Understanding Grant Submission and Grant Revision Processes at NIH

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Understanding Grant Submission and Grant Revision
Processes at NIH
Linda Collins College of Health and Human
Development Michael Hecht College of the Liberal
Arts
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NIH Organization

• Department of Health and Human Services
• National Institutes of Health
• 25 Awarding institutes/centers
• Also known as ICs
• Center for Scientific Review
• Office of the Director

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Grant Application Cycle
Investigator
NIH
Institution
Initiates Research
Peer Review
Submits Application
Council Review
Allocates Funds
Funding Decision
Conducts Research
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The NIH Extramural Team

• Review

Grants Management
Program
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The NIH Extramural Team
Program
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The Program/Institute StaffProgram Administrator

• Maintains knowledge of scientific area
• Attends study section meetings
• Makes funding recommendations
• Monitors scientific progress
• Identifies scientific area of importance
• Reports to senior staff
• Development of programs and initiatives

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The NIH Extramural Team
Grants Management
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Grants Management

• Interprets Federal regulations and policies
• Assures compliance with Federal regulations and
  policies
• Monitors financial aspects of projects
• Interprets regulations and policy

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NIH Assistance Mechanisms

• Research Project Grants
• Traditional Investigator-Initiated (R01)
• Research Program Project (P01)
• SBIR (R43, R44) STTR (R41, R42)
• Cooperative Agreements
• U01, U10, U13, U54
• Substantial programmatic involvement
• Usually initiated by NIH

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NIH Assistance Mechanisms

• Research Center Grants
• Established by ICs to meet special needs
• May support research and/or core facilities
• Usually initiated by the IC
• Request for Applications (RFA)
• P30, P50, P60, U54

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NIH Assistance Mechanisms

• Other Research
• Career Development - K Awards (different types)
• Academic Research Enhancement Awards - R15
• Conference Grants - R13
• Minority Biomedical Research Support - S06
• Small Grant R03
• Exploratory - R21
• See list of mechanisms in your folder

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The NIH Extramural Team

• Review

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Dual Peer Review Process(1st Level of Review)

• Administered by the Ctr. for Scientific Review
  (CSR) or an individual NIH Institute Center
  (IC)
• Conducted by Scientific Review Group (SRG)
• Composed of non-federal scientists with relevant
  expertise
• SRGs are led by a Scientific Review Officer (SRO)
  who is an extramural staff scientist
• SROs analyze each submission for completeness,
  document conflicts of interest, recruit
  reviewers, assign applications to reviewers,
  attend oversee administrative and regulatory
  aspects of peer review meetings, prepare summary
  statements

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1st Level of Review

• Scientific Review Group Members include the
  chair who moderates the review discussion and
  reviewers
• Chair and reviewers read and critique in writing
  each application assigned
• Chair and reviewers make recommendations
  concerning
• the scientific and technical merit
• protection of human subjects, inclusion of women
  and minorities, and children in clinical
  research animal welfare budget, etc.
• goal is critique, not advice

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1st Level of Review(Initial Peer Review Meeting)

• Assigned reviewers post scores prior to meeting
• SRGs convene for 1-2 days
• Applications reviewed based on established
  criteria
• Review order starts with best/lowest scored
  proposal, grouped by mechanism and
  new/experienced PI
• At meeting reviewers present their initial scores
  and prepared critiques to the group
• Open discussion follows
• 50 of proposals in each category must be
  discussed group votes whether to continue
  reviewing
• The rest of the proposals are not discussed

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1st Level of Review (2010 ENHANCED CRITERIA)

• Overall Impact will project exert a sustained,
  powerful influence on the research field(s) as
  indexed by 5 core review criteria
• 1. Significance important problem addressed
  how will this improve scientific knowledge,
  technical capability, and/or clinical practice
• 2. Investigators PI other researchers well
  suited to the project appropriate experience
  training ongoing record of accomplishment
  complementary integrated experience leadership
  approach, governance, and organizational
  structure appropriate for project

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1st Level of Review (2010 ENHANCED CRITERIA)

• 3. Innovation the work challenges and seeks to
  shift current research or practice paradigms
  utilizing novel theory, approaches or methods,
  instrumentation, or interventions the work is
  novel
• 4. Approach strategy, methodology, analyses are
  well-reasoned and appropriate potential problems
  alternative strategies thought through
  benchmarks set risk is managed
• 5. Environment the environment will contribute
  to the projects success institutional support,
  equipment, other resources sufficient unique
  features of the environment, subject population,
  collaborative arrangements

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1st Level of Review (2010 ENHANCED CRITERIA)

• Additional Review Criteria
• 1. Protection of human subjects
• 2. Inclusion of women, minorities, children
• 3. Vertebrate animals
• 4. Resubmission applications
• 5. Revision applications
• 6. Biohazards

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1st Level of Review (2010 ENHANCED CRITERIA)

• Additional Review Considerations
• 1. Budget and period of support
• 2. Select agent research
• 3. Applications from foreign organizations
• 4. Resource sharing plans

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1st Level of Review (2010 ENHANCED CRITERIA)

• Scoring (1-9)
• 1. Overall Impact Score likelihood project will
  exert a sustained, powerful influence on the
  research field(s) involved.
• 2. A separate score for each of the 5 core
  criteria (significance, investigators,
  innovation, approach, environment)
• 3. Additional review criteria help determine
  scientific and technical merit BUT are not scored
  separately
• 4. Additional review considerations are addressed
  by reviewers, but are not scored are discussed
  after group scores.

