Conflict of Interest Policy

The following Financial Conflict of Interest Policy (“FCOI Policy”) requirements apply to all Nous Foundation research applications submitted to agencies within the Public Health Service (PHS), such as the National Institutes of Health (NIH). They may also apply to other funders that have adopted the PHS rules.

This FCOI Policy must be met in addition to Nous Foundation’s standard Conflict of Interest Policy (“COI Policy”). As a result, the requirements outlined in this Policy apply to researchers who are planning to conduct, or are conducting, research that is not otherwise prohibited by the COI Policy. Nous Foundation maintains and enforces a general COI Policy that requires its Board members, officers, and key employees to disclose actual, potential, or apparent conflicts of interest so that Nous Foundation can manage, reduce, or eliminate them. This FCOI Policy supplements that general COI Policy for the specific context of PHS-funded Research. A disclosure made under this FCOI Policy does not relieve any person of the separate obligation to disclose under the general COI Policy, and a disclosure under the general COI Policy does not satisfy the disclosure obligations of this FCOI Policy. Where the two policies both apply, the more stringent obligation governs.

This FCOI Policy applies to researchers involved in any research project that is part of a PHS application for funding that has either been submitted by, or awarded to, Nous Foundation. Presented below is a summary of the PHS policies on COI:

I. Definitions

The following definitions apply specifically in the context of this FCOI Policy

Designated Officials. The Designated Officials will be the non-conflicted members of the Nous Foundation Board designated by the Board to serve in that role, as identified on a current roster maintained by the Chief Executive Officer. The roster may be updated by Board action without amending this Policy. If a matter presents a conflict for a Designated Official, that official is recused and the remaining non-conflicted Designated Official(s), or a substitute designated by the Board, will act.

Family. The “Family” of an employee includes his or her spouse or domestic partner, and dependent children.

Financial Conflict of Interest (FCOI). A Significant Financial Interest or Travel (as defined below) that could directly and significantly affect the design, conduct, or reporting of Research (as defined below).

Employment Responsibilities. An Investigator’s professional responsibilities on behalf of Nous Foundation.

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 supported by a grant awarded to Nous Foundation.

Research. A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to the Nous video library, end of life care decision-making, and related topics. The term encompasses basic and applied research (e.g. a published article, book or book chapter) and product development (e.g. creation of a new video). As used in this Policy, the term includes any such activity for which research funding is available from a PHS agency through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, institutional infrastructure award, institutional training grant, program project, or research resources award.

Reviewable Interest. Any Significant Financial Interest (as defined below) belonging to an Investigator or an Investigator’s Family, and any Travel, to the extent that it relates to the Investigators’ Employment Responsibilities.

Senior/Key Personnel. The PD or PI and any other person identified as senior/key personnel by Nous Foundation in the grant application, progress report, or any other report submitted to the PHS by Nous Foundation.

Significant Financial Interest (SFI). A financial interest consisting of one or more of the following interests:

1. With regard to any publicly traded entity, when the value of any remuneration (salary and any payment for services that are not otherwise identified as salary, for example consulting fees, honoraria, paid authorship) received from the entity in the twelve (12) months preceding disclosure of the interest aggregated with the value of any equity in the entity (for example, stock, stock options, or other ownership interests as determined through reference to public prices or other reasonable measure of fair market value) in the entity as of the date of the disclosure exceeds $5,000;

2. With respect to any non-publicly traded entity, when the aggregated value of any remuneration received from the entity in the twelve (12) months preceding disclosure of the interest exceeds $5,000, or any equity in the entity; or

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

Exclusions: The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Travel. Any travel that is reimbursed (i.e., the Investigator is made whole for the financial outlay required) or sponsored (i.e., the costs are paid on behalf of the Investigator such that the exact monetary value may not be readily available) other than by Nous Foundation, a Federal state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

II. Investigator Disclosure to Nous Foundation

All persons covered under this FCOI must disclose the information required herein and by the COI Policy on an annual basis in accordance with the process established. At a minimum and no later than the time of application for funding, Investigators planning to participate in PHS-funded Research are required to disclose all Reviewable Interests (namely, (i) any Significant Financial Interests (SFIs) belonging to the Investigator or the Investigator’s Family, and (ii) any Travel, to the extent the Investigator determines that the Reviewable Interest relates to the Investigators’ Employment Responsibilities). Investigators must update their disclosures annually during the period of the PHS award, as well as within 30 days of discovering or acquiring a new Reviewable Interest.

A. Travel Disclosures [For PHS-funded Research Only]: The following information must be provided in connection with any Travel disclosure in the context of PHS-funded Research:

1. The purpose of the trip;
2. The identity of the sponsor/organizer of the trip;
3. The destination of the trip; and
4. The duration of the trip.

B. Additional Information Requested by Nous Foundation: Investigators must provide in a timely manner any information related to their disclosed Reviewable Interests that Nous Foundation, in its discretion, deems relevant to its review and FCOI assessment.

III. Review by Nous Foundation

Prior to expenditure of any funds under a Research award, a Designated Official must reasonably determine whether any Reviewable Interest disclosed by any Investigator is related to the Research, and if so, whether it can reasonably be determined that the Reviewable Interest constitutes a Financial Conflict of Interest (FCOI); and if a FCOI is determined to exist, how the FCOI will be managed.

A. Relatedness Standard: An Investigator’s Reviewable Interest is related to Research when Nous Foundation reasonably determines that the Reviewable Interest could be affected by the Research; or is in an entity whose financial interest could be affected by the Research. Nous Foundation will be informed by the relevant Investigator in the determination of whether a Reviewable Interest is related to the Research.

B. FCOI Standard: An FCOI exists if Nous Foundation reasonably determines that the Reviewable Interest related to the Research could directly and significantly affect the design, conduct or reporting of the Research.

IV. Management of Identified FCOIs

A. Management Techniques: For any identified FCOI, Nous Foundation, through its Designated Officials and with the advice and counsel of the board of directors, will take appropriate action to manage the conflict in order to reduce the potential for it to compromise the safety or validity of the Research. Research in which an Investigator is found to have an FCOI will not be permitted to proceed until the Investigator has agreed to implement an acceptable management plan.

B. Disclosed Interests That are Not FCOIs: Nous Foundation reserves the right to impose any requirements it sees fit on any disclosed interest, even those that are not prohibited by the COI Policy, do not constitute Reviewable Interests and/or do not constitute an FCOI requiring management in accordance with this policy and/or applicable regulations.

C. Compliance with Management Plans: Investigators have an on-going obligation to adhere to an imposed management plan and failure to do so may be grounds for sanctions under this policy. Nous Foundation will monitor Investigator compliance with an imposed management plan on an ongoing basis until the completion of the Research project.

V. Reporting FCOIs to PHS

A. Content of Report: For all PHS awards, prior to expenditure of any funds under the award, Nous Foundation is required to report to the PHS awarding agency the existence of an FCOI and submit an FCOI report.

B. Timing of Report: Nous Foundation is responsible for submitting FCOI reports to PHS initially (prior to expenditure of funds), annually during the award period, and within 60 days of any subsequently identified FCOI.

VI. Subrecipient or Subcontractor

When proposed Nous Foundation Research is to be funded by PHS and carried out through a subrecipient, Nous Foundation will establish in writing, at the time of proposal submission, whether this Policy, or that of the subrecipient will apply to the subrecipient’s Investigators, as well as the time frames within which the subrecipient must provide any information necessary to ensure that Nous Foundation is able to meet its reporting obligations to the PHS awarding agency. Where Nous Foundation is itself a subrecipient under a pass-through entity it will comply with the FCOI allocation and reporting terms set in the subaward agreement, and will conform this Policy to those terms if they govern. Separately, this Policy does not displace the mandatory-disclosure duty under 2 CFR 200.113: any person who becomes aware of credible evidence of a violation of federal criminal law involving fraud, conflict of interest, bribery, or gratuity, or of the civil False Claims Act, in connection with a federal award, must promptly report it so that Nous Foundation can make any required written disclosure to the federal awarding agency, its Office of Inspector General, and the pass-through entity.

VII. Public Accessibility [For PHS-funded Research only]

For PHS-funded Research, Nous Foundation will ensure public accessibility of information concerning the FCOIs currently held by senior personnel subject to this Policy. Because Nous Foundation maintains a publicly accessible website, it will post this Policy on that website, consistent with 42 CFR 50.604(a). If Nous Foundation does not have a current presence on a publicly accessible website, it will make this Policy available to any requestor within five business days of a request, and if it acquires such a presence during a PHS award it will post the Policy within 30 calendar days. In addition, and separate from posting the Policy, Unless and until Nous Foundation determines otherwise, it will, upon receipt of a complete written request for information in accordance with the process and requirements outlined in section XIII, provide a written response within five (5) business days regarding any SFI disclosed and still held by the senior personnel that has been determined to relate to the PHS- funded research and constitute an FCOI pursuant to this policy.

VIII. New Interests that Arise During an On-Going Research Project

To the extent a new Reviewable Interest is disclosed to Nous Foundation in the course of an on-going Research project (i.e., an Investigator who is new to participating in the Research discloses a Reviewable Interest or an existing Investigator discloses a new Reviewable Interest), or Nous Foundation identifies a Reviewable Interest that was not previously reviewed in a timely manner by Nous Foundation in accordance with this policy, Nous Foundation will, within 60 days from the date of the disclosure: (i) determine if the Reviewable Interest relates to the Investigator’s Research; (ii) if it relates, determine if it qualifies as an FCOI; and (iii) if it is an FCOI, implement on at least an interim basis a management plan in accordance with this policy. Nous Foundation may, depending on the circumstances of the SFI, conclude that additional interim measures are necessary with regard to the Investigator’s participation in the Research between the date of disclosure or identification and the completion of review (including, where warranted for PHS-funded Research, a retrospective review as discussed below).

IX. Retrospective Review, Identification of Bias and Mitigation Reporting of PHS-Funded Research

A. Retrospective Review: In the event of failure to meet PHS regulations, including failure by the Investigator to disclose timely a Reviewable Interest that is determined to constitute an FCOI; Nous Foundation’s failure to review or manage such an FCOI; or Investigator failure to comply with an FCOI management plan, Nous Foundation will, within 120 days of its determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS- funded Research project to determine any bias in the design, conduct or reporting of Research during the time period of the noncompliance. Nous Foundation will document the retrospective review in accordance with its policies and procedures and applicable PHS regulations.

B. Mitigation. If bias is found during the retrospective review, Nous Foundation will notify the PHS awarding agency promptly, if applicable, develop and implement a mitigation plan, and submit the PHS required mitigation report, which will include at least the elements documented in the retrospective review and a description of the impact of the bias on the Research project and Nous Foundation’s plan of action or actions taken to eliminate or mitigate the effect of the bias. Any FCOI report submitted to the PHS awarding agency with respect to such Research will be updated as necessary in light of the results of the retrospective review.

C. Disclosure for PHS-Funded Drug/Device Research: In any case in which the Department of Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by Nous Foundation, the Investigator will be required to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

X. Training [For PHS-funded Research only]

For PHS-funded Research, Investigators must complete all required conflicts of interest training prior to engaging in Research at or under the auspices of Nous Foundation, and at least every four years following the initial training. Additionally, Investigators will be required to receive training immediately in any of the following circumstances:

• Nous Foundation revises its policy or procedures governing FCOI in PHS-funded Research in any manner that affects the requirements applicable to Investigators;
• An Investigator is new to Nous Foundation;
• Nous Foundation finds that an Investigator is not in compliance with this policy or an imposed management plan.

XI. Record Retention

Nous Foundation will retain documentation related to its FCOI review and management process to the extent required by law and any other applicable Nous Foundation record retention policies, but in no case will records be maintained for less than three years from the date of submission of the final financial report under the award, or from other dates specified in the applicable record-retention rule (45 CFR 75.361; 2 CFR 200.334), whichever is later.

XII. Noncompliance and Sanctions

In the event an Investigator fails to comply with this policy or an FCOI management plan imposed hereunder, Nous Foundation may impose a wide variety of sanctions, including but not limited to restricting or conditioning the Investigator’s ability to apply for grants through Nous Foundation. Additionally, if the failure of an Investigator to comply with this policy or an FCOI management plan appears to have biased the design, conduct or reporting of the PHS Research, Nous Foundation shall promptly notify the funder of the corrective action taken or to be taken.

Subcontractor and Consultant Flow-Down Clauses

This section applies only to a subcontractor or consultant who is responsible for the design, conduct, or reporting of the Research and therefore meets the definition of an Investigator. Vendors that provide production or technology services to Nous Foundation’s specification (for example, a video production studio or a platform developer) are not Investigators and are not subject to this Policy. Where a subcontractor or consultant does meet the Investigator definition, the subcontract or consulting agreement must include the following clause.

Subcontractor agrees to comply with 42 CFR Part 50, Subpart F. Subcontractor certifies that it maintains a written FCOI policy that complies with those requirements, or, if it does not, agrees that its Investigators are subject to Nous Foundation’s FCOI Policy. Subcontractor shall report each identified financial conflict of interest to Nous Foundation in time for Nous Foundation to meet its reporting obligations, and shall include an equivalent clause in any lower-tier agreement with a person who meets the definition of an Investigator. Failure to comply is a material breach of this Agreement.

XIII. Public Accessibility Process

The Public Health Service requires that award recipients provide public access to certain information regarding financial conflicts of interest held by senior personnel on research projects funded by the Public Health Service. Nous Foundation will make available the following information:

• Name of senior personnel with the financial conflict of interest;
• The individual’s title and role in the research project;
• The name of the entity in which the financial interest is held;
• The nature of the financial interest;
• The approximate value of the financial interest (by ranges).

When the value of a financial interest is reported by range, Nous Foundation will use the following bands, consistent with 42 CFR 50.605(b)(4): $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; and amounts above $100,000 by increments of $50,000. Where the value of an interest cannot readily be determined through reference to public prices or other reasonable measures of fair market value, Nous Foundation will so state in place of a range. Where Nous Foundation posts this information on its publicly accessible website, the posting will note the date as of which the information is current, will be updated at least annually and within 60 days of a newly identified financial conflict of interest, and will remain available for at least three years from the date the information was most recently updated.

How to make a request:

Please fill out the “Request for Information on Identified Financial Conflicts of Interest (FCOIs) in Public Health Service-Funded Research Form.” Completed forms must be sent to:

Aretha Delight Davis, M.D., J.D.
Chief Executive Officer
Nous Foundation
[Address]

Please note that this is the exclusive procedure for obtaining this information from Nous Foundation. As required by the regulations, information will be provided within five (5) business days of receipt of the written request.

Request for Information on Identified Financial Conflicts of Interest (FCOIs) in Public Health Service-Funded Research Form

In compliance with the Public Health Service (PHS) regulation on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F), members of the public may request information about Financial Conflicts of Interest (FCOIs) associated with principal investigators and senior personnel on Public Health Service-supported projects at Nous Foundation.

Nous Foundation will send out the following information within 5 business days of the receipt of a complete request:

• Name of senior personnel with the financial conflict of interest;
• The individual’s title and role in the research project;
• The name of the entity in which the financial interest is held;
• The nature of the financial interest;
• The approximate value of the financial interest (by ranges).

All requests must be submitted by completing this form. Completed forms must be mailed to:

Aretha Delight Davis, M.D., J.D.
Chief Executive Officer
Nous Foundation
[Address]

Information about the requestor:

• Name:
• Affiliation:
• Email Address:
• Street Address:
• Phone number:

Information about the request:

• NIH Award Number:
• Name of Investigator:
• Reason for Request:
• Signature:
• Date:

Date: 6/30/26