Your NIH Grant Application

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Your NIH Grant Application

• 2009 MORE Program Directors Meeting
• June 10-12, 2009 Colorado Springs, CO

Paul Sheehy, Ph.D. Deputy Associate
Director National Institute of General Medical
Sciences (NIGMS)
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ABSTRACT

• The NIH has introduced major changes in processes
  and policies relating to grant application
  (submission and review) and award management.
  This presentation reviews the changes in grant
  submission (transition of various grant
  activities to electronic submission and migration
  of applications forms from PureEdge to Adobe
  software), grant review (new scoring system,
  limited resubmission, designation of New
  Investigator status, reformatted Critique
  template), and the upcoming changes to grant
  application forms (page limits decreased, ,
  reformatted Critique template), and the upcoming
  changes to grant application forms (page limits
  decreased, sections aligned to review criteria,
  reformatted biosketch). The legal requirement to
  submit an electronic version of every
  peer-reviewed taxpayer-supported manuscript to
  PubMed Central (Public Access policy) is also
  presented. Finally, NIH and NIGMS have developed
  new communications vehicles to better communicate
  funding data and policies to the public.

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Agenda

• Enhancing Peer Review
• Changes so far / ongoing / yet to come
• Implications for training applications
• eSubmission
• Forms Changes
• Upcoming transitions
• Policies
• Whats new
• What to look for
• Information Resources
• Whats new
• Where to look

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Enhancing Peer Review
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Receipt and Referral of Applications
Application assessed for completeness
eligibility
Notice of assignment available in eRA Commons in
4 weeks.
1st Month
2nd Month
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Review System for Grant Applications

• Scientific Review Group (SRG)
• Independent outside review
• Evaluate scientific merit, significance
• Recommend length and level of funding

1st level
Output Priority Score and Summary Statement
2nd level

• Advisory Council
• Assess quality of SRG process
• Offers recommendation to Institute Staff
• Evaluates program priorities and relevance
• Advises on policy

3 - 7 months
Output Funding Recommendations
1 - 3 months

• Institute Director
• Makes final decision based on Council input,
  programmatic priorities
• Must also Pass Administrative Review

Output Awards or Resubmission
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Enhancing Peer Review at NIH
NIH Peer Review

• Virtues
• Cornerstone of the NIH extramural mission
• Standard of excellence worldwide
• Collaboration between NIH extramural staff and
  scientific community
• Complaints
• Overly burdensome
• Applications too long
• Process too long
• Disproportionate effect of negatives
• Uneven quality of reviews and reviewers

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Enhancing Peer Review at NIH
Purpose

• Facilitate changing nature of science
• Interdisciplinary and team science
• Recognizes and utilizes new sources of
  information
• 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

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Enhancing Peer ReviewKey Recommendations
More at http//enhancing-peer-review.nih.gov
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Enhancing Peer Review
Primary Implementation Actions

• Reduce Resubmissions
• Phase out second revisions
• Identify and cluster New Investigator and
  Clinical applications
• Improve Scoring
• Compress the range of possible scores (10-90)
• Report percentiles in whole numbers.

• Improve Critiques
• Shorten and focus critiques.
• ALL applications receive feedback.
• Enhance Review Criteria
• Core Review Criteria Score individual criteria.
  
• Additional Review Criteria (scored) and
  Considerations (not) reviewed as applicable
• Shorten Research Plans

More at http//enhancing-peer-review.nih.gov/
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Enhancing Peer Review at NIH
Timeline
Changes SO FAR
Changes NOW
Changes LATER
January 2009
May/June 2009
January 2010 Submissions

• Phase out of
• A2 applications
• Identification of
• Early Stage
• Investigator (ESI) applications

• Enhanced review criteria
• New scoring system
• Criterion scoring
• Structured critiques
• Clustering Applications
• Score order review

• Alignment of applications review criteria
• Shorter Research Plans

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Enhancing Peer Review at NIH
Changes Happening So Far

• Phase out of A2 applications
• Identification of Early Stage Investigator (ESI)
  applications

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Changes So Far
Phase Out of A2 Applications

• NIH limiting all original new (i.e. never
  submitted) and competing renewal applications to
  only one resubmission.
• Applies to all applications submitted for January
  25, 2009 due date and beyond.
• Previously submitted applications will be allowed
  two resubmissions (grandfathered) until January
  7, 2011.
• Based on recommendations from the Peer Review
  Oversight Committee to increase the number of
  high quality and first resubmissions that can be
  funded earlier.
• Reduces applicant burden of multiple
  resubmissions.
• Removes delays in funding for meritorious science.

