Competing Renewal Awards of SBIR Phase IIB Grants for Brain and Behavior Tools (R44-Clinical Trial Optional)

There are important technologies within the biomedical and biobehavioral space that do not require federal regulatory approvals as part of the technology development efforts, but that still require extraordinary time and effort to develop. The purpose of this FOA is to encourage applications for renewals of existing Phase II grants which are supporting research and development of such technologies. 

Technologies encouraged by this FOA fall into three broad categories, which are described, below:

• Complex instrumentation: This is instrumentation comprising several distinct parts that must work together. Very often the goal of such projects is to deliver turnkey products for researchers. For example, high density electroencephalography instrumentation includes electrode arrays, amplifiers, data analytic and data visualization software, etc. Another example is non-invasive near infrared imaging instrumentation, which might include photon sources and detectors, timing devices for delivering photons, amplifiers, and software. Some high throughput assay systems may fall into this category.
• Clinical research tools: Such tools would include those that are developed for clinical research use that do not require any federal regulatory approval, but still require extensive development in order to demonstrate validity in a diverse population. For example, state of the art computerized patient assessment tools for mental disorders that are sensitive to developmental change, gender and cultural diversity, variation in cognitive and behavioral functioning and speech impairment.  These tools may include data from blood work, medical history, objective biobehavioral information, and functional capacity.  
• Behavioral interventions/treatments: Evidence-based behavioral interventions can play a role in the treatment of behavioral disorders. Novel means of providing these types of therapies (e.g., smart phone-based programs) require not only their development, and small efficacy studies, but also extensive, large scale testing to determine the treatments true effectiveness across diverse patient populations.  Feasibility studies, such as participant acceptability, are important considerations to assess utility of novel behavioral tools.

It is important to emphasize that the example provided in the preceding descriptions are meant only to be illustrative, and not exhaustive or exclusive of other technologies that fall into what are intended to be broad categories.

NIH strongly encourages potential applicants to contact program staff prior to submitting their application to make sure it fits within the intent of this FOA.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice.  Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

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