Spectragen Informatics, LLC (Spectragen) is committed to ensuring objectivity in the design, conduct, and reporting of research, including by following Public Health Service (PHS) Federal Regulations in the implementation of protocols, to ensure such research is free from bias, including those resulting from financial conflicts of interest (FCOI) of the individual. The PHS places the responsibility of Spectragen to manage, reduce and/or eliminate any FCOI, and to report such FCOIs to the PHS awarding component. It is the responsibility of all Spectragen employees, consultants, collaborators and subwardees engaged in scientific research to personally ensure that PHS funded research is performed objectively and without bias, including the completion of FCOI training, disclosure of significant financial interests (SFIs), and compliance with FCOI management plans. Persons failing to comply with this Policy shall be subject to sanctions as provided herein and by other applicable Spectragen and PHS policies and regulations.
Federal mandate requires that all PHS funded institutions maintain and implement an up to date, written policy on FCOI that complies with 42 CFR Part 50 Subpart F (for PHS-funded grants and cooperative agreements) and 45 CFR Part 94 (for PHS-funded contracts). This policy must be made available via a publicly accessible Web site, and the responsible institution must inform each investigator of the regulations as they pertain to the investigator's responsibilities regarding disclosure of SFIs. Institutions are also required to have each individual involved in scientific research complete FCOI training 1) prior to engaging in PHS-funded grant, 2) at least every four years, and 3) immediately when any of the following circumstances apply:
(1) The institution revises its FCOI policies or procedures in any manner that affects the requirements of investigators;
(2) An investigator is new to an institution; or
(3) An institution finds that an investigator is not in compliance with the institution's FCOI policy or management plan.
If the institution carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), the institution (awardee) must take reasonable steps to ensure that any subrecipient investigator complies, by incorporating, as part of a written agreement with the subrecipient, terms that establish whether the FCOI policy of the awardee institution, or that of the subrecipient, will apply to the subrecipient's investigators. If the subrecipient's investigators must comply with the subrecipient's FCOI policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with PHS regulations. If the subrecipient cannot provide such certification, subrecipient investigators are subject to the FCOI policy of the awardee institution for disclosing SFIs that are directly related to the subrecipient's work for the awardee institution. Reporting of FCOIs to the institution must be made in a timely manner, and in accordance with the institution’s federal FCOI reporting requirements to the PHS awarding component prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
Disclosure of significant financial interests means an investigator's disclosure of significant financial interests (SFI) to the awardee institution.
Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report means the awardee institution’s report of a financial conflict of interest to a PHS awarding component.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institution means any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, PHS research funding.
Institutional responsibilities means an investigator's professional responsibilities on behalf of the institution, and as defined by the institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards or data and safety monitoring boards.
Investigator means 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 the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.
PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
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). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
Significant financial interest (SFI) means:
(1) 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 appears to be related to the investigator's institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must disclose the occurrence of 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 their 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, an 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 an Institution of higher education. The institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest (SFI) does not include the following types of financial interests: salary, royalties, or other remuneration paid by the institution to the investigator if the investigator is currently employed or otherwise appointed by the institution, including intellectual property rights assigned to the institution and agreements to share in royalties related to such rights; any ownership interest in the institution held by the investigator, if the institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an 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 an institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an 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 an institution of higher education. Please note: these exemptions ONLY apply to domestic entities. Investigators must disclose all financial interests received from a foreign Institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).
All Spectragen employees, consultants, collaborators and subwardees engaged in scientific research must complete FCOI training 1) prior to engaging in PHS-funded research, 2) at least every four years, 3) if the FCOI policy and procedures have been revised, and 4) if Spectragen determines that the investigator is not in compliance with the FCOI policy or an agreed upon SFI management plan.
Federal regulations require that all Spectragen employees, consultants, collaborators and subwardees engaged in PHS-funded Spectragen awards, must complete and email an SFI disclosure to the Spectragen FCOI Officer prior to engaging in any PHS-supported Spectragen research. In addition, investigators must submit an updated disclosure of SFI by January 30th of each year during an active award period. Lastly, should any changes occur to the SFI status of the individual, an updated disclosure, including any additional attachments, must be emailed to the Spectragen FCOI Officer within 30 days of a newly identified SFI.
Please fill out the attached form:
If a SFI has been identified, please fill out the appropriate attachment:
Review of SFI Disclosures & Management of FCOIs
As is consistent with 42 CFR Part 50 Subpart F, the Spectragen FCOI Officer, with support from the Spectragen President, will review all investigator disclosures of SFI to determine whether an investigator SFI is related to Spectragen’s PHS-funded research in that it could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. A FCOI exists when the Spectragen FCOI Officer and President reasonably determine that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded Spectragen research.
If an FCOI is determined, the Spectragen FCOI Officer and President, in cooperation with the investigator, will develop a management plan to manage, reduce or eliminate the FCOI. The final approval of the Spectragen FCOI Officer and Spectragen President will be required for this process. As described in the regulation, and in the NIH Grants Policy Statement 4.1.10 Financial Conflicts of Interest, examples of how FCOIs might be addressed include but are not limited to, the following:
Further, if the investigator is involved in research involving human subjects, the appropriate institutional review board (IRB) will be notified of the FCOI, and will have the opportunity to require additional management strategies to address the rights and protection of human subjects participating in the research.
All investigators conducting research under a FCOI management plan managed by Spectragen must meet annually with the Spectragen FCOI Officer and President to review and update their FCOI disclosure(s) and related management plan(s). The Spectragen FCOI Officer will also work with the investigator to identify all current research activities that are related to the investigator’s FCOI. Further, the SI FCOI Officer will keep a record of investigator disclosures of SFI and a record of the review of, and response to, such disclosure and all actions under this Policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the subaward and relevant PHS regulations.
Spectragen will report to the PHS awarding component any identified FCOIs of investigators working on PHS-supported Spectragen research 1) prior to the receipt of an award, 2) annually at the time of the annual progress report, and 3) at the time of extension, is applicable. Additionally, Spectragen will submit a report for a new investigator with an FCOI, or a newly identified FCOI with an existing investigator, within 60 days of FCOI identification, and following a retrospective review to update a previously identified report as appropriate. If an FCOI in PHS-funded Spectragen research for an investigator is newly identified, the following will be made available within 60 business days to the PHS awarding component:
As per federal regulation, Spectragen will also make available the above information concerning identified FCOIs held by senior/key personnel on any PHS-funded Spectragen award, publicly accessible prior to the expenditure of funds. This information shall be posted on the Spectragen website, updated annually and remain available for 3 years from the final expenditure on the award. All newly identified FCOIs for senior/key personnel will be posted within 60 days. Lastly, FCOI information for senior/key personnel will be made available within 5 calendar days of a written request.
Consequences for Noncompliance
If an FCOI is not identified or managed in a timely manner, including if 1) an investigator fails to disclose a SFI that is determined by Spectragen to be a FCOI, 2) Spectragen fails to review or manage an identified FCOI, 3) an investigator fails to comply with a FCOI management plan, Spectragen shall, within 120 days of the determination of noncompliance, complete a retrospective review of the investigator's activities and the PHS-funded research to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Spectragen will document the retrospective review by recording the following information:
Based on the results of the retrospective review, if appropriate, Spectragen shall update the previously submitted FCOI report, specifying the actions taken to manage the FCOI going forward. If bias is found, Spectragen will notify the PHS awarding component within 30 days of completion of the retrospective review, and include a mitigation report. The mitigation report shall include the retrospective review, a description of the impact of the bias on the PHS-funded research project and Spectragen’s plan of action(s) taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support actual or future harm; analysis of whether the research project is salvageable). If the Department of Health and Human Services determines that a PHS-funded Spectragen award of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with an FCOI that was not managed or reported by Spectragen as required by federal regulation, the investigator must 1) disclose the FCOI in each public presentation of the results of the research and 2) request an addendum to previously published presentations.
Any failure by an individual to adhere to the FCOI policy and federal regulations may be cause for disciplinary action, including removal from PHS-funded research activities, and, in severe cases, termination. Spectragen shall follow federal regulations regarding the notification of the PHS Awarding Component in the event an investigator has failed to comply with this policy. Any questions regarding this policy should be addressed to the Spectragen FCOI Officer:
Stefani T. Rudnick, Ph.D.
Managing Member & Co-Founder
Spectragen Informatics, LLC
business: (206) 842-4980
National Institutes of Health Office of Extramural Research. NIH Grants Policy Statement: 4.1.10 Financial Conflicts of Interest. (April 2021). <https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.10_financial_conflict_of_interest.htm?Highlight=fcoi>
National Institutes of Health Office of Extramural Research. (Accessed July 25, 2021). Policy and Compliance: Financial Conflict of Interest. <https://grants.nih.gov/grants/policy/coi/index.htm>
National Institutes of Health Office of Extramural Research. (December 3, 2018). New Financial Conflict of Interest Training Module Available. <https://nexus.od.nih.gov/all/2018/12/03/new-financial-conflict-of-interest-training-module-available/>
Kansas State University. (Accessed July 25, 2021). Conflict of Interest: Forms for PHS Sponsored Project Investigators. <https://www.k-state.edu/conflict/forms/phs.html>
The University of Texas Office of Research Support and Compliance, Office of the President of Research, Conflict of Interest Background and Policy (accessed July 25, 2021) <https://research.utexas.edu/ors/conflict-of-interest/>