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1st Level of Review (2010 ENHANCED CRITERIA)

• Preliminary Impact Score
• Prior to initial review, each reviewer gives an
  preliminary impact score. This determines which
  proposals are discussed by the SRG.
• 9-Point Rating Scale
• 1 exceptional--9 poor
• Final Overall Impact Score
• Mean score from all the final reviewer impact
  scores X 10
• Range 10 (high impact) 90 (low impact)

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1st Level of Review (2010 ENHANCED CRITERIA)

• 9-Point Rating Scale
• 1 exceptional
• 2 extremely strong
• 3 very strong
• 4 strong, with many minor weakness
• 5 strong, with at least one moderate weakness
• 6 some strengths, some moderate weaknesses
• 7 some strength, at least one major weakness
• 8 a few strengths, a few major weaknesses
• 9 very few strengths, many major weaknesses

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1st Level of Review(2010 ENHANCED CRITERIA)

• Final Overall Impact Score
• Mean scores from each of the final reviewer
  impact scores X 10
• Range 10 (high impact)--90 (low impact)
• NOTE New scoring likely to produce more
  applications with identical scores (tie
  scores). Thus, other factors (e.g., mission
  relevance, portfolio balance) will be considered
  when all other things are essentially equal

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2nd Level of Review(Advisory Council or Board)

• The potential awarding IC performs the second
  level of review.
• Composed of scientists from the extramural
  community and public representatives.
• NIH program staff examine applications for impact
  or priority scores, percentile rankings,
  summary statements against the ICs needs.
• Program staff provide grant funding plan to
  Advisory Council or Board.
• Advisory Council or Board advises the IC
  director.
• Director makes final decision.

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Submission Its a process, not an event

• Communicating with Program Officers
• Introducing Ideas, Getting Feedback, Pre-review
• 2. Getting to the right review committee
• Review the rosters and talk to colleagues
• Effectively wording the abstract
• 3. Getting feedback from colleagues and
  consultants on drafts of the grant (prepare
  ahead!)
• 4. Consider who is likely to review your grant
  (review the rosters) and make sure to know and
  cite their work when relevant!!
• 5. Recognizing that funding on first submission
  is rare!

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Receiving the Summary Statements The Hardest
Part!

• The review process is critical, even harsh
• Reviewers usually see a central part of their
  mission as finding the grants weaknesses, while
  recognizing strengths
• Summary statements spend much more time on
  critique than praise!
• Many investigators experience a mixture of rage
  and depression when they read their summary
  statements and easily lose perspective
• It is often good to take a day or two (or more!)
  and then try to read it again with a cooler
  head

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Receiving the Summary Statements Bouncing Back!

• Having an experienced colleague read the summary
  statement is usually very helpful
• Many young investigators mistakenly interpret
  criticism in the summary as hopeless to fix or
  respond to
• Sometimes SRAs are helpful in clarifying
  questions
• Program staff usually observe the study sections
  and are also sometimes of help to investigators
• Almost any grant that is scored has a chance of
  funding in the second round of review
• Usually, the higher the initial score, the fewer
  problems and more likely to be successful after
  revision, but this is not always true!

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Resubmission Resilience and Flexibility!

• Persistence pays off in the grant process!!
• However, it is critical that the second
  submission carefully respond to the critiques by
  either making appropriate revision or clearly
  defending the reasoning or rationale for
  maintaining aspects that reviewers did not feel
  were satisfactory
• It is likely that most of the same reviewers will
  see the second submission
• The primary reviewers will also see the original
  summary statement and look carefully to see how
  the application has addressed these issues

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Most Common Reasons for a Poor Score(in priority
order)

• Lack of new or original ideas
• Hypothesis ill-defined, superficial, lacking,
  unfocused, or unsupported by preliminary data
• Methods unsuitable, not feasible, not rigorous or
  not likely to yield results
• Design not logical, inappropriate
  instrumentation, poor timing or conditions
• Data management and analysis vague, not rigorous
• Inadequate expertise or knowledge of field for
  PI, or too little time to devote to the work
• Poor resources or facilities limited access to
  appropriate population

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When to Revise

• How do you know when to revise your application
  and resubmit or when to begin over with a new
  idea?
• If reviewers thought your basic idea was
  interesting and important, the application may be
  worth revising. However, if they felt the aims
  were weak, begin with a new idea.
• If the problems are repairable, revise the
  application and resubmit it to the same study
  section.
• Common fixable problems
• Poor writing
• Insufficient information, experimental details,
  or preliminary data
• Case for significance not convincingly made
• Insufficient discussion of obstacles and
  alternatives approaches

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Not fixable or more difficult problems

• Philosophical issues, e.g., the reviewers believe
  the work is not significant
• Hypothesis not sound or not supported by data
  presented
• Work has already been done
• Methods not suitable for testing the hypothesis
• Suitable expertise was not available on the SRG
  that reviewed your grant
• Perceived bias (rare) reviewers and SRAs will be
  alert to bias
• If the problem lies with the SRG, revise the
  application and request review by a different SRG
• For fatal flaws and weaknesses, rethink your idea
  and start over

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A few tips from me

• Start early, make a timeline and STICK TO IT
• Should allow time for serious pre-submission
  review subsequent revision
• Develop a relationship with program staff
• It is not possible to overdo clarity
• Let your passion come through in your proposal