial interest does not include the following: (i) Salary, royalties, or other remuneration paid by Briteseed to the Investigator if the Investigator is currently employed or otherwise appointed by Briteseed, including intellectual property rights assigned to Briteseed and agreements to share in royalties related to such rights; (ii) 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; (iii) Income from seminars, lectures, or teaching engagements sponsored by 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, or a research institute that is affiliated with a United States institution of higher education; and (iv) Income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.

(3) Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities if the value of the travel received from a public entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000. The disclosure will include, at a minimum, the following details: (i) the purpose of the trip; (ii) the identity of the sponsor/organizer; (iii) the destination; and (iv) the trip duration. This disclosure requirement does not apply to travel that is reimbursed or sponsored by 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, or a research institute that is affiliated with a United States Institution of higher education.

Public Health Service (PHS): A division of the Department of Health and Human Services, consisting of the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).

Investigator: The Project Director (PD) or Principal Investigator (PI) and any other person, regardless of title or position, who is deemed by the PD/PI to be accountable for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Foreign Financial Interests: Investigators are obligated to reveal all financial interests of foreign origin, which includes earnings from seminars, lectures, teaching engagements, service on advisory committees or review panels, and sponsored or reimbursed travel. This applies to financial interests received from foreign entities, including foreign institutions of higher education or foreign governments (encompassing local, provincial, or similar governments of other nations). Such disclosure is necessary when the income surpasses the threshold for reporting, such as income exceeding $5,000.

Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Briteseed, which may include, but are not limited to research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

DISCLOSURE OF FINANCIAL INTERESTS

All Investigators associated with Briteseed research are required to disclose their Significant Financial Interests (SFIs) to a Briteseed designated official before the submission of an application for funding to the NIH Grantee. Any new Investigator who intends to join the project after the application's submission to NIH or during the project's execution must promptly and before their involvement, disclose their SFIs to the designated official.

For the duration of the NIH award, each Investigator participating in research is obligated to provide an updated disclosure of their SFIs at least annually. This updated disclosure should encompass any information that wasn't initially reported to Briteseed according to this Policy or in subsequent disclosures of SFIs. This includes details about any FCOIs identified in a NIH-funded project, either directly as a NIH Grantee or indirectly through a subaward. Additionally, the updated information should include any changes in previously disclosed SFIs, such as updates to the value of equity interests that were previously reported.

In cases where an Investigator is involved in research under an NIH award, any new SFIs, including those related to reimbursed travel, need to be reported within thirty (30) days of their discovery or acquisition. This includes instances such as obtaining new financial interests through means like purchase, marriage, or inheritance.

REVIEW

The designated official at Briteseed will conduct reviews of disclosures. The designated official will review any SFI that has been identified in a disclosure; these interests will be compared to each research award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the award and, if so, whether the SFI creates a FCOI related to that research award.

GUIDELINES FOR DETERMINING FCOI

Briteseed’s designated official will determine whether an Investigator’s SFI is related to the research under a NIH award and, if so, whether the SFI is a financial conflict of interest. An Investigator’s SFI is related to the research under the NIH award when the designated official reasonably determines that the SFI could be affected by the research conducted under the award or is in an entity whose financial interest could be affected by the research. The designated official may involve the Investigator in the determination of whether an SFI is related to the research supported by the award. A FCOI exists when the designated official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

In determining if an Investigator’s SFI is related to the research under a NIH award, and if so, whether the relationship creates a FCOI, the designated official considers the role of the Investigator and the opportunity (if any), to bias the results, the nature of the research being proposed, and the value of the SFI in relation to the size and value of the entity. In addition, the designated official may also consider the following factors:

Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes; or
Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely; or
Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention); or
Where the research involves human subjects, whether there are double blind conditions or the involvement of a data and safety monitoring board; or
Where the SFI is in a privately held company, whether the researcher’s SFI could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and STTRs); or
The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or
Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser’s technology, the amount of commercialization payments received by the Investigator from that technology, both currently or in the future; or
The number and nature of relationships an Investigator has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts; or
Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the SFI; or
Whether other scientific groups are independently pursuing similar questions; or
Whether sufficient external review of the research conducted and the reporting of research results exist to mitigate undue bias; or
Whether the goal of the project is a comparative evaluation of a technology in which an Investigator has an SFI; or
Whether the project involves a subaward to an entity in which the Investigator has an SFI.

