National Institutes of National Institutes of HealthHealth

National Institutes of National Institutes of HealthHealth

Much of the Much of the biomedical biomedical research in the research in the United States is United States is supported by the supported by the Federal Federal Government, Government, primarily the primarily the National National Institutes of Institutes of Health (NIH)Health (NIH)

U. S. U. S. DepartmentDepartment of Health and Human Services of Health and Human Services

Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

TheSecretary

Deputy Secretary

TheSecretary

Deputy Secretary

Administration onAging(AoA)

Administration onAging(AoA)

Health Care FinancingAdministration

(HCFA)

Health Care FinancingAdministration

(HCFA)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Program SupportCenter(PSC)

Program SupportCenter(PSC)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for Health Care Policy

and Research(AHCPR)

Agency for Health Care Policy

and Research(AHCPR)

NIH Extramural Awarding NIH Extramural Awarding ComponentsComponents

National Cancer Institute (NCI)National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI)National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Library of Medicine (NLM)National Library of Medicine (NLM) National Institute of Child Health and Human Development (NICHD)National Institute of Child Health and Human Development (NICHD) National Institute of Deafness and Other Communication Disorders National Institute of Deafness and Other Communication Disorders

(NIDCD)(NIDCD) National Institute of Environmental Health Sciences (NIEHS)National Institute of Environmental Health Sciences (NIEHS) National Institute of Neurological Disorders and Stroke (NINDS)National Institute of Neurological Disorders and Stroke (NINDS) National Institute on Aging (NIA)National Institute on Aging (NIA) National Institute of Allergy and Infectious Diseases (NIAID)National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases

(NIAMS)(NIAMS) National Institute of Dental and Craniofacial Research (NIDCR)National Institute of Dental and Craniofacial Research (NIDCR) National Eye Institute (NEI)National Eye Institute (NEI) National Institute of General Medical Sciences (NIGMS)National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH)National Institute of Mental Health (NIMH) National Institute for Nursing Research (NINR)National Institute for Nursing Research (NINR) National Institute on Alcohol Abuse and Alcoholism (NIAAA)National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute on Drug Abuse (NIDA)National Institute on Drug Abuse (NIDA) National Center for Complementary and Alternative Medicine (NCCAM)National Center for Complementary and Alternative Medicine (NCCAM) National Center for Research Resources (NCRR)National Center for Research Resources (NCRR) National Human Genome Research Institute (NHGRI)National Human Genome Research Institute (NHGRI) National Institute of Biomedical Imaging and BioengineeringNational Institute of Biomedical Imaging and Bioengineering (NIBIB) (NIBIB) Fogarty International Center (FIC) Fogarty International Center (FIC) National Center on Minority Health and Health DisparitiesNational Center on Minority Health and Health Disparities (NCMHD) (NCMHD)

A Typical Institute/CenterA Typical Institute/Center

Office of the ICOffice of the ICDirectorDirector

NationalNationalAdvisoryAdvisoryCouncilCouncil

Board ofBoard ofScientificScientific

CounselorsCounselors

ExtramuralExtramural

ScientificScientificProgramsPrograms

GrantsGrants ContractsContracts

IntramuralIntramural

LaboratoryLaboratoryStudiesStudies

ClinicalClinicalStudiesStudies

Overall Peer Review Overall Peer Review ProcessProcess

Dual Review System for Grant ApplicationsDual Review System for Grant Applications

Second Level of ReviewSecond Level of ReviewCouncilCouncil

Assesses Quality of SRGAssesses Quality of SRG Review of Grant ApplicationsReview of Grant Applications Makes Recommendation toMakes Recommendation to Institute Staff on FundingInstitute Staff on Funding Evaluates Program PrioritiesEvaluates Program Priorities and Relevanceand Relevance Advises on PolicyAdvises on Policy

First Level of ReviewScientific Review Group Scientific Review Group

(SRG)(SRG) Provides Initial Scientific Provides Initial Scientific

MeritMerit Review of Grant ApplicationsReview of Grant Applications Rates Applications and Makes Rates Applications and Makes

Recommendations for Recommendations for Appropriate Level of Support Appropriate Level of Support and Duration of Awardand Duration of Award

Review Process for a Research GrantReview Process for a Research Grant

ResearchGrant

Application

School or OtherResearch Center

National Institutes of Health

Center for Scientific Review

InitiatesResearchIdea

ConductsResearch

Submits Application

Allocates Funds

Assigns to IRG/Study Section & IC

Evaluates for Scientific Merit

Evaluates for Program Relevance

Advisory Councils and Boards

Institute Director

Recommends Action

Takes final action for NIH Director

Institute

Study Section

Typical Timeline for a Typical Timeline for a New Individual Research New Individual Research Project Grant Project Grant Application (R01)Application (R01)

