Overview of the Application Changes

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Overview of the Application Changes

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

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Application Preparation Pitfalls

• Not identifying personnel correctly when
  providing elements
• Key, Non-key Personnel, Other Significant
  Contributor, etc.?
• Consultants from the Univ. of Pittsburgh not
  permitted.
• People from the same institution as the PI cannot
  be called consultants.
• Subcontracts/subaccounts
• When people are on a project from another dept. _at_
  Pitt or another institution, it takes weeks to
  find contacts, communicate and obtain the
  documentation required to process and submit the
  application.
• Changes to personnel-need to restart all grant
  prep activities from scratch. Everyone is added
  in alphabetical order. One change affects entire
  personnel section. Takes a lot of time to fix.
  Even changes in OSCs.
• Credentials
• Need eRA Commons username
• Biosketches
• Not in the right format or on the correct form

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• Formatting style in Adobe is critical
• Failure to provide Project Narrative (what is
  it???)
• Letters of Support or Cover Letters are not on
  institutional letterhead, or do not contain a
  signature.
• Facilities Other Resources-Need to update this
  section re animal or clinical activities to match
  the project!
• Failure to provide Research Sharing Plan-The
  PA-07-070 states this should be provided. Also
  if you meet the criteria defined in the NIH PHS
  instructions, you must provide RSP (over 500K,
  sharing model organisms or Genome-Wide Research).
• In general, not reading or following grant
  instructions or guidelines
• Font type and size - Arial, Helvetica, Palatino
  Linotype or Georgia and a font size of 11 points
  or larger

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era commons name
Unable to delete no delete function
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If yes, then 8-10
If yes, then 12
Project Narrative
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Need all four attachments if you said yes to
human subjects
Required if animal research
Required
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Do NOT SCALE
Do NOT SCALE
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Major Changes to the Research Plan

• Specific Aims requires new language about the
  impact of the proposed research.
• Research Strategy will be created as a new
  section and includes 3 of present sections
• Background and Significance
• Preliminary Studies/Progress Report
• Research Design and Methods

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New Research Plan Components

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

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Role on Project Documents
Key Personnel Biosketch Era name Effort Support Letter
Co-Investigator REQUIRED REQUIRED REQUIRED NO
Other Significant Contributors REQUIRED Optional Not permitted Good Practice
Consultant NO NO NO fee for service REQUIRED
Post Doc Only if Key, not recommended YES If Key NO
Graduate Student Researcher Only if Key, not recommended No If Key NO
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Changes 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 (5 most relevant to application
  and 10 of importance to field)
• Make selections based on recency, importance to
  the field, and/or relevance to the application

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Changes to Biographical Sketch NOTE The
Biographical Sketch may not exceed four pages.
A. Personal Statement Briefly describe why your
experience and qualifications make you
particularly well-suited for your role (e.g.,
PD/PI, mentor, participating faculty) in the
project that is the subject of the
application. C. Selected Peer-reviewed
Publications NIH encourages applicants to limit
the list of selected peer-reviewed publications
or manuscripts in press to no more than 15. Do
not include manuscripts submitted or in
preparation. The individual may choose to include
selected publications based on recency,
importance to the field, and/or relevance to the
proposed research. When citing articles that fall
under the Public Access Policy, were authored or
co-authored by the applicant and arose from NIH
support, provide the NIH Manuscript Submission
reference number (e.g., NIHMS97531) or the PubMed
Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is
not yet available because the Journal submits
articles directly to PMC on behalf of their
authors, indicate "PMC Journal - In Process." A
list of these Journals is posted at
http//publicaccess.nih.gov/submit_process_journal
s.htm. Citations that are not covered by the
Public Access Policy, but are publicly available
in a free, online format may include URLs or
PMCID numbers along with the full reference (note
that copies of publicly available publications
are not accepted as appendix material.)
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TOTAL OF 15 PUBLICATIONS w/ PMCID or PMID
numbers
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DO NOT LIST EFFORT!
DO NOT LIST DOLLAR AMOUNTS!
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Changes to Resources and Facilities

