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This policy aims to promote objectivity and transparency in research funded or performed by Blackrock Microsystems, Inc. (d.b.a. Blackrock Neurotech). It establishes standards for identifying, managing, and reporting financial conflicts of interest to protect the integrity of the research and ensure compliance with all applicable regulations.
This policy sets forth the standards that provide a reasonable expectation that the design, conduct, and reporting of all government funded research will be free from bias resulting from financial conflicts of interest. This policy shall be routinely updated to reflect up-to-date, written, enforced policy that complies with the FCOI regulation. This policy will also be made available via the Company’s publicly accessible Web site, https://blackrockneurotech.com/. The Company and all of its employees shall comply with this policy and applicable regulations in all government funded research.
The following definitions apply to this policy.
Financial Conflict of Interest (“FCOI”): A situation in which an investigator’s Significant Financial Interest (SFI) could directly and significantly affect the design, conduct, or reporting of government funded research.
Investigator: Any individual responsible for the design, conduct, or reporting of any government funded research, including the principal investigator, key personnel, and other contributors.
Significant Financial Interest (“SFI”): A financial interest held by an investigator or their immediate family, defined as:
This policy applies to all government funded research projects and all Investigators involved in these projects.
Investigators must complete FCOI training:
Before engaging in NIH-funded research;
At least every four (4) years; and
Immediately if:
Initial Disclosure: Investigators must disclose all foreign and domestic SFIs related to their institutional responsibilities prior to engaging in any government funded research.
Annual Disclosure: Investigators must update their SFI disclosures at least annually during the project period;
Ad Hoc Disclosure: Investigators must disclose new SFIs within thirty (30) days of discovering or acquiring them.
Review Process:
Management Plans:
Initial FCOI Report: Any identified FCOI, along with its management plan, will be reported to the funding agency before government funds are expended.
Ongoing Reporting: If a new FCOI arises during the project, an FCOI report will be submitted within sixty (60) days of the disclosure.
Annual FCOI Report: For active FCOIs, an annual report will be provided to the funding agency, summarizing the status and management of each FCOI.
Retrospective Review: If an FCOI is not identified or managed timely, a retrospective review must be completed within 120 days. If bias is found by the retrospective review, the Company shall submit a Mitigation Report to the appropriate governmental entity.
Written Agreements: Blackrock must establish a written agreement with subrecipients to ensure compliance with FCOI regulations.
Certification & Management: The written agreement entered into by any subrecipient must either: (a) certify that subrecipient will comply with Blackrock’s FCOI policy; or (b) certify compliance through its own FCOI policy, and provide a copy of such to Company for record management.
Compliance Monitoring: The Company’s compliance officer will monitor adherence to management plans until the completion of any government funded project.
Sanctions: Non-compliance may result in disciplinary actions, including termination of employment or removal from the project.
Bias Disclosure: If any appropriate governmental entity determines a government funded clinical research project was biased due to an unmanaged FCOI, Blackrock will require the investigator to disclose the FCOI in public presentations and request an addendum to published research.
Blackrock will maintain all FCOI-related records for at least three (3) years after a final expenditure report submitted in connection with any government funded clinical research.
For any questions about this policy, please contact Anna Ratanawan – aratanawan@blackrockneuro.com (Head of HR).