Francisco S. Sy, NIMHD Shawn Gaillard, NIGMS

What is a grant? Grant-in-Aid = funding mechanism that allows you to carry out independent research on a problem of importance to public health Defined in law by Congressional authorization What kinds of RPGs are there? Many grant mechanisms at the NIH Fellowship training (F, T) Career Development (K) Regular Research (R series) Team Science (P, U) Shared instrumentation (S) Who is eligible to apply? Grants are made to institutions in the name of a principal investigator Some have citizenship requirements (F, T, K) If not, then there must be appropriate work visa in place The institution defines who is eligible to apply for an R01 Which Institutes at the NIH award grants? Of the 27 Institutes and Centers, 24 are authorized to award grants Most mechanisms are offered

* New, consolidated approach to the submission of grant applications to the Federal Government New, consolidated approach to the submission of grant applications to the Federal Government Submission to a Central site: Submission to a Central site: o All electronic submission o You must respond to a specific FOA eCommons: your account and window to the NIH eCommons: your account and window to the NIH

R01Research Project Grant To support a discrete, specified, circumscribed project on health related research and development based on the stated program interests of one or more of the NIH Institutes and Centers. PA ; * Budget: costs appropriate for the project, modular and non-modular formats * Project Period: up to 5 years * Renewable R03Small Research Grant To provide research support specifically limited in time and amount for studies in categorical program areas such as pilot/feasibility studies, secondary analyses, method/technology development. Small grants provide flexibility for initiating studies which are generally for preliminary short-term projects and are non-renewable. PA ; * Budget: up to $100,000 direct costs over 2 years with no more than $50,000 direct costs in any year, modular budget unless foreign entity * Project Period: up to 2 years; NOT Renewable * Not all NIH Institutes and Centers participate

R15Academic Research Enhancement Awards (AREA) To support individual research projects in the biomedical and behavioral sciences conducted by faculty, and involving their undergraduate students, who are located in health professional schools and other academic components that have not been major recipients of NIH research grant funds. PA ; * Direct costs up to $300,000 over 3 years, modular and non-modular budget * Project Period: up to 3 year; Renewable R21 Exploratory/Developmental Grant To encourage new, exploratory and developmental research activities in their early stages of development. Such projects may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models or applications that could have major impact on a field of biomedical, behavioral, or clinical research. PA ; * Direct costs up to $275,000 over 2 years, no more than $200,000 direct costs in any year, modular budget unless foreign entity * Project Period: up to 3 years; NOT Renewable * Not all NIH Institutes and Centers participate

R34 Clinical Trial Planning Grant Program For development of a Phase III clinical trial including establishment of the research team, development of tools for data management and oversight of the research, the definition of recruitment strategies, and finalization of the protocol and other essential elements of the study included in a manual of operations/procedures PA : * Direct costs of up to $100,000 may be requested for the one-year period ; NOT Renewable * NEI, NIA, NIAAA, NICHD, NIDA, ODS R34 Exploratory Clinical Research Grants Support for research and resources for evaluating feasibility, tolerability, acceptability and safety of novel approaches to improving mental health and modifying health risk behavior. Support resources for obtaining the preliminary data needed as a prerequisite to a larger-scale (efficacy or effectiveness) intervention or services study. E.g., “From Intervention Development to Services” PAR : * Direct costs of up to $450,000 over 3 years, with no single year exceeding $225,000 ; NOT Renewable * Scope and award limits vary by IC, which have specific FOAs using the R34 mechanism: NCCAM, NCI, NCRR, NHGRI, NHLBI, NIAID, NIBIB, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR, NLM, FIC

R13 Conference Grant To support recipient sponsored and directed international, national or regional scientific meetings, conferences and workshops. PA : * Budget and Project Period: appropriate for the conference * May be Renewed R24 Resource-Related Research Project To support research projects that will enhance the capability of resources to serve biomedical research. * See IC for availability R25 Education Project To support the development and/or implementation of a program as it relates to a category in one or more of the areas of education, information, training, technical assistance, coordination, or evaluation. * See IC for availability

