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2. Review of R21s in CSR (Part II) Elaine Sierra-Rivera, PhD Scientific Review Administrator Oncological Sciences IRG DBBD Center for Scientific Review

3. What are R21’s Mechanism to allow PIs to conduct define research on innovative ideas, develop new concepts or techniques Awards vary by IC and purpose of initiative Lead to a larger research grant (e.g. R01, P01, etc.) Must be submitted in response to a PA (PI initiated — PA-06-181) ~214 Currently Active PAs

4. Other Characteristics of R21s Modular Budget (Range of 75 – 175K/year) Award could last from one to five years (but generally last two years) 15 Page Research Plan (Few exceptions) Allow up to 2 revisions/amendments Preliminary data not required No competing continuations Appendix (PA specific) SF424 – June 1, 2006 all electronic submission

5. Outcome of Electronic R21 Applications Submission Process 3,474 Applications Assigned to Review Groups 472 (14%) Will be Review by IC’s 2,898 (86%) Will be Review by CSR 805 (13.2%)  A1 191 (5.5%)  A2 1,616 (48%) New PI (√ Face Page)

6. Findings from Data Presented PRAC Meeting – May 2006 No difference in the streamlining (UN) or scoring pattern of R21 applications compared to R01 applications, when evaluated in the context of review environment

7. Effect of Review Environment PERCENT R21 = 8,579 R01 = 23,445 201 UN

8. Questions Generated from Data Are R21s streamlined at a higher rate than R01s? Are there scoring discrepancies among study sections? Is the R21 mechanism being used for its intended purpose?

9. Review Guidelines Provided to Reviewers “The R21 mechanism is designed to support exploratory or developmental research R21 allowing investigators to conduct research on innovative ideas or develop new concepts or technologies. R21 applications generally can only be submitted in response to a specific NIH initiative. Each initiative has its own unique features and often unique review criteria. Final scores must reflect the scientific and technical merits of the application rather than whether the proposed studies meet the goals of the PA. Maximum duration of award varies by announcement from one to five years, but generally R21s are for two years duration. Budgets can also vary, but are typically between $75,000 to $150,000 per year, and thus follow the modular budget requirements. Reviewers must keep in mind that PAs cover a variety of goals. For example, some support high impact-high risk investigations, some support exploratory non-hypothesis driven studies, and some support the development of techniques. Applications must be evaluated in the context of the PA goals. Therefore, before initiating your review of an R21 grant application, the reading of the specific announcement is necessary” “Reviewers must keep in mind that Preliminary Data are not required for the R21 mechanism. Although any preliminary data provided should be evaluated, no new data should be requested. Applications should not be penalized for lacking preliminary data”

10. Further Analysis (Data obtained from 10 - 2005 to 5 - 2006 Review Cycles) R21 Applications have been grouped according to type (goals) of PAs (applications are not limited to High- Risk/High-Gain studies) Analysis limited to Type 1 applications A sample of Chartered Study Sections (representing all IRG’s) have been included in the analyses

11. Unscoring Pattern for R21 Applications Reviewed in Chartered Study Sections with <40% R21/R03

12. Unscoring Pattern for R21 Applications Reviewed in Chartered Study Sections with >40% R21/R03

13. Percent R21 Unscored Applications per PA Group/Classification (Total R21= 5,161) PERCENT High Impact/ High Risk/ Innovative Parent PA (PI Initiated) Biodefense Basic/ Clinical Research/ Methodological Exploratory/ Developmental Res./ New Diagnostic Techniques/ Pre-Clinical Develop. Basic non- Hypothesis Driven Innovative/ Use of Existing Data Sets Innovative Research Innovative Research To Attract New PI 197 794 3,075 399 66 122 396 55 57

14. Parent PA (PI Initiated) Total R21 = 2,132 Sample Study Sections PERCENT 46 41 51 12 41 51 40 46 11 18  R21 133 166 127 85 174 205 209 104 148 101  R01

15. Overall Scores for R21s Reviewed at Chartered Study Sections Total R21 = 5,161

16. SUMMARY R21s are not differentially unscored compared to R01s R21 Application Scores are comparable to Type 1 R01s Study Sections are following review characteristics specific to R21 applications, reflecting SRAs effort in properly orienting reviewers to the uniqueness of this mechanism

17. Acknowledgements Teresa Lindquist, Program Analyst Office of Planning, Evaluation and Analysis, CSR Valerie L. Durrant, Scientific Review Administrator, Health of the Population (HOP) Integrated Review Group Laura Roman, Assistant Director- DRR/CSR Michael Martin, Division Director - DPP Cheryl Kitt, Deputy Director - CSR

18. Innovative Research -To Attract New PI (Total R21 = 197) PERCENT Sample Study Sections R21  14 28 24 28 34 6 3 R01  285 109 104 131 156 148 230

19. Innovative Studies (Total R21 = 122) PERCENT R21  25 34 17 12 2 1 16 3 R01  140 278 188 233 220 166 73 246 Sample Study Sections 1

20. Diagnosis & Pre-Clinical Development (Total R21= 396) PERCENT R21  30 23 56 13 17 18 21 R01  127 162 174 201 199 133 144 Sample Study Sections

21. High Impact-High Risk/Innovative (Total R21 = 794) PERCENT R21  40 10 43 49 57 7 30 5 3 R01  86 140 131 54 237 89 133 169 241 Sample Study Sections 1

22. Basic/Non-Hypothesis Driven (Total R21 = 55) Sample Study Sections PERCENT R21  6 4 17 3 9 2 R01  166 191 148 238 153 169

23. Biodefense (Total R21 = 399) Sample Study Sections PERCENT R21  56 48 29 17 14 11 12 R01  138 163 157 201 88 101 127