R01 NIH GrantsR01 NIH GrantsJohn E. Lochman, PhD, ABPPJohn E. Lochman, PhD, ABPP

Center for Prevention of Youth Behavior ProblemsCenter for Prevention of Youth Behavior ProblemsDepartment of PsychologyDepartment of Psychology

Psychosocial Development, Risk and Prevention Study Section –Psychosocial Development, Risk and Prevention Study Section – 2006-2010 2006-2010

UA Junior Investigator Meeting – 12/15/10UA Junior Investigator Meeting – 12/15/10

NIH Grant MechanismsNIH Grant Mechanisms

R01R01 Traditional investigator- Traditional investigator-initiated grant initiated grant

< $500K/yr, 3-5 yrs. Need < $500K/yr, 3-5 yrs. Need approval if more than $500K approval if more than $500K for any year of the grantfor any year of the grant

R03R03 Small Grant Small Grant < $100K for 2 yrs< $100K for 2 yrs

R21R21 Exploratory/Developmental Grant Exploratory/Developmental Grant < $275K for 2 yrs< $275K for 2 yrs

R34R34 Grant – pilot and feasibility studies Grant – pilot and feasibility studies < $450K for 3 yrs< $450K for 3 yrs

Develop Your IdeaDevelop Your Idea Read and re-read the program Read and re-read the program

announcementannouncement Review literatureReview literature Generate Generate preliminary datapreliminary data Enlist Enlist collaboratorscollaborators, include letters of , include letters of

commitment; Find collaborators and commitment; Find collaborators and mentors who are experienced in writing and mentors who are experienced in writing and winning NIH grantswinning NIH grants

Review Review successful grant applications successful grant applications of of other colleaguesother colleagues

If you have not been on a study section, If you have not been on a study section, confer with confer with someone who hassomeone who has

Writing the ApplicationWriting the Application Clear, concise writing styleClear, concise writing style

Be focusedBe focused

Don’t rushDon’t rush

Critique, critique, and critique Critique, critique, and critique again again

Follow up with Follow up with NIH program directors NIH program directors before and after reviewbefore and after review

Preparing the ApplicationPreparing the Application Follow instructions – PHS 398Follow instructions – PHS 398

Never assume that reviewers “know what you Never assume that reviewers “know what you mean”mean”

Refer to literature thoroughly; Present a clear Refer to literature thoroughly; Present a clear rationale for the proposed work rationale for the proposed work

Make sure that the experimental approach is Make sure that the experimental approach is thorough and detailedthorough and detailed

Include Include well-designed tables and figureswell-designed tables and figures

Anticipate human subject issuesAnticipate human subject issues

R01 Research GrantsR01 Research Grants

REVIEW CRITERIA:REVIEW CRITERIA:

• SignificanceSignificance• InvestigatorInvestigator• InnovationInnovation• ApproachApproach• EnvironmentEnvironment

__________________• Protection of Human SubjectsProtection of Human Subjects• Inclusion of Women, Minorities, ChildrenInclusion of Women, Minorities, Children• Animal Welfare/BiohazardsAnimal Welfare/Biohazards

Overall Evaluation & Score Reflects Impact on FieldOverall Evaluation & Score Reflects Impact on Field

Grant Review Criteria Grant Review Criteria Significance: Does the study address an important Significance: Does the study address an important

problem? If the aims of the application are achieved, problem? If the aims of the application are achieved, how will scientific knowledge be advanced?how will scientific knowledge be advanced?

Investigator: Is the investigator appropriately Investigator: Is the investigator appropriately trained?trained?

Innovation: Does the project employ novel aims, Innovation: Does the project employ novel aims, concepts, approaches and methods?concepts, approaches and methods?

Approach: Are the conceptual framework, design, Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-methods, and analyses adequately developed, well-integrated and appropriate to the project’s aims?integrated and appropriate to the project’s aims?

Environment: Does the scientific environment Environment: Does the scientific environment contribute to the probability of success?contribute to the probability of success?

Grant Review Criteria Grant Review Criteria

Investigators: Investigators: Are the PD/PIs, collaborators, and Are the PD/PIs, collaborators, and other researchers well suited to the project?other researchers well suited to the project?

• If Early Stage Investigators or New Investigators, do they If Early Stage Investigators or New Investigators, do they

have appropriate experience and training? have appropriate experience and training?

• If established, have they demonstrated an ongoing record of If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? accomplishments that have advanced their field(s)?

