Effective: December 1st, 2020
Last updated: July 7th, 2021
Objective research is of paramount importance to Bridge12 Technologies, Inc. to ensure public trust and meet scientific, programmatic 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 (HHS) have published final rules. Bridge12 Technologies, Inc. believes we have fully addressed the requirements of this ruling and we will continue to update this policy as needed, particularly related to any changes in personnel, FCOI issues, or upon further HHS guidance.
Bridge12 Technologies, Inc.’s policy requires that its investigators and collaborators be in compliance with 42 CFR Part 50, Subpart F, for PHS grants and cooperative agreements and 45 CFR Part 94 for contracts. These enforce NIH’s commitment that the research it funds is conducted without bias and with the highest scientific and ethical standards. Bridge12 Technologies, Inc. intends to use this same FCOI standard for all other Federal agency grant and contract efforts, as tailored or amended accordingly. The following are key term definitions and Bridge12 Technologies, Inc.’s policy guidance for principal or program investigators, as well as collaborators affiliated with Bridge12 Technologies, Inc.
An Investigator is any person who is responsible for the design, conduct or reporting of research funded by PHS.
Significant Financial Interest is defined by the regulations as:
A financial conflict of interest exists when Bridge12 Technologies, Inc. reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct or reporting of NIH-funded research.
The PHS awarding component is any sub-agency of the Public Health Service or Department of Health and Human Services.
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.
PHS regulations and guidance require specific processes for compliance, not simple recitation of requirements.
Bridge12 Technologies, Inc. is required to complete training of its Investigators related to FCOI: the regulations, our Policy, and the Investigator’s disclosure responsibilities. The training must be given to each Bridge12 Technologies, Inc. Investigator (i) upon the effective date of this Policy, (ii) for each new Investigator upon hire, (iii) each time we change requirements for Investigators in this Policy (to the extent required to train the investigators on the new material implemented), (iv) whenever an Investigator has been found not to be following this policy, and (v) no less than every four years or as designated based on grant or role circumstances. Bridge12 Technologies, Inc. training will use information and other resources developed by NIH, presently at https://grants.nih.gov/grants/policy/coi/index.htm
If any financial conflicts of interest (FCOIs) are found or known, they must be disclosed. Prior to application for a PHS grant, and not less than annually during grant performance, all Bridge12 Technologies, Inc. Investigators will review their financial interests and disclose all Significant Financial Interests to the Bridge12 Technologies, Inc. Head of Grants or her designee. Any Investigator who is new to participating in a research project will review the financial interest policy and disclose all Significant Financial Interests to the Bridge12 Technologies, Inc. Head of Grants or her designee, prior to beginning effort on the grant. The Bridge12 Technologies, Inc. Head of Grants, or her designee, will solicit a disclosure from any grant Investigator from whom a required disclosure has not been received.
Prior to beginning performance of a grant project, Bridge12 Technologies, Inc.‘s Head of Grants and CEO, or their designees, will review all disclosures, and determine whether they contain any FCOI as defined above and in PHS regulations. All disclosure forms will be filed in a Bridge12 Technologies, Inc. SFI file. If a FCOI is identified it will be put on the FCOI report through PHS’s eRA Commons FCOI module as promptly as practicable, and prior to expending any grant funds. See also Management, below.
If, subsequent to the initial report through PHS’s eRA Commons FCOI module, a previously unreported SFI is disclosed or discovered by a Bridge12 Technologies, Inc. Investigator, or any other employee, office, agent, or subawardee of Bridge12 Technologies, Inc., such FCOI must be reported to Bridge12 Technologies, Inc. within 30 days. Bridge12 Technologies, Inc.’s Head of Grants and CEO, or their designees, will review and then report any actual FCOI as promptly as practical, and within 60 days, to the PHS awarding component that issued the award. See also Management, below.
Designees may be necessary where, for example, the Head of Grants or the CEO will have some role in reporting research results, and thus is an “investigator” under the regulations and must submit a disclosure of SFIs.
The records of all financial disclosures and all actions taken by Bridge12 Technologies, Inc. will be maintained in an SFI binder or binders, for at least three years from the date of submission of the final expenditures report for each PHS research grant, and throughout the completion of any litigation, claim, negotiation, audit or other action involving the records, whichever date is later. The Head of Grants is responsible to ensuring that records are placed in SFI binders and maintained the required time. SFI files may state a disposition date (the latest date) when they are full; such legends must be updated if a litigation, claim, negotiation, audit or other action involving the records require a later disposition date.
Bridge12 Technologies, Inc‘s designated official(s) will take case-by-case action to address each FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. Being a small company, this process must be adaptable, but in the event of any identified FCOI, must include either reducing or eliminating the FCOI, must include monitoring each Investigator to ensure compliance with management plan requirements, must include reporting promptly to NIH any discovery of noncompliance or other bias related to an enacted management plan, and must include reporting on the FCOI as described above and at least annually thereafter (during the grant performance) in time for the funding PHS Institution’s annual report.
If a PHS-funded project is conducted by an Investigator with a conflict that was not disclosed or managed, Bridge12 Technologies, Inc. will disclose the conflict in each public presentation related to the results of the research, and request an addendum to each previously published presentation. Any research that is performed despite an FCOI causes a requirement to publish details of the FCOI on the Bridge12 Technologies, Inc. web page, and to update the details annually on the web page, within 60 days of newly discovered FCOI, and remaining for at least three years from the most recent update. Note that it is Bridge12 Technologies, Inc. policy not to permit research to proceed with an FCOI; if FCOIs are avoided, such a publication requirement will not be triggered.
If an investigator fails to comply with Bridge12 Technologies, Inc.‘s FCOI policy, within 120 days, Bridge12 Technologies, Inc. shall complete a retrospective review of the Investigator’s activities to determine bias. If a bias is found, Bridge12 Technologies, Inc. shall report a mitigation plan to the NIH, as described in Processes, above. Bridge12 Technologies, Inc. will work with the Investigator to set up an FCOI management plan to mitigate the situation. Companywide, Bridge12 Technologies, Inc. is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported to NIH at the outset. In extreme cases of bias or noncompliance, the Investigator may lose the right to work on the project or receive any future NIH funding, and/or be terminated by Bridge12 Technologies, Inc.
Bridge12 Technologies, Inc.’s Policies Procedures For Federal Grant Subrecipients apply to all subrecipient awards (“subawards”) by Bridge12 Technologies, Inc. In addition, subawards for research funded by a PHS Institution will establish in that written agreement that the subrecipient will have and follow its own FCOI policy, compliant with PHS regulations, and will require the subrecipient to report FCOIs it has discovered for its Investigators (or those of its own subrecipients) to Bridge12 Technologies, Inc., in a time frame that allows Bridge12 Technologies, Inc. to timely report to NIH; each reporting time period above will therefore be shortened by at least 5 days in the written subrecipient agreement.
If you have a conflict of interest or if you have a question to discuss, contact Bridge12 Technologies, Inc.‘s Head of Grants held by the Vice President of Finance and Administration. The Head of Grants is Bridge12 Technologies, Inc.’s designated official to solicit and review disclosures of SFIs; this responsibility may be further delegated by the Head of Grants case-by-case.