Discovery and Applied Research for Technological Innovations to Improve Human Health

To support hypothesis-, design-, technology-, or device-driven research related to the discovery, design, development, validation, and application of technologies for biomedical imaging and bioengineering. The program includes biomaterials (biomimet

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform, through technology development, our understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB supports new tools and technologies to improve human health within its internal laboratories and through grants, collaborations, and training.

Any corporation, public or private institution or agency, or other legal entity, either nonprofit or for-profit, may apply for a research grant. An applicant for an individual NRSA must be a citizen of the United States or lawfully admitted for permanent residence. Those on temporary or student visas are not eligible. An eligible institution for an institutional NRSA must be capable of providing predoctoral and/or postdoctoral research training opportunities for engineers, bioengineers or other. SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit; are not dominant in the field in which research is being proposed; and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the United States or its possessions. To be eligible for funding, a grant application must be reviewed for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Research Grant funds may be used for salaries, consultation, equipment, travel and other usual costs, subject to Federal regulations applicable to the grant. Individual National Research Service Awards (NRSAs) are made directly to individuals for research training in specified areas related to the mission of NIBIB. Institutional NRSAs may be made to institutions to enable them to accept individuals for research training. Each individual who receives a NRSA postdoctoral fellowship or traineeship is obligated upon termination of the award to comply with certain service and payback provisions. Small Business Innovation Research (SBIR) Phase I grants are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Only Phase I awardees are eligible to apply for Phase II support. Small Business Technology Transfer (STTR) Phase I grants are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application. Indirect costs are paid at negotiated rates for most grant mechanisms. Exceptions are: conference grants (R13 and U13) receive no indirect costs; Training (T), Fellowship (F), and Career (K) awards receive an 8% indirect cost rate; R25 grants receive an 8% indirect cost rate; and SBIR/STTR grants are limited to a 40% indirect cost rate unless the grantee organization negotiates a higher rate.

Research Grant awards are usually made annually with no project periods to exceed 5 years in length. NRSA Institutional awards may be made for up to 5 years, and Individual awards may be made for up to 5 years at the predoctoral level, 3 years at postdoctoral level, and 2 years at senior level. Normally SBIR and STTR Phase I awards are for 6-12 months and Phase II awards are for up to 2 years.

The major elements in evaluating proposals include assessments of: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) the appropriateness of the proposed budget and duration in relation to the proposed research; (7) the relevance and importance to announced program objectives; (8) the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated; (9) the adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application; and (10) the adequacy of the proposed plan to share data, if appropriate. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a)safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.

All applications for research or training are reviewed for scientific merit by an appropriate initial review group and then by a national advisory council. All applications favorably recommended compete for available funds on the basis of scientific merit and program emphasis. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Research Grants: From 6 to 9 months NRSAs: From 6 to 9 months SBIR/STTR: About 7.5 months

Research Grant applications submitted for renewal are reviewed and selected for funding on a competitive basis, as applicable. NRSA awards may be made for 1 to 5 years. No individual may receive more than 5 years of aggregate NRSA support beyond the predoctoral level, and no individual may receive NRSA support for more than 3 years of support beyond the postdoctoral level. Institutional awards may be renewed.

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html