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OGS Graduate Student Seminar National Institutes of Health Breakout Session Susan E. Maier, Ph.D. Office of Proposal Development, Texas A&M University The Texas A&M University System Health Science Center NIH Overview Department of Health and Human Services (DHHS)

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OGS Graduate Student SeminarNational Institutes of HealthBreakout Session

Susan E. Maier, Ph.D.

Office of Proposal Development, Texas A&M University

The Texas A&M University System Health Science Center

Office of Proposal Development Texas A&M University


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NIH Overview

  • 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


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20 Institutes, 7 Centers

Office of Proposal Development Texas A&M University


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NIH Overview

  • Mission – improve the health and well-being of humans and reduce the burden of illness on population

  • NIH is a basic research agency

    • Different from a mission-based agency (e.g., NASA, DoD)

    • Fund basic science research (molecules to humans) in health-related topics

    • Encourage translation of bench research into patient practices

Office of Proposal Development Texas A&M University


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NIH Culture

  • Top down approach to strategic planning

    • Information on the strategic plan for NIH can be found at http://www.nih.gov/about/researchpriorities.htm

  • Office of the Director sets the tone for research priorities

  • Institute and Center (IC) Directors use this information to develop their institute’s strategic plan

  • Important to review the individual IC web pages and talk to program officers about the current research focus within an IC

Office of Proposal Development Texas A&M University


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NIH Culture

  • Intra-agency programs or trans-NIH initiatives; research that cuts across typical agency boundaries of various IC

    • http://www.nih.gov/about/transnih.htm

      • Bioengineering Consortium (BECON)

      • Model Organisms for Biomedical Research

      • Bioinformatics at the NIH

      • Mammalian Gene Collection (MGC)

  • Translational Research

    • Part of the NIH Roadmap

    • http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp

  • Office of Proposal Development Texas A&M University


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    NIH Funding Investments and Priorities

    • NIH has investment priorities based on past research findings and current trends in science

      • DHHS FY2006 budget is $592 billion

      • NIH FY2006 budget is $28.8 billion

  • Targeted areas: biodefense, HIV/AIDs, Roadmap, Blueprint

  • NIH funds research projects inside their own laboratories (intramural) and outside their laboratories at national and international locations (extramural)

    • Extramural funding

    • Intramural Funding

    • Research Infrastructure

  • 84%

    11%

    5%

    Office of Proposal Development Texas A&M University


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    Office of Extramural Research (OER)

    • http://grants1.nih.gov/grants/intro2oer.htm

    • Award Mechanisms

      • Funding Avenue

      • Funding Instrument

      • Research Activity

    • Distinction between 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



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    Identifying NIH Funding

    • Solicited proposals (RFA, RFP, PA, PAR)

    • 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


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    Identifying NIH Solicitations by Topic

    • Search by Topic

      • Identify funding opportunities

      • Determine supporting agencies

      • Identify mechanism (R, U, T, etc.)

      • Identify review criteria

    Office of Proposal Development Texas A&M University



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    Example - Biodefense

    Office of Proposal Development Texas A&M University


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    Example - Biodefense

    Office of Proposal Development Texas A&M University


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    Identifying NIH Solicitations by IC Topic

    • Search by Agency (IC)

      • Identify funding opportunities within an agency

      • Identify mechanism

      • Identify review criteria

    • Steps for searching….

      • Identify Agency (IC)

      • Go to their homepage (http://www.nih.gov/icd)

      • Go to their “Research Funding” or Extramural Funding” section

      • Perform search

    Office of Proposal Development Texas A&M University


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    Identifying NIH Solicitations by IC TopicExample - NIGMS

    Office of Proposal Development Texas A&M University


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    Identifying NIH Solicitations by IC TopicExample - NIGMS

    Office of Proposal Development Texas A&M University


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    Identifying NIH Solicitations by IC TopicExample - NIGMS

    Office of Proposal Development Texas A&M University



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    PROPOSAL

    FUNDING

    IDEA

    Unsolicited NIH Funding

    Office of Proposal Development Texas A&M University


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    Solicited

    Unsolicited

    Awards by Solicited or Unsolicited Applications

    Office of Proposal Development Texas A&M University


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    NIH Funding Mechanisms

    • Unsolicited proposals; regular receipt, review cycles

    • 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

      • R15 Academic and Research Enhancement Award (AREA) Grant

        • Small research projects in the biomedical and behavioral sciences conducted by students and faculty in health professional schools, and other academic components that have not been major recipients of NIH research grant funds

    Office of Proposal Development Texas A&M University


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    NIH Career Awards

    • 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


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    NIH Training Awards

    • Training awards – for predoctoral (F31), postdoctoral (F32) or short term training (F33)

    • Limited to US citizens or legal aliens

    Office of Proposal Development Texas A&M University


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    Submitting Proposals

    • All NIH proposals use PHS Form 398 or a variation of PHS398

    • Step 1: Download the Instructions and PHS398 forms

      • http://grants1.nih.gov/grants/funding/phs398/phs398.html

    • Step 2: READ THE INSTRUCTIONS

    Office of Proposal Development Texas A&M University


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    No page limit

    Common Elements of PHS398 R01

    • PHS398 (R01)

      • Cover page/face sheet (1 page)

      • Abstract, performance site, key personnel (2 pages)

      • Table of contents (1 page)

      • Budget page(s)

      • Budget justification

      • Biosketch of PI, biosketch of all other major/key personnel (4 pages*)

      • Resources (no page limit)

      • 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 (no more than 5 items)

      • Checklist

      • Personal data on PI

    Office of Proposal Development Texas A&M University


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    Budget & Budget Justification

    • Budget

      • Get help (institutional grants administrator)

      • Be reasonable. The reviewers also do research!

  • Budget Justification

    • Personnel

      • Who? What will they do? How much effort (%)? Why is this person critical to the success of the project?

    • Equipment

      • What do you need? Why do you need it? Is there a similar apparatus nearby that you can use (if yes, why not use it)?

    • Travel

      • Where do you need to go? How many times will you go there? How many of the project personnel will go? Approximately how much will it cost and why?

    • Other Supplies

      • Equipment maintenance contracts? Fee for service resource?

  • Office of Proposal Development Texas A&M University



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    NIH Biographical Sketch

    • Four (4) page maximum; sections A. Positions and Honors, and B. Publications, must end at bottom of page 2

    • List only current and completed support

      • no total or annual amount

      • no percent effort

  • List publications reflective of the topic of the current proposal (or maximum)

  • Office of Proposal Development Texas A&M University


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    PHS398 (Rev 09/04)

    Office of Proposal Development Texas A&M University


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    Review of NIH Proposals

    • 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

    Office of Proposal Development Texas A&M University


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    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


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    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)

    CSR – Integrated Review Groups

    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)

    Office of Proposal Development Texas A&M University

    Respiratory Sciences IRG (RES)


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    NIH 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


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    CSR – ‘Streamlining’

    • 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

    • All 3 reviewers must agree on the streamlined proposals in order for the proposal to be triaged

    Office of Proposal Development Texas A&M University


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    • Study section

    • Score

    • Budget

    Summary Statement - Triaged

    Office of Proposal Development Texas A&M University


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    CSR – Scoring Proposals

    • SS meets to review applications

    • 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 (100-500)

      • 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


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    • Study section

    • Score

    • Budget

    CSR – Scored Proposal

    Office of Proposal Development Texas A&M University


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    Revisions

    • Three strikes “you’re out”

    • Read the reviewer’s comments

    • Take a break

    • Re-read the reviewer’s comments

    • Don’t take them personally

    • Read the reviewer’s comments, AGAIN

    • Begin working on the revisions, incorporating the revisions that you think make your proposal better than the previous submission

    • If you have a question about a particular comment, contact the SRA

    Office of Proposal Development Texas A&M University


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    • Study section

    • Score

    • Budget

    Summary Statement for Revised Proposal

    Office of Proposal Development Texas A&M University


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    Success at NIH

    • Understand NIH’s mission and overall goals

      • Propose research topics that cross the boundaries of various IC; leverage tools and resources from other research areas to approach your research topic; create multidisciplinary research teams

      • Focus on NIH priorities

    • Search for funding opportunities often and using different strategies, e.g., agency or topic search, and submit unsolicited proposals when possible

    • Look for various opportunities to acquire funding, e.g., diversity supplements, career awards

    • Partner with established NIH investigators

    Office of Proposal Development Texas A&M University


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    Questions About NIH?

    Craft of Writing Workshop

    Room 601 Rudder

    3:00-5:00pm

    Presenter: Dr. Phyllis McBride

    Office of Proposal Development Texas A&M University