Purpose

1. To protect the integrity of all research studies performed by MiraDX by ensuring that the design, conduct, and reporting of research is free from bias stemming from financial conflicts of interest (FCOI).
2. To define remedies for non-compliance with the financial conflicts of interest policy by any persons involved with research studies performed by MiraDX.

Scope

1. This policy applies to all MiraDX employees and subcontractors who are involved with research funded, fully or in part, by any Public Health Service (PHS) award through means of direct contract or otherwise.

Responsibilities

1. Signing Official (SO) is responsible for assigning FCOI roles in eRA Commons to users within the organization, reviewing submissions, and providing signature approval on submissions.
2. FCOI designated user is responsible for updating the Mira Dx FCOI policy to ensure compliance with 45 CFR Part 94, reviewing any potential FCOI, initiating, editing, managing, and submitting the FCOI report.
3. Project Director (PD), Principle Investigator (PI), and all employees involved in the research study as described in the scope are responsible for understanding the FCOI policy and informing the FCOI designated user with any pertinent updates to his or her FCOI.

Details

Maintenance of Policy

1. The FCOI designated user will review this policy annually, or as updates are released, to ensure compliance with current standards outlined by the governing office.
2. Any updates that are made to this policy will be communicated to all personnel participating in any research study performed at MiraDX.
3. Documentation of training will be kept on record as per the MiraDX Document Control Policy.

Significant Financial Interest Disclosure

1. Each investigator, collaborator, consultant, subcontractor, and person(s) involved in the design, conduct, and reporting of research is required to read and understand the FCOI policy before participating in any research performed at MiraDX.
2. All subrecipients, contractors, collaborators, consultants, and person(s) involved with the research will sign an attestation of understanding and compliance.
3. The PI/PD will identify all senior and key personnel involved with the research study and require such person(s) to disclose their significant financial interest (SFI) to the FCOI designated user.
   1. Each investigator who is participating in the research study must disclose to the FCOI designated user any SFI no later than the date of submission of the proposal.
   2. Any investigator or FCOI identified after the date of submission must disclose any SFI within 60 days of discovery.
   3. Each investigator must submit an updated disclosure of SFI annually during the period of the award and shall include any SFI that was not previously disclosed.
4. Disclosures must document, at minimum, the following:
   1. Project number
   2. Project title
   3. PD/PI
   4. Name of investigator with the FCOI
   5. Name of the entity with which the investigator has a FCOI

Review of Disclosures

1. Disclosures will be reviewed by the FCOI designated user upon submission to MiraDX for potential FCOI prior to the individual being allowed to participate in the research study.
   1. Disclosures are reviewed for interests that:
      1. May directly and/or significantly impact the design, conduct, or reporting of research funded by a PHS award.
      2. May impact the integrity of research data, safety of any research subjects, availability of results to the public.
      3. May pose the appearance of a conflict of interest.
   2. Disclosures found to be potential FCOI must be submitted to the regulating body via the FCOI report.

Mediation of Non-Compliance or FCOI

1. Failure to disclose SFI within the required timeframe will require the removal or limitation of participation of said person(s) from the research study until all SFI has been disclosed, reviewed, and properly submitted.
2. Individuals found to be non-compliant with this policy will undergo retraining and documentation kept on record as per the MiraDX Document Control Policy.
3. Continual non-compliance will result in the individual being permanently removed from the study and banned from participating in future studies with Mira Dx.
4. Individuals with SFI found to contain conflicts of interests that significantly impact the integrity and confidence of the research study will be allowed to make arrangements to divest of interests, limited in his or her participation in the research study, or removed entirely from the research study.
5. In the event of a FCOI identified beyond the approved timeframe, the FCOI designated user will perform a retrospective review and document, at minimum, the following key elements:
   1. Project Number
   2. Project Title
   3. PD/PI
   4. Name of Investigator with the FCOI
   5. Name of the entity with which the Investigator has a FCOI
   6. Reason(s) for the retrospective review
   7. Detailed methodology used for the review
   8. Findings of the review
   9. Conclusions of the review
6. Any FCOI discovered that may have biased the design, conduct, or reporting of the research study will be immediately investigated and reported the PHS Awarding Component for corrective action.

Reporting

1. Any request with respect to FCIO will be released to the public within 5 days with the following information:
   1. Investigator’s name, title, and role with the research study
   2. Name of the entity in which financial interest is held
   3. The nature and approximate dollar value of the interest reported as a range, unless otherwise unable to be determined.

Definitions

1. Key personnel: PD/PI and any other personnel considered to be essential to work performance and identified as key personnel in the contract proposal and contract.
2. Financial Conflict of Interest (FCOI): significant financial interest that could directly affect the design, conduct, or reporting of the research study.
3. Investigator: project director (PD), principal investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research.
4. Public Health Service (PHS): component of the U.S. Department of Health and Human Services to which authority involved may be delegated, including the National Institues of Health (NIH)
5. PHS Awarding Component: organizational unit of the PHS that funds the research that
6. Research: both basic and applied, systematic investigation, study, or experiment relating to public health
7. Significant Financial Interest (SFI): financial interest consisting of remuneration received of value exceeding $5,000 received from the entity in the preceding twelve months of disclosure.

References

1. 45 CFR Subtitle A, Subchapter A, Part 94
2. 42 CFR Chapter I, Subchapter D, Part 50, Subpart F
3. Financial Conflict of Interest (FCOI) External User Guide. eRA Commons Version 3.36.5. Document Version 4.13.4. (https://era.nih.gov/files/fcoi_user_guide.pdf)

Attachments

NONE