Dynamoid Financial Conflict of Interest Policy
Introduction
The federal Department of Health and Human Services has developed regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. The regulations were first developed in 1995, and in 2011, the regulations were revised. These regulations describe the actions an individual and an organization must take to promote objectivity in PHS-funded research. The regulations apply to all Public Health Service (PHS) (e.g., National Institutes of Health (NIH))-funded grants, cooperative agreements, and research contracts. The regulations are not applicable to Phase 1 Small Business Innovation Research or Small Business Technology Transfer applications and/or awards. This policy implements the regulatory requirements for Dynamoid.
Scope
This policy applies to all personnel, including all full-time, part-time, temporary, and contract employees of Dynamoid, who are participating in, or planning to participate in, the design, conduct, or reporting of Public Health Service (“PHS”) funded research and research proposals. This policy does not apply to research and development conducted under Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) awards.
For federally-supported research projects involving subawardees or contractors (collectively “subrecipients”), the subrecipient institutions are required to provide written assurance that a FCOI policy is in effect that is compliant with all applicable federal regulations, or that the subrecipient will conform to and abide by Dynamoid FCOI policy and procedures. Consistent with PHS regulations, this policy will be made available via a publicly accessible website. All Dynamoid Investigators (that is, individuals who, regardless of position or title, are responsible for the design, conduct or reporting of PHS supported research, and Investigators seeking PHS research support) shall be informed where this policy and relevant reporting requirements may be accessed via the web.
Definitions
Financial conflict of interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Institutional responsibilities are the professional activities an investigator performs on behalf of Dynamoid (e.g., administration, research, or consulting).
The FCOI Official, who has been designated by Dynamoid, oversees the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests and identify FCOIs per the regulatory criteria provided in 42 CFR 50.604(f).
Investigator: The Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by award or proposed for such funding.
Research means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health.
PHS: The Public Health Service of the U.S. Department of Health and Human Services.
NIH: the biomedical research agency of the PHS.
Senior/key personnel means the PD/PI and any person identified as senior/key personnel by the Institution in the grant application.
Significant Financial Interest (SFI):
A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities performed on behalf of Dynamoid.
- For publicly traded entities, a significant financial interest exists if the aggregate value of remuneration received and equity interest exceeds $5,000.
- For non-publicly traded entities, if remuneration exceeds $5,000 or if the Investigator holds equity interest exceeding $5,000.
- For intellectual property rights, a significant financial interest exists upon receipt of income of greater than $5,000.
The term significant financial interest does not include the following types of financial interests:
- Salary, royalties, or remuneration paid by Dynamoid to the Investigator.
- Any ownership interest in Dynamoid held by the Investigator.
- Income from mutual funds and retirement accounts.
- Income from U.S. government, higher education institutions, or academic hospitals.
- Income from advisory committees or review panels for U.S. entities.
Training
Each Investigator must complete training prior to engaging in PHS funded research. Acceptable forms of training include, but are not limited to, the NIH Office of Extramural Research FCOI online tutorial or other training courses approved by Dynamoid. Investigators must complete training at least every four years.
1. Disclosure Requirements:
At the time of application, the Principal Investigator and all other individuals must disclose their SFIs to Dynamoid designated official. Updated disclosures of SFI are required at least annually and within thirty (30) days of discovering a new SFI.
2. Review
The designated official conducts reviews of SFI disclosures. The review determines if the SFI is related to PHS/NIH-funded research and if it creates a FCOI.
3. Management
If a FCOI exists, the designated official will develop a management plan specifying actions taken to manage the FCOI. Examples include public disclosure, modifying the research plan, or disqualifying personnel from participation.
4. Public Accessibility to Information Related to Financial Conflicts of Interest
Dynamoid will ensure public accessibility by written response to any requestor within five business days of a request regarding any SFI disclosed.
5. Reporting of FCOI
Prior to the expenditure of any funds under an award funded by NIH, Dynamoid will provide to NIH a FCOI report regarding any Investigator’s Significant Financial Interest found to be conflicting.
6. Non-Compliance
When an FCOI is not managed, Dynamoid will conduct a retrospective review of the Investigator’s activities and submit annual FCOI reports to NIH.
7. Subrecipient Requirements
Subrecipients are accountable to Dynamoid for programmatic outcomes and must comply with federal FCOI regulations.
8. Maintenance
Records of all Investigator disclosures and the Institution’s responses will be maintained for at least three years.
9. Implementation
This policy shall be implemented in accordance with federal regulations governing financial conflicts of interest in research.
10. Failure to Comply
Compliance with this policy is a condition of employment, and non-compliance may lead to disciplinary action.
11. Review
This policy shall be reviewed periodically and revised as necessary.
12. Contact
For questions or additional information regarding this FCOI policy, please contact:
Laura Lynn Gonzalez
CEO, Dynamoid
1633 Broadway Suite C, Oakland, CA 94612
Phone: 510-646-1304
Email: info@dynamoid.com