• More at http//grants.nih.gov/grants/guide/notice
  -files/NOT-OD-09-003.html

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Changes So FarLimited Resubmission of
Applications
Criteria for a New Application

• Not a New Issue
• Substantially different in content and scope
• Fundamental changes in questions and/or outcomes
• Rewording of the Title and Specific Aims or
  incorporating minor changes in response to
  reviewer comments does not constitute substantial
  change
• Request for a different review committee or a
  different IC are not sufficient
• Important implications for training , policies
  have not yet been worked out
• Applications changing activity codes are new
  submissions
• Change in activity code
• Applications to RFAs (usually) including ARRA

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Changes So FarNew/Early Stage Investigators
Purpose

• Expectations for preliminary data or track record
  should not be the same as for established
  investigators
• Encourage earlier transition to research
  independence
• Strongly encourage New Investigators,
  particularly ESIs, to apply for R01 grants when
  seeking first-time NIH funding 
• Clustering facilitates consistency

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Changes So FarNew/Early Stage Investigators
Definitions

• New Investigator (NI) is a PD/PI who has not yet
  competed successfully for a substantial NIH
  research grant
• Receipt of the following awards does not remove
  new investigator status R00, R03, R15, R21,
  R34, R36, R41, R42, R55, R56, SC2, SC3, all Fs,
  most Ks, all Loan Repayment contracts, G07, G08,
  G11, G13, G20, S10, S15, S21, S22.
• Early Stage Investigator is NI who is within 10
  years of completing the terminal research degree
  or is within 10 years of completing medical
  residency (or equivalent)
• Both eligible for the Shortened Review Cycle
  option
• Status applies only to R01s
• For multiple PD/PIs all PD/PIs must meet
  definition

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Enhancing Peer Review at NIH
Changes Happening NOW

• Enhanced review criteria
• New scoring system
• Criterion scoring
• Structured critiques
• Clustering of New Investigator applications
• Score order of review
• Implemented for applications submitted
• for Fiscal Year 2010 funding consideration
• for Recovery Act (ARRA) RFAs

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Changes Happening NOWEnhanced Review Criteria
Overall Impact/Priority Score
Reflects the reviewers assessment of the
likelihood for the project to exert a sustained,
powerful influence on the research field(s)
involved

• In consideration of
• Core criteria
• Additional review criteria (RFA or PAR)
• Additional review criteria (scored) as
  applicable
• Additional review considerations (not scored)

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Changes Happening NOWEnhanced Review Criteria
Overall Impact ? Overall Impact/Priority Score

• Core criteria order
• Significance
• Investigator(s)
• Innovation
• Approach
• Environment

Will receive individual criterion scores

• Additional review criteria
• Protections for Human Subjects
• Inclusion of Women, Minorities, and Children
• Vertebrate Animals
• Resubmission Applications
• Renewal Applications
• Biohazards

Side-by-side comparison http//grants.nih.gov/gran
ts/peer_review_process.htm
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Changes Happening NOWEnhanced Review Criteria
Significance

• Does the project address an important problem or
  a critical barrier to progress in the field?
• If the aims of the project are achieved, how will
  scientific knowledge, technical capability,
  and/or clinical practice be improved?
• How will successful completion of the aims change
  the concepts, methods, technologies, treatments,
  services, or preventative interventions that
  drive this field?

