Objective research is of paramount importance to Cognition Therapeutics, Inc. (“Cognition”). Cognition’s financial conflict of interest (FCOI) policy meets the expectation that the design, conduct, and reporting of research will be free from bias resulting from financial interests. This policy provides a framework to comply with requirements of 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research” for which PHS Funding is Sought” (FCOI Regulation), of the Federal Register pertaining to PHS-funded research, and is intended to ensure the research is free from bias due to financial conflicts of interest, and that potential financial conflicts of interests are identified, managed, reduced, or eliminated.
This Policy describes types of Financial Conflict of Interest (FCOI), identifies when disclosure should be provided, and explains Cognition’s administration and enforcement procedures. The policy is applicable to Senior/Key Personnel/ Investigators as defined below, who participate in Cognition’s research. Participation includes having an active role in the development of protocols, the conduct of clinical trials, as well as the reporting of study results.
A financial conflict of interest related to Cognition’s activities may occur when an investigator/senior/key personnel employed or appointed by Cognition has a significant financial interest that compromises, or appears to compromise, that individual’s independence and objectivity in the discharge of his/her Cognition responsibilities in the design, conduct, or reporting of Cognition’s research. Investigators/senior/key personnel should avoid conflicts and the potential for conflicts resulting from financial arrangements with third parties that could have a special interest in a Cognition protocol.
Disclosure: Senior/key personnel/investigators are required to disclose SFIs (and those of the investigators, senior/key personnel’s immediate family). This disclosure will be made at least annually during the award period [to include any information that was not disclosed initially to Cognition or updated information regarding any previously disclosed SFI] and within 30 days of discovering or acquiring a new SFI (such as through purchase, marriage or inheritance).
Cognition will name “Designated Official(s)” to manage the FCOI policy. The designated official(s) will take 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.
If a determination is made that a FCOI exists Cognition’s Designated Official(s) will recommend a suitable action plan or management plan to eliminate or manage the FCOI consistent with the objectives of this policy.
The action plan shall provide for its periodic review and updating at least annually.
In the event that there is no reasonable way to manage a FCOI then the investigator/senior/key personnel may be prohibited from participating in the related Research until such a time as the FCOI is eliminated.
A conflict should be managed, reduced, or eliminated within sixty (60) days of its identification by designated official(s). Cognition’s Designated Official(s) shall be responsible for monitoring and enforcing any management plan.
This shall also apply when, in the course of an ongoing PHS-funded research project, an investigator/senior/key personnel who is new to participating in the research project discloses a significant financial interest or an existing investigator/senior/key personnel discloses a new significant financial interest to Cognition.
If a senior/key personnel/investigator fails to comply with Cognition’s FCOI policy, within 120 days of discovery by Cognition, Cognition shall complete a retrospective review of the senior/key personnel/investigator’s activities to determine potential bias.
If a bias is found, Cognition shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias.
Cognition will work with the investigator/senior/key personnel to set up an FCOI management plan to mitigate the situation.
Companywide, Cognition is required to mandate that senior/key personnel/investigator disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the investigator/senior/key personnel may lose the right to work on the project.
Training: All persons subject to the Cognition Financial Conflict of Interest Policy will be required to train on the policy by reading and affirming their understanding of, and intent to comply with the FCOI policy and every four (4) years thereafter. Immediate training will be required if Cognition revises this policy in a manner that affects the investigator/senior/key personnel, when an investigator/senior/key personnel is new to Cognition, or as a result of a finding of noncompliance with this policy or a management plan, or other related misconduct.
Cognition’s senior/key personnel or investigators/study directors may also demonstrate understanding of FCOI by using the NIH web-based training which can be accessed online.
Reporting: As required by 42 CFR Part 50, Subpart F, Cognition shall file a report with the NIH providing information on every identified FCOI and the manner in which the FCOI is being or has been managed, reduced, or eliminated. Reports shall include the elements required by these regulations. Cognition will notify NIH promptly if bias is found with the design, conduct, or reporting of NIH-funded research, and file a Mitigation Report in accordance with federal regulations.
Records Management: The records of all financial disclosures and all actions taken by Cognition will be maintained for at least three years from the date of submission of the final expenditures report.
Subrecipients: When carrying out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), Cognition must incorporate by written agreement (e.g., subaward contract) that the investigator/senior/key personnel of the subrecipient institution is required to either:
Cognition’s Financial Conflict of Interest Policy shall be posted on the public portion of the Cognition website. In addition, upon receipt of a written request for information concerning identified FCOI’s held by Senior/Key Personnel (as defined by regulation), Cognition will make that information available within five (5) business days of the request. The information shall include all elements required by 42 CFR Part 50, updated through the date of the response.