nih grant writing
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NIH Grant Writing. Richard P. Donahue , University of Buffalo. Assignment to an IRG. Cover letter requesting a specific study section. Put keywords in title and abstract. R01 Review Criteria. Is it novel? Is it significant? - PowerPoint PPT PresentationTRANSCRIPT
NIH Grant Writing
Richard P. Donahue, University of Buffalo
Assignment to an IRG
Cover letter requesting a specific study section.
Put keywords in title and abstract.
R01 Review Criteria
Is it novel?
Is it significant?
Approach* Outcome Measure* Exposure or main effect* Covariates* Analysis* Power
Investigators
Environment
Minority/Gender
Human Subjects
General Types of Grants
Clinical
Etiology
Prevention
R01 Review Criteria
SignificanceSignificance
Does this study address an important problem?
If the aims of the application are achieved, how
will scientific knowledge be advanced? What will
be the effect of these studies on the concepts
or methods that drive this field?
R01 Review Criteria
ApproachApproachAre the conceptual framework, design
(including composition of study population),
methods, and analyses adequately
developed, well-integrated, and appropriate to
the aims of the project? Does the applicant
acknowledge potential problem areas and
consider alternative tactics?
R01 Review Criteria
InnovationInnovation
Does the project employ novel concepts,
approaches or methods? Are the aims
original and innovative? Does the project
challenge existing paradigms or develop new
methodologies or technologies?
R01 Review Criteria
InvestigatorInvestigatorIs the investigator appropriately trained and well
suited to carry out this work? Is the work
proposed appropriate to the experience level of
the principal investigator and other researchers
(if any)? PLEASE DO NOT INCLUDE
descriptive biographical information unless
important to the evaluation of merit.
R01 Review CriteriaEnvironmentEnvironment
Does the scientific environment in which the work will
be done contribute to the probability of success? Do
the proposed experiments take advantage of unique
features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of
institutional support? PLEASE DO NOT INCLUDE
description of available facilities or equipment unless
important to the evaluation of merit.
R01 Review CriteriaOverall EvaluationOverall Evaluation
In one paragraph, briefly summarize the most important points of the Critique, addressing the strengths and weaknesses of the application in terms of the five review criteria. Recommended a score reflecting the overall impact of the project on the field, weighting the review criteria, as you feel appropriate for each application. An application does not need to be strong in all categories to be judged likely to have a major scientific impact and, thus, deserve a high merit rating. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward.
Notes Concerning Funding Study Sections are advisory in nature - do not make funding
decisions.
Funding is decided at the Institute level with Advisory Council approval.
Institutions do not have to fund in order of priority score.
“Portfolio Balance” - may go outside the priority score order to fund grants that address needed areas.
Study Sections - “Unscore” one-half of all R01 submissions - approximately a score of 2.8 or above.
Fellowship applications cannot be unscored (scored 1 to 5)
Types of Grants (1) R03 - Analysis only.
Limited in $ (50K) totalLimited in years (2 years)
R21 - Support to investigators changing areas
of research.Limited in $ (100K) totalLimited in years (2 or 3 years)
R01 - Most investigator-initiated proposals.Average cost =300k/year (total)Years of support limited to 4 years(NHLBI)
Types of Grants (2)
R29 - FIRST AWARD
No longer accepted
NRSA - InstitutionalIndividual
K Series - Clinician Scientist
Reviewer’s Comments
The following is a list (in no particular order) of aspects of grant applications on which reviewers make comments or with which they express concerns.
Reviewer’s Comments (cont’d)
Representativeness of study samples
Generalizability
duration of the study/timing/sequencing
Absence of timelines/organization charts/graphic depictions of study designs
Conceptual/empirical rationales for variable
Reviewer’s Comments (cont’d) Statistical analyses/power analyses
Protection of human subjectsconsideration of physicians as subjectsavailability of draft or final informed consent formspecification of risks for each treatmentinclusion/exclusion criteria
Staffing (commensurate with scope of work; appropriate expertise at correct times); absence of justification
Reviewer’s Comments (cont’d) Budget (contributed time; flat over life of
project) Developmental or demonstration projects (need
evaluation component Hypothesis-generating vs. hypothesis-testing
designs Quantification of assertions/unfounded
assertions Instruments (pre-testing, reliability, validity,
psychometerics evaluations); draft of finals included in appendices?
Reviewer’s Comments (cont’d) Roles of staff (organization chart often helpful) Letters of support/commitment (need
assurances of commitment/collaboration), “in kind” support
Outcomes measures clearly specified? Representativeness of study sample (gender
and ethnicity); statistical data presented? (absence of this information necessitates entering a code that will preclude timely funding)
Matching objectives/hypotheses/process
Reviewer’s Comments (cont’d) Subject attrition, response rate, recruitment,
incentives Confounding/contamination considerations Inclusion of relevant publications (appendix) Comparison studies vs. descriptive studies (the
former do better in review Availability of preliminary data Use of medical charts for accessing data
(missing data, variability); factoring in time and effort required.
Reviewer’s Comments (cont’d) Homogeneity in cultures and race;
acculturation
Self-report/social desirability/recall bias/self-identification/self-selection
Limitations of study and how they will be handled
Clarification of use of various scales (why they are used/not used)
Reviewer’s Comments (cont’d) Addressing research issues from
multicultural/multidisciplinary perspective
Proposing too many activities within one application
Internal/external validity
Allocation on the timeline for data analysis and report writing
clear statement of hypotheses, focused appropriately
Reviewer’s Comments (cont’d)
Educational/reading levels of subects who must read instruments or participate in an intervention
Inappropriate, excessive use of jargon in the application
Matching study design to the questions posed Clarifying the unit of analysis Budget - make sure totals are correct in all
columns Absence of an appropriate comparison
Reviewer’s Comments (cont’d)
Adequate amount of data for characterizing research subjects
evidence of experience in management of large, multisite projects
time commitments of investigators (Other Support)
maintaining confidentiality of data (storage/handling)
tieing literature to hypothesis
Reviewer’s Comments (cont’d)
Translation/back translation (demonstrate understanding of the complexities of this effort for surveys
Use of advisory committees, executive committees to oversee large, complex, multisite, multi-investigator projects
Acknowledge temporal events, background noise
Reviewer’s Comments (cont’d)
Define endpoints clearly
use standard, appropriate English, have a disinterested colleague review for clarity and grammar; spell-check document
Agenda Getting started Sources of funding Different types of grants: Examples Elements in the receipt and review
process Elements in Writing a good application Overview of budget process Building a Multidisciplinary Team Use of consultants - Letters of Support Wrap up
Overview of Agenda
Grant Opportunities in Research Training, and Career Development
The Grant Application Process
Focusing and Packaging a Good Funding Idea
Receipt and Referral Process
Review Process
???Submits
Application
Allocates Funds
NIH Division ofResearch Grants assignsStudy Section & Institute
Study Section evaluates forscientific merit
Institute evaluates for Program Relevance
Advisory Council recommends action
Institute Director takesfinal action
for NIH director
Investigatorinitiates
research ideas
School or otherResearch Center
National Institutes of Health
Conducts research
How a Research Grant is Made
Dual Review System for Grant Applications
First Level of Review
Second Level of Review
Scientific Review Group
• Provide initial scientific review of grant applications
• Recommend appropriate level of support and duration of award
Council
• Assess quality of SRG review of grant application
• Make recommendations to institute staff on funding
• Evaluate program priorities and relevance
• Advise on policy
Sample Application Number
IndividualResearch Grant
SerialNumber Amended
NewApplication
NationalInstitute
ofNursing
Research
GrantSupport
Year
1 R01 NR 12345 01 A1
Streamlined Summary Statements
Critiques are unedited comments of individual reviewers prepared prior to the discussion.
Critiques do NOT reflect committee deliberations and conclusions.