Colectica Financial Conflict of Interest (FCOI) Policy for PHS/NIH-Funded Research
Effective Date: May 25, 2026
Version: 1.0

1. Purpose and Applicability

This policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS)/National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This policy implements 42 CFR Part 50 Subpart F.

This policy applies to each Investigator who is planning to participate in, or is participating in, PHS/NIH-funded research, except Phase I SBIR/STTR applications and awards. It applies to domestic and foreign Significant Financial Interests.

2. Definitions

  • Investigator: The Project Director/Principal Investigator (PD/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. This includes collaborators and consultants.

  • Institutional Responsibilities: An Investigator’s professional responsibilities performed on behalf of Colectica, including research, research consultation, teaching, professional practice, and service on institutional committees.

  • Significant Financial Interest (SFI): A financial interest of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears related to the Investigator’s Institutional Responsibilities and meets any of the following thresholds:

    • Publicly traded entity: Remuneration received in the 12 months preceding disclosure + equity interest as of the disclosure date, when aggregated, exceeds $5,000.
    • Non-publicly traded entity: Remuneration received in the 12 months preceding disclosure exceeds $5,000, or any equity interest is held.
    • Intellectual Property: Income from intellectual property rights and interests (e.g., patents, copyrights) received in the 12 months preceding disclosure exceeds $5,000.
    • Travel: Reimbursed or sponsored travel related to Institutional Responsibilities. Disclosure must include sponsor/organizer, destination, duration, and purpose.

  • Financial Conflict of Interest (FCOI): An SFI that could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded research.

Exclusions from SFI:

  • Salary, royalties, or other remuneration paid by Colectica to the Investigator if currently employed or appointed by Colectica.
  • Income from investment vehicles (e.g., mutual funds, retirement accounts) where the Investigator does not directly control investment decisions.
  • Income from seminars, lectures, teaching engagements, or service on advisory panels sponsored by U.S. federal, state, or local government agencies, U.S. institutions of higher education, academic teaching hospitals, medical centers, or affiliated research institutes.

3. Training Requirements

Each Investigator must complete FCOI training prior to engaging in PHS/NIH-funded research and at least every four years thereafter. Training is also required immediately if:

  • Colectica revises this policy in a manner that affects Investigator requirements;
  • The Investigator is new to Colectica; or
  • The Investigator is found not in compliance with this policy or a management plan.

Completion of the NIH FCOI Tutorial satisfies this requirement.

4. Disclosure Requirements

Investigators must disclose all domestic and foreign SFIs (including those of spouse and dependent children) related to their Institutional Responsibilities:

  • No later than the time of application for PHS/NIH funding.
  • At least annually during the period of the award.
  • Within 30 days of discovering or acquiring a new SFI.
  • Within 30 days of any reimbursed or sponsored travel (with required details: sponsor, destination, duration, purpose).

5. Review, Determination, and Management

Colectica’s Designated Official (CEO or designated Compliance Officer) is responsible for reviewing SFI disclosures.

  • Pre-Expenditure Review: Prior to expenditure of any PHS/NIH funds, the Designated Official will review disclosures, determine whether an SFI is related to the funded research, and determine whether an FCOI exists.
  • Ongoing Review: For new Investigators or newly disclosed SFIs, review within 60 days and implement an interim management plan if an FCOI is identified.

If an FCOI is identified, the Designated Official will develop and implement a written management plan. Management actions may include public disclosure of the FCOI, appointment of an independent monitor, modification of the research plan, change of personnel responsibilities, or reduction/elimination of the financial interest. The Designated Official will monitor compliance with the management plan.

6. Reporting to NIH

Colectica will submit FCOI reports via the eRA Commons FCOI Module:

  • Prior to expenditure of funds for any identified FCOI.
  • Within 60 days of identifying a new FCOI (new Investigator or new SFI).
  • Annually thereafter, addressing the status of the FCOI and any changes to the management plan.

Reports will include all elements required by regulation.

7. Noncompliance, Retrospective Review, and Mitigation

If Colectica identifies noncompliance (e.g., failure to disclose an SFI or follow a management plan), it will complete a retrospective review within 120 days to determine whether any bias occurred in the research.

If bias is found, Colectica will notify the NIH awarding component promptly and submit a mitigation report. For clinical research projects, Colectica will require disclosure of the FCOI in public presentations of the results and request addenda to previously published presentations if required by NIH.

8. Enforcement

Failure to comply with this policy or a management plan may result in disciplinary action, up to and including termination of employment or contract.

9. Record Retention

Colectica will maintain all records of disclosures, reviews, determinations, management plans, and retrospective reviews for at least three (3) years from the date the final expenditure report is submitted to NIH, or as otherwise required.

10. Public Accessibility

This policy will be made publicly available on Colectica’s website. For any FCOI of senior/key personnel, Colectica will make information available via its website or in writing within five (5) business days of a written request. Information provided will include the minimum elements required by 42 CFR Part 50 Subpart F.

11. Subrecipients

Colectica will establish written agreements with subrecipients specifying whether Colectica’s or the subrecipient’s FCOI policy applies. Subrecipients must report identified FCOIs to Colectica in sufficient time to allow Colectica to meet its NIH reporting obligations.

12. Useful FCOI and NIH Resources

Questions? Contact the Designated Official via Colectica Support at https://www.colectica.com/support/.