1. Purpose
Eliaz Therapeutics, Inc. (“ETI”) is committed to maintaining objectivity in its research activities. This document was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded by the government will be free from any bias resulting from a Financial Conflict of Interest of any Investigator. It establishes a process of Disclosure and independent review when an Investigator has a Significant Financial Interest (SFI). If ETI determines that such an interest might reasonably appear to affect the Research directly and significantly, ETI will develop a mitigation plan to manage or eliminate the conflict. This set forth Policy implements Financial Conflicts of Interest (FCOI) Disclosure requirements found in 42 CFR Part 50 and 45 CFR Part 94, both of which are applicable to Research funded by the U.S. Public Health Service (PHS).
2. Scope
These requirements are applicable to all Research projects for which ETI submits a proposal to or receives Research funding from PHS/NIH with the exception of Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) program applications or awards, where this policy does not apply.
3. Key Definitions
1. Clinical Trial means any PHS/NIH-sponsored research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.
2. Disclosure means disclosure of Financial Interests as per this Policy via the ETI FCOI Form.
3. Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse.
4. Financial Interest means any interest of economic value in or relationship with an entity, whether private or public, including, but not limited to, ownership of stocks, bonds, stock options, partnership or other equity interests, rights to patent or royalty payments, receipt of consulting fees, speaking fees, salary, loans, gifts, lectureship fees, compensation for serving on boards of directors, scientific and other advisory boards, reimbursed or sponsored travel expenses related to Investigator’s Company Responsibilities, or other remuneration.
5. Financial Interest does NOT include:
a. salary, royalties, or other remuneration from ETI;
b. income from the authorship of academic or scholarly works;
c. income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education; research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
d. equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.
For Investigators, this definition also includes any reimbursed or sponsored travel undertaken by the Investigator and related to his/her institutional responsibilities. This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.
6. Financial Conflict of Interest (FCOI) means a Significant Financial Interest (or, where the Institutional Official requires Disclosure of other Financial Interests, a Financial Interest) that ETI reasonably determines could directly and significantly affect the design, conduct or reporting of PHS- sponsored research.
7. Institutional Official means the individual within the Institution that is responsible for the solicitation and review of Disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s institutional responsibilities. For the purposes of this policy, the Institutional Official is designated as Anat Stern or Jose Teruel, Corporate Operations.
8. Institutional Responsibilities means an Investigator’s professional responsibilities performed on behalf of ETI.
9. Investigator means any individual who is responsible for the design, conduct, or reporting of PHS sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal Investigator or co-Investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants as appropriate.
10. Key Personnel means the Project Investigator and any other personnel considered to be essential to work performance.
11. PHS means the Public Health Service of the U.S. Department of Health and Human Services, which includes the National Institutes of Health (NIH), National Science Foundation (NSF), or US Food and Drug Administration (FDA), or proposals for such funding.
12. PHS Awarding Component means the organizational unit of the PHS that funds the Research.
13. 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 as well as product development.
14. Significant Financial Interest: means one or more of the following Financial Interests of an Investigator or their Family that reasonably appears to be related to such Investigator’s Institutional 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. 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.
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);
c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
4. Financial Conflict of Interest
This policy is predicated on the expectation that Investigators should conduct their affairs so as to avoid or minimize FCOIs, and must respond appropriately when FCOIs arise. To that end, this policy informs Investigators about situations that generate FCOIs related to research, provides mechanisms for Investigators and ETI to manage those FCOIs that arise, and describes situations that are prohibited. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of FCOI arises, an Investigator should discuss the situation with the Institutional Official.
1. Disclosure of Financial Interests
All Investigators are required to disclose their outside Financial Interests as defined above to ETI on an annual and on an ad hoc basis, as described below. The Institutional Official is responsible for the distribution, receipt, processing, review and retention of Disclosure forms.
a. Annual Disclosures
All Investigators must disclose their Significant Financial Interests that are related to the Investigator’s institutional responsibilities to ETI, through the Institutional Official, on an annual basis.
b. Ad hoc Disclosures
In addition to annual Disclosure, certain situations require ad hoc Disclosure. All Investigators must disclose their Significant Financial Interests to ETI, through the Institutional Official, within 30 days of their initial appointment or employment.Prior to entering into PHS/NIH-sponsored projects or applications for PHS/NIH-sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must affirm the currency of the annual Disclosure or submit to the Institutional Official an ad hoc updated Disclosure of his or her Significant Financial Interests with the outside entity. ETI will not submit a research proposal unless the Investigator(s) have submitted such ad hoc Disclosures.In addition, all Investigators must submit to the Institutional Official an ad hoc Disclosure of any Significant Financial Interest they acquire or discover during the course of the year within thirty (30) days of discovering or acquiring the Significant Financial Interest.
c. Travel
Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest and Significant Financial Interest. Such Disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Institutional Official will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a Financial Conflict of Interest with the Investigator’s research.
All ETI’s employees that meet the definition of Investigator are required to complete the disclosure form annually, even if they have no financial interest to report.
2. Review and Decision of the Institutional Official
If the Disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Institutional Official or designee for a determination of whether it constitutes a Financial Conflict of Interest. If a Financial Conflict of Interest exists, the Institutional Official will take action to manage the Financial Conflict of Interest including the reduction or elimination of the conflict, as appropriate.
A Financial Conflict of Interest will exist when the Institutional Official or designee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS/NIH- sponsored research. If the Institutional Official determines that there is a Financial Conflict of Interest that can be managed, he or she must develop and implement a written management plan. The affected Investigator must formally agree to the proposed management strategies and sign the written management plan before any related PHS/NIH-sponsored research goes forward.
The Institutional Official will periodically review the ongoing activity, monitor the conduct of the activity to ensure open and timely dissemination of the research results.
3. Clinical Trials - Review of Significant Financial Interests Related to Clinical Trials
Clinical trials involve particularly sensitive issues if the Investigator has a Financial Interest related to the clinical trial.
a. In the event of non-compliance with reporting and/or management of a Financial Conflict of Interest involving a PHS/NIH-sponsored clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment as required by this Policy, the Investigator must disclose the Financial Conflicts of Interest in each public presentation of the results of the affected PHS/NIH-sponsored research and request an addendum to previously published presentations.
4. Reporting to PHS/NIH
The institutional Official will report Financial Conflicts of Interest or non-compliance to PHS in accordance with PHS regulations. If the funding for the Research is made available from a prime PHS-awardee, such reports shall be made to the prime awardee prior to the expenditure of any funds and within 60 days of any subsequently identified Financial Conflict of Interest such that the prime awardee may fulfill their reporting obligations to the PHS.
5. Investigator Non-Compliance
a. Disciplinary Action
In the event of an Investigator’s failure to comply with this Policy, the Institutional Official may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the Institutional Official is implemented.
An Institutional Official’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the Institutional Official, will be described in a written explanation of the decision to the Investigator and, where applicable, the IRB, and will notify the individual of the right to appeal the decision. ETI will promptly notify the PHS Awarding Component of the action taken or to be taken. If the funding for the research is made available from a prime PHS awardee, such notification shall be made promptly to the prime awardee for reporting to PHS.
b. Retrospective Review
In addition, if the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, the Institutional Official or a committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the PHS/NIH-sponsored research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.
Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The Institutional Official will update any previously submitted report to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. This retrospective review will be completed in the manner and within the time frame established in PHS regulations. If bias is found, ETI will promptly notify the PHS Awarding Component and submit a mitigation report in accordance with the PHS regulations. The mitigation report will identify elements documented in the retrospective review, a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.
6. Training
Each Investigator must complete training on this Policy, the Investigator’s responsibilities regarding Disclosure and the PHS regulations prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, if the Investigator is new to ETI, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.
7. Record Retention
The Institutional Official will retain all Disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS/NIH or to the prime PHS/NIH awardee, unless any litigation, claim, financial management review, or audit is started before the expiration of the three year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken.
8. Confidentiality
To the extent permitted by law, all Disclosure forms, conflict management plans, and related information will be confidential. If ETI is requested to provide Disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this Disclosure.
9. Public Accessibility of FCOI
Prior to the expenditure of funds, ETI will publish on a publicly accessible website or respond to any requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
a. The Significant Financial Interest was disclosed and is still held by the senior and Key Personnel;
b. A determination has been made that the Significant Financial Interest is related to the PHS- funded research; and
c. A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.The information to be made available shall be consistent with the requirements of the PHS regulation.
10. Regulatory Authority
This policy implements the requirements of 42 CFR 50 Subpart F and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.
Questions or Comments relating to this policy should be addressed to ETI’s Corporate Operations team at info@eliaztherapeutics.com