–Submit in February (June, October)–Review in June (October, February)

–Council in September (January, May)–Earliest award in December (April, July)

Cycle 1---- Cycle 2---- Cycle 3----

There are three overlapping cycles per year:

NIH Grant Receipt, NIH Grant Receipt, Review, and Award Review, and Award ScheduleScheduleJan-MayJan-MayMay-SeptMay-Sept Receipt DatesReceipt DatesSept-JanSept-Jan

June-JulyJune-JulyOct-NovOct-Nov Review DatesReview DatesFeb-MarFeb-Mar

Sept-OctSept-OctJan-FebJan-Feb National Advisory Council Board DatesNational Advisory Council Board DatesMay-JuneMay-June

Dec 1Dec 1Apr 1Apr 1 Earliest Possible Beginning DateEarliest Possible Beginning DateJuly 1July 1

Center for Scientific Center for Scientific ReviewReview Serves as central receipt point for PHS Grant Serves as central receipt point for PHS Grant

ApplicationsApplications Assigns applications to CSR Integrated Assigns applications to CSR Integrated

Review Groups/Study Sections or Institute Review Groups/Study Sections or Institute Scientific Review GroupsScientific Review Groups

Assigns applications to NIH Institute(s) as Assigns applications to NIH Institute(s) as potential funding component(s)potential funding component(s)

Conducts initial scientific merit review of most Conducts initial scientific merit review of most research applications submitted to the NIH in research applications submitted to the NIH in more than 100 Study Sections more than 100 Study Sections

Grant Application Grant Application Receipt and Receipt and AssignmentAssignment

Applications Submitted to Applications Submitted to NIHNIH

Approximately Approximately 60,000 grant 60,000 grant applications are applications are submitted to NIH submitted to NIH each year, of which each year, of which 25-30% are funded25-30% are funded

Competing grant Competing grant applications are applications are received for three received for three review cycles per review cycles per yearyear

Applications are Applications are Assigned byAssigned by

Referral Officers:Referral Officers:

Professional scientists, most Professional scientists, most of whom also serve as of whom also serve as scientific review scientific review administrators of CSR study administrators of CSR study sectionssections

Applications are Assigned Applications are Assigned to:to:

Scientific review groups based Scientific review groups based on:on:–Specific review guidelines for each Specific review guidelines for each scientific review groupscientific review group

Institutes based on:Institutes based on:–Overall mission of the InstituteOverall mission of the Institute–Specific programmatic mandates Specific programmatic mandates and interests of the Instituteand interests of the Institute

Assignment to CSR Study Assignment to CSR Study Sections (continued)Sections (continued)

Within an IRG, applications are assigned for Within an IRG, applications are assigned for review toreview to

Standing Study Sections Standing Study Sections when the subject when the subject matter of the application matches the referral matter of the application matches the referral guidelines for the study sectionguidelines for the study section

Ad Hoc Special Emphasis Panels (SEPs) Ad Hoc Special Emphasis Panels (SEPs) when the when the subject matter does not fit into any study subject matter does not fit into any study section, or when assignment of an application to section, or when assignment of an application to the most appropriate study section would create the most appropriate study section would create a conflict of interest. Also used for special a conflict of interest. Also used for special mechanisms (e.g., fellowships, SBIRs, AREAS)mechanisms (e.g., fellowships, SBIRs, AREAS)

Sample Application Sample Application NumberNumber

Individual Serial Individual Serial AmendedAmended Research Number Research Number GrantGrant

11 R01 R01 CA CA 1234512345 0101 A1A1

New National GrantNew National GrantApplication Cancer SupportApplication Cancer Support Institute YearInstitute Year

Initial Review in CSRInitial Review in CSR

Peer Review in CSRPeer Review in CSR CSR Study Sections are managed by a Scientific CSR Study Sections are managed by a Scientific

Review Administrator (SRA) who is a Review Administrator (SRA) who is a professional, usually at the Ph.D. level, whose professional, usually at the Ph.D. level, whose scientific background is close to the expertise scientific background is close to the expertise of the study sectionof the study section

Each CSR standing study section has 12 - 24 Each CSR standing study section has 12 - 24 members who are primarily from academiamembers who are primarily from academia