R41/R42Small Business Technology Transfer (STTR) Grants To support cooperative research and development (R&D) projects between small business concerns and research institutions, limited in time and amount. * Phase I (R41) projects establish the technical merit and feasibility of ideas that have potential for commercialization. * Phase II (R42) awards support development of projects whose feasibility has been established in Phase I. PA ; * Budget and Project Period. Phase I awards normally up to $100,000 total for up to 1 year. Phase II awards normally up to $750,000 total for up to 2 years. Only Phase II is renewable. R43/R44Small Business Innovation Research (SBIR) Grants To support small businesses in developing products or services that may ultimately lead to commercialization. * Phase I (R43) projects establish the technical merit and feasibility of R&D ideas. * Phase II (R44) awards support the development of projects whose feasibility has been established in Phase I and which are likely to result in commercial products or services. PA ; * Budget and Project Period. Phase I awards normally up to $100,000 total for up to 6 months. Phase II awards normally up to $750,000 total for up to 2 years. Only Phase II is renewable.

P01 Research Program Project To support a broadly based, multidisciplinary, multi-investigator, multi-project research program which has a specific major objective or basic theme. A program project application should have a central research focus, in contrast to the usually narrower thrust of the traditional research project. Each project supported through this mechanism should contribute or be directly related to the common theme of the total research effort, and should demonstrate an essential element of unity and interdependence. The grant can also provide support for certain basic resources used by these groups in the program, including clinical components, the sharing of which facilitates the total research effort. * See IC for availability and specific conditions

P20 Exploratory Grant To support planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of the NIH. These exploratory studies may lead to specialized or comprehensive centers. * See IC for availability P30 Center Core Grant To support shared resources and facilities for use by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort, or from the same discipline who focus on a common research problem. The center core grant is integrated for shared use by multiple research projects, but funded independently from them. The center core grant provides more accessible resources than obtainable from individual research or program projects. * See IC for availability

P50 Specialized Center To support any part of the full range of health-related research and development from very basic to clinical. These centers may also involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities provided within the Center will comprise a multidisciplinary attack on a specific disease entity or biomedical problem area. Centers may also serve as regional or national resources for special research purposes. * See IC for availability P60 Comprehensive Center To support a multipurpose unit designed to bring together into a common focus divergent but related facilities within a given community. The comprehensive center may be based in a university or may involve other locally available resources, such as hospitals, computer facilities, regional centers, and primate colonies. It may include specialized centers, program projects and projects as integral components. Regardless of the facilities available to a program, it usually includes the following objectives: to foster biomedical research and development at both the fundamental and clinical levels; to initiate and expand community education, screening, and counseling programs; and to educate medical and allied health professionals concerning the problems of diagnosis and treatment of a specific disease. * See IC for availability

T32 Institutional National Research Service Award To enable institutions to make National Research Service Awards to individuals selected by them for predoctoral and postdoctoral research training in specified shortage areas. This grant enables the director of the program to select the trainees and to develop a curriculum of study and research experiences necessary to provide high quality research training. PA ; * Project Period: up to 5 years * May be Renewed T35 NRSA Short-Term Research Training To provide students in health professional schools with intensive, short- term (such as off-quarters or summer periods) research training experiences to encourage research careers and/or research in areas of national need. PA ; * Project Period: up to 5 years * May be Renewed

F30 Individual Predoctoral NRSA for M.D./Ph.D. Fellowships To provide support for predoctoral training which leads to the combined M.D./Ph.D. degrees. Addresses the need for training physicians to become physician-scientists including those conducting translational and patient- oriented research. PA ; F31 Predoctoral Individual National Research Service Award To provide predoctoral individuals (doctoral candidates) with supervised research training in specified health and health-related areas leading toward the research degree (e.g., Ph.D.). PA ; Diversity: PA ; F32 Postdoctoral Individual National Research Service Award To provide postdoctoral research training within the broad scope of biomedical, behavioral or clinical research to individuals to broaden their scientific background and enhance their potential for research in specified health-related areas. PA ;

K99/R00 NIH Pathway to Independence (PI) Award To facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm. Two Phases: initial phase (K99) of mentored support to allow the candidate time to obtain additional training, complete research, publish results, and bridge to an independent research position. Second phase(R00) provides support to conduct research toward establishing his/her own independent research program and to prepare an application for regular research grant support (R01). PA ; * Project Period: K99, up to 2 years; R00, up to 3 years * Budget: see specific NIH Institute and Center

