Academic Research Enhancement Award (R15) Grants Presented by: Sridhar Mani, MD Provided by: Principal Investigators Association Principal Investigators Association 800-303-0129
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NIH AREA PROGRAM: A HOW TO FOR R15 APPLICATIONS Sridhar Mani MD Professor of Medicine Albert Einstein College of Medicine Bronx, NY New R15 Renewal R15 923 69 WHY APPLY? 158 27 $45,427,164 $6,925,254 17.1% 39.1% 2010 2010 2010 NIAAA 9 3 33.3% $754,973 2010 NIA 48 4 8% $1,351,672 2010 NIAID 134 21 16% $6,054,043 2010 NIAMS 26 6 23% $1,432,869 2010 NCCAM 10 2 20% $408,651 2010 NCI 120 24 20% $7,475,247 2010 NIDA 21 4 19% $923,025 2010 NIDCD 13 1 8% $219,369 2010 NIDCR 9 3 33% $974,267 2010 NIDDK 38 19 50% $5,368,154 2010 NIBIB 27 3 11% $836,901 2010 NIEHS 37 10 27% $3,047,112 2010 NEI 24 5 21% $1,608,391 2010 NIGMS 199 36 18% $9,686,918 2010 NICHD 81 8 10% $1,917,869 2010 NHGRI 3 1 33% $316,455 2010 NHLBI 71 11 16% $2,936,353 2010 NLM 1 0 0% $0 2010 NIMH 41 6 15% $1,543,010 2010 NINR 28 3 11% $803,313 2010 NINDS 49 15 31% $4,693,826 2010 NCRR 3 0 0% $0 2010 FY Total 992 185 19% $52,352,418 YEAR SUCCESS RATE (%) TOTAL FUNDING 2001 33.8 $23,901,165 2002 37.2 $25,279,770 2003 42.3 $30,466,704 2004 31.2 $37,633,031 2005 29.8 $39,740,776 2006 25.4 $37,938,780 2007 25.1 $45,228,704 2008 28.1 $44,395,633 2009 22.1 $37,299,776 2010 19 $52,352,418 SUCCESS RATE http://report.nih.gov/success_rates/index.aspx NIAAA NIA NIAID NIAMS NCCAM NCI NIDA NIDCD NIDCR NIDDK NIBIB NIEHS NEI NIGMS NICHD NHGRI NHLBI NLM NIMH R15: Academic Research Enhancement Award (AREA) http://grants.nih.gov/grants/funding/area.htm Before even contemplating applications, must check for your ELIGIBILITY If you feel you are doing meritorious research (all types) + foster student learning environment that is tied to your research students (undergraduates + other) + meritorious research (impact in field, publishable, peer recognized) 1
WHAT ARE THE INTENDED GOALS FOR R15 PROGRAM R15 focuses on meritorious research o Renewable, research should have impact (peer reviewed contributions) Students should be exposed to this research o Evidence of performing research o Clear learning environment o Coauthored publications/presentations most useful Enrichment of Institutional research environment R15: Academic Research Enhancement Award (AREA) Eligibility + Checklist Look at Program Announcement (PA-10-070) and before you apply prepare a short summary of your research + resources + checklist components (click here) on one page and contact your GRANTS OFFICER AND THEN PROGRAM OFFICIAL AT NIH! Baccalaureate or advanced degree granting institutions; < $6M in NIH grants per year x 4 years over past 7 years (excluding C,S & G grants). Even if you qualify, must cross check against LIST of AREA eligible and ineligible-institutions listed in R15 home page! Majority of work must be done at home institution R15: KEY FEATURES Renewable with competing continuations; special supplements allowed (minority, disability) < 300,000 direct cost per project period of up to 3 years * + negotiated F & A (Indirect cost) rate Modular budgets for < 250,000 direct cost. Anything higher are NOT modular and require detailed budget and strong budget justification Standard 5 NIH criterion rules (Impact, Significance, Investigators, Environment, Approach) + AREA specific goals of the program need to be emphasized 12 page limit for Research Strategy Electronic Receipt dates: February 25, June 25, October 25 * Exclusive of consortia F & A costs 2
