Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so t

The Center for Translation Research and Implementation Science (CTRIS) supports the conduct of pragmatic trials which identify the best strategies for ensuring successful integration of evidence-based interventions within clinical and public health settings, such as health centers, worksites, communities, and schools in the United States and abroad. Trials may use qualitative, quantitative, and/or mixed methods approaches. Mixed methods-also known as multi-methods-involve the integration of quantitative and qualitative data collection and analytical approaches into a single study or program of inquiry to generate new knowledge. It can include either concurrent or sequential use of these two classes of methods to follow a line of inquiry. Pragmatic trials constitute a cornerstone of late-stage T4 translation research process. They are unlike explanatory trials that confirm a physiological or clinical hypothesis and form the pillars of the earlier stages of the translational research spectrum. Rather, pragmatic trials are designed to generate the knowledge needed for the adoption of interventions, already proven to be effective in explanatory trials, into real-world clinical practice and community settings. This research helps to turn discoveries into improved health. Programs support the biomedical research workforce and career development and research dissemination including training of early-stage scientists and established investigators to conduct late-stage translation phase (T4) and implementation science research in heart, lung, and blood diseases and sleep disorders and research education. Small Business Innovation Research (SBIR) program: To stimulate technological innovation; use small business to meet Federal research and development needs; foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons; and increase private-sector commercialization of innovations derived from Federal research and development funding related to late-stage translation phase (T4) , including implementation science, research education, and research dissemination products, for both domestic and global health. Small Business Technology Transfer (STTR) program: To stimulate technological innovation; foster technology transfer through cooperative R & D between small businesses and research institutions, and increase private sector commercialization of innovations derived from federal R & D to late-stage translation phase (T4) research including implementation science, research education, and research dissemination products for both domestic and global health.

Local (includes State-designated lndian Tribes, excludes institutions of higher education and hospitals, Public nonprofit institution/organization (includes institutions of higher education and hospitals), Individual/Family, Small business (less than 500 employees), Private nonprofit institution/organization (includes institutions of higher education and hospitals). Any nonprofit organization engaged in biomedical research and institutions or companies organized for profit may apply for almost any kind of grant. Only domestic, non-profit, private or public institutions may apply for NRSA Institutional Research Training Grants. An individual may apply for an NRSA or, in some cases, for a research grant if adequate facilities to perform the research are available. SBIR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit or owned by another small business that itself is independently owned and operated for profit, or owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these and have no more than 500 employees including affiliates). 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 U.S. or its possessions except under rare and unique circumstances where foreign components are thoroughly justified and necessary to the overall completion of the project. 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. Normally, SBIR projects must be performed at least 67% by the applicant small business in Phase I and at least 50% of the Project in Phase II. STTR grants can be awarded only to United States small business concerns (entities that are independently owned and operated for profit and have no more than 500 employees) that formally collaborate with a university or other non-profit research institution in cooperative research and development. The principal investigator of an STTR award may be employed with either the small business concern or collaborating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant small business concern and is willing to devote at least 10% effort (1.2 calendar months) to the project. At least 40% of the project is to be performed by the small business concern and at least 30% by the non-profit research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions except under rare and unique circumstances where foreign components are thoroughly justified and necessary to the overall completion of the project.

Any nonprofit or for-profit organization, company or institution engaged in biomedical research. Only domestic for-profit small business firms may apply for SBIR and STTR programs.

Grants may support stipends, research expenses, supplies, travel, and research training tuition as required to perform the research effort. Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research. Individual predoctoral and postdoctoral national research service awards (NRSAs) are made directly to individuals through their universities for research training in heart and vascular diseases. NRSA awards may be made to eligible institutions to enable them to appoint individuals selected by the institution for research training. Certain service and payback provisions may apply to postdoctoral individuals upon termination of the award or termination of the appointment. SBIR Phase I awards (of approximately 6 to 24 months in duration) are to establish the scientific and technical merit of the proposed research effort, and feasibility of ideas that appear to have commercial potential. Direct to Phase II SBIR awards are for projects that have been developed beyond the feasibility phase using resources other than NIH Phase I awards that meet program needs and exhibit potential for commercial application. SBIR Phase IIB awards are for promising projects that require additional time and funding to advance to commercialization as well as ultimate approval or clearance by a Federal regulatory agency . The Phase IIB program promotes partnerships between previously funded SBIR or STTR Phase II awardees and third-party investors and/or strategic partners by encouraging matching contributions. STTR Phase I awards (normally of 6 to 24 months in duration) are to establish the scientific and technical merit of the proposed cooperative research effort between a small business and non-profit research institution, and feasibility of ideas that appear to have commercial potential. Phase II awards are for the continuation of research initiated in Phase I that meets particular program needs and exhibits potential for commercial application. Fast-Track is an option whereby Phase I and Phase II SBIR or STTR projects are submitted and reviewed concurrently with the aim of reducing or eliminating the funding gap between Phase I and Phase II. The SBIR/STTR Commercialization Readiness Pilot Program awards facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization phase by providing additional support for technical assistance and later stage research and development activities not typically supported through Phase II or Phase IIB grants or contracts including replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance or a combination of services. While the intent of the SBIR/STTR programs is commercialization (Phase III), only SBIR/STTR technical and business assistance (TABA) funds are allowed to be used for commercialization activities such as intellectual property protections; market and sales; market research; business development/product development/market plans; legal fees, travel and other costs including labor relating to license agreements and partnerships. The remaining SBIR/STTR funds are for research and development purposes only and exclude these commercialization activities.

Restrictions or limitations are imposed against the use of funds for entertainment, foreign travel, general-purpose equipment, alterations and renovations, and other items not regularly required for the performance of research.

The National Heart, Lung, and Blood Advisory Council may recommend funding for periods ranging from 1 to 7 years. Funding commitments are made annually. Funding commitments are made annually. SBIR: Normally, Phase I awards are for 6 to 24 months; normally, Phase II awards are for 1-3 years. STTR: Normally, Phase I awards are for 6 to 24 months; normally, Phase II awards are for 1-3 years. Award length may vary depending on the recommendation of the scientific review group, the national advisory council, successful annual performance, and availability of funds. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2)the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. 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 importance of the problem the proposed research will address; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation of the proposed research; (5) the potential of the proposed research for commercial application; (6) the appropriateness of the budget requested; (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. 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) the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated; and (9) 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 accepted applications are evaluated by an appropriate initial review group (study section). All grant applications receive a final secondary review by the National Heart, Lung, and Blood Advisory Council. Staff inform applicants of the results of the review. If support is contemplated, staff will initiate preparation of awards for grants. 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.

> 180 Days. Regular Grants: From 7 to 9 months. SBIR/STTR Grants: About 7-1/2 to 9 months.

> 180 Days. Renewal applications are reviewed in the same manner as new applications.

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 in the NIH Guide at the following URL http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.