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Company Wide. The Government Awards Compliance Program (Program) covers all projects conducted with government funds at Nasoni and is applicable to all employees, sub recipients, consultants, or any other covered organizations or persons involved in governmental awards.
Nasoni is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. Nasoni has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest.
The procedures described in this policy were created and designed primarily to comply with the specific regulatory requirements for U.S. Public Health Service (PHS)-sponsored research but are also intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to Nasoni’s other research activities. For non-PHS research, the specific steps, timing, determinations, documentation, and notifications may be tailored as appropriate but will remain focused on maintaining Nasoni’s high standards for research integrity and effectively eliminating or managing actual or potential financial conflicts of interest.
This policy and related procedures have been developed to identify, manage, mitigate, neutralize, or eliminate actual, apparent, and potential financial conflicts of interest. The policy was written to be in conformance with the Code of Federal Regulations (CFR) 42, Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought [1] and 45 CFR Part 94, Responsible Prospective Contractors.
[1] These regulations do not cover Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Program Phase 1 applications or awards but do apply to applicants and recipients under the SBIR/STTR Program Phase II. SBIR is the extramural research program for small business that was established by the Awarding Components of PHS and certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation Development Act, as amended. The term SBIR Program includes the STTR Program, which was established by Pub. L. 102-564.
For purposes of this policy, the following definitions shall apply:
Designated Official is the individual designated by Nasoni to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.
Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.
Financial conflict of interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research as determined by Nasoni through the Designated Official.
Financial interest means anything of monetary value, whether the value is readily ascertainable.
Immediate family refers to an Investigator’s spouse and dependent children.
Investigator means the project director/principal investigator and any other person who is responsible for the design, conduct, or reporting of the research or proposed research including collaborators and consultants.
PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.
PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.
Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
Research means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.
Significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s institutional responsibilities performed on behalf of Nasoni (e.g., research, research consultation, etc.), including:
Significant financial interests also include any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency located in the United States; a United States institution of higher education as defined at 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with a United States institution of higher education.
Significant financial interest does not include the following:
Responsibilities of Nasoni’s Designated Official
The Designated Official or his/her designee shall be responsible for the following:
For PHS-funded research, the Designated Official shall also have the following responsibility:
If Nasoni’s policy will apply to the subrecipient Investigators, Nasoni will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.
For PHS-funded research, as part of the funding application or proposal and prior to performing any work on the research, each Investigator who is planning to participate in the research is required by regulation to complete a Significant Financial Interest Disclosure (SFID) Form and submit the SFID Form to Nasoni’s Administrator. This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. SFID Forms will be provided to Investigators in conjunction with the annual training and will be otherwise made available. Nasoni’s Administrator will review SFID submissions with the Designated Official. The information reported on the SFID Form includes a listing of the Investigator’s known significant financial interests and those of his/her immediate family that reasonably appear to be related to the research or that are in entities whose financial interests could be affected by the research.
Nasoni Investigators in non-PHS-funded research who have any significant financial interest that may reasonably appear to be affected by the research are also expected to complete the SFID Form and submit it to Nasoni’s Administrator.
Investigators are expected to submit an updated SFID Form during the period of the award as necessary (at least annually for PHS-funded research). The annual update will typically be done in conjunction with completion of the annual training. Such disclosures shall include any information that was not previously disclosed; any change in information regarding any previously disclosed significant financial interest; or, within 30 days of discovery or acquisition, any new significant financial interest (e.g., an interest acquired through purchase, marriage, or inheritance).
Upon receipt of a completed SFID Form, the Designated Official shall determine whether an Investigator’s significant financial interest is related to the subject research and, if so, whether the interest constitutes a financial conflict of interest under this policy and any applicable regulations. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
If Nasoni determines that a financial conflict of interest exists, a financial conflicts of interest management plan will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:
In addition to the conditions or restrictions described above, Nasoni may require the management of conflicting financial interests in other ways as it deems appropriate.
Nasoni will disclose financial conflicts of interest as required by applicable laws or regulations. Before expending any funds under a PHS award, Nasoni will ensure public accessibility by posting financial conflicts of interest information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any financial conflict of interest that has not been eliminated and will ensure that Nasoni has implemented a plan to manage the conflict.
If a financial conflict of interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, Nasoni will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant financial interest that was not disclosed by an Investigator or not previously reviewed or managed by Nasoni (e.g., not reviewed or reported by a subrecipient in a timely manner), Nasoni will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, Nasoni will promptly notify the PHS Awarding Component and submit a mitigation report. Upon request, Nasoni will provide HHS with information relating to any Investigator disclosure of significant financial interests; Nasoni’s review of, and response to, such disclosure; and whether the disclosure resulted in Nasoni’s determination of a financial conflict of interest.
Nasoni will, to the extent possible, protect the confidentiality of disclosures. In every instance, Nasoni will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to Nasoni staff only on a need-to-know basis and will not be disclosed outside of Nasoni unless necessary to comply with contractual, legal, or regulatory requirements.
If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential financial conflict of interest), Nasoni may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research. In addition, for PHS-funded research, failure to comply with this policy or the applicable regulations shall result in the following:
Retrospective Review FAQs.
I.1. What is a retrospective review and when is it required? (Institution)
Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:
the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.
I.2 What are the key elements for documenting the retrospective review? (Institution)
The Institution shall document the retrospective review which must include at least the following key elements:
I.3 What should the Institution do if bias is found during the retrospective review? Is a mitigation report required? (Institution)
If bias is found, the Institution must notify NIH promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” (see FAQ H.2.). The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually as prescribed by the regulation.
Investigators receive training to promote objectivity in research and to ensure Investigator compliance regarding the applicable regulations and significant financial interest disclosure obligations. The training module and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site.
Investigators must complete training regarding this policy and the applicable regulations at the following times:
The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information consistent with Nasoni’s Record Retention policy. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by Nasoni with respect to each financial conflict of interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR PART 75.361, Subpart 4.7.
Steve Waddell
President & CEO
Nasoni, LLC
7007 Harbour View Blvd, Ste 117
Suffolk, VA, 23435
Phone: (757) 541-8032
Email: FCOI@nasoni.com
Nasoni’s Downloadable Disclosure Form