Navigating the Changes to Navigating the Changes to the NIH Application the NIH Application

InstructionsInstructions

EFFECTIVE JANUARY 25, 2010EFFECTIVE JANUARY 25, 2010

Why the Change?Why the Change?To Enhance NIH Peer ReviewTo Enhance NIH Peer Review

► Align the structure and content of the forms with Align the structure and content of the forms with review criteriareview criteria To focus the applicants and reviewers on the same elementsTo focus the applicants and reviewers on the same elements

To help ensure a more efficient and transparent review To help ensure a more efficient and transparent review processprocess

► Identify and encourage new and early stage Identify and encourage new and early stage investigatorsinvestigators New Investigator checkbox removed from PHS 398 Face New Investigator checkbox removed from PHS 398 Face

Page (paper) and PHS 398 Cover Page Supplement Page (paper) and PHS 398 Cover Page Supplement (electronic) (electronic)

► Streamline time to awardStreamline time to award► Fund the best science, by the best scientists, with Fund the best science, by the best scientists, with

the least amount of administrative burdenthe least amount of administrative burden

Overview of the ChangesOverview of the Changes

►Research PlanResearch Plan►Biographical SketchBiographical Sketch►Facilities and Other Facilities and Other

ResourcesResources

Research Plan Research Plan ShorterShorter Page Page LimitsLimits

Current Page LimitCurrent Page Limit New Page LimitNew Page Limit

<25 (e.g R21, R03)<25 (e.g R21, R03) 66

25 (e.g. R01)25 (e.g. R01) 1212

New page limits are applicable to ALL New, Renewal, New page limits are applicable to ALL New, Renewal, Resubmission, and Revision applications, unless Resubmission, and Revision applications, unless

otherwise stated in the Funding Opportunity otherwise stated in the Funding Opportunity Announcement (FOA).Announcement (FOA).

New Structured Research New Structured Research PlanPlan

1.1. Intro to Application Intro to Application (Resubmission/Revision only)(Resubmission/Revision only)

2. Specific Aims – 2. Specific Aims – 1 page limit1 page limit3. Research Strategy – 3. Research Strategy – R21=6 pages, R21=6 pages,

R01=12 pagesR01=12 pagesa.a. SignificanceSignificanceb.b. InnovationInnovationc.c. ApproachApproach

► Prelim Studies for new applicationsPrelim Studies for new applications► Progress Report for renewal/revisionsProgress Report for renewal/revisions

New Research Strategy New Research Strategy SectionSection

SStructure of research narrative changed tructure of research narrative changed to match new review criteriato match new review criteriaCurrent ApplicationCurrent Application New ApplicationNew Application

Background and Background and SignificanceSignificance

Research StrategyResearch Strategy

a.a. SignificanceSignificance

b.b. InnovationInnovation

c.c. ApproachApproach• Preliminary Studies Preliminary Studies

for New Applicationsfor New Applications• Progress Report for Progress Report for

Renewal/RevisionRenewal/Revision

Research Design and Research Design and

MethodsMethods

Preliminary Preliminary Studies/Progress ReportStudies/Progress Report

New Research Strategy New Research Strategy PreparationPreparation

►A A single PDF attachmentsingle PDF attachment for the for the Research Strategy (previously 3 Research Strategy (previously 3 separate files) increases applicant separate files) increases applicant control over the look and feel of the control over the look and feel of the application.application. Simplified preparation for the applicantSimplified preparation for the applicant Easier reading for reviewersEasier reading for reviewers Electronic validation of page limits for Electronic validation of page limits for

Research Strategy in one fileResearch Strategy in one file

New Order of Research Plan New Order of Research Plan SectionSection

Research Strategy - Research Strategy - SignificanceSignificance

►Explain importance of problem or Explain importance of problem or critical barrier to progress in field.critical barrier to progress in field.

►Explain how project will improve Explain how project will improve scientific knowledge, technical scientific knowledge, technical capability, clinical practice in one or capability, clinical practice in one or more broad fields.more broad fields.

►Describe how concepts, methods, etc. Describe how concepts, methods, etc. that drive this field will be changed if that drive this field will be changed if aims achieved.aims achieved.

Research Strategy - Research Strategy - InnovationInnovation

►Explain how application challenges and Explain how application challenges and seeks to change current research or seeks to change current research or clinical practice paradigms.clinical practice paradigms.

►Describe novel concepts, approaches, Describe novel concepts, approaches, methodologies, instrumentation or methodologies, instrumentation or interventions to be developed or used.interventions to be developed or used.

►Explain refinements, improvements, or Explain refinements, improvements, or new applications of theoretical new applications of theoretical concepts, approaches or methodologies, concepts, approaches or methodologies, instrumentation, or interventions.instrumentation, or interventions.

Research Strategy - Research Strategy - ApproachApproach

► Describe overall strategy, methodologies, and Describe overall strategy, methodologies, and analyses proposed in specific aims.analyses proposed in specific aims.

► Discuss potential problems, alternative Discuss potential problems, alternative strategies, and benchmarks for success.strategies, and benchmarks for success.

► If in early stages, describe strategy to establish If in early stages, describe strategy to establish feasibility, management of high risk aspects.feasibility, management of high risk aspects.

► Point out any hazardous procedures, materials.Point out any hazardous procedures, materials.► For new applications, include For new applications, include Preliminary Preliminary

StudiesStudies as part of Approach. as part of Approach.► For renewal/revision applications, provide a For renewal/revision applications, provide a

Progress ReportProgress Report as part of Approach. as part of Approach.

Facilities & Other Resources Facilities & Other Resources SectionSection

►Scientific EnvironmentScientific Environment – Describe how – Describe how the scientific environment will the scientific environment will contribute to the probability of success contribute to the probability of success of the project, and unique features of of the project, and unique features of the environment.the environment. Discuss ways in which the proposed studies Discuss ways in which the proposed studies

will benefit from unique features of the will benefit from unique features of the scientific environment or subject scientific environment or subject population or will employ useful population or will employ useful collaborative arrangement.collaborative arrangement.

Facilities & Other Resources Facilities & Other Resources SectionSection

► Early Stage Investigators (ESIs)Early Stage Investigators (ESIs) – will require – will require the institutional investment in the success of the institutional investment in the success of the investigator.the investigator. e.g. classes, travel, training, collegial support, e.g. classes, travel, training, collegial support,

administrative support, and financial support.administrative support, and financial support.

►Definition of Early Stage Investigator (ESI)Definition of Early Stage Investigator (ESI): : Within 10 years of completing their terminal Within 10 years of completing their terminal research degree or within ten years of research degree or within ten years of completing their medical residency.completing their medical residency.

Facilities & Other Resources Facilities & Other Resources SectionSection

►Biohazards or Other Potentially Biohazards or Other Potentially Dangerous SubstancesDangerous Substances – describe any – describe any special facilities used for working with special facilities used for working with these substances.these substances.

Biographical Sketch ChangesBiographical Sketch Changes►Section A - A new Section A - A new Personal StatementPersonal Statement

will be incorporated.will be incorporated. This will change the parts formerly called A, This will change the parts formerly called A,

B, and C, to Parts B, C, and D.B, and C, to Parts B, C, and D. Briefly describe why your experience and Briefly describe why your experience and

qualifications make you particularly well-qualifications make you particularly well-suited for your role (e.g. PD/PI, suited for your role (e.g. PD/PI, collaborator, mentor, etc.) in the project collaborator, mentor, etc.) in the project that is the subject of the application.that is the subject of the application.

Therefore, Biosketch may have to be revised for Therefore, Biosketch may have to be revised for EVERY proposal submission depending on your EVERY proposal submission depending on your role on the project.role on the project.

Biographical Sketch ChangesBiographical Sketch Changes► Section B (formerly Section A)Section B (formerly Section A)

Positions and HonorsPositions and Honors

► Section C (formerly Section B)Section C (formerly Section B) Publications (suggest limiting to 15 selected peer-Publications (suggest limiting to 15 selected peer-

reviewed pubs).reviewed pubs).►Choose 15 based on recency, importance to field, and/or Choose 15 based on recency, importance to field, and/or

relevance to proposed research.relevance to proposed research.►Be sure to include the Be sure to include the PMCID #PMCID # where applicable! where applicable!

► Section D (formerly Section C)Section D (formerly Section C) Research Support Ongoing and Completed – No Research Support Ongoing and Completed – No

change to instructions.change to instructions.

New Page Limitations New Page Limitations unless the FAO specifies otherwiseunless the FAO specifies otherwise

Important LinksImportant Links

► NIH Notice, NOT-OD-149, regarding the NIH Notice, NOT-OD-149, regarding the restructured application forms and restructured application forms and instructions.instructions.

► NIH website for Enhancing Peer Review.NIH website for Enhancing Peer Review.► NIH FAQs on application enhancements, peer NIH FAQs on application enhancements, peer

review, scoring, new investigators/ESIs, etc.review, scoring, new investigators/ESIs, etc.► New NIH Forms & Applications.New NIH Forms & Applications.► New NIH Biosketch SAMPLE, with an example New NIH Biosketch SAMPLE, with an example

of the Personal Statement.of the Personal Statement.► NIH New and Early Stage Investigator Policies.NIH New and Early Stage Investigator Policies.►DOM info on NIH Public Access Policy.DOM info on NIH Public Access Policy.

Steps for SuccessSteps for Success

►Read the new instructions thoroughly Read the new instructions thoroughly and carefully to ensure successful and carefully to ensure successful preparation and submission.preparation and submission.

►Submit Submit EARLY EARLY for the February and for the February and March deadline to allow enough time March deadline to allow enough time to make any required corrections prior to make any required corrections prior to proposal submission.to proposal submission.

DOM DRA 3-Day PolicyDOM DRA 3-Day Policy

►Reminder: All Grants.gov/Cayuse Reminder: All Grants.gov/Cayuse proposals are required to be submitted proposals are required to be submitted to the Department of Medicine’s to the Department of Medicine’s Departmental Research Associate Departmental Research Associate (DOM DRA) at (DOM DRA) at least 3 business days least 3 business days PRIOR to the federal agency deadline.PRIOR to the federal agency deadline.