Quicksilver Biosciences Inc.  Company Policy – Financial Conflict of Interest (FCOI) Policy

 

December 1, 2020

 

Objective research, performed with care and integrity, is a very important requirement of Quicksilver Biosciences technology development goals.  This requirement extends to any subgrantees or vendors that our organization interacts with.  This is necessary in order to engender public trust and meet the ethical goals of our National Institutes Health (NIH) grant efforts.  The financial interests of biomedical researchers can be very complicated and the Public Health Service (PHS) and the Office of the Secretary of the U.S.  Department of Health and Human Services (HHS) has published rules governing these interests.  Quicksilver Biosciences (as well as any defined sub-level vendors) believes we are in full compliance with these regulations although we will continue to update this policy as needed.  Updates and revisions will accompany changes in personnel FCOI issues or additional DHHS guidance.

 

Effective December 1, 2020, Quicksilver Biosciences’ policy requires that each investigator, subrecipient, subgrantee and collaborator affiliated with Quicksilver Biosciences, by NIH or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts).  This legislation spells out NIH’s commitment to preserving the public’s trust that NIH-supported research is conducted without bias and with the highest scientific and ethical standards.  Quicksilver Biosciences intends to use this same FCOI standard for all other Federal agency grants and contracts modified in those instances where necessary.

 

 

Training

 

Quicksilver Biosciences and all vendors are required to complete training related to Financial Conflict of Interest.  If any conflicts of interest are found or known, they must be disclosed.  The training must be updated no-less than every four years 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.  (https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html).

 

 

Important Definitions

 

The following are key term definitions and Quicksilver Biosciences’ policy guidance for principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Quicksilver Biosciences.  This policy and all FCOI Quicksilver Biosciences guidance are also available at https://www.quicksilverbiosciences.com/fcoi so that all interested parties, including the general public have access to this policy.

 

 

Financial Conflict of Interest (FCOI) -- A Financial conflict of interest exists when Quicksilver Biosciences reasonably determines that a Significant Financial Interest (defined below) could directly and significantly affect the design, conduct or reporting of NIH-funded research.

 

Management of a FCOI – This means 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.

 

PHS Awarding Component -- The PHS awarding component is any sub-agency of the Public Health Service or Department of Health and Human Services.

 

Records Management -- The records of all financial disclosures and all actions taken by AmberGen will be maintained for at least three years from the date of submission of the final expenditures report.

 

Research -- PHS research is 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.

 

Investigator -- An Investigator is any person who is responsible for the design, conduct or reporting of research funded by PHS.  This includes subrecipients, subgrantees and collaborators.

 

 

What is a Significant Financial Interest?

 

Significant Financial Interest (SFI) is defined as 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 Investigators institutional responsibilities:

       

+ A Significant Financial Interest in a PUBLICLY TRADED ENTITY exists where 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, exceeds $5,000 in total.  This can include 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.

       

+ A Significant Financial Interest in a NON-PUBLICLY TRADED ENTITY exists if the value of any remunerations from the entity in the twelve months preceding the disclosure, exceeds $5,000 in total, 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).

 

+  INTELLECTUAL PROPERTY rights and interests (e.g.  patents, copyrights), upon receipt of any income related to such rights and interests.

   

 

A Significant Financial Interest also exists in cases where 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.

 

There is no requirement to disclose a Significant Financial Interest related 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.  Such an institution’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 Institution’s FCOI policy, the institutional 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.

   

 

A Significant Financial Interest is NOT represented by several other types of financial interests: salaries, royalties or other remuneration paid by the institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the investigator, if the Institution is a commercial or for profit organization; 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.

 

 

Disclosures and Reporting

 

Quicksilver Bioscience’s designated official(s) will review all “disclosure” and evaluate whether they contain any FCOI.  If no FCOI is found the “disclosure forms” will be scanned where applicable or otherwise stored in electronic format.  If a 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 Quicksilver Biosciences within 30 days.  Quicksilver Biosciences will then report it to the PHS 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 PHS-funded project is conducted by an investigator or SO with a conflict that was not disclosed or managed, Quicksilver Biosciences is required to disclose the conflict in each public presentation related to the results of the research.

 

 

Penalties for Non-Compliance

 

If an investigator fails to comply with Quicksilver Bioscience’s FCOI policy, within 120 days, Quicksilver Biosciences will review of the Investigator’s activities to determine bias.  If a bias is found, Quicksilver Biosciences will submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that will address the impact of the bias on the research project and the actions it has taken to mitigate the bias.  Quicksilver Biosciences will work with the Investigator to set up an FCOI management plan to mitigate the situation.  Quicksilver Biosciences is required to mandate disclosure by the Investigator FCOI in each public presentation with research results if it was otherwise reported explicitly.  In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.

Disclosure statements for submission are available here.