Atux Iskay Group LLC FCOI Policy
Atux Iskay Group LLC. FCOI Policy (24 November 2023)
Purpose
This FCOI policy documents the process for identifying and managing financial conflicts of interest, ensuring
the integrity of NIH-funded research at Atux Iskay Group LLC. It aligns with the Regulations (42 CFR Part 50
Subpart F) and adheres to the 2011 Revised Financial Conflict of Interest Regulation, which mandates
standards for unbiased research design, conduct, and reporting under NIH grants or agreements. Atux Iskay
Group LLC will enforce an FCOI policy that meets regulatory requirements to be eligible for NIH funding. The
regulation is available at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.
Definitions
These definitions are provided for understanding FCOI federal regulations. For official definitions, refer to 42
CFR 50.603.
Investigator – means the project director or principal investigator and any other person, regardless of title or
position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH,
which may include, for example, collaborators or consultants.
Institution – means any domestic or foreign, public, or private, entity or organization (excluding a federal
agency) applying for or receiving NIH research funding.
Financial conflict of interest (FCOI) – means a significant financial interest that could directly and significantly
affect the design, conduct, or reporting of NIH-funded research.
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 (company) responsibilities:
a. 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.
b. 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
c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such
rights and interests in excess of $5,000.
2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel in excess of $5,000
related to their company responsibilities; provided, however, that this disclosure requirement does not apply to
travel that is reimbursed or sponsored by Federal, state, or local government agency located in the United
States, an United States institution of higher education, an academic teaching hospital, a medical center, or a
research institute that is affiliated with an United States institution of higher education.
Note: Reimbursed or sponsored travel from a foreign government, which includes local, provincial, or
equivalent governments of another country or foreign institutions of higher education must be disclosed when
such income is more than $5,000. The details of the disclosure will include, at minimum, the purpose of the trip,
the identity of the sponsor/organizer, the destination, and the duration.
3. The term significant financial interest does not include the following types of financial interests:
a. salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is
currently employed or otherwise appointed by the Institution
b. intellectual property rights assigned to the Institution and agreements to share in royalties related to such
rights
c. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit
organization
d. 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
e. income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local
government agency located in the United States, a United States institution of higher education, an academic
teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of
higher education
f. income from any service on advisory committees or review panels for a Federal, state, or local government
agency located in the United States, a United States institution of higher education, an academic teaching
hospital, a medical center, or a research institute that is affiliated with a United States institution of higher
education.
Note: Income from seminars, lectures, or teaching engagements and from service on advisory committees or
review panels received from a foreign government, which includes local, provincial, or equivalent governments
of another country or foreign institutions of higher education must be disclosed when such income meets the
threshold for disclosure.
Responsibilities – means an Investigator's professional responsibilities on behalf of the Institution, and as
defined by the Institution, including but not limited to, 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.
Financial interest – means anything of monetary value, whether or not the value is readily ascertainable.
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.
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 NIH by the Institution
under the regulation.
Procedure
1. Training Requirements
a. Investigators involved in NIH-funded research must know Atux Iskay Group LLC’s FCOI policy, the relevant
federal regulations (42 CFR Part 50 Subpart F), and their disclosure obligations. The Principal Investigator
must identify all Investigators with disclosable SFIs and ensure the submission of an SFI Disclosure Form.
b. Investigators must complete training on 42 CFR Part 50 Subpart F and Atux Iskay Group LLC’s FCOI policy
before starting NIH-funded research, every four years, and immediately if the company's FCOI policy changes,
if they are new to the company, or if they breach the FCOI policy or management plan.
c. Training requires Investigators to acknowledge they've read:
i. Atux Iskay Group LLC's FCOI Policy.
ii. NIH’s FCOI tutorial on 42 CFR Part 50 Subpart F, necessary for all involved in NIH-funded projects. Training
is mandated before any NIH-funded research begins, after FCOI policy updates, upon non-compliance, or
when joining the company, and must be repeated every three years. The course can be accessed online at
any time by visiting: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
d. The FCOI Policy implementation includes:
i. Providing a written copy to each Investigator.
ii. Adding the policy to the company's secure shared drive and a public website.
