National Centers for Biomedical Imaging and Bioengineering (NCBIB) (P41 Clinical Trials Optional)

Notice of Funding Opportunity Description The National Institute of Biomedical Imaging and Bioengineering (NIBIB) uses the P41 mechanism to support National Centers for Biomedical Imaging and Bioengineering (NCBIB) to accelerate the development and dissemination of new biomedical technology. It is expected that each Center would have a nationwide impact. NCBIB creates critical and unique technologies that are at the forefront of their respective fields and enable researchers to apply these technologies to a broad range of basic, translational, and/or clinical research. Information on current NCBIB can be found at https://www.nibib.nih.gov/research-funding/featured-programs/ncbib/supported-centers A Center assembles a critical mass of both technological and other intellectual resources with the intent of advancing the development of instrumentation and methodology for biomedical research. NCBIB should develop new technologies for use in biomedical research or clinical application(s). This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the Center and with other laboratories outside of the Center. The central components of each Center are the Technology Research and Development (TR&D) projects. These projects serve as the foundation of all the activities within the Center. TR&D projects should be at the cutting edge of their technological field and develop new technology in response to the emerging needs of the biomedical research community. The TR&D projects of a Center are scientifically distinct, but are not stand-alone projects, thus they should build on and strengthen the synergistic interactions within the Center. NCBIB interacts with Collaborative Projects (CPs) that serve as technology drivers, users, and testbeds for the cutting-edge technology developed in TR&D projects. Working in a push-pull, iterative relationship with CPs, a TR&D project should develop and optimize additional new tools and methods to address specific biomedical and/or clinical research problems that are otherwise difficult to address using existing tools and methods. The research needs of the CPs should drive the technology development in each TR&D project by presenting important technology-development challenges to the TR&D project. The new technologies developed in TR&D projects should advance the research efforts of the CPs. NCBIB provides their technology to Service Projects (SPs) that serve as users of the well-developed and stable technologies of the Center. SPs make use of the technology and expertise of the Center but are not intended to serve as primary drivers for technology development. Unless there are technological and/or clinical constraints that limit the distribution of the technology developed in the TR&D projects, the CPs and SPs should have a national geographic distribution. The national geographic distribution of the CPs and SPs in new Centers may be somewhat limited initially, but, as the Center matures, it is expected that there will be a broad national distribution. A Center must provide training and dissemination with the goal of exporting their technology and expertise to the broader community to achieve a wide impact on biomedical research. Training should be provided to researchers and end-users at various levels of clinical and scientific expertise, including clinicians, scientists, graduate students, postdocs, and junior faculties. Another important aspect of a Center is dissemination of information on its newly developed technologies and methods. These training and dissemination efforts require the commitment of greater financial and personnel resources to non-science activities than is expected for other types of research efforts. Industrial partnerships are not required, but they are welcome when appropriate. An illustration of the interactions among the required components of a Center can be found at NIBIB's NCBIB website: NIBIB P41 NCBIB Components. The synergistic combination of TR&D projects, the intense push-pull interaction between continuously innovative technology development of the Center and biomedical problem-solving CPs, the deployment of technologies through biomedical problem-solving SPs, together with training and dissemination, set apart NCBIB from other investigator-initiated research (such as research supported R01s) that generally has more narrowly defined goals. Because extensive planning is required in preparing the Center applications, it is strongly recommended that prospective new applicants discuss their plans with the relevant NIBIB Program Director (refer to Scientific Program Areas at https://www.nibib.nih.gov/research-funding) to determine the appropriateness of their applications to the P41 program and the NIBIB mission. It is strongly recommended that these discussions occur at least 4-6 months prior to the application due date. To maintain a balance between the conflicting demands of nurturing new technology areas versus providing for sustained development in established areas, NIBIB limits funding for NCBIB to 15 years. Clinical Trials: For applications submitted that propose clinical trials, this NOFO will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. This NOFO 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 the Scientific/Research contact for this NOFO 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 (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial projects that each IC supports. National Institute of General Medical Sciences (NIGMS) is not a participant in this NOFO but has a similar program that supports Biomedical Technology Development and Dissemination Centers. Details about that program can be found at PAR-23-110: Biomedical Technology Optimization and Dissemination Center (BTOD)(RM1-Clinical Trial Not Allowed) (nih.gov). Applicants who are interested in applying for the NIGMS program need to follow the NIGMS application procedures rather than those in this announcement. Applicants are encouraged to explore both the NIBIB and NIGMS programs, and contact Institute staff for guidance in determining which program is a better fit for their proposed Center. See Section VIII. Other Information for award authorities and regulations.