Financial Conflict of Interest (FCOI) Policy

FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY

Americord Registry LLC | PHS/NIH-Funded Research | 42 CFR Part 50, Subpart F

Policy Version 1.0

1. Purpose, Scope, and Investigator Definition

This policy implements the Public Health Service (PHS) regulation, Responsibility of Applicants for Promoting Objectivity in Research, 42 CFR Part 50, Subpart F. It applies to Americord Registry LLC applications for and awards of PHS/NIH research funding to which the regulation applies, including applicable SBIR/STTR Phase II and Direct-to-Phase II applications and awards. Phase I SBIR/STTR applications and awards are excluded as provided by the regulation.

Investigator means the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS/NIH-funded research or research proposed for such funding. This may include employees, consultants, collaborators, subrecipient personnel, or contractors when their responsibilities meet this definition.

2. FCOI Official and Independent Review

Americord designates Martin Smithmyer, Founder and Chief Executive Officer, as the FCOI Official. The FCOI Official will inform Investigators of this policy and their responsibilities; solicit and review Significant Financial Interest (SFI) disclosures; determine whether an SFI is related to PHS/NIH-funded research and whether it constitutes an FCOI; develop, implement, and monitor management plans; maintain required records; and submit required FCOI reports to NIH.

Kendal Schoettlin, Director of Finance, HR & Operations, is the Alternate FCOI Reviewer. She will act when the FCOI Official is the subject of a disclosure, has an actual or apparent conflict concerning the matter under review, or otherwise cannot independently perform the review. If both are conflicted, Americord will use another disinterested authorized officer or independent outside counsel. No person may determine or manage their own FCOI.

3. Significant Financial Interests (SFI)

Investigators must disclose domestic and foreign financial interests of themselves, their spouse, and dependent children that reasonably appear related to their institutional responsibilities and meet the applicable criteria below:

  • Publicly traded entity: prior-12-month remuneration plus current equity value, aggregated, exceeds $5,000.
  • Non-publicly traded entity: prior-12-month remuneration exceeds $5,000, or any equity interest is held, regardless of value.
  • Intellectual property rights/interests: upon receipt of income related to such rights or interests.
  • Reimbursed or sponsored travel related to institutional responsibilities, unless an exclusion applies; disclose at least purpose, sponsor/organizer, destination, and duration.

Excluded from SFI to the extent permitted by 42 CFR 50.603 are salary, royalties, or other remuneration paid by the Investigator's employing/appointing Institution; IP rights assigned to that Institution and related royalty-sharing agreements; ownership interest in the applicant Institution held by an Investigator when the Institution is commercial/for-profit; investment-vehicle income when the Investigator does not directly control investment decisions; and qualifying income or travel from U.S. federal, state, or local government agencies, U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with U.S. institutions of higher education.

Foreign financial interests are not excluded merely because the payer is a foreign government or foreign institution of higher education. Equity in a separate affiliate is not automatically excluded by the for-profit applicant-Institution exclusion. Disclosure does not itself mean that an FCOI exists.

4. Disclosure and Training Requirements

Each Investigator must submit a complete SFI disclosure:

  • No later than the time an applicable PHS/NIH application is submitted.
  • At least annually during the period of award.
  • Within 30 days of discovering or acquiring a new SFI.

Each Investigator must complete FCOI training before engaging in research related to an applicable NIH-funded grant, at least every four years thereafter, and immediately when Americord revises this policy in a manner affecting Investigator requirements, the Investigator is new to Americord for the NIH-supported research, or Americord finds the Investigator noncompliant with this policy or an FCOI management plan. Americord will document completion.

5. Review, Determination, and Management

The FCOI Official or Alternate Reviewer will determine whether an SFI is related to PHS/NIH-funded research. An SFI is related when it could be affected by the research or is in an entity whose financial interest could be affected by the research. If related, the reviewer will determine whether it constitutes an FCOI, meaning it could directly and significantly affect the design, conduct, or reporting of the research.

If an FCOI is identified, Americord will implement a written management plan before expenditure of funds under a new award. Management may include public disclosure, disclosure to research participants when appropriate, independent monitoring or blinded review, modification of the research plan, change or disqualification of personnel, reduction or elimination of the SFI, or severance of relationships creating the conflict. Management-plan compliance will be monitored until the project is completed or the FCOI no longer exists.

6. NIH Reporting and Noncompliance

Americord will submit required FCOI reports through the eRA Commons FCOI Module. For a new award, an identified FCOI will be reported before expenditure of NIH funds. For a newly participating Investigator or newly discovered or acquired SFI determined to be an FCOI, Americord will report within 60 days. Required annual FCOI reports will describe the status of the FCOI and any changes to the management plan.

For untimely disclosure, review, identification, or management, Americord will review the SFI and implement interim management when appropriate; complete and document a retrospective review within 120 days of determining noncompliance; and, if bias is found, promptly notify NIH and submit the required mitigation report and revised FCOI report.

7. Subrecipients and Other External Investigators

When applicable PHS/NIH-funded research is carried out through a subrecipient, consortium participant, collaborator, consultant, or contractor whose personnel meet the Investigator definition, written agreements will establish whether those Investigators comply with Americord's policy or the other organization's compliant policy and will establish disclosure and reporting timeframes that allow Americord to meet NIH obligations. Fee-for-service status alone does not determine Investigator status.

8. Public Accessibility and Records

Americord will maintain this FCOI policy on a publicly accessible website and submit it to NIH through the eRA Commons Institutional Profile (IPF) Module. Before expenditure of funds under an applicable NIH award, Americord will also make required information concerning identified FCOIs held by Senior/Key Personnel publicly accessible, either on a public website or by written response within five business days of a request, as permitted by the regulation. Required public information will be updated at least annually and within 60 days of a newly identified FCOI and remain available for at least three years from the date most recently updated.

Americord will retain Investigator disclosures, institutional reviews and determinations, management plans and monitoring, retrospective reviews, and related records for at least three years from submission of the final expenditures report or longer if required by federal record-retention rules, and will promptly make FCOI/SFI information available to NIH/HHS upon request.

9. Enforcement and Clinical-Research Requirement

Failure to comply with this policy or a management plan may result in corrective or disciplinary action appropriate to the person's relationship with Americord. If noncompliance has biased the design, conduct, or reporting of NIH-funded research, Americord will promptly notify NIH and take corrective action.

For NIH-funded clinical research evaluating the safety or effectiveness of a drug, medical device, or treatment, if HHS determines that the research was designed, conducted, or reported by an Investigator with an FCOI that was not disclosed or managed as required, Americord will require disclosure of the FCOI in each public presentation of the results and request an addendum to previously published presentations as required by the regulation.

10. Institutional Certification

By submitting each applicable NIH application, the Authorized Organization Representative/Signing Official certifies that Americord has an up-to-date, written and enforced administrative process to identify and manage FCOI; will promote and enforce Investigator compliance; will manage and report FCOIs as required; will make required information available to NIH/HHS upon request; and will otherwise comply with 42 CFR Part 50, Subpart F.