2. Disclosure, Review, and Monitoring Requirements:
a. Investigators must report SFIs (including those of their spouses and dependent children) that are pertinent to
their institutional duties and meet or surpass the SFI criteria established by this policy:
i. At the NIH-funded research application stage
ii. Annually throughout the award duration
iii. Within 30 days of identifying or obtaining a new SFI.
b. The Founder, CEO or interim CEO of Atux Iskay Group LLC, serving as the designated institutional official,
is tasked with eliciting and evaluating SFI disclosures from Investigators (and those of the Investigator’s family)
connected to their institutional duties to ascertain any FCOIs. The designated institutional official is Dr Michael
Ohlmeyer, effective 24 November 2023.
i. An SFI Is related to NIH-funded research if the designated institutional official deems that it:
1. Might be influenced by the NIH-funded research; or
2. Belongs to an entity that could be impacted financially by the research.
ii. Investigators may participate in determining the relevance of the SFI to NIH-funded research.
iii. An FCOI is present if the designated institutional official believes that the SFI could notably sway the NIHfunded
research's design, conduct, or reporting. In such cases, appropriate actions will be considered based
on a SFI Disclosure Form, potentially necessitating a management plan that specifies the terms and conditions
to adhere to this policy (refer to Enforcement Mechanisms).
c. Should an SFI be identified as an FCOI, the company will manage it at its discretion, which might include
public disclosure, the appointment of an independent monitor, modifications to the research plan, or the
Investigator's removal from the NIH-funded research.
d. Before utilizing any NIH funds, the CEO is required to:
i. Assess all SFI disclosures from Investigators
ii. Decide whether any SFIs relate to the NIH-funded research
iii. Ascertain the existence of any FCOIs and, if they exist,
iv. Formulate and enforce a management plan to address the FCOIs.
e. Should a new Investigator join, or an existing Investigator report a new SFI in an NIH-funded research
project, the designated institutional official must, within 60 days, evaluate the SFI disclosures, ascertain the
presence of an FCOI, and if one is found, initiate a management plan outlining the measures taken and to be
taken to address the FCOI.
f. If the company discovers an SFI that an Investigator did not disclose in a timely manner or that the company
has not previously assessed during an ongoing NIH-funded research project, the designated institutional
official is required to, within 60 days, review the SFI disclosures, decide if an FCOI is present, and if affirmative,
implement a management plan detailing the actions undertaken and those planned for future management of
the FCOI.
g. The company is tasked with overseeing FCOIs for all Investigators, including those of a Subaward
Investigator, ensuring adherence to management plans until the research project is concluded.
3. Reporting Requirements to NIH
a. Atux Iskay Group LLC will submit initial, yearly, and updated FCOI reports containing all details mandated by
42 CFR Part 50 Subpart F to the NIH through the eRA Commons FCOI Module for both the Institution and its
subawardees, where relevant, as outlined below:
i. Before using any funds
ii. Within 60 days of discovering an FCOI for an Investigator who is new to the project
iii. Within 60 days upon finding new or previously unidentified FCOIs for current Investigators
iv. Annually, concurrent with the submission of the annual progress report, detailing the FCOI’s status and any
modifications to the management plan until the project’s conclusion
v. Following a retrospective review to amend an earlier report if additional information comes to light after the
review is completed.
b. Atux Iskay Group LLC will immediately inform NIH if any bias is detected in the design, execution, or
reporting of NIH-funded research. A Mitigation Report will be provided to outline steps taken to counteract the
impact of the bias in line with 42 CFR Part 50 Subpart F. The report will include all required components such
as the entity name, the Investigator with the FCOI, the nature and value of the SFI(s), among others, as
specified by 42 CFR Part 50 Subpart F.
c. Atux Iskay Group LLC will immediately inform NIH if an Investigator breaches Atux Iskay Group LLC’s FCOI
policy or if there's evidence suggesting that an FCOI management plan may have skewed the design,
execution, or reporting of NIH-funded research. The company is responsible for implementing necessary
corrective measures in response to any such noncompliance or influence on research outcomes.
