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 applicable regulations are the 2011 version of 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research,” which set requirements for promoting objectivity in Public Health Service (PHS)-funded research for grants and cooperative agreements. This policy and the underlying regulation 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 per 42 CFR Part 50 Subpart F and NIH’s guidance. Family Room, LLC (“Family Room, LLC,” “the Company”) adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research conducted by or through Family Room, LLC. It establishes processes to identify, disclose, and manage Investigator financial conflicts of interest to protect research integrity, ensure the safety of human subjects, and maintain public trust in PHS/NIH-supported research.

2) Applicability

This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the NIH. This policy applies to all 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 conducted by or through Family Room, LLC.

3) Definitions

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

Financial Conflict of Interest (FCOI)

A significant financial interest that the Designated Official (or Independent Reviewer, as applicable) determines is related to the PHS/NIH-funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest

Anything of monetary value, whether or not its value is readily ascertainable.

Institutional Responsibilities

An Investigator’s professional responsibilities on behalf of Family Room, LLC, specifically including: (1) design, conduct, and reporting of PHS/NIH-funded research conducted by or through Family Room, LLC; (2) research consultation and collaboration with subrecipients, academic medical centers, and other project partners; (3) development, testing, and validation of Family Room, LLC’s digital health platform and related technologies; (4) clinical implementation and deployment activities carried out in partnership with health system collaborators; (5) publication, presentation, and other public communication of research results arising from Family Room, LLC-sponsored or PHS/NIH-funded research; and (6) service on Family Room, LLC’s or Family Room Studios, LLC’s governance bodies (e.g., the Board of Managers) or on research oversight panels such as Institutional Review Boards or Data and Safety Monitoring Boards, where an Investigator is appointed to such a role.

Designated Official (DO)

The individual appointed by Family Room, LLC 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. See Section 5 regarding circumstances in which Family Room, LLC will seek an Independent Reviewer.

Institution

Any public or private organization, domestic or foreign (excluding a federal agency), that is applying for or receives PHS/NIH research funding, including Family Room, LLC and its subrecipients.

Investigator

The Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH or proposed for such funding, which may include, for example, collaborators or consultants. Family Room, LLC determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research, considering the individual’s role (rather than title) and degree of independence in carrying out the work.

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, and product development (e.g., the Familyroom.health digital platform).

PHS-Funded Research

Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract.

PHS / NIH

The Public Health Service of the U.S. Department of Health and Human Services and its components, including the National Institutes of Health, which 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 Family Room, LLC in a grant application, progress report, or other submission to PHS/NIH. This term applies specifically to the public accessibility requirement 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 and dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities:

• Publicly Traded Entities: Remuneration received in the 12 months preceding disclosure, and the value of any equity interest as of the date of disclosure, which, when aggregated, exceeds $5,000. For purposes of this definition, remuneration may include salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
• Non-Publicly Traded Entities: Remuneration received in the 12 months preceding disclosure that, when aggregated, exceeds $5,000, OR any equity interest (e.g., membership interest, stock options) regardless of value.
• Intellectual Property: Income greater than $5,000 in the 12 months preceding disclosure related to IP rights and interests (e.g., patents, copyrights, licenses), including royalties and agreements to share royalties related to licensed IP rights.
• Travel: Reimbursed or sponsored travel related to Institutional Responsibilities in excess of $5,000 in the previous 12 months, paid on behalf of the Investigator rather than reimbursed directly. Disclosure must include the purpose, sponsor, destination, and duration of each trip. This does not apply to travel reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or an affiliated research institute.

The term “significant financial interest” does not include, and Investigators are therefore not required to disclose:

• Salary, royalties, or other remuneration paid by Family Room, LLC or Family Room Studios, LLC to the Investigator if the Investigator is currently employed or otherwise appointed by those entities, including intellectual property rights assigned to Family Room, LLC and any agreements to share royalties related to those rights.
• Any equity interest in Family Room, LLC or Family Room Studios, LLC, since both are for-profit organizations and the Investigator’s interest arises from that employment or ownership relationship.
• Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions.
• Income from seminars, lectures, or teaching engagements, or from service on advisory committees or review panels, sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or an affiliated research institute.

Exclusions Related to Foreign Financial Interests: Investigators must disclose all foreign financial interests (including foreign seminars/lectures, advisory panel service, and reimbursed or sponsored travel) received from any foreign entity, including foreign institutions of higher education or a foreign government, when such income meets the $5,000 disclosure threshold.

4) Significant Financial Interest (SFI) Disclosure Requirements

Investigators will disclose their SFIs that are related to their Institutional Responsibilities, as defined above. Disclosure is not limited to an Investigator’s research responsibilities or funded research, consistent with the 2011 regulation. All Investigator SFI Disclosures will be retained by Family Room, LLC as part of the record maintenance requirements in Section 15.

Investigators are required to disclose SFIs at the following times, using the Institutional Disclosure Form:

• A. At the time of application: The PI and all other individuals meeting the definition of “Investigator” must disclose their SFIs to the DO before the application is submitted. Any new Investigator joining the project after submission, or during the course of the research, must disclose SFIs promptly and before participating in the project.
• B. Annual disclosure during the award: Each Investigator must submit an updated SFI disclosure at least annually, on or before the original NOA issue date of each year of the award (aligned with the start of each new budget period), during the award period. The annual disclosure must include: (1) any new information not previously disclosed, including SFIs associated with NIH-funded projects transferred from another institution; and (2) updated details for any previously disclosed SFI, such as a change in the value of an equity interest.
• C. Ad hoc basis during the award: Each Investigator must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, inheritance, or change in employment). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

For each PHS-funded project, the Principal Investigator and the Designated Official will maintain a current roster of all covered Investigators, established at the start of the project and updated as personnel are added, removed, or their roles change.

5) Review of SFI Disclosures

Family Room, LLC designates its Chief Executive Officer as the Designated Official (DO) responsible for reviewing SFI disclosures and making FCOI determinations, including her own disclosures and those of closely affiliated parties, consistent with the discretion afforded institutions under 42 CFR 50.604(f). The DO is authorized to review and determine all SFI disclosures under this policy, including her own.

Where the DO determines that additional independence is warranted for a particular disclosure, Family Room, LLC will seek out and designate an Independent Reviewer — an individual with no financial interest in Family Room, LLC, Family Room Studios, LLC, or the outcomes of the research — to review that disclosure, make the FCOI determination, and approve or modify any related management plan. The basis for seeking an Independent Reviewer and the identity of the reviewer will be documented in Family Room, LLC’s FCOI records.

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.

• A. Prior to issuance of a new award or before any expenditure of funds (e.g., Just-in-Time stage): The DO (or Independent Reviewer, as applicable) 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.
• B. Annual SFI disclosure: As part of the annual disclosure process, Investigators must provide updated information on previously disclosed SFIs. The reviewer will determine whether changes to an existing management plan are needed, with modifications reflected in the next Annual FCOI report, if applicable.
• C. Ad hoc basis during the award period: If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI, the reviewer will, within 60 days: (1) review the disclosure; (2) determine whether the SFI is related to the PHS/NIH-funded research; (3) determine whether an FCOI exists; and, if so, (4) 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 (or Independent Reviewer, as applicable) 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 (“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 (or Independent Reviewer, as applicable) will determine and implement management strategies to ensure the research is conducted objectively. Examples of management conditions include, but are not limited to:

1. Public disclosure of the FCOI (e.g., in publications or presentations, to study personnel, to the IRB or Data Safety Monitoring Board).
2. For human subjects research, disclosure of the FCOI to participants in the informed consent document.
3. Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research.
4. Modification of the research plan.
5. Change of personnel roles or removal from portions of the research.
6. Reduction or elimination of the financial interest (e.g., divesting equity).
7. Severance of relationships that create financial conflicts.

The DO (or Independent Reviewer, as applicable) will communicate the determination and the management plan in writing to the Investigator and will require the Investigator to certify compliance with the management plan. No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DO will submit an FCOI report to NIH via the eRA Commons FCOI Module.

8) Monitoring Investigator Compliance

Family Room, LLC will monitor Investigator compliance with each management plan for the duration of the NIH award.

Where this policy applies to subrecipient Investigators, Family Room, LLC will monitor subrecipient Investigator compliance with the management plan (see Section 14).

As part of this monitoring process, the DO or Independent Reviewer may request and review documentation demonstrating compliance with required FCOI disclosures, including publications, presentation materials, abstracts, posters, and written communications to study personnel. Investigators must provide copies of such materials, including relevant emails or other written disclosures, for recordkeeping. These records will be maintained to document compliance with the management plan and to support institutional review and audit activities.

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

FCOI Policy: Family Room, LLC will post this FCOI policy on its publicly accessible website (familyroom.health) prior to the expenditure of any grant funds and will maintain it there for the duration of the award. The policy must also be submitted as a PDF by the institutional Signing Official to NIH via the eRA Commons Institution Profile (IPF) Module, Policy Documents tab, per NIH Guide Notice NOT-OD-21-002 and NIH GPS Section 4.1.10. This submission is institution-level and does not need to be repeated with each grant application, but the policy must be kept current.

Identified FCOIs held by Senior/Key Personnel: Before any funds are spent under an NIH award, Family Room, LLC 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, is still held by Senior/Key Personnel (the PD/PI and any other individual identified by Family Room, LLC as senior/key personnel in the application, progress report, or other NIH submission).
• Family Room, LLC has determined that the SFI is related to the NIH-funded research.
• Family Room, LLC has determined that the SFI constitutes an FCOI.

When applicable, Family Room, LLC 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 Family Room, LLC’s identification of a new FCOI, which should be requested subsequently by the requestor.

If Family Room, LLC 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, Family Room, LLC will submit an identified FCOI report to NIH, in accordance with the FCOI regulations, for any Investigator’s SFI determined to be an FCOI. Family Room, LLC will also ensure that the Investigator has agreed to and begun implementing the associated management plan.

Family Room, LLC 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 (i.e., no award means no FCOI report, and no FCOI means no FCOI report).

The NIH eRA Commons FCOI Module User Guide, available at the following location, provides instructions for preparing and submitting FCOI reports: https://www.era.nih.gov/files/fcoi_user_guide.pdf

Family Room, LLC will submit the following types of reports as explained below:

A. Initial (Original) FCOI Reports: The report must include all information required under 42 CFR 50.605(b)(3). When an FCOI is identified, the Original Report will be submitted as described below:

• 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 of identifying a new FCOI during the award: If an FCOI is identified during the award period (e.g., a new SFI is disclosed or a new Investigator joins the project), Family Room, LLC must submit an Original FCOI report within 60 days of identifying the FCOI.

B. Annual FCOI Reports: For the duration of an award, including any extensions with or without funds, Family Room, LLC 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 Family Room, LLC by email when an annual report is due.
• Annual FCOI reports are not required at grant closeout.

C. Revision (or Mitigation) FCOI Reports: After completing a retrospective review (Section 12), Family Room, LLC 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

Required FCOI Reports to NIH via eRA Commons FCOI Module

Investigator management plans will be retained in Family Room, LLC’s records and will not be submitted to NIH, consistent with NIH guidance.

11) Training Requirements for Investigators

Each Investigator will be informed of this FCOI Policy and trained on the responsibility to disclose foreign and domestic SFIs under this policy and 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:

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

To supplement the regulatory training requirements, Family Room, LLC will utilize NIH’s training programs to train Investigators on the FCOI regulation. Family Room, LLC requires Investigators to complete either:

• The NIH Training module at grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training and print and retain the Completion Certificate for audit purposes. The certificate should be shared with the DO; OR
• Review the NIH Virtual Seminar presentation on FCOI compliance from the following location: https://www.youtube.com/watch?v=D292YZ6BX24. Send the DO the date of completion through email for audit purposes.

12) Noncompliance With FCOI Policy and Corrective Actions

If Family Room, LLC identifies an SFI that was not disclosed, reviewed, or managed in a timely manner, the DO (or Independent Reviewer, as applicable) 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. Family Room, LLC will also submit an FCOI report to NIH via the eRA Commons FCOI Module.

In addition, whenever an FCOI is not identified or managed in a timely manner, including:

• Failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI;
• Failure by Family Room, LLC to review or manage an FCOI; or
• Failure by the Investigator to comply with an established management plan;

Family Room, LLC will, within 120 days of identifying noncompliance:

1. Complete a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether the research, or any part of it, was biased in the design, conduct, or reporting.
2. Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or as described in NIH’s FAQ I.2. Based on the results of the retrospective review, if appropriate, Family Room, LLC shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward.

If bias is found, Family Room, LLC will promptly notify NIH and submit a Mitigation Report as required by 42 CFR 50.605(a)(3)(iii) or as described in NIH’s FAQ I.3. 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.

Family Room, LLC 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, Family Room, LLC 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, Family Room, LLC 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 previously submitted report information (e.g., an increase in the value of the SFI or newly identified SFIs) following completion of the retrospective review.

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/NIH-funded research, Family Room, LLC 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 Family Room, LLC for further action, which may include directions on how to maintain appropriate objectivity in the PHS/NIH-funded research project.

13) Clinical Research Requirements

If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, digital health intervention, or treatment (including the Familyroom.health platform) was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, Family Room, LLC 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 Family Room, LLC to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to Family Room, LLC for programmatic outcomes and compliance.

Subrecipients (e.g., collaborators or consortium members) are subject to Family Room, LLC’s terms and conditions. Family Room, LLC will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. Family Room, LLC will include in each written agreement with a subrecipient terms specifying whether Family Room, LLC’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators (see NIH Grants Policy Statement Section 15.2.1, Written Agreement).

• 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 Family Room, LLC in time for Family Room, LLC to meet NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI). For its subaward with the University of Nebraska Medical Center (UNMC), which maintains its own institutional FCOI policy reviewed and enforced by the UNMC Conflict of Interest Committee (COIC), Family Room, LLC requires UNMC to report identified FCOIs no later than 45 days after identification and prior to the expenditure of funds. Family Room, LLC’s DO 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 Family Room, LLC’s FCOI Policy applies. In this case, subrecipient Investigators must disclose their SFIs to Family Room, LLC. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for Family Room, LLC. The agreement will allow sufficient time for Family Room, LLC to review, manage, and report any resulting FCOIs. When an FCOI is identified, Family Room, LLC 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.

Regardless of which FCOI policy applies to subrecipient Investigators, Family Room, LLC remains responsible for providing FCOI reports to NIH for all identified FCOIs, including those of its subrecipient Investigators, and will take such actions as necessary to monitor subrecipient Investigator compliance with applicable management plans until completion of the project.

15) Maintenance of Records

Family Room, LLC will maintain records of all Investigator financial interest disclosures, Family Room, LLC’s review and response to those disclosures (whether or not they resulted in an FCOI determination), 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 different situations. Family Room, LLC will retain these records for each competitive segment as required by regulation. Investigator management plans will be retained in Family Room, LLC’s records and will not be submitted to NIH, consistent with NIH guidance.

16) Enforcement Actions for Investigator Noncompliance and Remedies for Noncompliance

Family Room, LLC will establish enforcement mechanisms and administrative actions as appropriate to ensure Investigator compliance with this policy. Failure to comply with this policy, including failure to disclose Significant Financial Interests, failure to comply with an FCOI management plan, or failure to complete required training, may result in corrective or administrative action determined by Family Room, LLC in its discretion, up to and including restriction from participation in the research project.

Family Room, LLC will take actions required under applicable federal regulations and sponsor requirements, including conducting retrospective review and notifying the sponsor when required.

In addition, the PHS/NIH Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and the Institution’s review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of an FCOI. The Institution will submit or permit on-site review of all records pertinent to compliance with the regulation and this policy. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS/NIH Awarding Component may decide that a particular FCOI will bias the objectivity of the PHS/NIH-funded research to such an extent that further corrective action is needed or that the Institution has not managed the FCOI in accordance with the regulation or this policy. The PHS/NIH Awarding Component may determine that imposition of specific award conditions under 2 CFR 200.208 (ecfr.gov/current/title-2/section-200.208), or suspension of funding or other enforcement action under 2 CFR 200.339 (ecfr.gov/current/title-2/section-200.339) is necessary until the matter is resolved.

17) Useful FCOI and NIH Resources

• NIH e-mail address for FCOI-related inquiries: fcoicompliance@mail.nih.gov
• FCOI Regulation 42 CFR Part 50 Subpart F – Promoting Objectivity in Research: ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F
• Financial Conflict of Interest: grants.nih.gov/policy-and-compliance/policy-topics/fcoi
• FCOI Training: grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training

18) Point of Contact

If you have a question related to the FCOI Policy of Family Room, LLC, or would like to disclose a financial interest, contact: