Notice ID: 75N91023R00043
The National Cancer Institute seeks continuation of the Central Institutional Review Board (CIRB) Support Services through full and open competition procedures under NAICS Code 541611 with the size standard of $ 24.5 Million. Currently, the Initiative involves four CIRBs, the Adult CIRB – Late Phase Emphasis reviewing adult NCI-sponsored primarily Phase 3 treatment trials; the Adult CIRB – Early Phase Emphasis reviewing adult NCI-sponsored Phase 0, 1, 2 treatment trials; the Pediatric CIRB reviewing NCI-sponsored pediatric Phase 0, 1, 2, 3, and pilot treatment trials; and the Division of Cancer Prevention (DCP) reviewing studies to evaluate cancer risk and to find methods to prevent those risks. The CIRB uses an independent model of IRB review where a local institution and principal investigators inform the CIRB about local context considerations, including local laws and requirements, via the submission of annual worksheets. Each CIRB reviews the NCI-sponsored trials within their purview and additionally reviews the local context considerations for each institution with investigators credentialed to participate in those trials. The NCI recruits and appoints individuals to serve on the CIRB. The purpose of the contract is to provide the Government with the expertise in IRB and other Federal regulations, IRB operations, ethics, quality, information technology, and program management necessary to manage the NCI CIRB and support the institutions that rely on it. Some of the major activities the awardee would perform shall include: 1. CIRB Central Operations – The activities required to run the daily operations of the boards and the studies they review. Ensure that the four CIRB boards are populated according to 45 CFR 46.107, are operated according to 45 CFR 46.108, and review research in compliance with CFR 46.109-111, 116 and 21 CFR parts 50 and 56. 2. CIRB Local Operations – Capacity to conduct the activities necessary to ensure that all CIRB-enrolled organizations comply with their Authorization Agreement with the CIRB and have acceptable infrastructure, expertise, support, and oversight to conduct NCI-sponsored research. 3. CIRB Helpdesk – Provide two channels, telephone, and email to service an average of 1,200 contacts/month. The queries come from members of enrolled institutions and are of a technical and often complex nature. 4. Communication and Education – The activities required to provide well planned, clear, and consistent communications, to ensure smooth operations of the program and that government staff are apprised of operational or regulatory issues related to the conduct of boards, support of institutions, or other issues necessary to ensure compliance with IRB regulations. 5. Ensure uninterrupted continuation of the NCI CIRB’s full accreditation status with AAHRPP by complying with all reporting requirements and accreditation standards. 6. Quality Assurance (QA) and Quality Improvement – The activities required to conceptualize and implement a robust quality assurance and continuous quality improvement program. 7. Provide IT software and support for all CIRB activities – The activities required to ensure the continuous operation and security of IT systems that support the Operations Office, the enrolled institutions, the boards, and the NCI. All IT tools must meet Federal IT requirements and are integrated with NCI Systems…
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