A Surgeon’s Perspective of the Grant Review Process

1. A Surgeon’s Perspective of the Grant Review Process Pedro J. del Nido, M.D. Boston Children’s Hospital Harvard Medical School

2. My Grant Review History • 1993 NIH-NIGMS,Minority Institution and MBRS Special Emphasis Panel - Member • 1996-1998 National Affiliate Research Committee: Study Section C - Co-Chairman, American Heart Association • 1997 NIH-NHLBI, Mitochondrial Cardiomyopathy Special Emphasis Panel - ad hoc • 1997-2001 NIH-CSR, Surgery and Bioengineering Study Section - Member • 2002-2004 NIH-CSR, Surgery and Bioengineering Study Section - Chair • 2008 NIH-CSR, Myocardial Ischemia and Metabolism Study Section – ad hoc • 2011-2013 NIH-SBIB Pediatric and Fetal Applications Study Section - Chair

3. Funding History • 1987-1989 Chicago Heart Association, Principal Investigator, “Oxygen Mediated Reperfusion Injury in the Immature Myocardium” • 1989-1991 American Heart Association - Western Pennsylvania Affiliate, Grant-in-Aid, Principal Investigator, “Cytosolic Calcium Accumulation During Ischemia in Immature Myocardium” • 1992-1995 American Heart Association - National Center, Grant-in-Aid, Principal Investigator, “Cardiac Hypertrophy and Surgical Ischemia” • 1992-1996 National Institutes of Health (NHLBI), Principal Investigator, “The Stunned Heart and Cardiac Surgery: Ca2+ and Energetics” (R29-HL46207) • 1997-2000 American Heart Association - National Center, Grant-in-Aid, Principal Investigator, “Glucose Metabolism in the Hypertrophied Heart During Surgical Ischemia” (9650407N) • 1996-2001 National Institutes of Health (NHLBI), Principal Investigator, “The Stunned Heart and Cardiac Surgery: Protein Kinase C” (RO1- HL46207) • 2000-2004 National Institutes of Health (NHLBI), Principal Investigator, “Glucose Metabolism in the Hypertrophied Heart During Surgical Ischemia” (RO1 – HL63095) • 2001-2007 National Institutes of Health (NHLBI), Principal Investigator, “The Stunned Heart and Cardiac Surgery: Apoptosis/Necrosis” (competing continuation of RO1-HL46207) • 2002-2007 National Institutes of Health (NHLBI), Principal Investigator. “Analysis of Beating Heart Intracardiac Surgery” R01 (HL71128) • 2004-2010 National Institutes of Health (NHLBI), Principal Investigator, “Angiogenesis, Cardiac Hypertrophy and Surgical Ischemia” (RO1 –HL63095) • 2007-2008 US Army Medical Research Acquisition Activity (MGH-Parrish), "Cardio-port for Minimally Invasive Intra-cardiac Beating Heart Surgery", Principal Investigator Children’s Hospital Medical Corporation, W81XWH-07-2-001 • 2003-2009 NIH – National Heart Lung and Blood Institute “Randomized Trial of Pulmonary valve Replacement in TOF” (Geva), “SSCOR in Pediatric Heart Development and Disease” Co-Investigator; Children’s Hospital Boston (Newburger), P50 (HL074734) • 2003-2013* National Institutes of Health (NHLBI), Principal Investigator, “Image Guided Intracardiac Beating Heart Surgery” (RO1 – HL073647) Bioengineering Research Partnership • 2007-20012 NIH - National Heart, Lung, and Blood Institute, Consortium-Principal Investigator "Steerable MEMS Instruments for Precise Intracardiac Surgery". R01 (HL87797) (Dupont – Project P.I.) • 2009-2014* NIH- National Heart Lung and Blood Institute, Principal Investigator, “3D MRI-Based Modeling for Computer-Aided Right Ventricle Remodeling Surgery” (RO1 - HL089269) • 2009-2013* Food and Drug Administration (FDA)-Principal Investigator, “Pediatric Cardiovascular Device Consortium” (1P50FD003792-01) • 2011-2013 USAMRAA/MGH – CIMIT, Principal Investigator "Catheter-based Adaptable Device for Closure of Intracardiac Defects in Children” W81XWH-09-2-0001 • 2012-2017* NIH- National Heart Lung and Blood Institute, Principal Investigator, “Surgical Planning Tool for Aortic Valve Reconstruction” (R01HL110997)

4. In the days of paper!

5. What Happens When Your Grant Arrives at NIH • Scientific Review Administrators confirm completeness and determine who the best reviewers/discussants are • 2-3 written reviews per grant • 1-2 discussants • Reviews/Discussants are members of the study section – 18-20 people

6. What is an SRA, and Why should you care?

7. Scientific Review Administrator • Assigned to one study section • Receives the grants assigned to SS and assigns reviewers based on scientific content of proposal and reviewer expertise (not necessarily discipline or profession) • Deals with COI • Collects reviews and organizes SS meeting • Addresses administrative concerns • Conflicts, research integrity, budget

8. Study Section Meeting

9. Who are the reviewers and what are they being asked to do? • Study sections: • CSR • Bioengineering Technology and Surgical Sciences • Surgery, Anesthesia, Trauma • NCI, NHLBI, NINDS, GMS, etc. • Special panels

10. Reviewer’s tasks • Five criteria • Significance, Investigator, Innovation, Approach, and Environment • Score 1-9 • Strengths and weaknesses • Overall impact score • At SS meeting - discussion • Primary- introduces the proposal and their comments • Secondary – comments or rebuttal • Discussant – additional comments

11. Primary Reviewer

12. Secondary Reviewers and Discussants

13. Other SS Members

14. Reviewer’s tasks – cont. • Vertebrate animals • Human subjects • Final score: • All SS members vote a score • Allowed to vote outside range but asked for reason • Budget • Appropriate for the work proposed?

15. What do reviewers focus on? • Title and abstract • Scan introduction (Significance) if it is new to them • PRELMINARY DATA & APPROACH • Your Bio and your collaborators • Support structure • budget

16. How do I find out about study sections? http://public.csr.nih.gov

17. What are the Keys to Success • YOUR MENTOR OR MENTORSHIP TEAM • Having new or original ideas or approaches • A well prepared proposal, critically reviewed by as many “reviewer-like” people as possible • STARTING AS EARLY AS POSSIBLE

18. What are the Keys to Success? • Really knowing what is going on in your field • Talks, meetings • Go and visit key researchers – what they think about your ideas – scientifically rational? • Collecting some high quality pilot data • Will also inform you about logistics

19. What are the Keys to Success? • Paying exquisite attention to detail of your methods • Precisely describing the logistics of your study • Exactly how will each aspect of your study be done

20. Step 1 – Familiariaze Yourself with the Funder • Review grants from other people who were successful in getting funded • Review the types of projects that have been funded previously – make sure that yours “fits” • Check the web site to find out who reviews their grants

21. Step 2 – Get Organized • Meet with your mentor (and CRCPO) • Map out grant sections • Find out what all the institutional deadlines are, e.g., budgets, sponsored programs, department chair sign off, resources and environment statements, etc. • Develop a timeline with deadlines you MUST keep

22. Step 3 – Start with a Concept Sheet • Usually 2-3 pages • Include the specific aim of your proposal and your actual research hypothesis • Provide key background points • Why your aim is important (e.g., public health) • Justify need and timeliness of your approach

23. Step 3 – Start with a Concept Sheet • Describe what YOU have already done to start to address this problem • Outline (e.g., with diagram) a possible study design, explaining key items such as • Intervention, control • Outcomes

24. Step 4- Get Everyone to Review • Review with ALL your mentors • Review with other potential reviewers, as directed by your mentors • When optimized, under your mentor’s guidance consider discussing with contact people at Foundations, NIH

25. Step 5 – Polish, Polish, Polish • Develop full study protocol – keep reviewing instructions, make sure you are on track • Keep reviewing with ALL your mentors • Make sure that all your support documentation is ready

26. Remember the Study Section

27. Common Reasons for Failure • Lack of clarity and focus in the specific aims • Lack of acceptable scientific rationale • Lack of knowledge of published relevant work • Lack of pilot data, no-one in your team has experience in essential methodology

28. The reviewer is probably not that familiar with your particular field of research

29. Common Reasons for Failure? • Lack of attention to detail in your research methods – superficial, overly ambitious • Lack of a critical approach • Lack of recognition of potential problems and proposed solutions • Lack of value of the proposal – result and methods already well established

30. The reviewer can be your friend Give them ammunition to defend you

31. Common Reasons for Failure • Lack of confidence that you will complete the protocol • It must be clear that you (and other relevant people) will spend enough time on the project • Demonstrate that you have all the necessary people, PATIENTS and laboratory resources to be successful

32. Even if one reviewer is very familiar with your area The others may not be The end results depends on whether the advocates can prevail over the detractors

33. Common Reasons for Failure • STARTING TOO LATE • Remember the “pros” take months (full-time) preparing grants – you are being compared with them

34. Thank you