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Changes Happening NOWEnhanced Review Criteria
Investigator

• Are the PD/PIs, collaborators, and other
  researchers well suited to the project?
• If Early Stage Investigators or New
  Investigators, do they have appropriate
  experience and training?
• If established, have they demonstrated an ongoing
  record of accomplishments that have advanced
  their field(s)?
• If the project is collaborative or multi-PD/PI,
  do the investigators have complementary and
  integrated expertise are their leadership
  approach, governance and organizational structure
  appropriate for the project? (Moved from
  Approach)

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Changes Happening NOWEnhanced Review Criteria
Innovation

• Does the application challenge and seek to shift
  current research or clinical practice paradigms
  by utilizing novel theoretical concepts,
  approaches or methodologies, instrumentation, or
  interventions?
• Are the concepts, approaches or methodologies,
  instrumentation, or interventions novel to one
  field of research or novel in a broad sense?
• Is a refinement, improvement, or new application
  of theoretical concepts, approaches or
  methodologies, instrumentation, or interventions
  proposed?

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Changes Happening NOWEnhanced Review Criteria
Approach

• Does the application challenge and seek to shift
  current research or clinical practice paradigms
  by utilizing novel theoretical concepts,
  approaches or methodologies, instrumentation, or
  interventions?
• Are the concepts, approaches or methodologies,
  instrumentation, or interventions novel to one
  field of research or novel in a broad sense?
• Is a refinement, improvement, or new application
  of theoretical concepts, approaches or
  methodologies, instrumentation, or interventions
  proposed?
• Are the overall strategy, methodology, and
  analyses well-reasoned and appropriate to
  accomplish the specific aims of the project?
• Are potential problems, alternative strategies,
  and benchmarks for success presented?
• If the project is in the early stages of
  development, will the strategy establish
  feasibility and will particularly risky aspects
  be managed?
• If the project involves clinical research, are
  the plans for 1) protection of human subjects
  from research risks, and 2) inclusion of
  minorities and members of both sexes/genders, as
  well as the inclusion of children, justified in
  terms of the scientific goals and research
  strategy proposed?

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Changes Happening NOWEnhanced Review Criteria
Environment

• Will the scientific environment in which the work
  will be done contribute to the probability of
  success?
• Are the institutional support, equipment and
  other physical resources available to the
  investigators adequate for the project proposed?
  
• Will the project benefit from unique features of
  the scientific environment, subject populations,
  or collaborative arrangements?

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Changes Happening NOWEnhanced Review Criteria
Additional Review Considerations

• As applicable for the project proposed
• Reviewers will address each item
• Reviewers will not give scores for these items
  should not consider them in providing an overall
  impact score.

• Budget and Period Support
• Select Agent Research
• Applications from Foreign Organizations
• Resource Sharing Plans

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Changes Happening NOW New Scoring System
9-Point Scale

• Reduces number of rating discriminations
• Provides rating descriptors
• To improve reliability
• To encourage use of the entire range
• Will be used for
• Overall impact/priority scores
• Individual criterion scores
• Will be implemented for applications submitted
  for
• FY2010 funding consideration and beyond
• Recovery Act funding opportunity announcements

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Changes Happening NOW New Scoring System
New Score Descriptors
Impact Score Descriptor
High Impact 1 Exceptional
High Impact 2 Outstanding
High Impact 3 Excellent
Moderate Impact 4 Very Good
Moderate Impact 5 Good
Moderate Impact 6 Satisfactory
Low Impact 7 Fair
Low Impact 8 Marginal
Low Impact 9 Poor
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Enhancing Peer Review at NIH
Structured Critiques

• Decrease variability
• Increase quality of information in critiques
• More succinct, better organized
• Encourage evaluative statements
• Ensure that reviewers address all review criteria
  and considerations

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Changes Happening NOW Structured Critiques
Phases of Process
Critique Templates

• Bulleted comments
• Scores for five review criteria
• Required comments
• Protections for Human Subjects
• Inclusion Plans
• Vertebrate Animal Welfare
• Biohazards
• Budget

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Changes Happening NOWScore Order Review
Order of Discussion

