Institutional Review Board or Independent Ethics Committee Approval. Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document and federal wide number. The Contractor must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide BARDA copies of documents related to all major changes in the status of ongoing protocols, including the following: All amendments or changes to the protocol, identified by protocol version number, date, or both and dates it is valid. All changes in informed consent documents, identified by version number, dates, or both and dates it is valid. Termination or temporary suspension of patient accrual. Termination or temporary suspension of the protocol. Any change in IRB approval. Any other problems or issues that could affect the participants in the studies. The Contractor must notify BARDA through the COR or CO of any of the above changes within five (5) working days by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC. If a clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Institutional Review Board or Independent Ethics Committee Approval. Before initiation of the study, the Investigator must provide the Sponsor with a copy of the written IRB/IEC approval of the protocol, the main study ICF and the pre-screening ICF (latter ICF is applicable for sites requesting permission to pre-screen for FRα positivity (high FRα) before performing any additional study related tests). This approval must refer to the ICF(s) and to the study title, study number, and version and date of issue of the study protocol, as given by the Sponsor on the cover page of the protocol. Status reports must be submitted to the IRB/IEC at least once per year or as per institutional guidelines. The IRB/IEC must be notified of completion of the study and a final report must be provided to the IRB/IEC. A copy of these reports will be sent to the study clinical monitor or designee. The Investigators must maintain an accurate and complete record of all submissions made to the IRB/IEC, including a list of all reports and documents submitted. AEs, which are subject to expedited reporting to the FDA or other regulatory agencies (SUSARs), must be submitted promptly to the IRB/IEC.
