Financial Conflict of Interest (FCOI) Policy
Financial Conflict of Interest (FCOI)
Regulation or FCOI regulation:
Significant Financial Interest (SFI):
- With regard to any publicly traded entity a SFI 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value;
- With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remunerations from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator/senior/key personnel (or the Investigator/senior/key personnel ’s spouse or dependent children) holds any equity interests (e.g. stock, stock options, or other ownership interest) or
- Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
- Investigator/senior/key personnel s also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator/senior/key personnel and not reimbursed to the investigator/senior/key personnel so that the exact monetary value may not be readily available) related to their responsibilities to Cognition; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by 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, medical center, or research institute that is affiliated with an Institution of higher education. Cognition’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with Cognition’s FCOI policy, Cognition Designated Official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.
- The term significant financial interest (SFI) does not include the following types of financial interests: salaries, royalties or other remuneration paid by Cognition Therapeutics, Inc. to the investigator/senior/key personnel if the investigator/senior/key personnel is currently employed or otherwise appointed by Cognition, including intellectual property rights assigned to Cognition and agreements to share in royalties related to such rights; any ownership interest in Cognition held by the investigator/senior/key personnel; income from investment vehicles, such as mutual funds and retirements accounts, as long as the investigator/senior/key personnel does not directly control the investment decisions made in these vehicles; income from seminars, lectures or teaching engagements sponsored by 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, 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.
Small Business Innovation Research (SBIR):
IV. POLICY AND MANAGEMENT
- Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g. sale of an equity interest);or
- Severance of relationships that create financial conflicts; and
- Cognition Therapeutics, Inc. shall review the proposed action plan or management plan and can approve, modify and approve additional work. Final review and determination must be completed prior to the expenditure of any PHS funds for the applicable Research.
V. TRAINING, REPORTING, AND RECORD KEEPING
- Prior to engaging in research related to any PHS-funded grant,
- At least every 4 years, and
- Immediately if:
- Cognition revises the FCOI Policy in a manner that affects requirements of investigator/senior/key personnel,
- An investigator/senior/key personnel is new to Cognition, or
- An investigator is not in compliance with the FCOI Policy or management plan.
VI. ADDITIONAL CONSIDERATIONS
- Comply with the Cognition’s FCOI Policy, or
- Comply with the FCOI Policy of the subrecipient institution and have said institution certify that its policy complies with 42 CFR Part 50 Subpart F.
The written agreement, under either policy, must specify the time period for the subrecipient to provide investigator/senior/key personnel disclosure and report of any FCOI to Cognition.
It is suggested that at least 30 days from the reporting deadline for Cognition’s annual disclosures, or in cases of discovery or acquiring new SFI a maximum of 10 business days be considered to which the subrecipient is to report to Cognition, to enable Cognition to comply timely with its review, management, and reporting obligations.
Cognition will provide FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient investigator/senior/key personnel s prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.