• Where feasible, discussion order based on
• Clustering of New Investigator applications
• Clustering of clinical applications
• Clustering of similar activity codes
• Preliminary overall impact/priority scores

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Changes Happening NOW
Additional Information

• Enhancing Peer Review Website
• (http//enhancing-peer-review.nih.gov/index.html)
• NOT-OD-09-025
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-09-025.html
• Side-by-side comparison of enhanced and former
  review criteria
• http//grants.nih.gov/grants/peer_review_process.h
  tm
• Guidelines for Reviewers
• http//grants.nih.gov/grants/peer/reviewer_guideli
  nes.htm

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Happening LATER
Application Changes

• Beginning with Jan 2010 Submissions
• Alignment of applications review criteria
• Shorter Research/Research Training Plans
• NIH Plans a Fall Release of new Forms

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Happening LATERApplication Changes
Alignment of Applications and Review Criteria

• Changes to three parts of application
• Biographical sketch
• Research/Research Training Plan
• Resources

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Happening LATERApplication Changes
Biographical Sketch

• Personal Statement why experience and
  qualifications make the applicant particularly
  well-suited for role in the project
• Publications limited to 15
• 5 most recent
• 5 best
• 5 most relevant to the application

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Happening LATERApplication Changes
Restructured Research Plan

• Introduction (amended appls only)
• Specific Aims
• Background and Significance
• Preliminary Studies/Progress Report
• Research/Research Training Design and Methods
• Inclusion Enrollment Report (as applicable)
• Progress Report Publication List
• Human Subjects Sections.
• protections, women/minorities, enrollment,
  children
• Other Research Plan Sections.
• animals, select agent, MPI, consortium, support,
  sharing
• Appendix

Research Strategy
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Happening LATERApplication Changes
Current Application
New Application
Background and Significance Research / Training Strategy Significance Innovation Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision
Research Design and Methods Research / Training Strategy Significance Innovation Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision
Preliminary Studies/Progress Report Research / Training Strategy Significance Innovation Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision
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Happening LATERApplication Changes

• Facilities and Other Resources
• (in 424 part of the RR Other Project
  Information in 398 the Resources Format Page)
• Environment - New instruction to address how
  scientific/training environment will contribute
  to probability of success, unique features of
  environment, etc. For ESIs, provide description
  of institutional investment in success of the
  investigator.

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Happening LATER Alignment of Application with
Review Criteria
Core Review Criteria
Application
Significance Research Strategy a. Significance
Investigator(s) Biosketch Personal Statement
Innovation Research Strategy b. Innovation
Approach Research Strategy c. Approach
Environment Resources Environment
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Happening LATERShorter Applications
Page Limit Revisions
Introduction (to Resubmission or Revision) 1 page
Specific Aims 1 page
Research Strategy (R03,13, R21, R36, R41, R43), Fellowship (F) (R01, R10, R15, R18, R21/33, R24, R25, R33, R34, R42, R44) Career (K) (Combined Candidate Information Research Strategy) Institutional Training(Ts K12) (Research Training Plan) all other activity codes, including Cs, Ps, Ss, Us 6 pages 12 pages 12 pages 25 pages See FOA
Biosketch 4 pages
Appendices Unlimited
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Adobe Application Forms and Electronic Submission
Changes to electronic applications are on the
way. Learn how this affects YOU today!
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Adobe Not very different

• The new Adobe forms look very similar to PureEdge
  forms -- Changes are cosmetic and navigational
  (see comparison at http//era.nih.gov/ElectronicR
  eceipt/files/PureEdge_v_Adobe.pdf
• Overall electronic submission process remains the
  same
• Find opportunity
• Download application package
• Develop research plan and other PDF attachments
• Complete forms
• Submit application
• Check assembled application in eRA Commons

Works on both Macs and PCs
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but follow these important tips to ensure
success