MANAGEMENT OF FCOI INVOLVING SFIs

If Briteseed determines that an SFI constitutes a FCOI, a Conflict Management Plan (“CMP”) will be established and monitored to avoid or manage the conflict in a way that minimizes undue bias. The designated official will refer to the principles outlined in this FCOI Policy and assess appropriate strategies to address the situation.

These strategies might include the recusal from decisions related to the conflicting entity, abstaining from external activities that could lead to conflicts, adapting the nature of the activities, or creating a subcommittee to implement oversight.

Should a conflict be identified by the designated official, it will convey its determination and the devised methods for resolving or mitigating the conflict in written form to the concerned individual, the relevant PD/PI, and the appropriate immediate supervisor. The designated official will maintain records of the disclosure and pertinent details for a minimum of three years. If monitoring is prescribed for the activity, the designated official will outline the specific monitoring procedures and required record-keeping.

Expenditures on an NIH award will only be authorized once the Investigator complies with the Policy's Disclosure requirements and commits in writing to adhere to any necessary Conflict of Interest management plans determined by the designated official. The designated official will inform the NIH Grantee in writing about the presence and nature of a Financial Conflict of Interest, as well as the steps taken to address it. No expenditures can occur until the FCOI is reported to NIH by the Grantee, who will also inform Briteseed when expenses can be incurred.

The designated official will maintain records of Investigator disclosures, their review, and responses to such disclosures, along with all actions taken under this policy. These records will be kept for at least three years from the date of submitting the final expenditures report or, if applicable, in accordance with specified dates outlined in 45 C.F.R. 75.361 for different scenarios.

Measures for FCOI management include:

Public disclosure in presentations and publications
Notifying participants in human subjects research
Appointing an independent monitor
Adjusting the research plan
Changing personnel roles or disqualifying involvement
Reducing or eliminating financial interests
Severing relationships causing conflicts
Establishing a data and safety monitoring board for human subjects research
Implementing double-blind conditions
Conducting work at multiple sites
Explicitly disclosing the conflict to team members
Providing annual progress reports to officials
Disclosing FCOIs in presentations

PUBLIC ACCESS TO FCOI INFORMATION

Before disbursing any funds from an NIH award, Briteseed will ensure public accessibility of information by responding in writing to any request within five business days. This information will pertain to disclosed SFIs that meet these three criteria:

(i) The SFI is currently held by senior/key personnel, including the PD/PI and others identified as senior key personnel in award documents submitted to the NIH Grantee.
(ii) Briteseed confirms the SFI's relevance to the funded research.
(iii) Briteseed determines the SFI qualifies as a financial conflict of interest.

The information provided via a publicly accessible website or written response within five days will minimally include: (i) Investigator's name. (ii) Investigator's role in the research project. (iii) Name of the entity with the SFI. (iv) Nature of the SFI. (v) Approximate dollar value of the SFI in predefined ranges or a note if its value can't be readily determined.

If a publicly accessible website is used for disclosure, the posted information will be updated annually and within sixty days of receiving new SFI details that haven't been previously disclosed. Information on an individual's SFI, as per policy limitations, will be available for a minimum of three years from the most recent update date, accessible through written requests or posted on Briteseed’s public website.

REPORTING OF FCOIs

Before utilizing funds from an NIH-funded award, Briteseed will submit a FCOI report to NIH, adhering to NIH regulations. This report will detail any Investigator's identified SFI Interest that poses a conflict, along with confirmation of the Investigator's commitment to and execution of the corresponding management plan.