• If the project is collaborative or multi-PD/PI, do the If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; investigators have complementary and integrated expertise; are their leadership approach, governance and organizational are their leadership approach, governance and organizational structure appropriate for the project?structure appropriate for the project?

Grant Review Criteria Grant Review Criteria

Environment: Environment: Will the scientific environment in Will the scientific environment in which the work will be done contribute to the which the work will be done contribute to the probability of success? probability of success?

• Are the institutional support, equipment and other physical Are the institutional support, equipment and other physical resources available to the investigators adequate for the resources available to the investigators adequate for the project proposed? project proposed?

• Will theWill the project benefit from unique features of the scientific project benefit from unique features of the scientific environment, subject populations, or collaborative environment, subject populations, or collaborative arrangements? arrangements?

New NIH Formats: R01

1.1. Specific Aims (1 page)Specific Aims (1 page)2.2. Research Strategy (12 pages)Research Strategy (12 pages)

• SignificanceSignificance• InnovationInnovation• Approach Approach

• By each aim By each aim • Introductory paragraphIntroductory paragraph• Justification and feasibilityJustification and feasibility• Research Design, including type of dataResearch Design, including type of data• Analyses, by Aim/HypothesisAnalyses, by Aim/Hypothesis• Potential Problems and Alternative strategiesPotential Problems and Alternative strategies• Preliminary studies for new applicationsPreliminary studies for new applications

TimelineTimeline Future DirectionsFuture Directions

Significance & Innovation

1.1. Overall: help justify the need for what is Overall: help justify the need for what is proposedproposed

2.2. SignificanceSignificance: positive effect something is : positive effect something is likely to have on other thingslikely to have on other things

3.3. InnovationInnovation: a new and substantially : a new and substantially different way of doing this, which results in different way of doing this, which results in positive changepositive change

4.4. New Formats: increase detail as the review New Formats: increase detail as the review reads further into the applicationreads further into the applicationa.a. Does not begin with major literature Does not begin with major literature

reviewreviewb.b. Strategically distributed among the Strategically distributed among the

different sectionsdifferent sections

Significance & Innovation

1.1. SIGNIFICANCESIGNIFICANCE

a.a. Does application address an important Does application address an important problem or critical barrier in the fieldproblem or critical barrier in the field

b.b. If aims are achieved, how will scientific If aims are achieved, how will scientific knowledge, clinical practice be improvedknowledge, clinical practice be improved

c.c. How will successful completion of aims How will successful completion of aims change the concepts, methods, change the concepts, methods, treatments or preventive interventions treatments or preventive interventions that guide this field?that guide this field?

Significance & Innovation

1.1. SIGNIFICANCESIGNIFICANCE

a.a. Part 1: critical analysis of literature with Part 1: critical analysis of literature with identified research gap (substantiate identified research gap (substantiate and validate problem)and validate problem)

b.b. Part 2: Part 2: Statement of significanceStatement of significance

c.c. Part 3: Discussion of benefits if aims Part 3: Discussion of benefits if aims completedcompleted

i.i. Positive impact emphasis on the Positive impact emphasis on the advance itself, and why relevant to advance itself, and why relevant to NIHNIH

Significance & Innovation

1.1. INNOVATIONINNOVATIONa.a. Does application challenge and seek Does application challenge and seek

to shift current research or clinical to shift current research or clinical practice paradigms by using novel practice paradigms by using novel theoretical concepts, approaches or theoretical concepts, approaches or methodologies, etc.methodologies, etc.

b.b. Is a refinement, improvement or new Is a refinement, improvement or new application of theoretical concepts, application of theoretical concepts, approaches or methodologies approaches or methodologies proposed?proposed?

Significance & Innovation

1.1. INNOVATIONINNOVATIONa.a. Part 1: Document literature that Part 1: Document literature that

will support a claim of innovationwill support a claim of innovation

b.b. Part 2:Part 2: “This project is innovative “This project is innovative because….”because….”

c.c. Positive impact attributed to the Positive impact attributed to the substantive departure from the substantive departure from the status quo that enabled the status quo that enabled the advancementadvancement

New NIH Formats: R01

1.1. Specific Aims (1 page)Specific Aims (1 page)2.2. Research Strategy (12 pages)Research Strategy (12 pages)

• SignificanceSignificance• InnovationInnovation

• Approach Approach • By each aim By each aim • Introductory paragraphIntroductory paragraph• Justification and feasibilityJustification and feasibility• Research Design, including type of dataResearch Design, including type of data• Analyses, by Aim/HypothesisAnalyses, by Aim/Hypothesis• Potential Problems and Alternative Potential Problems and Alternative

strategiesstrategies• Preliminary studies for new applicationsPreliminary studies for new applications

TimelineTimeline Future DirectionsFuture Directions

Grant Review Criteria Grant Review Criteria

Approach: Approach: Are the overall strategy, methodology, Are the overall strategy, methodology, and analyses well-reasoned and appropriate to and analyses well-reasoned and appropriate to accomplish the specific aims of the project?accomplish the specific aims of the project?

• Are potential problems, alternative strategies, and Are potential problems, alternative strategies, and

benchmarks for success presented? benchmarks for success presented?

• If the project is in early stages of development, will the If the project is in early stages of development, will the strategy establish feasibility and will particularly risky strategy establish feasibility and will particularly risky aspects be managed? aspects be managed?

• If the project involves clinical research are the plans for If the project involves clinical research are the plans for (1) (1) protection of human subjects from research risksprotection of human subjects from research risks, and , and (2) inclusion of (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of minorities and members of both sexes/genders, as well as the inclusion of childrenchildren, justified in terms of the scientific goals and research , justified in terms of the scientific goals and research strategy proposed?strategy proposed?

General Design IssuesGeneral Design Issues

Valid InstrumentsValid Instruments

Pilot data – very importantPilot data – very important

Reality check – subject burdenReality check – subject burden

Will compliance rate(s) be adequateWill compliance rate(s) be adequate

Methodological IssuesMethodological Issues

Sampling MethodsSampling Methods

Power CalculationsPower Calculations

Theoretically-based InterventionTheoretically-based Intervention

Data Acquisition and ManagementData Acquisition and Management

Data AnalysisData Analysis

Application Tips from the trenchesApplication Tips from the trenches Make it readableMake it readable (breaks between paragraphs, (breaks between paragraphs,

use clear transitions and headings and use clear transitions and headings and subheadings, number and bold the headings and subheadings, number and bold the headings and subheads)subheads)

Summarize at end of sections: what are the Summarize at end of sections: what are the important gaps this application will important gaps this application will address, what is the significance, what is address, what is the significance, what is the innovation – BE SHAMELESS HEREthe innovation – BE SHAMELESS HERE

Aims and Aims and testabletestable hypotheses: these hypotheses: these aims/hypotheses should go from aims/hypotheses should go from signifcance to measures to data analysessignifcance to measures to data analyses

Tips from the trenches Tips from the trenches (cont)(cont)

Conceptual framework must be Conceptual framework must be presentpresent and and specific specific to this application; figures of models are useful as to this application; figures of models are useful as long as don’t have extraneous constructslong as don’t have extraneous constructs

Define key constructs with brief lit. review and make Define key constructs with brief lit. review and make sure they are assessed sure they are assessed specificallyspecifically by the measures by the measures usedused

Make sure that terms like mediators and moderators Make sure that terms like mediators and moderators are used correctlyare used correctly

If moderators are proposed, don’t just provide If moderators are proposed, don’t just provide background on the main effects of the moderator background on the main effects of the moderator variables on the outcomesvariables on the outcomes

Tips from the trenches Tips from the trenches (cont)(cont)

Make sure details are in agreement throughout Make sure details are in agreement throughout (e.g.sample size, names of conditions..)(e.g.sample size, names of conditions..)

Use multi-source, multi-method measures when Use multi-source, multi-method measures when possiblepossible

Special attention to providing details in the Data Special attention to providing details in the Data Analytic section Analytic section (examples, clear power estimates)(examples, clear power estimates)

Importance of the investigative TEAMImportance of the investigative TEAM

“THAT’S IT? THAT’S PEER REVIEW?”

Initial Review (Peer Review)Initial Review (Peer Review)

Who are the Reviewers?Who are the Reviewers?• They all have day jobs They all have day jobs • Active researchersActive researchers• Review applications in “spare time”Review applications in “spare time”• Will review Will review manymany applications; applications;

careful application preparation is careful application preparation is valuedvalued

Initial Review (Peer Review)Initial Review (Peer Review)SRA selects reviewers

Keys To SuccessKeys To Success Recognize that NIH peer review has a special culture Recognize that NIH peer review has a special culture

based on standing study sections composed of based on standing study sections composed of senior academic researchers with long histories of senior academic researchers with long histories of service and expectations of style, academic rigor, service and expectations of style, academic rigor, and hypothesis-based researchand hypothesis-based research

Good Luck!Good Luck!

If at first you don’t succeed –If at first you don’t succeed –

Revise and resubmitRevise and resubmit