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NIBIB Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)


  1. The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by supporting and conducting interdisciplinary research and training in biomedical imaging and bioengineering, and at the convergence of the physical and biological sciences. This is achieved through supporting the development and early translation of emerging technologies that enable fundamental biomedical discoveries or facilitate disease detection, management, and treatment.

    This NIBIB Funding Opportunity Announcement for early stage clinical trials represents 1) NIBIB's longstanding commitment to development and early translation of novel technologies that support public health biomedical discovery and 2) alignment with the NIH policy that effective with January 25, 2018 receipt dates, all grant applications with plans to conduct clinical trials must be submitted in response to an FOA which specifically states that clinical trials are allowed (

    For this Funding Opportunity Announcement, the NIBIB will only support SBIR applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility or other small clinical trials that inform early-stage technology development. The NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials or trials in which the primary outcome is efficacy, effectiveness or a post-market concern.

    Applicants are strongly encouraged to contact NIBIB Program staff or the Scientific/Research contact for this FOA for guidance in advance of submitting an application 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 projects that the NIBIB supports.

    This Funding Opportunity Announcement requires that at least one clinical trial be proposed. For SBIR applications not proposing a clinical trial, applicants should consider the NIH Omnibus Solicitation for Small Business Innovation Research Grant Applications (Parent SBIR) (

    See Section VIII. Other Information for award authorities and regulations.

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