• Instructions added to Resources
• Provide a description of how the scientific
  environment will contribute to the probability of
  success of the project
• For Early Stage Investigators (ESIs), describe
  the institutional investment in the success of
  the investigator

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Resources All applications

• Identify the facilities to be used
  (laboratory, clinical, animal, computer, office,
  other). If appropriate, indicate their
  capacities, pertinent capabilities, relative
  proximity and extent of availability to the
  project. Describe only those resources that are
  directly applicable to the proposed work. Provide
  any information describing the Other Resources
  available to the project (e.g., machine shop,
  electronic shop) and the extent to which they
  would be available to the project.
• Describe how the scientific environment in
  which the research will be done contributes to
  the probability of success (e.g., institutional
  support, physical resources, and intellectual
  rapport). In describing the scientific
  environment in which the work will be done,
  discuss ways in which the proposed studies will
  benefit from unique features of the scientific
  environment or subject populations or will employ
  useful collaborative arrangements.

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Resources if applicable

• For Early Stage Investigators, describe
  institutional investment in the success of the
  investigator, e.g., resources for classes,
  travel, training collegial support such as
  career enrichment programs, assistance and
  guidance in the supervision of trainees involved
  with the ESIs project, and availability of
  organized peer groups logistical support such as
  administrative management and oversight and best
  practices training and financial support such as
  protected time for research with salary support.
• If there are multiple performance sites,
  describe the resources available at each site.
• Describe any special facilities used for
  working with biohazards or other potentially
  dangerous substances. Note Information about
  Select Agents must be described in the Research
  Plan, 5.5.11 (Select Agent Research).

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Basic Elements of NIH Grant Science 13
pagesenhancing-peer-review.nih.gov/docs/applicat
ion_changes.pdf
Freeman will try for 2/10

• Specific Aims 1
• Research Strategy 12
• Significance 0.5
• Innovation 0.5
• Approach 5-6
• Preliminary Studies 5-6

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Specific Aimsenhancing-peer-review.nih.gov/docs/
application_changes.pdf

• Overall goal (excitement)
• Importance of research (why?)
• Preliminary data (why you?)
• Hypothesis (innovation)
• Specific aims (plan)
• Impact (so what)

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Specific Aims
This is the blueprint for the proposal. It is
the most important page in the entire application.

• ONE PAGE ONLY!
• Define the problem and key issues first.
• Briefly state the background, basis, scientific
  rationale (can be based on your preliminary data)
  for the hypothesis.
• State a clear, succinct, focused, and testable
  hypothesis which stems from the information
  above.
• List 2 5 one sentence Specific Aims ( of aims
  depends on application type and funding
  period/time requested) which are obvious tests of
  the hypothesis. Brief experimental approaches
  can be included.
• Finish with a significance statement, i.e., what
  it will all mean and do for us if completed.
  The project should have relevance to a human
  health issue.

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Background and Significance Does Not Exist
Anymore!!!

• Refer to and analyze relevant literature with
  current citations.
• Short paragraphs to one-half page sections with a
  boldface heading. Use schemes to simplify
  concepts/paradigms.
• Lay the foundation for your preliminary studies
  and experimental aims (establish their
  significance). If you base a statement on your
  preliminary studies, make note where the data
  will appear (page and figure s).
• Identify (diplomatically) gaps in knowledge and
  discrepancies in the literature.
• Summarize key issues and gaps in knowledge that
  you will address in the proposal.

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Significanceenhancing-peer-review.nih.gov/docs/a
pplication_changes.pdf

• Importance of the problem
• Critical barrier to progress
• Improve knowledge
• Drive the development of the field

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Regarding Significance

• Will original and important contributions be
  made?
• Fundamental science and/or clinical relevance
  is important. Be sure to highlight disease
  relevance.
• Addresses gaps in present knowledge

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Innovationenhancing-peer-review.nih.gov/docs/app
lication_changes.pdf

• Shifts current research paradigm
• Novel concepts, approaches, or interventions
• Application of innovation/results

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Regarding Innovation

• Will the proposed studies change the view of a
  scientific issue or clinical problem?
• Stress new technologies brought to bear in
  research plan
• Studies viewed as observational, correlative,
  phenomenology, fishing expeditions, simple data
  gathering, etc., dont fly.

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Approachenhancing-peer-review.nih.gov/docs/appli
cation_changes.pdf

• Overall strategy
• General methods
• Specific methods
• Problems/alternative
• Feasibility

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Regarding Approach
For each Aim Restate Specific Aim Overall
strategy and rationale General experimental
approach Specific experimental
approach Anticipated results and potential
pitfalls Statistical Analysis
Check for mandates/guidelines re page allocations
for the various sections. Approach should be
approximately 40 of grant text pages. Getting
our point across is becoming more challenging as
page limits are reduced!
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Regarding Approach

• Note what you expect to observe and how these
  results will fill a gap in our understanding of
  this subject.
• Acknowledge potential weaknesses and technical
  limitations in the experimental plan. Be
  introspective and forthright.
• Do not state Since weve already done this
  lots of times before, we anticipate no problems
  with the proposed studies.
• Propose alternative approaches to test or
  circumvent weaknesses, limitations, and
  surprising results.

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Preliminary Resultsenhancing-peer-review.nih.gov
/docs/application_changes.pdf

• Expertise of investigators and investigative team
• Results relevant to area of research and specific
  to aims
• What you have speaks to feasibility

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Regarding Preliminary Results
A principal function of preliminary studies is to
provide support for your hypothesis and
demonstrate your capabilities to perform the
proposed work.

• Show key data using challenging methodologies.
• Preliminary does not mean below publication
  quality!
• Summarize your recent research in 3 5 points.
  Outline what is coming up.
• Say why you are showing specific data. (E.g., a
  key finding that supports your hypothesis,
  documents a new method, demonstrates feasibility
  to perform the experiments, etc.)
• Dont waste space, waste the reviewers time, or
  confuse the issue by showing irrelevant data.

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Dont want your application to be funded?

• Let NIH assign your grant to a SS they choose.
• Mislabel figures and tables or dont use them at
  all.
• Dont use legends, after all they just take up
  space.
• Propose studies using reagents that you do not
  have and are challenging to generate.
• Propose to generate a KO mouse
• Ignore statistical analysis

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Dont want your application to be funded?

• Dont include potential pitfalls, alternative
  approaches, or interpretations of the experiments
  you propose.
• We do not envisage any problems with the
  proposed studies.
• No letters of support
• Take inspiration from mentors R01 neither
  your mentor nor the study section will notice????
• In a revised application, ignore key reviewers
  comments
• Add new specific aims when not prompted by the
  review.

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Final Points to Consider
Dont use appendices as a means to circumvent the
page limit. Dont rely on the reviewers to read
your appendices.
Look at a successful grant to get the global
picture of how one all fits together.
Sending in a haphazard, poorly thought out or
flawed grant costs more time to achieve success
than missing a deadline to improve it for later
submission.
Paying attention to detail can dramatically
improve your potential to succeed!
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New NIH R01
Notification of Proposal Submission Thursday, December 03, 2009
Initial Elements (Form Attached) Thursday, December 10, 2009
Final Budget Wednesday, December 23, 2009
Non-Science Final Documents Thursday, January 07, 2010
Non-Science Review Thursday, January 21, 2010
Final Research Wednesday, January 27, 2010
To Office of Research Thursday, January 28, 2010
Due to Agency Friday, February 05, 2010
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Application Alignment with Review CriteriaMajor
Examples
Criteria Application
Significance Research Strategy a. Significance
Investigator(s) Biosketch
Innovation Research Strategy b. Innovation
Approach Research Strategy c. Approach
Environment Resources
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Overview of Shorter Page Limits
Current Page Limit (Section 2-5 of the Research Plan) New Page Limit (Research Strategy)
lt25 6
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gt25 Follow FOA Instructions

• Note Follow FOA page limit requirements if
  different from the application instructions.
• Full table of page limits available at
• http//enhancing-peer-review.nih.gov/page_limits.
  html