• Adobe Reader 8.1.3 or 9.0 required to open forms
• Stay tuned to Grants.govs Download Software
  page for changes (http//www.grants.gov/help/down
  load_software.jsp)
• A pop-up usually warns if you have a wrong
  version
• If using an Adobe Acrobat product to create PDFs,
  check Grants.govs Web site for help on settings
• To ensure the application reader opens in the
  correct version of Adobe

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Reminder Avoid Common eSubmission Errors

• Use PDF format for text attachments and do not
  embed movies or other materials in PDF
  attachments.
• RR Senior/Key Person Profile(s) form
• Include eRA Commons Username in the Credential,
  e.g., agency login field for all individuals
  assigned a PD/PI role.
• Include the Organization Name for all Senior/Key
  Persons listed.
• RR Budget form - Senior/Key Person effort must
  be greater than zero.
• http//era.nih.gov/ElectronicReceipt/app_help.htm
  
• Clicking Submit is not the last step.
  Remember. . . if you cant view it (in Commons),
  we cant review it !

More at http//era.nih.gov/ElectronicReceipt/avoi
ding_errors.htm
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Electronic Submission Update

• Adobe-based grant application forms are now
  available for all FOAs requiring eSubmission.
• Career Development Awards (Ks) transitioned to
  electronic submission.
• Next set of transitions
• New PHS 398 and SF 424 (RR) Application forms
  expected in Fall, 2009
• Fellowship (F) August 8, 2009 (forms soon to be
  released )
• Training (T K12) January 25, 2010 (Tentative)

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Support
Resources Help Desks

• Contact Grants.gov Contact Center for questions
  on form functionality or submission of the forms
  to Grants.gov. 
• http//grants.gov/applicants/app_help_reso.jsp
• Contact the eRA Help Desk at NIH for technical
  issues that threaten NIHs timely receipt of your
  application.
• Work with the Grants.gov Contact Center and be
  sure to document the issue and provide NIH with
  the tracking number received from Grants.gov
  Contact Center.
• http//era.nih.gov/ElectronicReceipt/
• http//era.nih.gov/ElectronicReceipt/app_help.htm

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New Scientific and Grants Management Policies
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Public Access Policy
All investigators funded by NIH must submit to
PubMed Central an electronic version of their
final, peer-reviewed manuscripts upon acceptance
for publication.

• Compliance mandated by Law
• Applicable to peer-reviewed articles accepted for
  publication on or after 4/7/08
• Submission of articles to NIH Deposit final
  manuscript in NIH Manuscript Submission (NIHMS)
  system. Many journals will submit articles on
  behalf of author. Articles must be publicly
  available on PubMed Central no later than 12
  months after date of publication
• Citing Articles in Applications Progress
  Reports Beginning with 5/25/08 submission date,
  use the PubMed Central ID or NIH MS ID number for
  each article.

• More at http//grants.nih.gov/grants/guide/notice
  -files/NOT-OD-09-071.html

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Helpful NIH Technical Assistance Resources
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New Tool to Search NIH Funding

• New reports, data and analyses website released
  in March, 2008 and expanded significantly in
  January, 2009 with addition of RCDC data
  (Research, Condition and Disease Categorization
  process)
• Replaces the current Award Information and Data
  web pages (including CRISP) and will provide
• Quick access to Frequently Requested Reports
• FAQs on how success rates are computed and
  questions on the NIH budget
• Search tools for locating data and reports
  quickly and easily
• Links to funding estimates for certain research
  areas, conditions, and diseases.
• Foundation for broader NIH-wide Research
  Portfolio Online Reporting Tool (RePORT)
• http//report.nih.gov/

• More at http//report.nih.gov

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NIGMS Feedback Loop

• Weekly Updates from NIGMS
• Funding Opportunities
• Meetings
• Resources
• Other useful information
• Interactive
• Community discussion is encouraged through
  comments
• Sample Content
• Early Notice New Microbial-Host Interactions
  Grants (Upcoming RFA)
• Discussion of the Scientific Workforce
• FY 2010 NIGMS Budget Request
• FAQs
• Available via email, web and RSS

• More at http//loop.nigms.nih.gov

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Thank You!
Any Questions?