Financial Conflict of Interest

 

Financial Conflict of Interest Policy

The purposes of this policy is for DNA Software (DNAS) and all related parties to maintain compliance with the U.S. Department of Health and Human Services (HHS) Final Rule on Financial Conflicts of Interest (FCOI) and the associated sections of Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought, 42 C.F.R. Part 50, Subpart F, and Responsible Prospective Contractors, 45 C.F.R. Part 94. The design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

Compliance Committee

DNAS maintains a compliance committee, consisting of the Vice President and Controller, that reviews all financial disclosures by Investigators and determines whether any Significant Financial Interest is related to a NIH-funded research and a Financial Conflict of Interests exists by making a reasonable determination that the Significant Financial Interest: could be affected by the NIH-funded research or is in an entity whose financial interest could be affected by the research.

Individuals subject to these regulations must submit disclosure statements upon hire and prior to the application submission for NIH-funded research. Disclosure must also be made at any point upon entering, or if a potential exists for, a financial conflict of interest.

After disclosure is made, it is then the responsibility of the Compliance Committee to investigate if the financial conflict of interest is significant and can be reasonably managed. The individual must comply with the investigation until a determination is made. At the point the committee determines the conflict cannot be reasonably managed, the individual will be asked to terminate the relationship resulting in the financial conflict of interest.

Management Plan

If the Compliance Committee determines the conflict can be reasonably managed, a management plan will be implemented immediately. The management plan will include, but is not limited to, the following:

  1. The role and principal duties of the conflicted Investigator in the research project;
  2. Conditions of the management plan;
  3. Procedures designed to safeguard objectivity in the research project;
  4. Confirmation of the Investigator’s agreement to the management plan; and
  5. Procedures for monitoring Investigator compliance.

Annual FCOI reports will include the status of the management plan and a description of any changes to the management plan since the last FCOI report was submitted to the NIH. The individual will remain on the management plan until the financial conflict of interest no longer exists, or is terminated.

Violation

Any individual found to have violated this policy will be subject to disciplinary actions, up to and including termination of employment and/or business relationship with DNAS. Violation enforcement is left to the full discretion of the Compliance Committee.

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