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Forecast
Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)
This NOFO is issued during a period of accelerating development, validation, and adoption of human new approach methodologies (NAMs).
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From the notice
This NOFO is issued during a period of accelerating development, validation, and adoption of human new approach methodologies (NAMs). Accordingly, it has two integrated priorities for NIH-funded HIV/AIDS research: (1) implementation of a NAMs-enabled stewardship framework, including optional HIV-relevant human in vitro testing support and pilot benchmarking activities, to reduce or replace specific pathogen free (SPF) in vivo model use where scientifically appropriate without compromising rigor, reproducibility, or translational relevance; and (2) support for high-quality SPF colony resources for studies in which well-characterized in vivo models remain scientifically necessary.Under the NAMs-enabled component, required elements include: (1) integration of a NAMs triage and consultation service within request intake and allocation workflows to identify NAM-feasible studies and document reductions or replacements in in vivo use; and (2) establishment of a formal referral pathway to NAM centers as well as human tissue and other human science based resources to facilitate collaborative HIV-relevant human NAM development, benchmarking, and refinement. Applicants may also propose optional NAMs-enabled HIV human in vitro testing support (research use only), including standardized operating procedures, quality control frameworks, and user guidance for viral load quantification, drug resistance assessment, and ex vivo susceptibility assays, as well as optional pilot benchmarking proj
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