Getting Started – Preparation/ Grantsmanship/ Dealing with the New Format and Page Limits Mark Ratcliffe

Enhancing NIH Peer Review Redesign of the NIH application and review process

NIH Data Book – ( provided by the Division of Information Services, Reporting Branch Research Project Grants Applications, awards, and success rates

NIH ARRA FUNDING SUMMARY TOTAL ARRA FUNDING: $10.4B GRANTS: $8.97B1 to 21,581 projects R&D CONTRACTS: $0.8B OTHER: $0.63B

 Facilitate changing nature of science  Identify and encourage new and early stage investigators  Ease burden on research enterprise  Streamline time to award  Fund the best science, by the best scientists, with the least amount of administrative burden Enhancing NIH Peer Review

Background Year-long Deliberative Effort Gathering Feedback & Input: Request for Information NIH Staff survey IC White Papers Internal Town Hall Meetings External Consultation Meetings Data Analysis Internal and External Working Groups Working Groups Established to: 1. 1.Engage the Best Reviewers 2. 2.Improve the Quality and Transparency of Review 3. 3.Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages 4. 4.Continuous Review of Peer Review Diagnostic Design Implementation Plan Begin Phased Implementation of Selected Actions June 2007 – Feb March 2008 – June 2008 September 2008 Identified Key Recommendations

7 Enhancing Peer Review Overview and Timeline  Phase out of A2 applications  Identification of Early Stage Investigator (ESI) R01 applications  Enhanced review criteria  New scoring system  Criterion scoring  Structured critiques  Score order review  Clustering of New Inv. Applications  Restructured Applications  Shorter Page Limits and New Instructions January 2009 May/June 2009 Reviews January 25, 2010 Submissions

1-9 Scoring System  The new scoring system will use a 9- point scale (1 = exceptional, 9 = poor)  This scale will be used for overall impact/priority scores AND for individual criterion scores  Preliminary impact/priority scores will help determine which applications are discussed

Five Scoring Criteria Significance Investigator Innovation Approach Environment

Scoring of Individual Review Criteria  Assigned reviewers will use the 9-point scale for five review criteria –Each assigned reviewer’s criterion scores will be reported in the summary statement –Criterion scores will be reported for ALL applications  Reviewers will consider criterion scores as appropriate for each application in determining overall impact/priority score

Templates for Reviewer Critiques  Templates contain a box for reviewers to write their comments for: –each of the core review criteria –overall impact –other review criteria and additional considerations  Comments will be in the form of bullet points or short narratives  The template will be uploaded to become part of the summary statement

12 Enhancing Peer Review Overview and Timeline  Phase out of A2 applications  Identification of Early Stage Investigator (ESI) R01 applications  Enhanced review criteria  New scoring system  Criterion scoring  Structured critiques  Score order review  Clustering of New Inv. Applications  Restructured Applications  Shorter Page Limits and New Instructions January 2009 May/June 2009 Reviews January 25, 2010 Submissions

Major Changes to Applications For due dates on or after Jan 25, 2010  Restructured Application Forms  Shorter Page Limits and New Instructions For ALL competing applications: New, Renewal, Revision, and Resubmission 13

Overview of Shorter Page Limits Current Page Limit (Section 2-5 of the Research Plan) New Page Limit (Research Strategy) < >25Follow FOA Instructions Note: Follow FOA page limit requirements if different from the application instructions. Full table of page limits available at:

Goals of Shortened Page Limits  Reduce burden  Focus on the essentials of the science  Avoid information overload 15

Major Changes to the Research Plan  Specific Aims will include new language about the impact of the proposed research.  Research Strategy will be created as a new section and will include 3 of the current sections –Background and Significance –Preliminary Studies/Progress Report –Research Design and Methods 16

New Research Plan Components Introduction Specific Aims Background and Significance Preliminary Studies/Progress Report Research Design and Methods Inclusion Enrollment Report Bibliography and References Cited Human Subjects Sections…. protections, women/minorities, enrollment, children Other Research Plan Sections…. animals, select agents, multi PD/PI, consortium, support, resource sharing Appendix Research Strategy 17

Research Strategy Background and Significance, Preliminary Data and Research Design and Methods sections are now included in the Research Strategy section. Organization of the Research Strategy section is often not clear. It is often difficult to distinguish preliminary data from proposed work.

