1. Introduction
The Federal Department of Health and Human Services has developed regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. The regulations were first developed in 1995, and in 2011, the regulations were revised. The 2011 revised regulations describe the actions an individual and an organization must take to promote objectivity in Public Health Service (PHS) funded research. The regulations apply to all PHS (e.g., National Institutes of Health [NIH]) funded grants, cooperative agreements, and research contracts. The regulations are not applicable to Phase 1 Small Business Innovation Research or Small Business Technology Transfer applications and/or awards.
This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for HeartPoint Global Inc. (hereinafter “HPG”).
The implementation of the regulation through the issuance of this policy ensures that the design, conduct, and reporting of PHS/NIH-funded research will be protected from bias resulting from an Investigator’s financial conflict of interest (FCOI). In addition, the policy serves to protect the safety of animals and human research participants, the reputation of the recipient institution and of the Investigator who participates in PHS/NIH-funded research. These requirements work together to preserve the public’s trust that the research supported by the PHS/NIH is conducted without bias and with the highest scientific and ethical standards.
2. Definitions
For the purpose of these policies and procedures, the following definitions apply:
a. Financial Conflict of Interest (FCOI)
A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
b. Financial Interest
Anything of monetary value, whether or not the value is readily ascertainable.
c. Institutional Responsibilities
The professional activities an investigator performs on behalf of HPG, including: research, clinical development, publication, consulting, administration, or institutional committee memberships.
d. Designated Official (DO)
The Designated Official(s) designated by HPG to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests and investments on a periodic basis to identify FCOIs per the regulatory criteria provided in 42 CFR 50.604(f).
e. Investigator
The Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by an award or proposed for funding, which may include collaborators or consultants. HPG will consider the individual’s role rather than title when determining responsibility.
f. 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. Encompasses basic and applied research and product development.
g. PHS-Funded Research
Any activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.
h. PHS
The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
i. NIH
The biomedical research agency of the PHS.
j. Senior/Key Personnel
The PD/PI and any other person identified as Senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS/NIH. This term relates only to public accessibility requirements of identified FCOIs, as described under Section 8.
k. Significant Financial Interest (SFI)
A domestic or foreign financial interest of the Investigator (and those of the Investigator’s spouse and dependent children) consisting of one or more of the following that reasonably appear to be related to the Investigator’s institutional responsibilities:
- Publicly traded entity: SFI exists if the value of remuneration received in the twelve months preceding disclosure and the value of any equity interest, when aggregated, exceeds $5,000.
- Non-publicly traded entity: SFI exists if remuneration in the twelve preceding months exceeds $5,000, or when the Investigator or their spouse/dependent children holds any equity interest.
- Intellectual property rights: SFI exists upon receipt of income greater than $5,000 in the twelve months preceding disclosure related to such rights.
Investigators must also disclose reimbursed or sponsored travel exceeding $5,000 related to their institutional responsibilities, including the purpose, sponsor, destination, and duration. This disclosure requirement does not apply to travel reimbursed by federal/state/local US government agencies, US institutions of higher education, academic teaching hospitals, medical centers, or affiliated research institutes.
The term SFI does not include: salary or royalties paid by HPG to the Investigator; ownership interest in HPG held by the Investigator (as HPG is a for-profit organization); income from investment vehicles not directly controlled by the Investigator; income from seminars or teaching engagements sponsored by qualifying US institutions; or income from service on advisory panels for qualifying US institutions.
Foreign Financial Interests: Investigators must disclose all foreign financial interests (including income from seminars, advisory panels, and reimbursed travel) received from any foreign entity when such income meets the $5,000 disclosure threshold.
3. Significant Financial Interest Disclosure Requirements
a. At the time of application: The Principal Investigator and all other Investigators must disclose their SFIs to the Designated Official(s). Any new Investigator who plans to participate in the project must similarly disclose their SFI(s) promptly and prior to participation.
b. Annual Disclosure: Each Investigator must submit an updated disclosure of SFI at least annually, on or before July 01, during the period of the award. This must include any information not previously disclosed and updated information regarding any previously disclosed SFI.
c. New SFIs during the award: Each Investigator must submit an updated disclosure within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Investigators must also submit updated disclosures of reimbursed or sponsored travel within 30 days of each occurrence.
4. Review of SFI Disclosures by HPG Designated Official(s)
A Designated Officials Committee (consisting of: Dr. Elena Amin, Chief Medical Officer; Hannalore Ilesan, Ph.D., Chief Operating Officer; Brian William Seidman, Head of Corporate Development) has been assigned at HPG to conduct reviews of SFI disclosures.
a. Prior to the issuance of a new award: The Designated Officials Committee will review the Investigator’s SFI(s) prior to NIH issuing a new award and, if an FCOI is identified, will submit an FCOI report to NIH via the eRA Commons FCOI Module prior to the expenditure of funds.
b. Annual SFI disclosure: The Designated Officials Committee will review the Investigator’s annual disclosure and use updated information to determine if any changes are needed to an existing management plan.
c. During award period: Whenever an Investigator new to the project discloses an SFI, or an existing Investigator discloses a new SFI, the Designated Officials Committee will within 60 days review the disclosure, determine relatedness, determine whether an FCOI exists, and if so, implement an interim management plan. The FCOI report will be submitted to NIH within 60 days of identifying the FCOI.
5. Guidelines for Determining Relatedness of SFI and FCOI
Relatedness Test: An Investigator’s SFI is “related” to the research when the Designated Official(s) reasonably determines the SFI could be affected by the PHS/NIH-funded research, or is in an entity whose financial interest could be affected by the PHS/NIH-funded research.
FCOI Determination: A financial conflict of interest exists when the Designated Officials Committee reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research.
6. Management of Significant Financial Interests that Pose FCOI
If a financial conflict of interest exists, the Designated Officials Committee will determine management conditions and/or strategies. Examples of conditions that might be imposed include:
- Public disclosure of financial conflicts of interest when presenting or publishing the research, to research personnel, to the IRB, IACUC, or Data Safety and Monitoring Board
- For research projects involving human subjects, disclosure of financial conflicts directly to participants in the informed consent document
- Appointment of an independent monitor capable of protecting the design, conduct, and reporting of the research against bias
- Modification of the research plan
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
- Reduction or elimination of the financial interest (e.g., sale of an equity interest)
- Severance of relationships that create financial conflicts
7. Monitoring Investigator Compliance
HPG will monitor investigators’ compliance with the management plan for the duration of the NIH award or until the FCOI no longer exists. Monitoring will include reviewing publications and presentations to confirm that the investigator disclosed the FCOI. Investigators will be required to disclose the FCOI in writing to research personnel in the study and send a copy of the communication to the Designated Officials Committee.
8. Public Accessibility of FCOI Policy and Information Related to a FCOI
a. FCOI Policy: A copy of the FCOI policy is posted on HPG’s public website per NIH requirements.
b. Identified FCOIs held by Senior/Key Personnel: Prior to the expenditure of any funds under an NIH award, HPG will ensure public accessibility by written response to any request within five business days. Information made available will include at minimum: the Investigator’s name; title and role; the name of the entity in which the SFI is held; the nature of the SFI; and the approximate dollar value in the following ranges: $0–$4,999; $5,000–$9,999; amounts between $10,000–$19,999 by increments of $5,000; amounts above $20,000 by increments of $10,000; or a statement that the value cannot be readily determined.
Information concerning an individual’s SFI will remain available for at least three years from the date the information was most recently updated.
9. Reporting of Financial Conflicts of Interest
Prior to the expenditure of any funds under an NIH award, HPG will provide to NIH a FCOI report compliant with NIH regulations regarding any Investigator’s SFI found to be conflicting. FCOI reports are submitted to NIH only when a grant or cooperative agreement is active and an FCOI is identified.
| Report Type | Content | When |
|---|---|---|
| New FCOI Report (Initial) | Grant number, PI name, entity with FCOI, nature of FCOI, value in increments, description of how FI relates to research, key elements of management plan | Prior to expenditure of funds; within 60 days of any subsequently identified FCOI |
| Annual FCOI Report | Status of FCOI (still managed or no longer exists) and changes to management plan, if applicable | At same time as annual progress report or at time of extension |
| Revised FCOI Report | Updated actions to manage FCOI or changes to the originally submitted report | Following completion of retrospective review when there is noncompliance, if needed |
| Mitigation Report | Project number, title, contact PI/PD, investigator with FCOI, entity with FCOI, reason for review, detail, methodology, findings and conclusion | When bias is found in retrospective review |
10. Training Requirements
Each Investigator will be trained on the responsibility to disclose foreign and domestic SFIs. FCOI training will occur: prior to engaging in PHS/NIH-funded research; at least every four years; and immediately when HPG revises this Policy, when an Investigator is new to HPG research under an NIH award, or when HPG finds an Investigator is not in compliance with this Policy.
HPG requires investigators to complete the NIH Financial Conflict of Interest tutorial: grants.nih.gov/grants/policy/coi/tutorial
11. Failure to Comply with HPG’s FCOI Policy
Whenever HPG identifies an SFI that was not disclosed, identified, reviewed, or managed in a timely manner, the Designated Officials Committee will within 120 days review the SFI, determine whether it is related to research, determine whether an FCOI exists, and if so, implement an interim management plan.
Whenever an FCOI is not identified or managed in a timely manner, HPG will within 120 days complete a retrospective review of the Investigator’s activities and the PHS/NIH-funded research to determine whether any research conducted during the period of noncompliance was biased. If bias is found, HPG shall notify NIH promptly and submit a mitigation report. If bias is not found, no further action is required.
12. Clinical Research Requirements
If HHS determines that one of its funded clinical research projects 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 a Financial Conflict of Interest that was not managed or reported by HPG, HPG shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
13. Subrecipient Requirements
A subrecipient relationship is established when federal funds flow down from or through HPG to another individual or entity conducting a substantive portion of a PHS-funded research project. Subrecipients, including collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to HPG’s terms and conditions. HPG will take reasonable steps to ensure any subrecipient Investigator is in compliance with the federal FCOI regulation at 42 CFR Part 50 Subpart F.
HPG will incorporate as part of a written agreement with the subrecipient terms that establish whether HPG’s FCOI Policy or the subrecipient institution’s policy will apply. If the subrecipient cannot provide certification of compliance, the agreement shall state that the subrecipient Investigator is subject to HPG’s FCOI Policy.
14. Maintenance of Records
HPG will keep all records of all Investigator disclosures of financial interests and HPG’s review of or response to such disclosure, whether or not a disclosure resulted in a determination of a Financial Conflict of Interest. Records will be maintained for at least three years from the date of submission of the final expenditures report, or as otherwise specified in 45 C.F.R. 75.361.
15. Enforcement Actions: Investigator Noncompliance
Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Investigators who fail to comply are subject to discipline, including letters of reprimand, restriction on the use of funds, termination of employment or contract, and/or disqualification from further participation in any PHS/NIH-funded research.
16. Useful FCOI and NIH Resources
- NIH FCOI inquiries: FCOICompliance@mail.nih.gov
- FCOI Regulation 42 CFR Part 50 Subpart F: ecfr.gov
- Financial Conflict of Interest (NIH): grants.nih.gov
- FCOI Training: grants.nih.gov/fcoi-training
- Information for Foreign Grants: grants.nih.gov/foreign-grants
17. Point of Contact
If you have a question related to the Financial Conflict of Interest Policy of HPG or would like to disclose a financial interest, contact us using the information below.
18. Public Availability
A copy of the current version of HeartPoint Global Inc.’s Financial Conflict of Interest Policy is available on the HPG website.
| Rev # | Section/Page | Reason for Change | Effective Date |
|---|---|---|---|
| 000 | N/A | Initial release | 16 July 2025 |