Review of R21s in CSR Part II Elaine SierraRivera, PhD Scientific Review Administrator Oncological S

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Review of R21s in CSR(Part II)Elaine
Sierra-Rivera, PhDScientific Review
AdministratorOncological Sciences
IRGDBBDCenter for Scientific Review
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What are R21s

• 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

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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

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Outcome of Electronic R21 Applications Submission
Process

• 3,474 Applications Assigned to Review Groups
• 472 (14) Will be Review by ICs
• 2,898 (86) Will be Review by CSR
• 805 (13.2) ? A1
• 191 (5.5) ? A2
• 1,616 (48) New PI (v Face Page)

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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

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Effect of Review Environment
R21 8,579 R01 23,445
PERCENT
lt150 151 - 175 176 200
gt201 UN
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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?

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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

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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 IRGs) have been included in
  the analyses

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Unscoring Pattern for R21 Applications Reviewed
in Chartered Study Sections with lt40 R21/R03
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Unscoring Pattern for R21 Applications Reviewed
in Chartered Study Sections with gt40 R21/R03
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Percent R21 Unscored Applications per PA
Group/Classification (Total R21 5,161)
57
55
396
122
66
399
3,075
794
197
PERCENT
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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
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Overall Scores for R21s Reviewed at Chartered
Study Sections
Total R21 5,161
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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

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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

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Innovative Research -To Attract New PI(Total R21
197)
Sample Study Sections
PERCENT
R21 ? 14 28 24 28 34
6 3 R01 ? 285 109 104
131 156 148 230
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Innovative Studies (Total R21 122)
Sample Study Sections

PERCENT
1

R21? 25 34 17 12 2
1 16 3 R01? 140 278 188
233 220 166 73 246
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Diagnosis Pre-Clinical Development(Total R21
396)
Sample Study Sections

PERCENT
R21? 30 23 56 13
17 18 21 R01? 127 162
174 201 199 133 144
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High Impact-High Risk/Innovative(Total R21 794)
Sample Study Sections

PERCENT
1
R21? 40 10 43 49 57 7
30 5 3 R01? 86 140 131 54
237 89 133 169 241
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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
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Biodefense (Total R21 399)
Sample Study Sections
PERCENT
R21? 56 48 29 17 14
11 12 R01?138 163 157
201 88 101 127