crafting an outstanding nih grant application an insider’s perspective
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Crafting An Outstanding NIH Grant Application An insider’s perspective. Martin Padarathsingh, Ph.D. Referral Officer & Scientific Review Administrator Center for Scientific Review/NIH Research Proposal Consultant, H. Lee Moffitt Cancer Center & Research Institute. Outline. - PowerPoint PPT PresentationTRANSCRIPT
Crafting An Crafting An Outstanding NIH Grant Outstanding NIH Grant ApplicationApplicationAn insider’s perspectiveAn insider’s perspective
Martin Padarathsingh, Ph.D.Referral Officer & Scientific Review Administrator Center for Scientific Review/NIHResearch Proposal Consultant, H. Lee Moffitt Cancer Center & Research Institute
• NIH Peer Review Process
• Grantsmanship Guidelines
• Study Section Actions
• Application - Revision
Outline
REVIEW PROCESS FOR A RESEARCH GRANT
PrincipalInvestigator
School or OtherResearch Center
National Institutes of Health
InitiatesResearch Idea
Conducts Research
Submitsapplication
AllocatesFunds
Center for Scientific Review
Scientific Review Group
Institute
Advisory Council or Board
Institute Director
Assign to IC and IRG
Review for
ScientificMerit
Evaluate for Relevance
Recommend Action
Review Process for a Research Grant
Receipt DeadlinesR01 Applications
NEWNEW
• February 5
• June 5
• October 5
REVISED REVISED
(Competing)(Competing)
• March 5
• July 5
• November 5
Receipt Deadlines – R01/Fellowship Applications
FELLOWSHIPFELLOWSHIP
• April 8
• August 8
• December 8
Applications Submitted to NIH
Duties of Referral Officers
Applications Funding Institutes
SRA/Study SectionCSR, Institutes
ReviewersStudy Section Meeting
1. Assignment to Funding Institutes
2. Assignments to Study Sections
• The applications are first examined by Asst. Chiefs in the
Division of Referral and Review; they are forwarded to
the appropriate Referral Officer based on the area of
proposed research. Referral Officers ensure that the
applications are assigned to the appropriate Initial
Review Groups (IRGs).
• There are about 23 IRGs, specializing in Oncology, Cell
Biology, Immunology, Neurology etc. Each IRG has
multiple study sections
Assignment of Applications
• There are 17 study sections within the ONC IRG. They
cover a wide spectrum of cancer research ranging from
basic biology, drug discovery, translational sciences and
clinical trials.
• Each application is assigned to a specific study section
based on the type of studies proposed. This assignment is
determined by the Referral Officers and the SRAs of the
ONC IRG.
• Some applications will be assigned to a Special Emphasis
Panel based on certain criteria.
Applications Related to Cancer
Interact with NIH staff & Colleagues
• Scientific Review Administrator- Identify study session
• Program Director- Specific research areas- RFA’s, PA’s, special initiatives
• Seek the advice of colleagues at your home institution
Presubmission Preparation
• MERIT AwardsProvides extended funding period for outstanding competing renewal RO1 applications
• Shannon AwardsProvides funding for grants from new investigators who are marginally outside the payline applications
• Minority Supplements
Other Types of Awards
• Read Instructions – PHS 398/SF424
• Attention to Administrative Details
• Font Size Font Size
• Animal and Human Studies
• Letters from Collaborators
• Appendices – Manuscripts
• Mentor (Fellowship)
When Preparing Your Application
• Never assume that the reviewers “will know what you mean” - CLARITY
• Refer to the literature thoroughly
• State rationale of proposed investigation
• Present an organized, lucid write-up
• Include well-designed tables and figures
• Obtain pre-view from colleagues - in essence an internal pre-review before submission to the NIH
When Preparing Your Application Cont.
• Significance
• Approach
• Innovation
• Investigator
• Environment
• Budget is not considered in the scientific evaluation
Review Criteria
• Important area of research
• Target sites: breast, lung, prostate, skin…
• Carcinogenesis mechanisms
• Development of new reagents, methodology, treatment
• Convince the reviewers that the proposed work is important
Significance
• Hypothesis and Mechanism
• Preliminary Data - should be strong and convincing
• Specific Aims
• Experimental Design - questions
• Results, impact, future directions
• Potential Pitfalls and Alternatives
Approach
A substantial weakness is a serious lack of
potential problems and alternative possible
results, and consequent alternative
approaches which will be utilized. This
imparts the impression that the success of
the proposal is absolutely dependent on
achieving the expected results.
Potential Pitfalls and Alternatives
• Novel concepts and approaches
• Project challenges existing paradigms and/or introduces new paradigms
• Original and innovative aims
• Innovative use of existing technologies
• Development of new reagents, models, methodologies and technologies
Innovation
• Appropriate training and expertise
• Productivity – track record
• Collaborators and consultants
• Network
Investigator
• A person who has never been a pi on a NIH RO1 grant
• Check new investigator box (2) on PHS 398 face page
• Productivity
• Independence, resources
• Letters of support from collaborators and chairperson
• Period of award
• Paylines – special treatment (?)
New Investigator
• Intellectual and physical environment
• Unique features – facilities, resident experts
• Does the scientific environment contribute to the probability of success?
Environment
• Divide applications into upper and lower halves
• Unscore applications in lower half
• Decision to unscore – MUST BE UNANIMOUS
• Unscored applications are not discussed. Applicants receive unedited critiques from the reviewers in their Summary Statements
Streamlining: Pre-study Section Action
• Scored, Scientific Merit Rating: priority scores
• Unscored: unanimous decision
• Deferred
Scientific Review Group or Study Section Actions
• Outstanding 1.0 – 1.5
• Excellent 1.5 – 2.0
• Very Good 2.0 – 2.5
• Good 2.5 – 3.5
• Acceptable 3.5 – 5.0
• Unscored applications fall in the range of 3.0 -5.0; they are not without scientific merit!
Priority Scores
• Proposed studies are highly significant
• Addresses important questions
• Potential for providing valuable insights
• Solid foundation for proposed studies
• Novel concepts
Outstanding Application
• Revise and Resubmit (2 Chances)
• Funding Outside the Payline
• Exception, Shannon, Private Foundations, Supplementary Support (Competing Renewal)
• Program Director’s Advice
• Scientific Review Administrator’s Advice
• Give up (I hope not!)
Options If Not Funded
• Introduction – 3 pages
• Diplomacy: thank the reviewers
• State concerns fully and provide response
Revision
• Concerns by Reviewers and Response
• Reviewer 1:- Concern 1
- Response 1
• Reviewer 2:- Concern 1- Response 1
Introduction Format
• Other Government Agencies – Cancer Research:
– Department of Defense Funding Initiatives
– Office of Orphan Products Development (FDA)
– Veterans Health Administration
Other Funding Organizations
• American Cancer Society
• Burroughs Wellcome Fund
• The Charlotte Geyer Foundation
• Damon Runyon Cancer Research Foundation
• Robert Wood Johnson Foundation
Private Foundations
• NIH/NCI Grant Funding is becoming highly competitive
• Applications should be prepared with utmost diligence and insight
• The help and advice of SRAS at CSR, program officers at the institutes, and colleagues at your institution who have been successful will provide an added advantage in crafting an outstanding application
Summary
Questions & Answers
Martin Padarathsingh, Ph.D.Referral Officer & Scientific Review Administrator Center for Scientific Review/NIHResearch Proposal Consultant, H. Lee Moffitt Cancer Center & Research Institute