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Texas A&M University - Kingsville

Office of Proposal Development Texas A&M University Connally Bldg Jack Williams Administration Bldg Office of the Vice President for Research and Graduate Studies The Texas A&M University System Health Science Center Texas A&M University - Kingsville System Research Proposal Workshop

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Texas A&M University - Kingsville

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  1. Office of Proposal Development Texas A&M University Connally Bldg Jack Williams Administration Bldg Office of the Vice President for Research and Graduate Studies The Texas A&M University System Health Science Center Texas A&M University - Kingsville System Research Proposal Workshop Susan E. Maier, Ph.D. Research Development Officer Office of Proposal Development, Texas A&M University

  2. Outline of Presentation • Overview of National Institutes of Health… • Understanding NIH Funding Priorities.. • Submitting Proposals to NIH… • Award Mechanisms • Application Process and Forms • The Review Process… • Learning More…. • NIH Toolkit Office of Proposal Development, Texas A&M University

  3. Overview of NIH… • Department of Health and Human Services (DHHS) • Substance Abuse and Mental Health Services Administration (SAMHSA) • Agency for Toxic Substances and Disease Registry (ATSDR) • Agency for Healthcare and Research Quality (AHRQ) • Centers for Medicare and Medicaid Services (CMS) • Centers for Disease Prevention and Control (CDC) • Administration for Children and Families (ACF) • Food and Drug Administration (FDA) • National Institutes of Health (NIH) • Administration for Aging (AoA) • Program Support Center (PSC) • Indian Health Service (IHS) Office of Proposal Development, Texas A&M University

  4. Overview of NIH… • Primary agency for funding biomedical, behavioral and mental heath research 20 Institutes, 7 Centers Office of Proposal Development, Texas A&M University

  5. Overview of NIH… • Mission • OD suggests general areas of research focus • IC directors use this information to do strategic planning within own IC • Important to review the individual IC web pages and talk to specific program officers about the current research focus within an IC • Current *hot* trends in research include intra-agency programs/trans-NIH initiatives; research that cuts across typical agency boundaries of various IC • (http://www.nih.gov/about/transnih.htm) Office of Proposal Development, Texas A&M University

  6. Understanding NIH funding priorities.. • NIH has investment priorities based on past research findings and current trends in science • NIH funds research projects inside their own laboratories (intramural) and outside their laboratories at national and international locations (extramural) • FY2006 budget for NIH is $28.8 billion (4%) • Majority of funds go towards funding extramural research • 84% extramural • 11% intramural • 5% research support Office of Proposal Development, Texas A&M University

  7. Understanding NIH funding priorities.. • Targeted areas of support for FY2006 • Biodefense (11% increase from FY2005) • Research directed at detecting and countering bioterrorism • HIV/AIDs Research (<1%) • Development of AIDs vaccine • NIH Roadmap (<1%) • New Pathways to Discovery • Research Teams of the Future • Re-Engineering the Clinical Research Experience • NIH Blueprint for Neuroscience Research • 15 IC participating Office of Proposal Development, Texas A&M University

  8. Submitting Proposals to NIH… • Award Mechanisms • Application Process • Proposal Basics • Forms, forms, forms… • Budget, modular and non-modular Office of Proposal Development, Texas A&M University

  9. Award Mechanisms… • Differentiate among mechanisms • Important to determine which NIH award mechanism to use • Early career development award • Small grant • Exploratory grant • Independent research grant Office of Proposal Development, Texas A&M University

  10. Award mechanisms… • Solicited versus unsolicited proposals • Solicited (agency-initiated) proposals (18%) • Request for Applications/Proposals (RFA/RFP) • One time request to fulfill specific agency research objective or need • Program Announcements (PA) • New research programs and updates to ongoing programs (renewable) • Unsolicited (investigator-initiated) proposals (82%) Office of Proposal Development, Texas A&M University