Throughout the duration of the award, including any extensions, Briteseed will submit an annual FCOI report to NIH, outlining the FCOI's status and any changes to the management plan.

In situations where an SFI conflicting with the research emerges after the initial FCOI report during an ongoing NIH-funded project (such as when a new Investigator joins), Briteseed will furnish an FCOI report to NIH within 60 days. This report will address the financial conflict of interest, confirm the implementation of a management plan, and ensure the Investigator's agreement with the relevant plan.

TRAINING REQUIREMENTS 

Investigators must complete training regarding this policy and the applicable regulations at the following times: (i) upon becoming an Investigator for Briteseed; (ii) before engaging in research related to any Government funded award; (iii) when this policy is revised to alter the responsibilities of an Investigator; (iv) and at least every four years. Additionally, if an Investigator is found to be non-compliant with this Policy or a management plan issued under it, training within 30 days of such a finding is required as directed by the designated official.

For training fulfillment, Briteseed mandates its investigators to complete the National Institutes of Health's Financial Conflict of Interest tutorial accessible at:

http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

This training aligns with the stipulations and expectations of this Policy. Upon completion, all investigators are required to print a certification of completion, which should be retained for audit purposes.

NON-COMPLIANCE

Whenever a FFCOI is not identified or managed in a timely manner, including:

Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
Failure by the Institution to review or manage such a Financial Conflict of Interest; or
Failure by the Investigator to comply with a Financial Conflict of Interest management plan;

the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.

Documentation of the retrospective review shall include all information required based on 42 CFR 50.605d.

The designated official will update any previously submitted report to the PHS relating to the research, specifying the actions that will be taken to manage the FCOI going forward. Briteseed will promptly notify the PHS Awarding Component and submit a mitigation report in accordance with the Award agreement. The mitigation report will identify elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.

Expenditures of funds for an NIH-supported award will only proceed if the Investigator has fulfilled the Policy's Disclosure prerequisites and has provided written consent to adhere to an approved FCOI management plan authorized by the designated official.

SUBRECIPIENT COMPLIANCE WITH FCOI

A subrecipient relationship occurs when federal funds are channeled from or through Briteseed to another entity that plays a substantial role in a PHS-funded research project and is accountable to Briteseed for program outcomes and compliance. Subrecipients, including collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, must adhere to Briteseed's terms and conditions. Consequently, Briteseed will ensure reasonable measures to confirm subrecipient Investigators' compliance with federal FCOI regulations.

Within a written agreement, Briteseed will incorporate terms that outline whether Briteseed’s FCOI Policy or the subrecipient's institution's policy applies to the subrecipient Investigator.

If the subrecipient's policy applies:

the subrecipient institution will certify its compliance with federal FCOI regulations and its alignment with the policy. If certification cannot be provided, the agreement will state the subrecipient Investigator's adherence to Briteseed’s FCOI Policy for disclosing relevant SFI.
Briteseed will report FCOIs, if applicable, for subrecipient Investigators to NIH through the eRA Commons FCOI Module.
The agreement will specify a reporting period for the subrecipient to disclose identified FCOIs to Briteseed. This timeframe must allow timely FCOI reporting to NIH through the eRA Commons FCOI Module.

For subrecipient Investigators subject to Briteseed’s FCOI Policy:

The agreement will outline a reporting window for the subrecipient to submit all Investigator SFI disclosures to Briteseed. This period will ensure Briteseed compliance with review, management, and reporting obligations under the regulation.
Briteseed will report NIH FCOI findings for subrecipient Investigators via the eRA Commons FCOI Module.

MAINTENANCE OF RECORDS

Records of financial disclosures and any resulting action will be maintained by the Institution for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 75.361 for different situations. Briteseed will retain records for each competitive segment as provided in the regulation.

POINT OF CONTACT

Jonathan Gunn 

Chief Executive Officer 

Briteseed, LLC 

4660 N Ravenswood Ave 

Chicago, IL 60640

 Phone: ‭(773) 907-9500‬

Email: info@briteseed.com