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A Tour Through the NIH SBIRSTTR Review Process

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A Tour Through the NIH SBIR/STTR Review Process. Sally A. Amero, Ph.D. ... Mature and objective judgement. Oral and written communication skills ... – PowerPoint PPT presentation

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Title: A Tour Through the NIH SBIRSTTR Review Process


1
A Tour Through the NIH SBIR/STTR Review Process
  • Sally A. Amero, Ph.D.
  • Scientific Review Administrator
  • Suzanne E. Fisher, Ph.D.
  • Director, Division of Receipt and Referral
  • Center for Scientific Review, NIH

2
FOCUS ON THREE ASPECTS
  • Submission
  • Assignment
  • Review

3
SUBMISSION
  • CSR receives all competitive applications for NIH
    - 45,000/year
  • About 4500 are SBIR/STTR
  • Three receipt dates per year
  • April 1, August 1, December 1
  • (CDC only December 1)

4
HOW TO GET INFORMATION
  • NIH Home Page (http//www.nih.gov)
  • CSR Home Page (http//www.csr.nih.gov)
  • Reviewer Guidelines
  • SRAs
  • NIH SBIR/STTR Coordinator
  • 301-435-2688
  • Division of Receipt and Referral, CSR
  • 301-435-0715

5
PREPARING AN APPLICATION
  • Start early
  • Read and follow instructions
  • Clarify any confusing instructions early
  • Do not assume staff or reviewers will know what
    you mean
  • Include well designed tables and figures
  • Format - consider the reviewers
  • Proofread and check before sending

6
PREPARING AN APPLICATION (cont.)
  • Explicitly state the purpose of the proposed work
  • Refer to the literature thoroughly but
    thoughtfully
  • Present an organized, lucid write-up
  • Be mindful of the review criteria to be used
  • Get advice from colleagues

7
REFERRAL
  • Application Number
  • SBIR (R43/R44) or STTR (R41/R42)
  • Institute/Center for Funding Consideration
  • Dual assignments frequent
  • Study Section
  • Indicate preferences via cover letter
  • Principal Investigator and Organization notified

8
BASIS FOR ASSIGNMENTS
  • Referral Guidelines for Institutes and Review
  • Applicant Requests
  • Institute Requests
  • Program Announcements
  • Assignment History

9
ASSIGNMENT NOTIFICATION
  • Scientific Review Administrator
  • Address, telephone number, etc.
  • Institute Assignment
  • Primary and any dual
  • General contact number
  • Unique Identifier (1 R43 xx123456-01)
  • Should receive within one month

10
ASSIGNMENT
  • Concerns regarding review or Institute assignment
  • Contact SRA
  • Institute Home Page and telephone number
  • Request for change in writing to CSR (fax
    301-480-1987)
  • More efficient to include cover letter with
    submission

11
REVIEW
  • Dual Review - Study Section and Advisory Council
  • Study Section Streamlined Review
  • Generally only the top half of the applications
    discussed must be unanimous agreement to be
    unscored
  • Remainder discussed and scored
  • National Advisory Council

12
SCIENTIFIC REVIEW ADMINISTRATOR
  • Point of contact during the review process
  • Discuss before sending additional material
  • Administrative review
  • Responsible for recruitment and assignment of
    reviewers
  • Designated Federal Official
  • Prepares Summary Statement

13
PEER REVIEWERS
  • Scientific and technical expertise
  • Stature in field
  • Mature and objective judgement
  • Oral and written communication skills
  • Ability to work in group setting
  • Geographic, gender, and minority group balance
  • At least one small business affiliated reviewer
    is required

14
REVIEW CRITERIA
  • Significance
  • Important problem
  • Commercial potential
  • Commercial/societal benefit
  • Advance scientific knowledge
  • Enabling technologies
  • Competitive advantage

15
REVIEW CRITERIA (cont.)
  • Approach
  • Framework, design, methods
  • Technical and commercial feasibility
  • Problems/alternate strategies
  • Milestones/evaluation
  • Innovation
  • New paradigm/novel technology

16
REVIEW CRITERIA (cont.)
  • Investigator(s)
  • Principal Investigator
  • Experience level
  • Environment
  • Access to resources
  • Contribute to success
  • Unique features/collaborations

17
REVIEW CRITERIA (cont.)
  • Phase II
  • Progress in Phase I/Demonstration of feasibility
  • Fast Track
  • Measurable goals in Phase I
  • Product Development Plan
  • Commercialization

18
REVIEW ALSO CONSIDERS
  • If human subjects are involved, plans to include
    both genders, minorities and subgroups, and
    children as appropriate for scientific goals of
    research
  • Proposed protection for humans, animals, and the
    environment
  • Reasonableness of the proposed budget and
    duration

19
RESULTS OF REVIEW
  • Unscored (approximately bottom half) or priority
    score
  • Score (generally between 100 and 300)
  • Deferral (very rare)
  • Not Recommended for Further Consideration (very
    rare serious concerns)
  • Notification of Principal Investigator
  • Summary Statement

20
SUMMARY STATEMENT
  • Study Section Recommendation
  • Resume and Summary of Discussion (if scored)
  • Essentially unedited comments of reviewers
  • Organized by review criteria

21
SUMMARY STATEMENT (cont.)
  • Administrative notes
  • Coding for human subjects, animals, gender,
    minorities, children
  • Program Directors name and telephone number
  • Primary contact after review

22
COMMON PROBLEMS
  • Overly ambitious
  • Lack of novel ideas/approach
  • Diffuse, unfocused research plan
  • Lack of evidence of understanding published
    relevant work
  • Lack of experience in critical methodology
  • Uncritical approach lack of scientific rationale
  • Lack of commercial potential/societal benefit

23
REVISED APPLICATION
  • 2 amendment / 2 year limitation
  • Must have received summary statement
  • Need to make changes in Research Plan
  • Need to include Introduction and mark text to
    show changes
  • Next review may be by same or different study
    section

24
COUNCIL REVIEW AND FUNDING DECISIONS
  • Handled by the Institutes and Centers
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