  11. Award Mechanisms… Office of Proposal Development, Texas A&M University

  12. Award Mechanisms… • Solicited proposals (RFA, RFP, PA) • NIH funding opportunities page • Includes funding opportunities for NIH IC only • Located at http://grants1.nih.gov/grants/guide/index.html • Subscribe to weekly listserv • Grants.gov • Includes funding opportunities for NIH in addition to the other 25 federal grant-making agencies • Located at http://www.grants.gov/Index • Subscribe to weekly listserv Office of Proposal Development, Texas A&M University

  13. Award Mechanisms… • Unsolicited proposals • Numerous funding mechanisms • R01 Research Project Grant • Supports discrete, specific, highly successful outcome projects • All IC support this mechanism • R03 Small Grant • Supports small research projects; limited time and resources are the key elements • R21 Exploratory/Independent Research Grant • Supports ‘high risk-high yield’ research projects Office of Proposal Development, Texas A&M University

  14. Award Mechanisms… • Other types of proposals (solicited or unsolicited) • Program project (P01) • Specific to IC; large scale projects with many investigators and oversight/advisory committees • Institutional research training grants (T32, T35) (through NRSA) • Develop and enhance research training for careers in biomedical, behavioral or clinical areas Office of Proposal Development, Texas A&M University

  15. Award Mechanisms… • Career awards – targeted programs • Some directed at retraining, professional career development, and recognition of career success • K01 Mentored Research Scientist Award • Provide mentored career development in a new research area • K02 Independent Scientist Award • Develop career of funded scientist • K05 Senior Scientist Award • Recognize outstanding scientist with sustained level of high productivity • K08 Mentored Clinical Scientist Award • Development of independent clinical research scientist • K18 Career Enhancement Award for Stem Cell Research (restricted to certain IC) • K25 Mentored Quantitative Research Career Development Award • Foster collaborative research in areas integrating biomedical science and engineering Office of Proposal Development, Texas A&M University

  16. Award Mechanisms… • Training awards – for predoctoral (F31), postdoctoral (F32) or short term training (F33) • National Research Service Awards • F31, F32, F33 Office of Proposal Development, Texas A&M University

  17. Application Process… • The Office of Research and Sponsored Programs (ORSP) http://osr.tamuk.edu/ • Submits and administers grants and contracts that solicit external funding in support of activities furthering the university's mission and purpose • ORSP ensures the stewardship of the external funds, protects the researchers' freedom of investigation and reporting, and monitors compliance with all university grants and contract administration policies and procedures, as well as those of the funding source • ORSP provides information and technical support for the development of institutional proposals and the administration of grant awards and contracts.  Office of Proposal Development, Texas A&M University

  18. Application Process… • Proposal needs to be well-written • Proposal needs to incorporate good idea Office of Proposal Development, Texas A&M University

  19. Application Process… • All NIH proposals use PHS Form 398 or some variation • Step 1: Download the instructions • Step 2: READ the instructions! • Step 3: Keep the instructions handy Office of Proposal Development, Texas A&M University

  20. Application Process… • PHS398 (R01) • Cover page/face sheet • Abstract, performance site, key personnel • Table of contents • Budget page(s) • Budget justification • Biosketch of PI, biosketch of all other major personnel • Resources • Research Plan (Items A-D) 25 page limit • Other Information under Research Plan (Items E-J) no page limit • E.g., references cited, human or animal research subjects, inclusion of minorities/children in clinical studies, data sharing plans, etc.) • Appendix items • Checklist • Personal data on PI Office of Proposal Development, Texas A&M University

  21. PHS398 Cover Sheet/Face Page Office of Proposal Development, Texas A&M University

  22. PHS398 Abstract, Performance Site Office of Proposal Development, Texas A&M University

  23. PHS398 Key Personnel Office of Proposal Development, Texas A&M University

  24. PHS398 Budget • Modular budget • Most R01s • Less than $275,000 per year • Non-modular budget • Larger centers, program project proposals • Some RFPs • Requesting more than $275,000 per year Office of Proposal Development, Texas A&M University

  25. PHS398 Modular budget/justification Office of Proposal Development, Texas A&M University

  26. PHS398 Non-modular Budget Yr1 Office of Proposal Development, Texas A&M University

  27. PHS398 Non-modular Budget Yr2-5 Office of Proposal Development, Texas A&M University

  28. PHS398 Resources Page Office of Proposal Development, Texas A&M University

  29. Application Process… • The Research Plan – the what, why, how of the proposal • Minimum requirements for the research plan include Sections A-D, which cannot be more than 25 pages, unless specified differently by the RFA or PA or mechanism (e.g., R21) • Section A – Specific Aims (the “what”); Hypotheses • Section B – Background and Significance (the “why”) • Section C – Preliminary Data/Progress Report (the “why” and “how”) • Section D – Research Design and Methods (the exact “how”) • Subsequent sections: E-human subjects research, F-vertebrate animals, G-literature cited, H-consortium/contractual agreement, I-resource sharing (data*, model organisms), J-consultants • Appendix items Office of Proposal Development, Texas A&M University

  30. The Review Process… • Center for Scientific Review (CSR) • http://www.csr.nih.gov/default.htm • Divisions (4) • Integrated Review Groups (IRG) – 23 • Study Sections (SS) – 220 • Scientific Review Administrator (SRA) • Members (peers with expertise in SS research) • Standing members • Ad hoc members • http://www.csr.nih.gov/Roster_proto/sectionI.asp • Indication of when specific members of SS will rotate off • Special Emphasis Panels Office of Proposal Development, Texas A&M University

  31. The Review Process… Office of the Director (OD) DMCMDivision of Molecular & Cellular Mechanisms DBBDDivision of Biological Basis of Disease DMSDivision of Management Services Administrative Services Branch DCPSDivision of Clinical & Population-Based Studies DPPDivision of Physiology & Pathology Travel and Consultant Reimbursement Section Committee Management Branch Financial Management Branch RDivision of Receipt & Referral Technology Services Branch • CSR – Organizational Chart Office of Proposal Development, Texas A&M University

  32. CSR – Integrated Review Groups Behavioral & Biobehavioral Processes IRG (BBBP) AIDS and Related Research IRG (AARR) Endocrinology, Metabolism, Nutrition and Reproductive Sciences IRG (EMNR) Immunology IRG (IMM) Infectious Diseases and Microbiology IRG (IDM) Oncological Sciences IRG (ONC) Division of Molecular and Cellular Mechanisms Donald Schneider, Ph.D. Division of Physiology and Pathology Michael Martin, Ph.D. Division of Clinical and Population-Based Studies Anita Miller Sostek, Ph.D Division of Biologic Basis of Disease Elliot Postow, Ph.D. Bioengineering Sciences & Technologies IRG (BST) Cardiovascular Sciences IRG (CVS) 9 Biological Chemistry and Macromolecular Biophysics IRG (BCMB) Brain Disorders and Clinical Neuroscience IRG (BDCN) Digestive Sciences IRG (DIG) 8 Biology of Development and Aging (BDA) 5 Hematology IRG (HEME) Health of the Population IRG (HOP) 14 Cell Biology IRG (CB) Integrative, Functional and Cognitive Neuroscience IRG (IFCN) Risk, Prevention, and Health Behavior IRG (RPHB) Genetic Sciences IRG (GNS) Surgical Sciences, Biomedical Imaging and Bioengineering IRG (SBIB) Musculoskeletal, Oral, and Skin Sciences IRG (MOSS) Molecular, Cellular and Developmental Neuroscience IRG (MDCN) Renal and Urological Sciences IRG (RUS) Respiratory Sciences IRG (RES) Office of Proposal Development, Texas A&M University