FORMAT FOR APPLICATION Specific Aims (1-page) Research Strategy (12-pages) o Significance, Innovation, Approach, Preliminary data and Progress report (renewal applications) o Introduction (1-page) for resubmissions Biosketch: Personal Statement is key!!! Why are you well suited to be the PI especially in training students Resource Page is CRITICAL for description of environment INSTITUTIONAL COMMITMENT AND SUPPORT Identify faculty mentor (senior), business office (administrator), Deans Office (clerical) who have previously supported and submitted NIH grants o guidelines, checklist, deadlines, submission & corrections process, review criteria Does your institution provide and support an environment that facilitates faculty success? o start up packages, student environment, course work and credits, faculty promotions, tenure decisions based on independent and/or collaborative research Must be able to directly help with Resource Page, Equipment and Student Profiles (Environment Criterion) Encourage restrained submissions: ONLY APPLY ONCE YOU FEEL COMPETITIVE AND CONFIDENT (2 strikes rule) INSTITUTIONAL COMMITMENT AND SUPPORT Design and craft COVER LETTER to NIH R & R o NIH Institute & NIH study section, areas of review expertise, potential ti reviewer conflicts (if any), brief description of research (1 page max) Encourage mentorship o provide platform for faculty interactions in research, permit NIH workshop attendance, encourage presubmission contact with NIH staff by email with submission of specific aims page 3
APPLICANT PREPARATION Familiarize yourself with NIH, Institute AND appropriate CSR research goals/focus. Does your research fit this? o any research impacting health (http://www.nih.gov/about/mission.htm) o look up specific research missions by institute (click on Institutes at NIH ) o look up Center for Scientific Review (CSRs) (http://cms.csr.nih.gov/aboutcsr/) for Review Group Descriptions (click on Peer Review Meetings right corner, then on Review Group Descriptions ). Note, special AREA applications review sections and if your chosen/preferred study section has reviewed R15s before!! o look at study section expertise that would cover your area Generate Preliminary data supportive of BOTH your research and preferably the students. Show that all TOOLS + REAGENTS are readily available Focus on student recruitment and training - enthusiasm + commitment factor RESEARCH STRATEGY Mentor + NIH PO/SRA feedback on 1-page specific aims Focus on IMPACT of your research http://grants.nih.gov/grants/peer_review_process.htm#criteria QuickTime and a decompressor are needed to see this picture. http://nexus.od.nih.gov/all/2011/03/08/overall-impact-and-criterion-scores/ RESEARCH STRATEGY REVIEW CRITERION SIGNIFICANCE INVESTIGATOR(S) INNOVATION APPROACH ENVIRONMENT RELATED SECTION OF PROPOSAL Research Strategy: Significance subsection Biographical Sketch: Personal Statement Research Strategy: Innovation subsection Research Strategy: Approach subsection Facilities & Other Resources: Environment subsection From: Russell SW, Morrison DC. The Grant Application Writer s Workbook- National Institutes of Health (info@grantcentral.com) 4
RESEARCH STRATEGY Specific Aims ( 1 page) Research Strategy (12 pages) Significance (3/4 page max) Innovation (1/2-3/4 page max) Approach (~10 pages max) For each Specific Aim (identical format for each aim) Introductory Paragraph Justification & Feasibility - review literature as background - present preliminary data here (manuscripts published save space) Research Design critical Expected Outcomes (for you + STUDENT) Potential pitfalls & solutions (for you + STUDENT) Timetable (1/4 page) Future Directions (optional but recommended)(1/4 page) Self-critical Rigorous Persistent REVISIONS, RESUBMISSIONS INTRODUCTION 1-PAGE IS KEY BREVITY AND CONCISENESS ARE SOULS OF WIT (AND FUNDING) what you did per critique and where one can find it in the application break it down by review criterion be diplomatic, yet factual don t be combative QuickTime and a decompressor are needed to see this picture. QuickTime and a decompressor are needed to see this picture. etc SIGNIFICANCE Does this project address an important problem or a critical barrier in the field? If the aims of the project are achieved, how will it further drive scientific knowledge, technical capability, and/or clinical practice? How will successful completion of aims change existing knowledge driving that particular field? 5
INVESTIGATOR(S) Are PD/PIs, collaborators and key personnel well suited to the project? The R15 award (unlike R01s) does not recognize ESIs/NIs. Evidence of balanced Research & teaching is key (show over past 5 years) Evidence of successful research mentoring is key (show over past 5 years_ Multi-PI/PD grants must show complementary expertise INNOVATION Novelty (NOT just NEW) Impetus to change current paradigm in the field Substantial refinement of existing methods/paradigms that would be NECESSARY for a change in research direction APPROACH Well reasoned, logical, feasible (given your resources), building step-wise and appropriate to accomplish project goals Independent but linked aims Each aim should have a section dealing with Expected Results and Potential Problems& Solutions If the project is early in development and there is high risk but also high reward, will the strategy used establish feasibility in your environment? For clinical projects be very careful to fill out Protection of Human Subjects, Minorities/Gender/Children Inclusion sections. 6
ENVIRONMENT demonstrate appropriate scientific environment (included in facilities & resources) Institutional support and commitment especially with regards to student research/teaching etc spell out UNIQUE features (e.g., Dean allows you to forgo teaching for the first year in support of developing your project, yet pays your salary!!) of your institution that supports why you deserve this R15 award!! Profile students (data): % bachelor degree, postbacc degrees over past 5 years Describe impact of the R15 on PI/PD development and the research environment of the school/academic component Description of University, its mission, its demographics, degree programs with URLs will be most useful (4-5 paragraphs total) ENVIRONMENT 1 paragraph number of graduates enrolled in graduate, medical, dentistry, pharmacy, nursing, or other health program, or in industry Expectations for future growth (if applicable) ENVIRONMENT Description of university level program for faculty undergraduate research recognized by the highest office Example of new university wide internal grants program to encourage interdisciplinary research by faculty who have primarily engaged in teaching Departmental environment: student researchers, active student chapters, scholarships and grants for students, student presentations, available equipment, opportunities for inter departmental/university collaboration 7
ENVIRONMENT Summary Paragraph Though primarily a teaching institution, the university is highly supportive of faculty research initiatives. The attainment of university status in and the increased focus on research within the last few years have brought about a higher expectation for faculty scholarship. To build research capability while upholding the teaching mission, has taken a strategic approach to encouraging and supporting a faculty research/teaching model with a focus on involving undergraduates. Since the early, the university has awarded internal Faculty Incentive Grants of up to $ each to enable faculty to develop pilot programs and gather preliminary data. The intent is that faculty will produce results to be used in securing external funding as well asfor publication. Faculty Incentive Grants have supported successful applications for NIH R01 ( in #) NSF ( in #), and private foundation grants, as well as a number of peer reviewed publications. In, despite significant state budget cuts, the university's administration made a strong commitment to assist faculty in building active research programs to provide meaningful research opportunities for students. In addition, the administration recognizes that new faculty hires will need reduced course loads and start up funds if they are to have time to conduct research and apply for external support. In, the university allocated $ to provide new hires with start up funds. First semester course loads were also reduced etc.. etc.. INSTITUTIONAL SUMMARY As XYZ has grown into a comprehensive university, the ABC College has recognized the importance of research to an outstanding undergraduate science education and has sought to enhance faculty research and research opportunities for undergraduates by making significant investments to improve the research environment. The need for extramural support has grown commensurately. An AREA award would be a primary support for Dr. P&Q s research, strengthen the research environment, expose more undergraduates to research and enhance their prospects for health related h l careers. R15 SPECIFIC REVIEW EMPHASIS RESEARCH: Is the research project meritorious and appropriate for available students? ENVIRONMENT: Likely impact award will have on enhancing the research environment and promoting successful research among its student body 8
BIBLIOGRAPHIC SOURCES http://grants.nih.gov/grants/funding/area.htm CHIN J, THE NIH AREA PROGRAM. SOFITEL WASHINGTON SQUARE HOTEL, WASHINGTON DC, AASCU EXTERNAL FUNDING CONFERENCE (CLICK HERE FOR PDF) MARSHALL UNIVERSITY RESEARCH CORPORATION: PREAWARD PROPOSAL CHECKLIST NIH R15 (CLICK HERE FOR PDF) AREA PROGRAM CONTACTS: http://grants.nih.gov/grants/guide/conta cts/parent_r15.html 9
REQUIRED ITEMS BY NIH: SF 424 Form (form) Research & Related Project Performance Site Locations (form) Research & Related Other Project Information (form) Project Summary/Abstract: 30 line maximum project description with a statement of objectives and methods to be employed. Project Narrative (Public Relevance Statement): Two to three sentences for lay audience explaining Relevance to Public Health Bibliography & References Cited: No page limit Facilities & Other Resources: Identify and describe facilities to be used (lab, animal, computer, etc.). Indicate capacities, pertinent capabilities, proximity and extent of availability. In addition, you must provide the following information: profile of available students, description of special characteristics of the school/academic component, statement of institutional support, if relevant. Equipment: List of major equipment already available for project; if appropriate, list location and pertinent capabilities. Research & Related Senior/Key Person (form) All Key Personnel must be registered in eracommons prior to submission. Biographical sketch (attachment; 4 page limit for each Senior/Key personnel) All biosketches must follow latest NIH format, which is listed in the SF_424 Guide. Remember that a Personal Statement must be included and the number of publications listed on your biosketch is limited to 15. PHS 398 Cover Page Supplement (form) PHS 398 Research Plan (form) Specific Aims (attachment) 1 page limit Research Strategy (attachment) 12 page limit (a. significance, b. innovation, c. approach) Human Subjects (attachment; if applicable) Vertebrate Animals (attachment; if applicable) Address five points as listed on p. I 114 of the SF_424 Guide* Letters of Support (attachment, if applicable) Resource Sharing Plan (attachment) Appendix (attachment) Follow instructions as indicated in SF_424 Guide*(page I 119) For further guidance, please visit NOT OD 10 077 PHS 398 Checklist (form) PHS 398 Budget (Modular) ** (form) Budget Justification (attachment) List all personnel, effort, no salary information; if student involvement, indicate aspect to which they will be involved. Inclusion of undergraduate and graduate students encouraged. Cover Letter Cover Letter (attachment) Optional **For complete individual component instruction and clarification, please consult with the SF_424 Guide. ** For projects requesting the entire $300,000, a detailed budget must be provided to the NIH. The modular budget form may be used for budgets $250,000 or less. The entire budget will be entered into budget period 1. OTHER REQUIRED ITEMS: Authorization to Submit (ATS) Form: The ATS form must be routed for administrative approval and signature prior to proposal submission. Significant Financial Interest Disclosure Form (SFID): The PI must have an updated form on file at the Office of Research Integrity at the time of submission. All Key Research personnel who contribute in a substantive way to the development or execution of a project must have an SFID on file in the ORI before any awarded funds may be expended. If your project involves the following*: Human Subjects: submit IRB protocol to: Vertebrate Animals: submit protocol to: Hazardous Materials: submit protocol to: Radioactive Materials: submit protocol to: rdna, Infectious Agents or Blood borne Pathogens submit protocol to: *Protocols must be approved before awarded funds may be expended.
NIH R15 Deadline(s): February 25; June 25; October 25 (new applications) Anticipated Project Start Date(s): December 1; April 1; July 1 Budget: Up to $300,000 in direct costs for entire project period of 3 years. The following checklist is for the Area Research Enhancement Award (AREA) (Parent R15) PA 10 070. When applying for a program specific R15, please make sure that you and your assigned Grants Officer review the guidelines thoroughly for any additional requirements and/or variations. You are responsible for providing the items below (Word or.pdf format) that are preceded with a " ". You are not responsible for completing NIH forms. Formatting (from the SF_424 Guide): Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black font color, and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies.) Type density, including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch. ITEMS REQUIRED BY THE NIH: SF 424 Form (form) Research & Related Project Performance Site Locations (form) Research & Related Other Project Information (form) Project Summary/Abstract: 30 line maximum self contained description of the project which includes a statement of objectives and methods to be employed. Project Narrative (Public Relevance Statement): 2 3 sentences for lay audience explaining Relevance to Public Health Bibliography & References Cited: No page limit; however conciseness is recommended Facilities & Other Resources: Identify and describe facilities to be used (lab, animal, computer, etc.). When appropriate, indicate capacities, pertinent capabilities, proximity and extent of availability. In addition, you must provide the following: profile of available students, description of special characteristics of the school/academic component, statement of institutional support, if relevant. Equipment: List of major equipment already available for project; if appropriate, list location and pertinent capabilities. Research & Related Senior/Key Person (form) All Key Personnel must be registered in eracommons prior to submission. Biographical sketch (attachment; 4 page limit for each Senior/Key personnel) All biosketches must follow latest NIH format, which is listed in the SF_424 Guide*or stop by the grants office for a sample biosketch. Remember that a Personal Statement must be included and the number of publications listed on your biosketch is limited to 15. PHS 398 Cover Page Supplement (form) PHS 398 Research Plan (form) Specific Aims (attachment) 1 page limit Research Strategy (attachment) 12 page limit (a. significance, b. innovation, c. approach) Human Subjects (attachment; if applicable) Vertebrate Animals (attachment; if applicable) Address five points as listed on p. I 114 of the SF_424 Guide* Letters of Support (attachment, if applicable) Resource Sharing Plan (attachment) Appendix (attachment) Follow instructions as indicated in SF_424 Guide*(page I 119) For further guidance, please visit NOT OD 10 077 PHS 398 Checklist (form) PHS 398 Budget (Modular) ** (form) Budget Justification (attachment) List all personnel, effort, no salary information; if student involvement, indicate aspect to which they will be involved. Inclusion of undergrad and grad students encouraged. Cover Letter Cover Letter (attachment) Optional **For complete individual component instruction and clarification, please consult with the SF_424 Guide. This guide is available online and also in hard copy in the MUSOM grants office for your convenience ** For projects requesting the entire $300,000, a detailed budget must be provided to the NIH. The modular budget form may be used for budgets $250,000 or less. The entire budget will be entered into budget period 1. Continued on page 2 R15 Standard template MURC Form PA-015 1 Revised 01-31-11
NIH R15 OTHER REQUIRED ITEMS: Authorization to Submit (ATS) Form: The ATS form must be routed for administrative approval and signature prior to proposal submission. Significant Financial Interest Disclosure Form (SFID): The PI must have an updated form on file at the Office of Research Integrity at the time of submission. All Key Research personnel who contribute in a substantive way to the development or execution of a project must have an SFID on file in the ORI before any awarded funds may be expended. Please contact Amy Melton, 304 696 4365, amy.melton@marshall.edu for further information. If your project involves the following*: Human Subjects: submit IRB protocol to: Bruce Day 304 696 4303 day50@marshall.edu Vertebrate Animals: submit protocol to: Monica Valentovic 304 696 7332 valentov@marshall.edu Hazardous Materials: submit protocol to: Brian Carrico 304 696 3432 carrico8@marshall.edu Radioactive Materials: submit protocol to: William McCumbee 304 696 7366 mccumbee@marshall.edu rdna, Infectious Agents or Blood borne Pathogens submit protocol to: Don Primerano 304 696 7388 primeran@marshall.edu *Protocols must be approved before awarded funds may be expended. Upon notification, your Grants Officer will begin to prepare your Grants.gov package. As you complete your required documents, please send them to your assigned Grants Officer for review in a timely manner. Documents received at the last minute run the risk of being rejected by the NIH for non compliance. For further information, please contact your Grants Officer. All Key Personnel must have an eracommons username. Your assigned Grants Officer will do this. It is also important to submit EARLY, as the NIH has eliminated the 2 day correction window (NOT OD 11 035). For more information on post submission materials, visit: NOT OD 10 115 Applications cannot be changed, corrected or resubmitted once the deadline has expired. No excuse will be accepted by the NIH. SUBMIT YOUR APPLICATION EARLY!!! Additional notes: QUESTIONS? Contact your assigned Grants Officer! R15 Standard template MURC Form PA-015 2 Revised 01-31-11
ACADEMIC RESEARCH ENHANCEMENT AWARD AREA or R15 Program http://grants.nih.gov/grants/funding/area.htm Strengthening the research environment at eligible institutions Exposing students at such institutions to meritorious biomedical & behavioral research (including basic research) Providing support for meritorious research at these AREA-eligible institutions Goals of the AREA or R15 Program R15 supports meritorious research AREA grants are renewable Research should contribute to the field Results should be useful & publishable Students t should be exposed to meritorious i and peer-reviewed research Students learn how to do research by doing it Students may be co-authors on scientific publications Insitutional research enviroment is enhanced More faculty will be involved in research Collaborations using complementary approaches 1
The NIH R15 or AREA Program Academic Research Enhancement Award For baccalaureate or advanced degree granting institutions with up to or less than $6M in NIH grants per year for 4 years over the past 7 years (excluding C, S & G grants) List of AREA-eligible and AREA-ineligible institutions on R15 home-page Most of work must be done at home institution Principal Investigator (PI) may recruit students to work full-time during the summer and/or part-time during the academic year R15 FEATURES: PA-10-070 Renewable grant; competing continuations Up to $300,000 direct cost for project period of up to 3 years plus negotiated F&A (IDC) rate $250K or $300K DC requested in budget year 1 Budgets of $250,000 DC or less are modular Modular budget & budget justification Budgets of more than $250,000 DC are NOT Detailed budget & strong budget justification Standard 5 NIH review criteria plus AREAspecific criteria addressing goals of program 12- Page limit for Research Strategy Three electronic receipt dates per year: February 25, June 25, and October 25 APPLICATION FORMAT 1-Page Specific Aims 12-Page Research Strategy with discussion of Significance, Innovation, Approach and Preliminary Studies for New Applications and/or Progress Report for Renewal Applications Biographical Sketch: Personal Statement on why you are well-suited to be the PI Resource Page for Scientific Environment 1-Page Introduction for Resubmissions 2
Preparation by the Institution Are the Faculty, Business Office, Deans all supportive of faculty research & knowledgeable about the NIH application process? Know the guidelines, deadlines, submission & correction process, and review criteria Does the Institution provide and support an environment for faculty to succeed? Start up packages for equipment, supplies & students Credit for student involvement in research Do tenure decisions include credit for independent and/or collaborative research (multiple investigators? Some projects require team work & more expertise More Institutional Preparation Help NIH applicants with the Resource page, equipment available and student profiles Environment is a review criterion Resources necessary to accomplish the aims Do not pressure applicants to apply if their projects are not ready for peer-review Only 2 submissions allowed per project Quality over quantity; submit best proposal Use the Cover Letter to help the Receipt and Referral Staff make the two assignments NIH Institute & NIH study section assignment More Preparation by the Institution Mentor new faculty & critique their research & application Discuss what reviewers look for, like or dislike Faculty should be very familiar with all the NIH Review Criteria questions Support faculty researcher to attend national and important meetings in their fields Present research and interact with other researchers Attend NIH grant workshops Encourage faculty to contact NIH staff by e-mail with specific aims and rationale on a one page (not visit) 3
Preparation by the Investigator Are you asking the important, next questions in the field? Do you or your collaborators have the appropriate expertise and experience? Does your research fit the NIH research goals? Have you generated preliminary data at your current institution with your students and other staff? Is your data supportive of your research proposal? Are your tools & reagents prepared & ready? Have you recruited and trained the necessary students and technicians? Are they enthusiastic and engaged? Are you? Research Strategy Get feedback early on your one-page Specific Aims page Understand the NIH review criteria & the review criteria questions Write a clear, reviewer-friendly proposal on your most exciting research project Be self-critical, rigorous, persistent, and enthusiastic about your research In the resubmission, respond thoroughly and diplomatically to all review comments, concerns, issues and suggestions Manuscripts versus Grant Proposals Manuscripts What experiments you did and why Enough details so others can do them Retrospective; looking back Grant Proposals What experiments you plan to do, why and what their significance might be Discussion of potential pitfalls and possible alternatives, results, their interpretation, and potential impact Prospective; looking forward 4
