1. Yolonda L. Colson MD, PhD Associate Professor of Surgery Brigham and Women’s Hospital Harvard Medical School 2011 AATS Grant Writing Workshop WRITING A REVISION: Formulation Your Response and Rebuttal

2. “PINK SHEETS” Reading your Summary Statement

3. Summary Statements Anger, Denial and Despair are a normal part of reading a critical review of your “perfect” grant… © Henry T. Kaiser/Photolibrary & www.avantipress.com

4. The 2 nd Stage of Reading Your Summary Statements.. Let’s agree to respect each others views, no matter how wrong yours may be … © Ashleigh Brillant on despair.com

5. Summary Statements: Acceptance Before you can write a successful revision and make your grant better, you must accept the criticism as constructive and address each point.

6. Parts of a Summary Statement Summary of Discussion Description (rephrasing what you said) Public Health Relevance 3-4 Reviewer Critiques with scores for each of 5 criteria (scale of 1-9)

7. The Reviewer Critique Summary of Strengths and Weakness Overall Impact Individual Scores in Each of 5 Criteria: - Significance, Investigators, Innovation, Approach, Environment Other Critical Areas that must be addressed: - Protection of Human Subjects, Vertebrate Animals, Biohazard, Resubmission (response to prior critique), Budget and period of support, Resource Sharing Plan

8. Understanding your Score ImpactScoreDescriptorAdditional Guidance on Strengths/Weaknesses High 1ExceptionalExceptionally strong with essentially no weaknesses 2OutstandingExtremely strong with negligible weaknesses 3ExcellentVery strong with only some minor weaknesses Medium 4Very GoodStrong but with numerous minor weaknesses 5GoodStrong but with at least one moderate weakness 6SatisfactorySome strengths but also some moderate weaknesses Low 7FairSome strengths but with at least one major weakness 8MarginalA few strengths and a few major weaknesses 9PoorVery few strengths and numerous major weaknesses Minor Weakness: An easily addressable weakness that does not substantially lessen impact Moderate Weakness: A weakness that lessens impact Major Weakness: A weakness that severely limits impact Impact/Overall Priority Score: Mean score from all eligible members' impact/priority scores x 10. Final overall impact/priority scores range from 10 (high impact) through 90 (low impact). *.* means not scored, generally rank in the lower half of all submitted applications.

9. REALITY One Chance to Revise a Grant and Raise The Score Into the “Fundable” Range

10. How Significant & Innovative is your proposal -- really? Identify Critical Strengths and Weaknesses What areas can and cannot be improved? Can you address the criticisms scientifically without using the word “Idiot”? Get Advice from your Program Officer Critically Evaluate Your Grant

11. Critically Assess Likelihood of a Revised Grant Getting Funded Did the Reviewers – Like the Overall Concept? Agree with Significance and Innovation? Identify Discrete “Fixable” Items that will yield Major Improvements? Identify Any Fatal Flaws?

12. Can You Improve Your Grant Enough to Get it Funded ?  It does not matter if you improve the score on your RO1 from the 50 th to the 25 th percentile – neither is fundable  It will likely matter significantly, however, if you can improve your score from the 18 th to the 14 th percentile, especially if you are a new investigator.

13. LISTEN There is value in what the Reviewers are saying to you

14. Set Your Ego Aside and Listen Make a worksheet that outlines the REVIEWERS Opinion …  The Important Clinical Problem Addressed  Strengths and Weaknesses  Areas/Questions NOT addressed  New Experiments Required  Fatal Flaws in Design or Concept

15. Common “Fixable” Problems  Poor writing  Significance not clear  Feasibility of approach not clear  Insufficient information in experimental details, preliminary data  Failure to discuss alternatives and obstacles as part of research design  Too Ambitious – Cut Aims, Experiments

16. More Difficult Issues Reviewers question significance - Rarely benefit from change in Study Section Hypothesis not supported or not credible Work previously described - (i.e. nothing new) Methods or experimental design are inaccurate or not appropriate for hypothesis

17. WRITING A REVISION: Giving your Grant a Second Chance!

18. Writing a Grant Revision Highlight Strengths Use reviewer’s own words Address Weaknesses Direct positive responses Answer Questions Respectful, factual data Risky to Add Unrequested New Ideas/Aims Seek Advice of “Experts” and Mentors

19. Befriend an Experienced Mentor  Show your Reviews and a draft of your response to an NIH-funded investigator Talk about what you can/cannot fix and how Have you answered the reviewers’ criticisms? How much difference is it likely to make in your score?  Remember they have been through this themselves … learn from their mistakes and experience

20. Example of Grant Revision Introduction (1 page ):  The proposal received many favorable reviews from the Study Section, including comments such as: “The local drug delivery approach they propose to understand and develop is at the cutting edge of materials science and therapy.”; “The proposed work could have very significant impact …”; “They have a clear vision for taking the science through to the translational research.”; “The idea of creating a scaffold that delivers drugs and must serve some mechanical function is challenging, and their solution to this is innovative.”…“Well-articulated proposal, with very few weaknesses.”; “The PI has a strong publication record… and significant preliminary data.”; “…experimental design is excellent, with logical progression ….”; ”Choice of models and imaging methods using dual labels …are excellent aspects of the experimental design.”; “… and innovation is high.”  The reviewers made insightful comments and provided valuable feedback on areas that have now been improved. Our responses are summarized below and new text in the proposal is highlighted by a * at the nearest paragraph indent. In addition, our first paper demonstrating prevention of tumor recurrence following resection in vivo is in press and was highlighted as a work of special interest to this field (Annals of Surgical Oncology, 2009, Epub Dec. 3).

21. Example of Grant Revision Detailed Responses to Reviewers ( included in 1-page intro ):  Q: “it is not clear that this will prevent reoccurrence.”  A: Our preliminary data show that we can prevent local recurrence after resection in a murine model (see section 3.3.2.3) using the paclitaxel loaded films. Although metastatic disease was not prevented given the aggressive nature of the LLC model, the longest surviving recipients all received drug- eluting copolymer films.  Q: “Biggest weakness of the proposed work (which overall is excellent) is their proposed mechanical characterization. The two big issues are (1) Cyclic loading is inherent to this application and a thorough test plan is not included, and (2) the fluidic environment and degradation will have a huge impact….”  A: We have included a test plan and will evaluate film performance in a fluid environment using an Instron equipped with a fluid chamber located in the BioInterface Technologies (BIT) center at BU.

22. Revised Grant Entire revised grant application + 1-page introduction Make clear what changes were made in answer to reviewers questions Incorporate new changes into grant proposal - “Free-standing” proposal with new improved science Mark changes in grant text - Sidebar marks, parentheses, or underline

23. PUBLICATIONS  One of the most important things you can do to support your revised grant is to publish papers supporting your grant hypothesis etc.  Peer-review in a high impact journal is very powerful Builds Basic Science Reputation – Credibility

24. If at First you Don’t Succeed Remember---

25. You Have to Just Keep Trying! We Have All Been There --

26. Because Eventually You Succeed!! © Stuart Crossett & www.avantipress.com