Objective research is of utmost importance to Enzyme by Design, our subaward partners, contractors, and vendors, to ensure public trust and to meet scientific, program, and ethical goals of our National Institutes of Health (NIH) grant efforts. To address the increasing complexities related to financial interests held by biomedical researchers, the Public Health Service (PHS) and the Office of the Secretary of the US Department of Health and Human Services (HHS) has published their final rules. Enzyme by Design and its affiliates believe we have fully addressed the requirements of this ruling and will continue to update this policy as necessary, particularly related to any changes in personnel FCOI issues or upon further DHHS guidance.
Effective December 1st, 2020, Enzyme by Design policy requires that each investigator, subrecipient, subgrantees and collaborators affiliated with Enzyme by Design, 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). In addition, this legislation spells out NIH’s commitment to preserving the public’s trust that the research support by them is conducted without bias and with the highest scientific and ethical standards. Enzyme by Design intends to use this same FCOI standard for all other Federal agency grant and contract efforts, as amended accordingly.
The following are key term definitions and Enzyme by Design’s policy guidance for principal or program investigators, subrecipients, subgrantees and collaborators affiliated with Enzyme by Design. This policy and all FCOI guidance are also available at www.enzymebydesign.com so that all interested parties, including the general public, have access to the Company Policy. In addition, this document is integrated into the employee handbook.
Investigator refers to the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH-funded research, including subgrantees, contractors, consortium participants, collaborators, or consultants.
Institution refers to any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, NIH research funding.
Training Requirement completion is required by Enzyme by Design and all defined sub-level vendors related to Financial Conflict of Interest (FCOI). If any conflicts of interest are found or know, 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 website (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm)
Significant Financial Interest (SFI) is defined by the regulation 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 reasonably appears to be related to the investigator’s institutional responsibilities
a.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 the disclosure, when aggregated, exceeds $5,000. For 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 includes any stock, stock option, or other ownership interest, as determined through reference to public prices; or other reasonable measures of fair market value;
b.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
c.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, a medical center, or a research institute that is affiliated with an institute of higher education. At minimum to be disclosed are as follows: the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Enzyme by Design’s 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 an FCOI with the PHS-funded research.
3)The term Significant Financial Interest does not include the following types of financial interest: salary, 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 retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles; income from the 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, 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.
Financial Conflict of Interest (FCOI) exists when Enzyme by Design reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
Disclosure refers to the investigator’s disclosure of Significant Financial Interest (SFIs) to their institution Enzyme by Design designated official(s) who will review all “disclosure” and evaluate whether they contain any FCOI. If no FCOI is found the “disclosure forms” will be filed electronically in the SFI Disclosures Folder. Information to include in the disclosure are:
1)The project number
2)The PD/PI or Contact PD/PI if there are multiple PD/PIs
3)The name of the investigator with the FCOI
4)The name of the entity with which the investigator has an FCOI
5)The nature of the financial interest, for example equity interest, consulting fee, travel reimbursement, honorarium.
6)The value of the financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value
a.When the value of the financial interest is given, the following dollar ranges are permissible: $0 to $4,999; $5,000 to $9,999; $10,000-$19,999, amounts between $20,000 and $100,000 by increments of $20,000; or amounts above $100,000 by increments of $50,000.
7)A description of how the financial interest relates to the research and the basis for the institution’s determination that the financial interest conflicts with such research
If any interests are identified as conflicting subsequent to the initial report, they must be reported to Enzyme by Design within 30 days. Each investigator must submit and 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, Enzyme by Design is required to disclose the conflict in each public presentation related to the results of the research.
Regulation or FCOI regulation refers to 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements.
Report refers to the institution’s report of identified FCOIs to the NIH. If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds. For any interests identified as conflicting subsequent to the initial report, Enzyme by Design will report any new disclosures to the PHS awarding component that has issued the award within 60 days.
Management of a FCOI refers to the action taken 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. Enzyme by Design’s management plan will include:
1.)The role and principal duties of the conflicted investigator in the research project
2.)The conditions of the management plan
3.)How the management plan is designed to safeguard objectivity in the research project
4.)Confirmation of the investigator’s agreement to the management plan
5.)How the management plan will be monitored to ensure investigator compliance
6.)Other information as needed
PHS Awarding Component refers to any sub-agency of the Public Health Service or Department of Health and Human Services.
Records Management refers to the maintenance of records of all financial disclosures and all actions taken by Enzyme by Design for a period of at least three years from the date of submission of the final expenditure report.
Research refers to 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 Enzyme by Design’s FCOI policy, within 120 days, Enzyme by Design shall complete a retrospective review of the investigator’s activities to determine bias. If a bias is found, Enzyme by Design 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. Enzyme by Design will work with the Investigator to set up an FCOI management plan to mitigate the situation. Company-wide, Enzyme by Design is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. The investigator may also lose the right to work on the project or receive any future NIH funding. Non-compliance with Enzyme by Design’s FCOI policy can also result in administrative action and employee sanctions, the nature of which will be determined by Enzyme by Design.
Point of Contact
If you have a conflict of interest or if you have a question to discuss regarding Enzyme by Design’s FCOI policy, contact Enzyme by Design’s designated officials Amanda Schalk and Arnon Lavie.