Financial Conflict of Interest Policy

THE CARE HACK, INC.

Financial Conflict of Interest Policy

Effective Date: August 3, 2026
FCOI Officer: Mitul Desai, Chief Executive Officer
Contact: compliance@thecarehack.com

1. Purpose and Scope

This policy applies to The Care Hack, Inc.’s NIH-funded research that is subject to 42 C.F.R. Part 50, Subpart F.

It applies to each Investigator, meaning the principal investigator, project director, or any other person responsible for the design, conduct, or reporting of the covered research, regardless of title or position.

2. Disclosure of Financial Interests

Each Investigator must disclose all domestic and foreign Significant Financial Interests, or SFIs, held by the Investigator, the Investigator’s spouse, or dependent children that reasonably appear related to the Investigator’s professional responsibilities performed on behalf of The Care Hack.

An SFI includes:

  • For a publicly traded entity, compensation received during the preceding 12 months plus the value of any equity interest, when the combined value exceeds $5,000;

  • For a non-publicly traded entity, compensation exceeding $5,000 received during the preceding 12 months or any equity interest in the entity;

  • Income related to intellectual-property rights; and

  • Reimbursed or sponsored travel related to the Investigator’s responsibilities for The Care Hack, subject to the exclusions in the federal regulations.  Travel disclosures must be submitted within 30 days of each occurrence and must include, at minimum, the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration.

An SFI generally does not include compensation or ownership interests in The Care Hack, investments over which the Investigator does not control investment decisions, or qualifying income from specified U.S. government or academic entities.

An unrelated outside activity that does not reasonably appear related to the Investigator’s responsibilities for The Care Hack is not required to be disclosed under this policy. An Investigator should consult the FCOI Officer if uncertain whether an interest must be disclosed.

Investigators must submit disclosures:

  • No later than the submission of an application for covered NIH funding;

  • At least annually during an award; and

  • Within 30 days after discovering or acquiring a new SFI.

Disclosure of an SFI does not necessarily mean that a Financial Conflict of Interest exists.

3. Review and Management

The FCOI Officer will review each disclosed SFI and determine:

  1. Whether it is related to the NIH-funded research; and

  2. Whether it could directly and significantly affect the design, conduct, or reporting of the research.

If both conditions are met, the SFI is a Financial Conflict of Interest, or FCOI.

If an FCOI exists, The Care Hack will document and implement appropriate measures to manage it before covered funds are spent. Measures may include disclosure of the interest, independent review or monitoring, separation from contracting or payment decisions, modification of research responsibilities, or removal from affected activities.

An Investigator may not make the final determination concerning the Investigator’s own SFI. If the FCOI Officer cannot conduct an impartial review, The Care Hack will designate another qualified reviewer.

The Care Hack will monitor Investigator compliance with any management plan on an ongoing basis until completion of the covered research.

4. NIH Reporting and Compliance

The Care Hack will report identified FCOIs to NIH through the eRA Commons FCOI Module as required, including any required initial report before covered funds are expended.  An FCOI identified after an award begins will be reviewed, managed, and reported within 60 days. The Care Hack will provide NIH or HHS promptly upon request with information concerning any Investigator financial-interest disclosure and the Company’s review and response.  

The Company will submit annual FCOI reports for the duration of the project, including any extensions with or without funds, addressing the status of the FCOI and any changes to the management plan, or explaining why the FCOI no longer exists.

If an SFI was not disclosed, reviewed, or managed in a timely manner, The Care Hack will complete the required retrospective review within 120 days. If bias is identified, The Care Hack will promptly notify NIH and submit the required mitigation report.

The Care Hack will inform each Investigator of this policy, the Investigator’s disclosure responsibilities, and the applicable federal regulation.  Investigators must complete required FCOI training before participating in covered research, at least every four years, when this policy materially changes, when joining The Care Hack, or following noncompliance.

Investigators must provide complete and timely disclosures and comply with all management measures. Noncompliance may result in restriction or removal from research activities, termination of the applicable relationship, notification to NIH, or other appropriate action.

5. Subrecipients, Public Access, and Records

For covered research involving a subrecipient, the applicable written agreement will specify whether the subrecipient follows its own compliant FCOI policy or this policy and will establish appropriate disclosure and reporting deadlines. If the subrecipient follows its own policy, it must certify that its policy complies with 42 C.F.R. Part 50, Subpart F. The agreement will require disclosures or reports sufficiently promptly to allow The Care Hack to identify, manage, and report applicable FCOIs to NIH within the required timeframes.

The Care Hack will:

  • Make this policy publicly accessible;

  • Submit the policy through the eRA Commons Institutional Profile Module when required;

  • Make required information regarding an identified FCOI held by senior or key personnel available in writing within five business days after receiving a request. Any written response will state that the information is current as of the date of the response and is subject to updates at least annually and within 60 days after identification of a new applicable FCOI; 

  • Keep such publicly accessible FCOI information available for at least three years after it was most recently updated; and

  • Retain disclosure, review, management, reporting, and training records for at least three years after submission of the applicable final expenditure report, or longer if required.


Requests for information under this policy may be submitted to:

FCOI Officer
The Care Hack, Inc.
compliance@thecarehack.com

Adoption

This policy was approved and adopted by The Care Hack, Inc. effective as of the date stated above.

Mitul Desai
Chief Executive Officer

Date: August 3, 2026