4. Maintenance of Records
a. Atux Iskay Group LLC shall preserve all records pertaining to Investigator financial interest disclosures, and
the company’s examination and response to these disclosures—irrespective of whether a disclosure led to an
FCOI determination—along with all proceedings in accordance with the company's policy or retrospective
analysis, as applicable:
i. For a minimum of 3 years following the submission date of the final expenditure report to the NIH.
ii. Or, if relevant, from dates delineated in 45 CFR 75.361.
5. Enforcement Mechanisms and Remedies and Noncompliance
a. To manage, mitigate, or eradicate actual or potential conflicts of interest, the management plan might
necessitate various actions, including but not limited to:
i. Making significant financial interests known to the public.
ii. Independent evaluation of research protocols.
iii. Independent oversight of the research.
iv. Altering the research strategy.
v. Prohibiting participation in part or all of the funded research.
vi. Selling off significant financial interests.
vii. Cutting ties that pose actual or potential conflicts.
All management strategies must be endorsed by both the Investigator and Atux Iskay Group LLC’s designated
institutional official.
Should an Investigator fail to adhere to the FCOI policy or management plan of Atux Iskay Group LLC,
disciplinary or administrative measures will be enforced, which could include a formal reprimand, restrictions
on fund usage, forfeiture of compensation, or dismissal.
b. If there is noncompliance due to untimely disclosure or management of an SFI or an FCOI, Atux Iskay
Group LLC will conduct a retrospective assessment within 120 days to address:
i. Non-disclosure of a significant financial interest by the Investigator which the company deems to be an FCOI.
ii. The company's failure to evaluate or manage an FCOI.
iii. The Investigator's non-compliance with the FCOI management plan.
c. The retrospective review will be documented and will include, at minimum, the following:
i. Project number
ii. Project title
iii. PD/PI and contact information
iv. Name of Investigator with the FCOI
v. Name of the entity with which the Investigator has an FCOI
vi. Reasons for the retrospective review
vii. Detailed methodology used for the retrospective review (e.g., methodology of the review process,
composition of the review panel, documentation reviewed)
viii. Findings of the review
ix. Conclusions of the review.
d. If a project funded by NIH involves clinical research evaluating the safety or effectiveness of technology from
Atux Iskay Group LLC and is designed, conducted, or reported by an Investigator with an FCOI not managed
or reported as mandated by 42 CFR Part 50 Subpart F, Atux Iskay Group LLC will mandate that the
Investigator:
i. Reveal the FCOI in all public disclosures of the research findings.
ii. Seek an amendment to any previously published presentations of the research.
6. Subawardee Requirements
a. When applicable, Atux Iskay Group LLC will comply with all subawardee requirements according to 42 CFR
50.604(c) and NIH Grants Policy Statement 15.2.1.
b. Atux Iskay Group LLC will determine through a formal agreement if the subawardee will adopt Atux Iskay
Group LLC’s FCOI policy or their own. This will be specified in the relevant consortium agreement with the
subaward institution. If the subawardee’s policy is adopted:
i. Atux Iskay Group LLC will acquire confirmation that the subawardee’s FCOI policy is consistent with 42 CFR
Part 50 Subpart F
ii. Atux Iskay Group LLC will mandate in the subawardee consortium agreement that the subawardee must
promptly report any FCOIs of its Investigators to enable the company to fulfill reporting obligations to the NIH
as dictated by 42 CFR Part 50 Subpart F
iii. As an alternative, Atux Iskay Group LLC will include a provision in the subawardee consortium agreement
obligating the subawardee to submit and allow review of Investigator disclosures, assisting the company in
identifying, managing, and reporting FCOIs to the NIH.
7. Public Accessibility Requirements
Atux Iskay Group LLC will store the FCOI Policy on a publicly available website. The policy will:
a. Include 42 CFR Part 50 Subpart F's minimum elements.
b. Be accessible within 5 business days upon request
c. Be updated annually, with current information provided upon request
d. Be revised within 60 days following the identification of a new FCOI, with current information provided upon
request
e. Remain available for 3 years after the latest update.