General Questions Does the AREA Program target New Investigators or Early Stage Investigators (ESIs)? ESIs of R01 proposals are targeted by NIH The R15 program does not target ESIs or New PI Does NIH favor translational and interdisciplinary research over basic, fundamental research? NIGMS supports basic research & model organisms NIH wants & needs a balance of research approaches: investigator-initiated, single PI, collaborative or team, transformational, translational, interdisciplinary, fundamental & basic research Impact and significance of the research needs to be discussed, rationalized and justified More General Questions When and why should a project be submitted to NIH versus NSF? NIH and NSF share many research goals in chemistry, biology, biochemistry, biophysics, bioengineering, g bioinformatics and biomath NIH focuses on biomedical and behavioral research, both clinical & applied as well as basic, fundamental and non-disease research using model organisms such as bacteria, plants, flies, worms & others (GM) Why is the entire, requested AREA budget in Year 1 only and not spread out over 2-3 years? R15 is a multi-year funding mechanism, funded in Y1. Application Assignments & Cover Letter The Division of Receipt and Referral at the Center for Scientific Review (CSR) will make two assignments for your applications, but you may request specific assignments An NIH Institute or Center (IC) for programmatic and funding consideration, such as NIGMS or NIAID or MIMH An Initial Review Group for review of scientific merit by a Scientific Review Group or Study Section, ie., Cell Biology Include a COVER LETTER with the following: Research goals and hypotheses/questions and specific aims Biological system or model used or studied (microbe vs animal) Major methods and approaches proposed (biological vs computational or chemical or pharmacological or social, etc. ) Areas of review expertise (NOT names of reviewers) Potential conflicts (name & reason, i.e., direct competitor) +/- Requested NIH Institute/Center +/- Study Section Choices 5
Biobehavioral Methods to Improve Outcomes Research (R01) http://grants.nih.gov/grants/guide/pa-files/pa-09-125.html PA-09-125 NINR, NIGMS, NIDDK, NIDCD, NCI, NIAMS and OBSSR Office of Biobehavioral & Social Sciences Research: http://obssr.od.nih.gov/index.aspx To foster biobehavioral research and develop innovative research designs, methods of measurement, and data analysis techniques To examine the impact of biologic & behavioral variables on individuals health outcomes R15 SPECIFIC REVIEW CRITERIA RESEARCH: Is the research project meritorious and appropriate for available students? ENVIRONMENT: Assess the suitability of the applicant school/academic component for an award in terms of the likely impact that an award will have on strengthening the research environment and exposing available students to research. New NIH SCORING System Final score (1 for best and 9 for worst) provided by all reviewers not in conflict Overall priority score is the mean score from all eligible reviewer scores multiplied by 10 Final scores will be reported in whole numbers and will range from 10 to 90 6
NIH SCORING SYSTEM Criterion Scores Assigned reviewers will provide preliminary overall impact or overall priority scores Assigned reviewers will use the 9-point scale for the five review criteria Each assigned reviewer s criterion scores will be reported on the summary statement Criterion scores will be reported for discussed and not discussed applications Reviewers will weigh criterion scores as appropriate for each application in determining overall impact or overall priority score Criterion & Overall Scores Assigned reviewers will provide preliminary overall impact or priority scores Assigned reviewers will use the 9-point scale for the five review criteria Each assigned reviewer s criterion scores will be reported on the summary statement Criterion scores will be reported for discussed and not discussed applications Reviewers will weigh criterion scores as appropriate for each application in determining overall impact or priority score 7
OVERALL IMPACT Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). REVIEW PROCESS Chair will ask for initial overall impact or overall priority scores from the assigned reviewer 1, reviewer 2, and the reader Summary of the project aims by reviewer 1 followed by assessment by the assigned reviewers Discussion of the application opened to the rest of the panel Assigned reviewers will state their final scores 8
The FIVE NIH Review Criteria for Research Proposals Significance Investigator(s) Innovation Approach Environment SIGNIFICANCE Does this project address an important problem or a critical barrier in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical i l practice be improved? How will the successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? INVESTIGATOR(S) Are the PD/PIs, collaborators, and other key researchers well suited to the project? If Early State Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated t d an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-pd/pi, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 9
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 inventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? APPROACH Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy t establish feasibility and will particularly risky aspects be managed? If the project involved clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? ENVIRONMENT Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 10
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