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.