1. Purpose
This policy establishes Aquilo Sports LLC's process for identifying, reviewing, managing, and reporting financial conflicts of interest related to Public Health Service (PHS), including National Institutes of Health (NIH), funded research. The purpose is to provide a reasonable expectation that the design, conduct, and reporting of PHS/NIH-funded research will be free from bias resulting from Investigator financial conflicts of interest.
2. Applicability
This policy applies to all PHS/NIH grants and cooperative agreements for which Aquilo Sports LLC applies or receives funding, except Phase I SBIR and Phase I STTR applications and awards. It applies to each Investigator who is planning to participate in, or is participating in, PHS/NIH-funded research.
For this policy, 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 PHS/NIH-funded research. This may include employees, consultants, collaborators, and subrecipient personnel when applicable.
3. Definitions
Financial Conflict of Interest
Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded research.
Significant Financial Interest
Significant Financial Interest (SFI) means a domestic or foreign financial interest of the Investigator, or the Investigator's spouse or dependent children, that reasonably appears to be related to the Investigator's institutional responsibilities and meets one of the following categories:
· For a publicly traded entity, remuneration received in the preceding 12 months plus the value of equity interests, when aggregated, exceeds $5,000.
· For a non-publicly traded entity, remuneration received in the preceding 12 months exceeds $5,000, or the Investigator holds any equity interest.
· Income from intellectual property rights and interests, such as patents or copyrights.
· Reimbursed or sponsored travel related to institutional responsibilities, unless excluded below. The disclosure must include, at minimum, the purpose of the trip, sponsor or organizer, destination, duration, and estimated value if known.
SFI does not include salary, royalties, or other remuneration paid by Aquilo Sports LLC to an Investigator currently employed or appointed by Aquilo; intellectual property assigned to Aquilo and royalty-sharing agreements related to such rights; ownership interests in Aquilo held by an Investigator because Aquilo is a commercial or for-profit organization; income from mutual funds or retirement accounts where the Investigator does not directly control investment decisions; or income from seminars, teaching, advisory committees, or review panels sponsored by a U.S. federal, state, or local government agency, U.S. institution of higher education, U.S. academic teaching hospital, U.S. medical center, or research institute affiliated with a U.S. institution of higher education.
Income or travel from a foreign government, foreign institution of higher education, or other foreign entity is not covered by the U.S.-institution exclusions above and must be disclosed when it otherwise meets this policy's disclosure requirements.
4. Policy
Aquilo Sports LLC will maintain, enforce, and publicly post this FCOI policy. Aquilo will inform Investigators of this policy, the applicable federal regulation at 42 CFR Part 50 Subpart F, and each Investigator's duty to disclose SFIs. Aquilo will review Investigator disclosures, determine whether an SFI is related to PHS/NIH-funded research, determine whether an FCOI exists, manage identified FCOIs, monitor compliance with management plans, and report FCOIs to NIH when required.
5. FCOI Official
Aquilo's VP, Finance, or a designated FCOI Official, is responsible for administering this policy. The FCOI Official may use a non-conflicted designee, outside counsel, or an independent compliance reviewer when the disclosure involves the FCOI Official, a senior company officer, or another situation where independent review is appropriate.
6. Training
Each Investigator must complete FCOI training before engaging in PHS/NIH-funded research, at least every four years thereafter, and immediately if Aquilo materially revises this policy, the Investigator is new to Aquilo, or Aquilo determines that the Investigator is not complying with this policy or an FCOI management plan.
Training includes review of this policy, Investigator disclosure obligations, and the federal FCOI regulation. Aquilo may use the NIH FCOI training module as part of this training and will maintain training records.
7. Investigator Disclosure Requirements
Each Investigator must disclose all SFIs, including domestic and foreign SFIs, that reasonably appear to be related to the Investigator's institutional responsibilities. Disclosures must be submitted:
· No later than the time of application for PHS/NIH-funded research;
· At least annually during the period of the award; and
· Within 30 days of discovering or acquiring a new SFI, including by purchase, marriage, inheritance, new consulting arrangement, equity grant, intellectual property income, or sponsored travel.
Disclosures must be submitted using Aquilo's SFI disclosure process or form and must include enough information for Aquilo to determine whether the SFI is related to the PHS/NIH-funded research and whether it constitutes an FCOI.
8. Review and Determination
Before any PHS/NIH funds are expended, the FCOI Official will review all Investigator SFI disclosures. The FCOI Official will determine whether each SFI is related to the PHS/NIH-funded research and whether it constitutes an FCOI.
An SFI is related to PHS/NIH-funded research when Aquilo reasonably determines that the SFI could be affected by the research or is in an entity whose financial interest could be affected by the research. Aquilo may involve the Investigator in determining whether the SFI is related to the research. An FCOI exists when Aquilo reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research.
9. Management of FCOIs
If Aquilo determines that an FCOI exists, Aquilo will develop and implement a written management plan before expenditure of PHS/NIH funds, or within 60 days for a newly identified FCOI. The management plan will describe the actions taken and to be taken to manage the FCOI and will remain in effect until the FCOI no longer exists or the PHS/NIH-funded project is completed.
Management actions may include public disclosure of the FCOI; disclosure to research personnel or, for human subjects research, to participants; appointment of an independent monitor; modification of the research plan; change in personnel responsibilities; disqualification from part or all of the research; reduction or elimination of the financial interest; or severance of the relationship creating the FCOI.
10. NIH Reporting
Aquilo will submit FCOI reports to NIH through the eRA Commons FCOI Module when required. Reports will be submitted before expenditure of PHS/NIH funds for any FCOI identified before funding is spent, within 60 days for newly identified FCOIs, and annually for previously reported FCOIs for the duration of the project period.
FCOI reports will include the information required by 42 CFR 50.605, including the project number, PD/PI, Investigator with the FCOI, entity involved, nature and value of the financial interest, description of how the financial interest relates to the research, and the key elements of the management plan. If an FCOI is eliminated before PHS/NIH funds are expended, Aquilo will not submit an FCOI report for that eliminated conflict unless otherwise required.
11. Noncompliance, Retrospective Review, and Mitigation
If an SFI was not disclosed or reviewed in a timely manner, or if an FCOI was not identified or managed in a timely manner, Aquilo will review the SFI within 60 days and, if an FCOI exists, implement an interim management plan.
If noncompliance may have affected PHS/NIH-funded research, Aquilo will complete and document a retrospective review within 120 days to determine whether the research, or any portion of the research, was biased in design, conduct, or reporting. If bias is found, Aquilo will promptly notify NIH and submit a mitigation report describing the impact of the bias and the actions taken or to be taken.
For clinical research evaluating the safety or effectiveness of an Aquilo medical device, diagnostic, or treatment, if the research was designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported as required, Aquilo will require the Investigator to disclose the FCOI in each public presentation of the research results and request an addendum to previously published presentations.
12. Subrecipients
When Aquilo carries out PHS/NIH-funded research through a subrecipient, Aquilo will include written FCOI terms in the subrecipient agreement. The agreement will state whether the subrecipient's FCOI policy or Aquilo's FCOI policy applies to subrecipient Investigators.
If the subrecipient uses its own policy, the subrecipient must certify that its policy complies with 42 CFR Part 50 Subpart F and must report identified FCOIs to Aquilo in time for Aquilo to meet NIH reporting deadlines. If the subrecipient cannot certify compliance, subrecipient Investigators will follow Aquilo's policy and disclose SFIs to Aquilo within the timeframe stated in the written agreement.
13. Public Accessibility
Aquilo will make this FCOI policy publicly accessible on its company website. The policy may be hosted on a legal, compliance, research, or policy page that is accessible by direct URL without login or special permission.
For any FCOI held by senior/key personnel that meets the public accessibility requirements of 42 CFR 50.605, Aquilo will make the required information publicly available by written response within five business days of a request, unless Aquilo elects to post the information directly on a public website. Publicly available FCOI information will be current as of the date provided, updated at least annually, updated within 60 days of newly identified FCOIs, and remain available for at least three years from the date the information was most recently updated.
14. Records
Aquilo will maintain records of all Investigator disclosures, reviews, determinations, management plans, FCOI reports, training records, retrospective reviews, mitigation reports, and related actions for at least three years from the date the final expenditure report is submitted to PHS/NIH, or longer when required by 2 CFR 200.334 or other applicable law or award terms.
15. Enforcement
Aquilo will enforce this policy through administrative actions appropriate to the circumstances. Actions may include additional training, written corrective action, restrictions on participation in PHS/NIH-funded research, modification of duties, suspension of research activities, employment or consulting consequences, or other corrective measures. Aquilo will notify NIH promptly when required by regulation or award terms.
16. Policy Review
Aquilo will review this policy periodically and update it as needed to remain consistent with 42 CFR Part 50 Subpart F, NIH Grants Policy Statement requirements, and related NIH guidance. This policy remains effective until revised or superseded.