Research Strategy 3. Research Strategy A. Significance B. Innovation C. Approach The approach section is organized with 3.C.1 Preliminary data (Including Progress report) first, followed by 3.C.2 Research Design, 3.C.3 Methods and then 3.C.4 Potential Problems and Alternative Strategies

Formatting of Sections Outline –1 (introduction to revised application), 2 (aims), 3 (research strategy) –3.A (significance), 3.B (innovation), 3.C (approach), 3.C.1 (preliminary data), etc Make it easy for reviewers to find key points within the story: –Bold face type –Underlining

Formatting of Paragraphs 1 main idea per paragraph Use topic sentences Use transitions (e.g., however, in contrast, next, although, nevertheless, likewise, etc) End paragraphs with closing sentences. Examples: –These studies demonstrate the importance of…. –These studies provide important background for this study in… –The proposed project will build on this previous work, [or will address limitation in the previous work by ____ ]…

Font Use an Arial, Helvetica, Palatino Linotype or Georgia typeface and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies.) Type density, including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch. Use black ink that can be clearly copied. Print must be clear and legible. Page Margins Use standard size (8 ½" x 11") sheets of paper. Use at least one-half inch margins (top, bottom, left, and right) for all pages, including continuation pages. PHS398

General Comments Make your grant easy to read. Tell a story. “It would be good if your (husband)/ wife can understand.” 1 “Err on the side of starting off simple. Write the engineering part for the surgeons and the clinical piece for the engineers.” 1 1.Rob Gorman, CT Surgery, UPenn

General Comments “Don’t use jargon” 1 “Avoid abbreviations unless used repeatedly.” 1 If multiple abbreviations are necessary provide a list of definitions. 1.Rob Gorman, CT Surgery, UPenn

Pictures, Figures and Cartoons “Pictures/Figures are good but they should be easy to understand and add something besides color to the grant.” 1 “Make sure the regions of interest in figures/images are highlighted, have arrows, etc, so the reviewer does not have to guess at what they are looking for.” 2 1.Rob Gorman, CT Surgery, UPenn 2.David Saloner, Surgery and Radiology, UCSF

General Comments Check to see that the references are correctly numbered. 1 A reference manager such as Endnote is strongly recommended. 2 References can be downloaded directly from PubMed thereby avoiding errors in the bibliography (very irritating when the reviewer wants to look something up). More efficient when reformatting is necessary. “Check carefully for typos. In the age of spellcheck, typos are extremely annoying to reviewers, especially if there are a large number of them.” 3 1.Kessel D, Chest 130: Joel Karliner, Cardiology, UCSF

Overview of the Application Changes Application forms will be revised in three sections:  Research Plan  Biographical Sketch  Resources and Facilities 28

Goals of Restructured Applications  Align the structure and content of the forms with review criteria –To focus the applicants and reviewers on the same elements –To help ensure a more efficient and transparent review process 29

Application Alignment with Review Criteria: Major Examples CriteriaApplication SignificanceResearch Strategy a. Significance Investigator(s)Biosketch InnovationResearch Strategy b. Innovation ApproachResearch Strategy c. Approach EnvironmentResources 30

Changes to Biographical Sketch  Personal Statement added: –“Briefly describe why your experience and qualifications make you particularly well- suited for your role in the project”  Publications revised: –Limit the list of publications or manuscripts to no more than 15 –Applicant is encouraged to make selections based on recency, importance to the field, and/or relevance to the application 31

Changes to Resources and Facilities  Instructions added to Resources: –Provide a description of how the scientific environment will contribute to the probability of success of the project –For Early Stage Investigators (ESIs), describe the institutional investment in the success of the investigator 32

What Has Not Changed  Need to have a good idea about how to answer an important question  Reviewers need to be able to understand WHAT you want to do, WHY it is important, and can YOU do it?  Need to align YOUR goals with the funding agency goals. 33

On line resources NIH Grantsmanship Site: AHA Grant Writing Tips : Grantwriting_Tips.pdf

For Additional Information: Enhancing Peer Review at NIH Web Site 35

General Comments Find out in advance as much as possible about the potential reviewers. 1 Study section rosters can be found at: 1. Inouye SD and Fiellin DA, Ann Int Med 142: