West Texas A

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West Texas AM UniversityResearch Proposal
Workshop

• Susan E. Maier, Ph.D.
• Research Development Officer

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NIH Overview
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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)

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NIH Organizational Chart

• Primary agency for funding biomedical, behavioral
  and mental heath research

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NIH Mission

• Mission improve the health and well-being of
  humans and reduce the burden of illness on
  population
• Office of Director suggests general areas of
  research focus
• Institute and Center (IC) directors use this
  information to do strategic planning within own
  IC
• Important to review the individual IC web pages
  and talk to program officers about the current
  research focus within an IC
• Current hot trends in research include
  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)

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NIH Budget Process

• NIH FY2006 budget is 28.8 billion

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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)
• For each fiscal year, the majority of funds go
  towards funding extramural research
• 84 extramural, 11 intramural, 5 research
  support

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NIH Funding Priorities

• Targeted areas of support for FY2006
• Biodefense (11 increase from FY2005)
• Research directed at detecting and countering
  bioterrorism
• HIV/AIDs Research (lt1 increase)
• Development of AIDs vaccine
• NIH Roadmap (lt1 increase)
• New Pathways to Discovery
• Research Teams of the Future
• Re-Engineering the Clinical Research Experience
• NIH Blueprint for Neuroscience Research
• 15 IC participating

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NIH Award Mechanisms

• 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)

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NIH Award Mechanisms

• http//grants2.nih.gov/grants/choosing_fundInstrum
  ent.doc

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Finding Solicited Opportunities

• Solicited proposals (RFA, RFP, PA)
• 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
• NIH funding opportunities page
• Includes funding opportunities for NIH IC only
• Located at http//grants1.nih.gov/grants/guide/ind
  ex.html
• Subscribe to weekly listserv

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Searching

• Search by Topic
• Identify funding opportunities
• Determine supporting agencies
• Identify mechanism (R, U, T, etc.)
• Identify review criteria
• Search by Agency
• Identify funding opportunities within an agency
• Identify mechanism
• Identify review criteria

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Example - Biodefense
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Examples Reading the RFA

• Title of RFA or PA (website location)

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Examples - Nursing

• Biobehavioral Methods to Improve Outcomes
  Research (http//grants.nih.gov/grants/guide/pa-fi
  les/PA-05-142.html)

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Examples infectious diseases

• Evolution of Infectious Diseases
  (http//grants.nih.gov/grants/guide/pa-files/PA-05
  -079.html)

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Examples Population Research

• Global Research Training in Population Health
  (http//grants.nih.gov/grants/guide/rfa-files/RFA-
  TW-05-002.html)

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Examples Promoting Diversity in Health Related
Sciences

• Research Supplements to Promote Diversity in
  Health-Related Research (http//grants.nih.gov/gr
  ants/guide/pa-files/PA-05-015.html)

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Examples Agency Search

• National Institute of General Medical Sciences
  (NIGMS or GM)
• The mission of the National Institute of General
  Medical Sciences is to support basic, biomedical
  research that contributes to fundamental cellular
  and physiological principles. General areas of
  interest include cell biology, biophysics,
  structural genomics, proteomics, bioinformatics,
  genetic mechanisms, developmental biology,
  chemistry, biochemistry, physiology, trauma and
  burn, anesthesiology, and pharmacology.
• The molecular, genetic, functional, and
  structural understanding of biological molecules,
  their interactions and their organization, as
  well as the discovery of approaches to their
  control will contribute to understanding
  mechanisms for a variety of diseases.
• NIGMS also supports research in the fields of
  mathematics, physics, computer science, and
  engineering that are applicable to its mission.
• E.g., http//nigms.cit.nih.gov/funding.asp

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Search NIGMS
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NIH Unsolicited proposals
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NIH Unsolicited proposals
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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
• 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
• 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

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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

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NIH Training Opportunities

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

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What Has Been Funded at NIH?

• 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

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The Key to NIH

• Understand NIHs 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

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NIH Detailed Discussion
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Office of Grants and Special Projects

• The Office of Grants and Special Projects is
  located on the West Texas AM University campus
• Office of Grants and Special Projects West Texas
  AM University  Kilgore Research Center 185
  2402 N 3rd Ave Canyon, TX  79016
• Facilitate efforts to receive external funding
  for research projects through website guided
  links of internal policy and procedures and links
  to external funding opportunities
• Contact  
• Frannie Nuttall, Director Phone  [phone]
  Fax  [phone] Email fnuttall_at_mail.wtamu.
  edu

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Getting Started

• 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

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Basic Components of a Research Proposal

• 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/key
  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

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Key Points Face Page

• Are you applying to a specific request?

• Are you a new investigator?

• How much do you need?

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Key Points Abstract, etc.

• Relevance to Human Health

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Key Points Modular Budget
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Key Points Non-Modular Budget

• Continued on additional pages

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Key Points 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?

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Key Points Research Plan

• Length will be determined by RFA, PA or forms
• Use headings provided in the RFA or PA, or PHS398
• Consider how the reviewers will review the
  project (i.e., know the review criteria before
  you start)
• Use white space, bullets, keep it organized and
  clear
• Follow PHS398 guidelines for font type and size
  (Ariel 11), and margins

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Submission

• Late applications will be returned
• Note whether application needs to be received by
  the due date or postmarked by the due date
• For electronic applications, be aware that the
  website for uploading documents in the time
  period preceding the application due date/time
  will be SLOWcount on this!
• Whew! Now what?

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Center for Scientific Review

• 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

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CSR Organizational Chart
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CSR Integrated Review Groups
Division of Biologic Basis of Disease Elliot
Postow, 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 Molecular and Cellular
Mechanisms Donald Schneider, 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)
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Cell Biology IRG (CB)
Integrative, Functional and Cognitive
Neuroscience IRG (IFCN)
Risk, Prevention, and Health Behavior IRG (RPHB)
Surgical Sciences, Biomedical Imaging and
Bioengineering IRG (SBIB)
Genetic Sciences IRG (GNS)
Musculoskeletal, Oral, and Skin Sciences IRG
(MOSS)
Molecular, Cellular and Developmental Neuroscienc
e IRG (MDCN)
Renal and Urological Sciences IRG (RUS)
Respiratory Sciences IRG (RES)
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CSR - 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

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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 meetingtriage 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

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Summary Statement - Triaged
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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 (1outstanding, 5forget 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 reviewers comments

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CSR Scored Proposal
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Revisions

• Three strikes youre out
• Read the reviewers comments
• Take a break
• Re-read the reviewers comments
• Dont take them personally
• Read the reviewers 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

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Summary Statement for Revised Proposal
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Getting to Know NIH

• Make use of available resources
• Visit with institute representatives at national
  meetings
• Let them connect a face with a name
• Learn the language of the IC
• Contact your program office 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

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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
• Also at this site are 3 examples of NIH
  applications (R01), K08), R03) and summary
  statements
• Read the instructions for your RFA or PA

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Questions?
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Small Business Innovation ResearchSmall Business
Technology Transfer Program

• Small Business Innovation Research (SBIR), Small
  Business Technology Transfer Program (STTR)
• SBIR program is a set-aside program (2.5 of an
  agency's extramural budget) for domestic small
  business concerns to engage in Research/Research
  and Development (R/RD) that has the potential
  for commercialization.
• Federal agencies with extramural research and
  development budgets over 100 million are
  required to administer SBIR programs
• SBIR Objectives
• using small businesses to stimulate technological
  innovation
• strengthening the role of small business in
  meeting Federal R/RD needs
• increasing private sector commercialization of
  innovations
• increasing small business participation in
  Federal R/RD
• fostering and encouraging participation by
  socially and economically disadvantaged small
  business concerns and women-owned business
  concerns

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Examples

• Manufacturing Processes of Medical, Dental, and
  Biological Technologies (STTR R41/R42)
  http//grants.nih.gov/grants/guide/pa-files/PA-06-
  012.html
• SBIR/STTR Collaboration Opportunitiesand
  Research Partnerships (CORP) http//grants1.nih.g
  ov/grants/funding/corp.htm

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Similarities and DifferencesSBIR/STTR

• Similar both programs seek to increase the
  participation of small businesses in Federal RD
  and to increase private sector commercialization
  of technology developed through Federal RD. The
  unique feature of the STTR program is the
  requirement for the small business concern
  applicant organization to formally collaborate
  with a research institution in Phase I and Phase
  II.
• Different both programs are different insofar as
  (a) under SBIR Program, the Principal
  Investigator must have his/her primary employment
  with the small business concern at the time of
  award and for the duration of the project period,
  however, under the STTR Program, primary
  employment is not stipulated, and (b) the STTR
  Program requires research partners at
  universities and other non-profit research
  institutions to have a formal collaborative
  relationship with the small business concern