The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of Soterix Medical (Company) research and to comply with federal regulations.
This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F). This regulation was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
Significant Financial Interests (SFI) (as defined below) shall be disclosed on the Significant Financial Interest Disclosure Form (Exhibit 1) by an Investigator requesting government-sponsored or company-sponsored funds for a research project or by an Investigator when a Significant Financial Interest arises during the course of research. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFI Disclosure Form annually.
It is the Principal Investigator's responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal or application for human subjects’ approval.
The Significant Financial Disclosure Form and supporting materials are forwarded to the Chief Financial Officer (CFO) for review. The Finance Department will be responsible for evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy.
Advance approval by the President or CFO is required prior to engaging in government-sponsored research. A SFI review must be completed before any expenses are incurred under an award.
Annual updates are required of all Investigators and key personnel participating in research. Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately to the CFO. Annual updates and newly acquired interests are reported using the Significant Financial Interest Disclosure Form.
The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes financial conflict of interest. This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Soterix Medical engaged in NIH-funded research or its compliance.
The course is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the training, a certificate of completion must be turned into the CFO. You should retain a copy for your records. This training is required prior to engaging in research relating to any NIH- funded grant or as deemed necessary by the Company due to changes in the FCOI policy, non- compliance of the Investigator/Key Personnel or new to the Company. At a minimum, the FCOI training shall be taken every three (3) years.
The following definitions are provided as a reference and are considered key definitions in understanding the federal regulations of FCOI. A complete list of official definitions can be found at 42 CFR 50.603.
Institution – means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for, or receiving NIH research funding.
Investigator – means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, which may include, for example, collaborators or consultants.
Institutional responsibilities – means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Financial interest – means anything of monetary value, whether or not the value is readily ascertainable.
Financial conflict of interest (FCOI) – means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
Manage – means taking 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.
Senior/Key Personnel – means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the regulation.
Significant Financial Interest (SFI) –