NIH R01 · 2024
The RATIOS Study: Risk/benefit AssessmenT by IRB review of Phase One Studies
PROJECT SUMMARY/ABSTRACT The ethical conduct of Phase 1 trials is conditioned on both there being a reasonable ratio between potential risks and benefits and research candidates being provided with key information about that potential during the informed consent process. IRBs must carefully assess the scientific information supporting the assessment of potential risks and benefits in order to meet these conditions. Several hurdles hinder such assessment. While the FDA carefully vets preclinical safety data that relate to Phase 1 trials, the same is not true for the preclinical efficacy data needed to support the potential for benefit. Further, IRBs receive no specific guidance regarding…
From the public funding record at NIH RePORTER. Describes the funded project, not the reviews below.