HIV/AIDS Clinical Trials Network Laboratory Centers
Contract Overview
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AI Contract Overview
The National Institute of Allergy and Infectious Diseases (NIAID) is seeking applications to establish up to four Laboratory Centers (LCs) as part of its effort to support four Clinical Trials Networks (CTNs) focused on HIV prevention, treatment, and implementation research. Each LC will provide essential laboratory infrastructure and technology to one or more CTNs, ensuring the conduct of protocol-specified laboratory testing in compliance with regulatory standards. The LCs will oversee affiliated clinical and specialized laboratories, maintaining sample integrity and employing advanced laboratory data management and tracking systems. Their responsibilities also include selecting and approving laboratories and promoting cutting-edge laboratory assays to support evolving advances in HIV prevention and treatment. This initiative aims to enhance testing capacity for HIV and related diseases, contributing to the broader goal of ending the HIV epidemic. The funding opportunity is authorized under Sections 301 and 405 of the Public Health Service Act and relevant federal regulations. The awardees will play a critical role in maintaining high standards of laboratory operations and ensuring seamless integration within the Clinical Trials Networks, supporting large-scale clinical trials and research efforts conducted by the NIH's Division of AIDS.
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Full Description
The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center, and Laboratory Center (LC) working with Clinical Trials Units, to test prevention and treatment strategies and conduct implementation research designed to end the HIV epidemic. This NOFO will solicit applications for up to four LCs that will provide laboratory structure and technologies to one or more CTNs and conduct laboratory testing for Network trials, according to regulatory standards. The LC oversees site-affiliated clinical and specialized laboratories and ensures protocol-specified laboratory testing. The LC will: 1) support sample integrity from collection to final testing/storage; 2) use appropriate laboratory data capturing management and tracking systems; 3) select, determine readiness, and approve laboratories; and 4) promote state-of-the-art laboratory assays. The LC will increase testing capacity to meet advances in prevention and treatment of HIV and HIV-related diseases.
Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.