For this Notice of Funding Opportunity, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB research program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development. 

Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this Notice of Funding Opportunity for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies and consistent with the types of clinical trial applications that NIBIB supports.