  33. The Review Process… • General Review Criteria • Investigator • Education, training, relevant experience • Environment • Suitability of facilities and institution support • Significance • Ability of the project to improve health • Approach • Feasibility of methods and appropriateness of budget • Innovation • Originality of research Office of Proposal Development, Texas A&M University

  34. The Review Process… • Investigator • Are the investigators 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? • Does the investigative team bring complementary and integrated expertise to the project? Office of Proposal Development, Texas A&M University

  35. The Review Process… • Environment • Does the scientific environment in which the work will be done contribute to the probability of success? • Do the proposed studies benefit from the unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? • Is there evidence of institutional support? Office of Proposal Development, Texas A&M University

  36. The Review Process… • Significance • Does this study address an important problem? • If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? • What will be the effect of these studies on the concepts, methods, technologies, treatments, services, ore preventative interventions that drive this field? Office of Proposal Development, Texas A&M University

  37. The Review Process… • Approach • Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? • Does the applicant acknowledge potential problem areas and consider alternative tactics? Office of Proposal Development, Texas A&M University

  38. The Review Process… • Innovation • Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice, address an innovative hypothesis or crucial barrier to progress in the field? • Does the project develop or employ novel concepts, approaches, methodologies, tools or technologies for this area? Office of Proposal Development, Texas A&M University

  39. The Review Process… • Proposal received at CSR • Assigned to an IRG, then to a SS • The SRA assigns a primary (P), secondary (S) and tertiary (T) reviewer • Investigator-initiated proposals (R01, R03, R21) are read by the P, S, T reviewers; bottom 50% of proposals are identified about 1 week prior to the SS meeting=triage or streamlining • Streamlined applications receive summary statements verbatim from each reviewer, but are not scored Office of Proposal Development, Texas A&M University

  40. The Review Process… Office of Proposal Development, Texas A&M University

  41. The Review Process-Scoring • SS meets to review applications • All 3 reviewers must agree on the streamlining proposals in order for the proposal to be triaged • Primary reviewer presents your proposal to the group (reads the abstract) • SS members discuss your application, the primary reviewer is able to answer questions about the proposal • SS members assign a score to the proposal between 1-5 (1=outstanding, 5=forget it) • After the meeting the SRA calculates the average score for each proposal, multiply by 100 to get a 3 digit score • SRA calculates a priority score or percentile ranking of the score; based on the past 3 cycles of grant scores within SS • SRA prepares a written critique of your proposal based on reviewer’s comments Office of Proposal Development, Texas A&M University

  42. The Review Process-Scoring Office of Proposal Development, Texas A&M University

  43. Learning More… • CRISP database • Computer Retrieval of Information on Scientific Projects • Searchable database of funded biomedical research conducted at universities, hospitals and other research institutions • Includes funded research from all grant-making agencies of the DHHS • Located http://crisp.cit.nih.gov Office of Proposal Development, Texas A&M University

  44. Learning More… • Make use of available resources • Visit with institute representatives at national meetings • Let them connect a face with a name • Contact your program officer early in the proposal process • Verify that your proposed project addresses the specific IC priorities • Ask the program officer if they would review your abstract written for a specific RFA or PA • If revising an application, address all the reviewer’s comments • Do compliment them on addressing concerns you had missed • Do not argue outright with them about certain points; acknowledge their comments and address them respectfully Office of Proposal Development, Texas A&M University

  45. Learning More… • Allow plenty of time to do your homework • Read the relevant NIH tutorials • http://www.niaid.nih.gov/ncn/grants/default.htm • Review the annotated NIAID R01 application • http://www.niaid.nih.gov/ncn/grants/app/app.pdf • Watch the video on the NIH peer review process • http://www.csr.nih.gov/Video/Video.asp • Read the instructions for your RFA or PA Office of Proposal Development, Texas A&M University

  46. Questions? Office of Proposal Development, Texas A&M University

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