Curate BiosciencesTM Company Policy – Financial Conflict of Interest (FCOI) Policy
Objective research is of paramount importance to GPB Scientific, Inc., dba Curate Biosciences (“Curate Biosciences” or the “Company”), to ensure public trust and meet scientific, program and ethical goals of our National Institutes Health (NIH) grant efforts.
To address the increasing complexities related to financial interests held by biomedical and behavioral researchers, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (DHHS) have published their final rules on these issues. Curate Biosciences believes we have fully addressed the requirements (including those of our defined sub-level vendors and subgrantees) of this ruling although we will continue to update this policy as needed, particularly related to any changes in personnel, FCOI issues, or upon further PHS or DHHS guidance.
Effective July 1, 2022, Curate Biosciences’ policy requires that each investigator, subrecipients, subgrantees and collaborators affiliated with the Company, engaged on any NIH or other applicable grant or contract (a “Funded Project”), be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). The Company intends to use this same FCOI policy for all other Federal agency grant and contract efforts, as tailored or amended accordingly.
In addition, this legislation spells out NIH’s commitment to preserving the public’s trust that the research supported by them is conducted without bias and with the highest scientific and ethical standards. Therefore, the Company will make this policy and all the Company’s FCOI guidance available at https://www.curatebio.com/.
The following guidance is for principal or program investigators, subrecipients, subgrantees and collaborators affiliated with the Company. This document and the associated disclosure form have been released in the Curate Biosciences Quality Management Document Control System where training requirements for all employees engaged in such activities tracked and managed.
Curate Biosciences’ employees engaged in or managing all NIH collaborations, grants or activities and all defined sub-level vendors are required to complete training related to Financial Conflict of Interest (FCOI) by reading and understanding this policy as well as completing the NIH training on FCOI, accessed through the link: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
If any conflicts of interest are found or known, they must be disclosed. The training must be updated annually as part of each employees Quality Management System training, or as designated based on grant or role circumstances. Information and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site.
Investigator: An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct or reporting of a Funded Project.
Regulation: Refers to 42CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements.
Disclosure: Refers to the Investigators’ disclosure of Significant Financial Interests (SFIs) to their institutions.
Significant Financial Interest (SFI): is defined by the regulations as:
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 reasonable 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 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 (or the Investigator’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.
2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities; 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. The Company’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 the Company’s FCOI policy, the 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 Funded Project.
3. The term “Significant Financial Interest” does not include the following types of financial interests: salaries, royalties or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; any ownership interest in the Company held by the investigator; income from investment vehicles, such as mutual funds and retirements 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 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.
Financial Conflict of Interest (FCOI): A Financial Conflict of Interest exists when the Company reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct or reporting of a Funded Project.
Management of a FCOI: Taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
Awarding Component: Any sub-agency of the Public Health Service or Department of Health and Human Services providing a grant or contract for any Funded Project of the Company.
Disclosures/Reporting Process: The Company’s Designated Official(s) (Chief Financial Officer) will review all “disclosure” and evaluate whether they contain any FCOI.
- If no FCOI is found the “disclosure forms” will be filed in the SFI Binder.
- If an FCOI is identified, it will be put on the FCOI Report through the eRA Commons FCOI module prior to expending any funds.
- If any interests are identified as conflicting subsequent to the initial report they must be reported to the Company within 30 days. Curate Biosciences will then report it to the Awarding Component that has issued the award within 60 days.
Each investigator must submit an updated disclosure of an SFI not less than annually. If a Funded Project is conducted by an Investigator with a FCOI that was not disclosed or managed, the Company is required to disclose the FCOI in each public presentation related to the results of the research.
Records Management: The records of all financial disclosures and all actions taken by the Company will be maintained for at least three years from the date of submission of the final expenditures report.
Research: Any project governed by PHS regulation but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Compliance and Penalties for Non-Performance: If an Investigator fails to comply with the Company’s FCOI policy, within 120 days the Company shall complete a retrospective review of the Investigator’s activities to determine bias. If a bias is found, the Company 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 Funded Project and the actions it has taken to mitigate the bias. The Company will work with the Investigator to set up an FCOI management plan to mitigate the situation. Companywide, Curate Biosciences is required to mandate the 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 may lose the right to work on the project or receive any future NIH funding.
Point of Contact
If you have a conflict of interest or if you have a question to discuss, contact Curate Biosciences’ Designated Official at [email protected]