K01 Mentored Research Scientist Development Award To provide support for supervised research and training in biomedical, behavioral or clinical sciences that will lead to independence. The career development experience must be in a research area new to the applicant and/or one in which an additional supervised research experience will substantially add to the research capabilities of the applicant. PA ; K08 Mentored Clinical Scientist Research Career Development Award To provide for the development of outstanding clinician research scientists to independence. The supervised research experience may integrate didactic studies with laboratory or clinically-based research, or focus solely on research. PA ;

K23 Mentored Patient-Oriented Research Career Development Award To provide support for the supervised career development of clinically trained professionals who have made a commitment of focus their research endeavors on patient-oriented (human subjects) research, and who have the potential to develop into productive, clinical investigators. PA ; K25 Mentored Quantitative Research Development Award To support the supervised career development of usually junior faculty with quantitative scientific and engineering backgrounds outside of biology or medicine who have made a commitment to focus their research endeavors on behavioral and biomedical research (basic or clinical). PA ;

K02 Independent Scientist Award To support newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of developing and enhancing the potential of their research careers. PA ; K05 Senior Scientist Research and Mentorship Award To support outstanding scientists who have demonstrated a sustained, high level of productivity and whose expertise, research accomplishments, and contributions to the field have been and will continue to be critical to the mission of a particular NIH institute or center. The candidate will usually also serve as a mentor to others. * See IC for availability; [NIAAA, NIDA, NCI] K24 Midcareer Investigator Award in Patient-Oriented Research To provide support for the clinicians to allow them protected time to devote to patient-oriented (human subjects) research and to act as research mentors for clinical residents, clinical fellows and junior clinical faculty. PA ;

Translating ideas into a research plan What? Why? How? Who? Where?

 Overall Impact: the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.  Core Review Criteria: Significance: Does the project address an important problem or a critical barrier to progress in the field? will scientific knowledge, technical capability, and/or clinical practice be improved? Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Environment: Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

 Overall Impact: the likelihood for the candidate to maintain a strong research program.  Core Review Criteria: Candidate: Does the candidate have the potential to develop as an independent and productive researcher? Career Development Plan/Career Goals & Objectives: What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Research Plan: Are the proposed research question, design, and methodology of significant scientific and technical merit, and is the research plan relevant to the candidate's research career objectives and development plan? Mentor(s), Co-mentor(s), Consultant(s), Collaborator(s): Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement? Environment and Institutional Commitment to the Candidate: Is the institutional commitment to the career development of the candidate appropriately strong?

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Lack of or weak impact Lack of or weak impact Significance not obvious or weak Significance not obvious or weak o Too ambitious, lacking focus o Unclear or flawed hypothesis o Feasibility unsupported Poor writing Poor writing Applicant track record weak or lacks appropriate expertise Applicant track record weak or lacks appropriate expertise Approach flawed Approach flawed Deficient Environment Deficient Environment Wrong grant mechanism for the project Wrong grant mechanism for the project

Carefully read the summary statement Carefully read the summary statement Talk with your Institute PD Talk with your Institute PD Seek help from experienced colleagues/mentors Seek help from experienced colleagues/mentors Submit a carefully considered revised application Submit a carefully considered revised application o Carefully address the critiques o Don’t use your response to rebut reviewers-show them where you agree or disagree and where you’ve made changes Don’t rush back with an incompletely or hastily revised application Don’t rush back with an incompletely or hastily revised application

Strong significance to an important problem in public health: IMPACT is high Strong significance to an important problem in public health: IMPACT is high o High degree of novelty and innovation Strong track record by a well qualified applicant and collaborators Strong track record by a well qualified applicant and collaborators Clear rationale Clear rationale Relevant and supportive preliminary data Relevant and supportive preliminary data Clear and focused approach that provides unambiguous results Clear and focused approach that provides unambiguous results Careful attention to details Careful attention to details o Presentation, readability, clarity of data, graphics, error bars, spelling, etc

* NIH homepage: * CSR website: * Grants at NIH: