Financial Conflict of Interest Policy
Version 1.0 | Prepared October 20, 2026 | Effective date: October 21, 2026
Designated officials: Kanishk Tantia, CEO (Designated Institutional Official); Jolie Lerner (Alternate). Adopted effective October 21, 2026. The DIO is responsible for monitoring the public contact inbox.
Public FCOI contact: hello@cicada.bio
1. Purpose and scope
Cicada Health, Inc. (Cicada) will identify, manage, and report financial conflicts of interest (FCOIs) in research proposed for or supported by Public Health Service (PHS) grants and cooperative agreements, including NIH awards, under 42 CFR Part 50, Subpart F. This policy applies to NIH CATALYZE R61/R33 applications and awards. The regulatory exception for SBIR/STTR Phase I does not exempt CATALYZE.
An Investigator is anyone responsible for the design, conduct, or reporting of the research, regardless of title, employment status, salary support, or senior/key designation. This includes PD/PIs and may include collaborators, consultants, and other personnel. The Contact PD/PI and Designated Institutional Official (DIO) will identify the covered Investigators for each project.
Institutional responsibilities are an Investigator's professional responsibilities on behalf of Cicada, including research, research consultation, scientific or engineering leadership, supervision, analysis, reporting, and related professional services. Disclosures concern these responsibilities, not only a single grant or the Investigator's own assessment of a conflict.
2. Administration and recusals
The DIO solicits disclosures, determines relatedness and FCOI status, establishes and monitors management plans, maintains records, coordinates subrecipient compliance, and arranges required NIH reports and public responses. The Signing Official ensures institutional certifications and eRA Commons submissions are accurate. Cicada retains responsibility when it uses outside assistance.
Kanishk Tantia is the DIO; Jolie Lerner is the Alternate. Jolie reviews Kanishk's disclosures, and Kanishk reviews Jolie's, only when the reviewer has no personal or shared interest that compromises the review. No one reviews or approves their own disclosure, management plan, or noncompliance determination. When both officials are conflicted, Cicada's authorized governing body will designate a qualified, unconflicted outside reviewer with authority to make and document the determination. The reviewer must accept confidentiality obligations. Cicada will not expend affected PHS funds until required review and management are complete.
3. Significant financial interests and exclusions
Investigators must disclose domestic and foreign significant financial interests (SFIs) of themselves, their spouses, and dependent children that reasonably appear related to their institutional responsibilities. Aggregate the covered family interests in each entity. An SFI includes:
Publicly traded entities: remuneration received during the 12 months before disclosure plus the current value of equity, when the combined value exceeds $5,000. Remuneration includes salary, consulting fees, honoraria, paid authorship, and other payments for services; equity includes stock, options, or other ownership interests.
Non-publicly traded entities: remuneration received during the preceding 12 months exceeding $5,000, or any equity interest, regardless of value. Report equity even if its value cannot reasonably be determined.
Intellectual property: rights and interests, such as patents or copyrights, upon receipt of related income, subject to the exclusions below.
Travel: reimbursed or sponsored travel related to institutional responsibilities, including travel paid directly on the Investigator's behalf. Disclose the purpose, sponsor/organizer, destination, dates, and duration. Report the amount if known; an unknown amount does not excuse disclosure. The DIO may request further information to assess relatedness and FCOI status. No monetary disclosure threshold applies to otherwise reportable travel under this policy.
The SFI definition excludes salary, royalties, or other remuneration paid by Cicada to an Investigator currently employed or otherwise appointed by Cicada, including IP assigned to Cicada and royalty-sharing agreements for that IP; and ownership interests in Cicada held by the Investigator because Cicada is a for-profit institution. Founder ownership or proposed Cicada salary alone is not automatically a reportable SFI or FCOI under this policy. These exclusions do not cover outside entities, a separate university's disclosure rules, or other corporate conflict requirements.
The definition also excludes income from mutual funds and retirement accounts when the Investigator does not directly control the investment decisions; and income from seminars, lectures, teaching, advisory committees, or review panels sponsored by U.S. federal, state, or local government agencies, U.S. institutions of higher education as defined in 20 USC 1001(a), academic teaching hospitals, medical centers, or research institutes affiliated with such institutions. The same qualifying U.S. sponsors are excluded from the travel disclosure requirement. Foreign equivalents do not receive these exclusions. Other remuneration from these entities is not automatically exempt.
If unsure whether an exclusion applies, disclose the facts for review rather than certify that no reportable interests exist. Disclosure does not by itself establish an FCOI.
4. Disclosure deadlines and training
Each covered Investigator submits a complete, dated disclosure, including an affirmative statement if no SFIs or reportable travel exist, no later than application submission. Initial disclosure covers the preceding 12 months of remuneration, IP income, and reportable travel, plus equity held on the disclosure date. The Investigator updates the disclosure at least annually during the award, including changes to previously reported interests, and within 30 days of discovering or acquiring a new SFI (including by purchase, marriage, or inheritance). Report new covered travel within 30 days of its occurrence. New project Investigators disclose before participation so Cicada can meet its review deadlines.
Cicada informs each Investigator of this policy, the federal regulation, and disclosure responsibilities. Each Investigator completes FCOI training before engaging in PHS-funded research, at least every four years, and immediately upon joining Cicada, a policy change affecting Investigator requirements, or a finding of noncompliance with the policy or a management plan. Training includes the NIH FCOI tutorial or equivalent regulatory instruction and instruction on Cicada's policy. Cicada retains completion records and policy acknowledgments. Research-security training and SciENcv certifications do not replace FCOI training or institutional disclosures.
5. Review and management
Before any PHS funds are expended, the unconflicted reviewer reviews all disclosures, determines whether each SFI relates to the funded research, and determines whether an FCOI exists. An SFI relates to the research if it could be affected by the research, or if the entity in which the interest is held could be affected. An FCOI exists when an SFI could directly and significantly affect the design, conduct, or reporting of that research. The reviewer may consult the Investigator but makes and records the determination and its rationale.
For each FCOI, Cicada implements a written management plan before expenditure. Depending on the facts, controls may include disclosure in publications and presentations or to research participants, independent monitoring, changes to the research plan or personnel duties, disqualification from affected work, reduction or elimination of an interest, or severance of a relationship.
The plan records the Investigator's role and duties, conditions, how the controls protect research objectivity, the Investigator's agreement, responsible monitor, review schedule, and compliance evidence. Cicada monitors compliance throughout the project. A disagreement or appeal does not suspend the controls or federal deadlines.
During an ongoing project, Cicada reviews newly disclosed or newly identified SFIs within 60 days, determines relatedness and FCOI status, and implements at least interim management if needed. This includes new Investigators and previously undisclosed or unreviewed interests. Cicada may restrict affected activities while review is pending.
6. Reporting to NIH
The authorized FCOI official submits reports through the eRA Commons FCOI Module before expenditure of NIH funds for an identified FCOI and within 60 days for a subsequently identified FCOI. An FCOI eliminated before any expenditure need not be reported, but Cicada retains its review record. No report is required solely because a disclosure was submitted or no FCOI was found.
Reports include the project number; PD/PI or Contact PD/PI; Investigator and entity names; nature and value of the interest (or why it cannot reasonably be valued); its relationship to the research; the basis for the FCOI determination; and management-plan details, including duties, controls, safeguards, Investigator agreement, and monitoring.
For each previously reported FCOI, Cicada submits annual reports describing its status, management-plan changes, or why it no longer exists, at the time and in the manner NIH specifies. Reporting continues for the project period, including funded and unfunded extensions.
7. Subrecipients
Each written subaward identifies whose FCOI policy governs the subrecipient's Investigators. If the subrecipient uses its own policy, it certifies that the policy complies with 42 CFR Part 50, Subpart F. Cicada obtains identified FCOI information, not routinely every individual financial disclosure. If the subrecipient cannot certify a compliant policy, the agreement requires its Investigators to follow Cicada's policy for SFIs directly related to their subaward work.
The agreement sets specific disclosure or FCOI-report deadlines early enough for Cicada to meet its own review, management, public-access, and NIH reporting deadlines. Cicada will not authorize expenditure before required initial reports and management are complete. The DIO tracks subsequent and annual reports and submits required reports to NIH for subrecipient Investigators. For CATALYZE, Rice and UML may use their institutional policies once the required institutional assurances and agreement terms are confirmed; no duplicate Cicada disclosure is automatically required.
8. Public access and confidentiality
Cicada posts its adopted, current policy on its publicly accessible website and submits the policy PDF through the eRA Commons Institution Profile, Policy Documents section. Cicada keeps both copies current. The exception allowing policy delivery within five business days instead of website posting applies only if Cicada has no publicly accessible website presence.
For an SFI still held by senior/key personnel that Cicada determines is related to PHS-funded research and is an FCOI, Cicada will provide the required public information by written response within five business days of a request. This process must be operational before expenditure. Each response states its date, that information may change, and that later information may be requested. Records are updated at least annually and within 60 days of identification of a new FCOI.
The public response includes the Investigator's name, project title/role, entity name, nature of the interest, and approximate dollar value or a statement that fair value cannot readily be determined. Permitted value ranges are $0-$4,999; $5,000-$9,999; $10,000-$19,999; $20,000-$100,000 in $20,000 increments; and amounts above $100,000 in $50,000 increments. Information remains available for at least three years after its most recent update.
Individual disclosure forms and supporting records remain in restricted-access storage, separate from public policies and general proposal folders. Access is limited to authorized reviewers, administrators, and others with a lawful need. Cicada provides records promptly to NIH/HHS on request and makes legally required public disclosures. It does not promise absolute confidentiality.
9. Noncompliance, retrospective review, and enforcement
Cicada may require corrective disclosure or training, restrict duties or spending, remove an Investigator from affected work, or impose disciplinary or contractual measures consistent with applicable law. The unconflicted reviewer documents noncompliance, corrective action, and follow-up. Investigators must not retaliate against good-faith reporting.
When an FCOI was not identified or managed timely, including failures of disclosure, review, reporting, or compliance with a management plan, Cicada completes a retrospective review within 120 days of its determination of noncompliance to determine whether research during the affected period was biased. The record includes project number and title, Contact PD/PI, Investigator and entity names, reason for review, detailed methodology, findings, and conclusions.
Cicada updates the FCOI report as appropriate. If bias is found, Cicada promptly notifies NIH and submits a mitigation report containing the retrospective-review elements, impact of the bias, extent of actual or potential harm, whether the research remains usable, and the actions to eliminate or mitigate the effects. If an Investigator's noncompliance appears to have biased research, Cicada promptly notifies NIH of corrective actions taken or planned. Annual reporting continues.
If HHS determines that clinical research evaluating the safety or effectiveness of a drug, device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, Cicada requires disclosure in each public presentation of results and requests addenda to prior publications, as required by 42 CFR 50.606(c). This standing policy provision does not classify the current CATALYZE project as clinical research.
10. Records, oversight, and adoption
Cicada retains all disclosures, review decisions (including no-FCOI decisions), management plans, training and reporting records, and retrospective-review records for at least three years from submission of the final expenditure report, or longer when required by 2 CFR 200.334, an audit, litigation, award terms, or another applicable rule. The DIO reviews this policy at least annually and tracks changes in federal requirements.
The AOR may certify institutional compliance in an application only when Cicada has an up-to-date, written, enforced process in effect. Adoption of this policy does not itself establish that disclosures, training, publication, Commons upload, or required reports have been completed.