Policy
It is the policy of CND Life Sciences, Inc. (“CND” or the “Institution”), to ensure the integrity of any research it conducts or participates in and eliminate biases in the design, conduct, and reporting of such research resulting from financial conflicts of interest.
Objective
This Financial Conflicts of Interest Policy (Policy) sets forth CND’s processes and procedures for identifying and managing financial conflicts of interest related to research funded by the US Public Health Service (“PHS”). It is intended to comply with federal laws and regulations concerning disclosure and management of financial interests held by individuals and entities who participate in Research funded, in whole or in part, by PHS, including, without limitation, the requirements of 42 C.F.R. Part 50, Subpart F.
Individuals responsible for implementing and executing this Policy should refer to 42 C.F.R. Part 50, Subpart F for details and specific instructions with respect to the various elements of this Policy or consult Institution’s General Counsel.
Definitions
As used in this Policy, the following terms have the meanings ascribed to them below:
Designated Official means an individual designated by Institution who is responsible for soliciting and reviewing disclosures of Significant Financial Interests from each Investigator who is planning to participate in, or is participating, in PHS-funded Research.
Financial Conflict of Interest (or FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded Research.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Institutional Responsibilities means an Investigator’s professional responsibilities performed on behalf of the Institution.
Investigator means the principal investigator, project director, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of Research funded, or proposed for funding, by the PHS, which may include collaborators or consultants.
PHS means the Public Health Service of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
Significant Financial Interest (or “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:
- 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 (12) months preceding the disclosure and the value of any equity interest- as determined through reference to public prices or other reasonable measures of fair market value, in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
- 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
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
3. Note: the term Significant Financial Interest does not include the following types of Financial Interests:
- salary, royalties, or other remuneration paid by Institution to the Investigator if the Investigator is currently employed or otherwise appointed by Institution, including intellectual property rights assigned to Institution and agreements to share in royalties related to such rights;
- any ownership interest in Institution held by the Investigator, if 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, or 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 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.
Capitalized terms used in this Policy and not defined herein shall be ascribed the meaning given to such terms in 42 C.F.R. § 50.603.
Disclosure Requirements for Investigators
- Initial Disclosure: Prior to participation in PHS-funded research, each Investigator shall submit a complete SFI disclosure to Institution.
- Annual Disclosure: Each Investigator shall submit an updated disclosure to Institution at least annually during the period of the award.
- Ad hoc Disclosure: Investigators shall disclose any newly acquired or discovered SFI to Institution within thirty (30) days.
- Institution may require an Investigator to report other types of financial interests (aside from financial interests defined in 42 CFR Part 50, Subpart F), such as those related to other Institution compliance policies.
Institutional Responsibilities
1. Disclosure Form, Review, and Management of Significant Financial Interests
1.1 Significant Financial Interest Disclosure Form. Investigators shall disclose their Significant Financial Interests using the Financial Conflicts of Interest Disclosure Form.
1.2 Review of Significant Financial Interests. Prior to the expenditure of any funds provided by PHS in connection with Research, the Designated Official will review each Investigator’s disclosures of Significant Financial Interests to determine whether an Investigator’s Significant Financial Interest is related to PHS-funded research and, if so, to determine whether the Significant Financial Interest is a Financial Conflict of Interest pursuant to 42 U.S.C. Part 50, Subpart F.
1.3 Management Plan. In any instance in which the Designated Official determines an Investigator has a Financial Conflict of Interest, the Designated Official will develop and implement a written management plan that specifies the actions taken, or that will be taken, by Institution and/or the Investigator to address the FCOI and ensure it does not bias the design, conduct, or reporting of any PHS-funded Research (the “Management Plan”). Thereafter, throughout the course of the applicable Research, the Designated Official will monitor the Investigator’s compliance with, and make any necessary adjustments to, the Management Plan, until completion of the Research.
