Lifespan Office of Research Administration, Grants

1
Lifespan Office of Research Administration,
Grants Contracts

• NIH PEER REVIEW CRITERIA AND RESTRUCTURED PHS 398
  SF 424 APPLICATION FORMS
• Presenters
• Mary L. OBrien and Joan M. Silva
• Administrative Managers
• December 2009

2
ENHANCING PEER REVIEWChanges to Application
Forms and InstructionsOctober 6, 2009
3
Enhancing NIH Peer Review

• Facilitate changing nature of science
• Identify and encourage new and early stage
  investigators (ESI) (NOT-09-021)
• Ease burden on research enterprise
• Streamline time to award
• Fund the best science, by the best scientists,
  with the least amount of administrative burden

4
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
• Engage the Best Reviewers
• Improve the Quality and Transparency of Review
• Ensure Balanced and Fair Reviews Across
  Scientific
• Fields and Career Stages
• Continuous Review of Peer Review

5
Recap New Policy on Resubmissions

• For January 25, 2009 due dates and beyond, NIH
  will accept only a single amendment to the
  original application
• original new applications (i.e., never submitted)
• competing renewal applications

6
Early Stage Investigator (ESI) Policy

• NIH will support New Investigators at success
  rates comparable to those for established
  investigators submitting new applications
• ESIs will comprise a majority of the NIs
  supported (FY 2009 funding and beyond).
• To ensure appropriate consideration for ESI
  eligibility, all NIs will need to update their
  eRA Commons profiles, and will now see their
  eligibility displayed in eRA Commons.

7
Goals of Identifying Early Stage Investigators
(ESIs)

• Encourage transition to independence for
  investigators
• Counter trend of increasing time spent in
  training phase of career
• Strongly encourage New Investigators (NIs),
  particularly ESIs, to apply for R01 grants when
  seeking first-time NIH funding 

8
Peer Review Criteria ChangesMay 2009 Review
Meetings Potential FY2010 funding

• New 1-9 Scoring System
• Scoring of Individual Core Criteria
• Templates for Structured Critiques
• For further information, see NOT-OD-09-024
  NOT-OD-09-025.

9
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

10
Scoring of Individual Review Criteria

• Assigned reviewers will use the 9-point scale for
  five review criteria
• Each assigned reviewers 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

11
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
Restructured Application Forms
13
Major Changes to Applications

• Major changes for due dates on or after January
  25, 2010
• Restructured application forms for both
  paper-based PHS 398 applications and electronic
  SF 424 (RR) applications.
• New instructions including shorter page limits

14
Applications Affected

• These changes affect ALL competing applications
  New, renewal, resubmission, and revision (see
  NOT-OD-09-149 NOT-OD-10-016) with the exception
  of
• Applicants who are eligible for continuous
  submission (Advisory Group Members,
  NOT-OD-09-114) should use current forms and
  instructions through February 7, 2010 for R01,
  R21, and R34 AIDS applications that would
  otherwise have been due on January 7, 2010.

15
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

16
Overview of the Changes

• Application forms will be revised in three
  sections
• Research Plan
• Biographical Sketch
• Resource and Facilities

17
Application Alignment with Review Criteria
Major Examples
18
New Research Plan Components

• Introduction
• Specific Aims
• Background and Significance
• Preliminary Studies/Progress Report
• Research Design and Methods
• Inclusion Enrollment Report
• Progress Report Publication List
• Human Subjects Sections.
• protections, women/minorities, enrollment,
  children
• Other Research Plan Sections.
• animals, select agents, MPI, consortium, support,
  resource sharing
• Appendix

19
Major Changes to the Research Plan

• Specific Aims will include new language about the
  impact of the proposed research.
• A single attachment for the Research Strategy
  (previously 3 files) increases applicant control
  over the look and feel of the application.
• Simpler preparation for the applicant
• Easier reading for reviewers
• Electronic validation of page limits for Research
  Strategy

20
New Research Strategy Section
21
Revisions 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
• Make selections based on recency, importance to
  the field, and/or relevance to the application
• Biographical Sketch Sample

22
Revisions to Address Environment

• Instructions added to Resources
• Provide a description of how the scientific
  environment will contribute to the probability of
  success of the project
• For ESIs describe the institutional investment in
  the success of the investigator
• Instructions added to Research Plan
• In Select Agents Research section, describe the
  biocontainment resources available at all
  performance sites

23
New Instructions Including Shorter Page Limits
24
Goals of Shortened Page Limits

• Reduce the administrative burden
• Focus on the essentials of the science
• Avoid information overload

25
Table of Page Limits (Part I)
26
Table of Page Limits (Part II)

• Each project or core will follow the page limit
  of the equivalent activity code. 

27
Table of Page Limits (Part III) - Table
28
What Does the Applicant Need to Do?
29
Steps for Success Part 1

• Read about the upcoming requirement changes now
  so that you can begin writing your Research
  Strategy
• Information available on the Enhancing Peer
  Review website
• Policy Announcement NOT-OD-09-149
  NOT-OD-10-016
• Details of Application Changes
• New FAQ
• Training Communications Resources

30
Steps for Success Part 2

• In December, go back to the updated FOA or
  reissued Parent Announcement
• Sign-up for Grants.gov Updates for the latest
  issues and news
• For both electronic and paper, choose the correct
  application package and instructions to download
  
• SF 424 (RR) ADOBE_FORMS_B
• PHS 398 Revision date June 2009
• Applications submitted using incorrect forms will
  be delayed and may not be reviewed!

31
Steps for Success Part 3

• Read the new application instructions carefully
• For due dates on or after January 25, 2010,
  submit your electronic and paper applications
  using the new application forms

32
Reminder Revised PHS 2590

• For Noncompeting Continuation Progress Reports
• Revised instructions and forms were required for
  all annual reports due on/after October 1, 2009
  (All Personnel Report, Biographical Sketch,
  Human Embryonic Stem Cells).
• The PHS 2590 now includes the instruction to
  address any changes to the innovative potential
  of the project (NOT-OD-09-139 NOT-09-150).

33
For additional information

• Enhancing Peer Review at NIH Web Site

• http//enhancing-peer-review.nih.gov

34
Application Support

• NIH Grants Information Help Desk For questions
  about the content of new forms and instructions.
• E-mail grantsinfo_at_od.nih.gov or
• Phone [phone]
• Grants.gov Contact Center For questions on form
  functionality or submission to http//www.grants.g
  ov/.
• E-mail support_at_grants.gov
• Phone [phone]
• NIH eRA Help Desk For post-submission questions
  or technical issues that threaten NIHs timely
  receipt of your application.
• Web support http//ithelpdesk.nih.gov/eRA/
• Phone [phone] or 301-402-7469

35
Lifespan Office of Research Administration,
Grants and Contracts

• For further assistance, please contact your
  Grants and Contracts Administrator
  http//www.lifespan.org/research/contact/docs/gran
  tcontractadministrators.pdf or
• Mary L. OBrien, Administrative Manager,
  mobrien_at_lifespan.org, X44487
• Joan M. Silva, Administrative Manager,
  jsilva_at_lifespan.org, X44006