Nest Genomics FCOI Policy

Nest Genomics FCOI Policy

Effective: September 1, 2025

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 2011 revised regulations are 42 CFR Part 50 Subpart F, "Promoting Objectivity in Research" and 45 CFR Part 94, "Responsible Prospective Contractors", which set requirements for promoting objectivity in Public Health Service (PHS)–funded research for grants, cooperative agreement, and research contracts, respectively.

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 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.

3) Definitions

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

Financial Conflict Of Interest (FCOI):

A significant financial interest that 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: The professional activities an Investigator performs on behalf of Nest Genomics including research, product and services development and testing, publication and communication of research, consulting, operations management, administration, fundraising, and institutional committee memberships or panels.

Designated Official (DO):

The individual appointed by Nest Genomics 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 FCOI.

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.

Manage:

Means 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:

Means 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.

PHS-Funded Research:

Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority.

4) Significant Financial Interest (SFI) Disclosure Requirements

Investigators will disclose their SFIs that are related to their "institutional responsibilities" as defined in the policy.

5) Review of SFI disclosures

The COO serves as the Designated Official (DO) responsible for reviewing all SFI disclosures. Each SFI will be evaluated to determine whether it constitutes a Financial Conflict of Interest (FCOI).

6) Relatedness of SFIs to PHS/NIH-Funded Research and FCOI

The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute a FCOI.

7) Management of SFIs that Pose an FCOI

Some management actions include:

  1. Public disclosure of the FCOI.
  2. For human subjects research, disclosure of the FCOI to participants.
  3. Appointment of an independent monitor.
  4. Modification of the research plan.
  5. Reduction or elimination of the financial interest.
  6. Severance of relationships creating the conflict.

8) Monitoring Investigator Compliance

Nest Genomics will monitor Investigator compliance with the management plan for the duration of the NIH award.

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

A copy of this FCOI policy is available on Nest Genomics’s public website. Identified FCOIs held by Senior/Key Personnel will be disclosed publicly as required.

10) Reporting Identified Financial Conflicts of Interest

Nest Genomics will submit an identified FCOI report to NIH prior to spending any funds under an NIH-funded award.

11) Training Requirements for Investigators

Each Investigator will be trained on their responsibility to disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training must be completed before participating in PHS/NIH-funded research, at least once every four years.

12) Noncompliance With FCOI Policy and Corrective Actions

If noncompliance is identified, Nest Genomics will take appropriate corrective actions as required by the regulations.

13) Clinical Research Requirements

Nest Genomics will require disclosure of conflicts in public presentations of research results if there’s an unmanaged or unreported FCOI.

14) Subrecipient Requirements

Nest Genomics will take reasonable steps to ensure compliance with the federal FCOI regulations by subrecipients.

15) Maintenance of Records

Nest Genomics will maintain records of all Investigator financial interest disclosures for at least three years.

16) Enforcement Actions for Investigator Noncompliance

Investigators who fail to comply with this policy may be subject to disciplinary action, including termination of employment or contract.

17) Useful FCOI and NIH Resources

Contact: Guy Snir (COO) at guy@nestgenomics.com