a. Elements of Management Plan. Each management plan shall identify:
i. The conflicting interest;
ii. The conditions imposed (e.g., corrective or mitigating actions);
iii. Responsibilities of the Investigator;
iv. Monitoring procedures
v. Confirmation of the Investigator’s agreement to the Management Plan; and
vi. Consequences of noncompliance
b. Proposed Actions to Manage FCOI. The Management Plan shall specify the actions that have been and shall be taken to manage identified Financial Conflicts of Interest. Such actions may include one or more of the following conditions or restrictions:
i. Public disclosure of FCOIs (e.g., when presenting or publishing Research);
ii. For Research projects involving human subjects, disclosure of FCOIs directly to participants;
iii. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the Research against bias resulting from the FCOI;
iv. Modification of the Research plan;
v. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the Research;
vi. Reduction or elimination of the FCOI (e.g., sale of an equity interest); or
vii. Severance of relationships that create FCOIs.
c. Monitoring of Management Plan. Whenever the Institution implements a Management Plan, it shall monitor Investigator compliance with the Management Plan on an ongoing basis until the completion of the PHS-funded Research project.
1.4 Retrospective Review. Whenever a FCOI is not identified or managed in a timely manner: the Institution will, within 120 days of determining noncompliance, complete a retrospective review of the Investigator’s activities and PHS-funded research project to ascertain whether any PHS-funded research or portion thereof conducted during the period of noncompliance was biased in its design, conduct, or reporting.
2. Reporting Financial Conflicts of Interest
2.1 Institution shall submit FCOI reports to the applicable PHS Awarding Component as required by federal regulations.
2.2 Reports shall be submitted:
a. Before expenditure of funds for identified FCOI
b. Within sixty (60) days of identifying a new FCOI
c. Annually for the duration of the award
2.3 Reports shall contain all information required by applicable federal regulations (see 42 CFR Part 50, Subpart F).
3. Public Accessibility, Maintenance of Records
3.1 Accessibility of Policy. The Institution will make this Policy accessible to the public by posting an up-to-date version on its website.
3.2 Before expending any funds under a PHS-funded Research project, the Institution will ensure public accessibility (via a publicly accessible website or written response to any requestor within five (5) business days), in accordance with 42 C.F.R. 50.605, of information concerning any Significant Financial Interest disclosed to the Institution that meets the following three criteria: (a) the Significant Financial Interest was disclosed and is still held by the Investigator / Research Personnel; (b) the Institution determines that the SFI is related to the PHS-funded research; and (c) the Institution determines that the Significant Financial Interest is a FCOI.
3.3 Maintenance of Records. The Institution will maintain all records created under or required by this Policy–including, without limitation, disclosures of Financial Interests; documentation of Institution’s review of, and response to, such disclosures; and all actions taken under a Management Plan or retrospective re-view, if applicable-for no fewer than three (3) years from the later of:
a. The date the final expenditures report for the applicable Research is submitted to PHS;
b. The date the information is last updated; or
c. Where applicable, other dates specified in 45 CFR 75.361 or 2 F.R. § 200.334.
4. Training
4.1 Institution will require each Investigator engaged to participate in PHS-funded Research to receive training on this Policy, the Investigator’s disclosure responsibilities, and the provisions of 42 C.F.R. Part 50, Subpart F (including any other regulations identified in 42 C.F.R. § 50.607, as appropriate) as follows:
a. Prior to an Investigator’s engagement in research related to any PHS funded project;
b. Every four years; and
c. Immediately under the following circumstances:
i. The Institution’s FCOI policies change in a manner that affects the requirements for research personnel; or
ii. The Institution finds that Key Personnel is not in compliance with this FCOI policy or a Management Plan.
5. Subcontracts
Institution shall ensure that any Investigators of a sub-recipient involved with its PHS-funded research award (e.g., subcontractors or consortium members) will comply with the regulatory requirements of 42 CFR Part 50 Subpart F. A written agreement will establish whether the Institution’s FCOI Policy or the Sub-recipient’s FCOI Policy will apply to the Sub-recipient’s Investigators and will contain provisions that comply with 42 CFR Part 50, Subpart F, as amended from time to time.
Updated 6/16/26