As many as 60 - 100 applications are reviewed As many as 60 - 100 applications are reviewed at each study section meetingat each study section meeting

Scientific Review Scientific Review AdministratorAdministrator

Performs administrative and technical review of applications

Selects reviewers Manages study sections Prepares summary statements Provides requested information

about study section recommendations to Institutes and National Advisory Councils/Boards

Criteria For Selection of Peer ReviewersCriteria For Selection of Peer Reviewers

Demonstrated Scientific ExpertiseDemonstrated Scientific Expertise Doctoral Degree or EquivalentDoctoral Degree or Equivalent Mature Judgment Mature Judgment Work Effectively in a Group ContextWork Effectively in a Group Context Breadth of PerspectiveBreadth of Perspective ImpartialityImpartiality Interest in ServingInterest in Serving Adequate Representation of Women Adequate Representation of Women

and Minority Scientistsand Minority Scientists

Scientific Review Group or Scientific Review Group or Study Section ActionsStudy Section Actions

Scored, Scientific Merit Scored, Scientific Merit Rating (priority scores Rating (priority scores and percentiles)and percentiles)

Unscored (lower half)Unscored (lower half)

DeferralDeferral

ActionAction Scored -- Scientific Merit Rating 1.0 to Scored -- Scientific Merit Rating 1.0 to

approximately 3.0 approximately 3.0

Based on the relevant review criteria, the Based on the relevant review criteria, the application is judged to be in the upper half application is judged to be in the upper half of applications reviewed by the study of applications reviewed by the study section or scientific review group. The section or scientific review group. The recommendation can be for the requested recommendation can be for the requested time and amount or for an adjusted time time and amount or for an adjusted time and amount. A priority score is provided, and amount. A priority score is provided, and a summary statement prepared that and a summary statement prepared that incorporates the written critiques plus a incorporates the written critiques plus a resume and summary of the discussion.resume and summary of the discussion.

ActionAction UnscoredUnscored

Application is unanimously judged Application is unanimously judged to be in the lower half of to be in the lower half of applications reviewed by the study applications reviewed by the study section or scientific review group. section or scientific review group. No priority score is assigned. The No priority score is assigned. The summary statement provided to summary statement provided to the applicant is a compilation of the applicant is a compilation of reviewers’ comments prepared reviewers’ comments prepared prior to the meeting.prior to the meeting.

ActionAction

DeferralDeferralThe study section cannot make The study section cannot make a recommendation without a recommendation without additional information. This additional information. This information may be obtained information may be obtained by a project site visit or by by a project site visit or by submission of additional submission of additional material by the applicant.material by the applicant.

Post Scientific Review Post Scientific Review Group ActionsGroup Actions

Calculations of priority scores and Calculations of priority scores and percentile rankingspercentile rankings

Preparation of summary statementsPreparation of summary statements

Removal of applications from Removal of applications from National Advisory Council / Board National Advisory Council / Board considerationconsideration

Summary StatementSummary Statement Once applications are reviewed, the results Once applications are reviewed, the results

are documented by the SRA in a summary are documented by the SRA in a summary statement and forwarded to the Institute (and statement and forwarded to the Institute (and the PI) where a funding decision is made: the PI) where a funding decision is made:

The summary statement contains:The summary statement contains:

Overall Resume and Summary of Review DiscussionOverall Resume and Summary of Review Discussion Essentially Unedited CritiquesEssentially Unedited Critiques Priority Score and Percentile RankingPriority Score and Percentile Ranking Budget RecommendationsBudget Recommendations Administrative NotesAdministrative Notes

National Advisory National Advisory Council or Board Council or Board

ReviewReview

Council ActionsCouncil Actions

Concurrence with study Concurrence with study section actionsection action

Modification of study section Modification of study section actionaction

Deferral for re-reviewDeferral for re-review

What Determines What Determines Which Awards Are Which Awards Are Made?Made?

Scientific meritScientific merit

Program ConsiderationsProgram Considerations

Availability of fundsAvailability of funds

Preparation of an Preparation of an ApplicationApplication

PHS Research GrantPHS Research Grant Application Kit (form PHS Application Kit (form PHS 398)398)

Mail Completed Forms To:

CENTER FOR SCIENTIFIC REVIEWNATIONAL INSTITUTES OF HEALTHROCKLEDGE II ROOM 1040 MSC-7710BETHESDA MD 20892-7710

When Preparing an When Preparing an ApplicationApplication Read instructionsRead instructions Never assume that reviewers “will know Never assume that reviewers “will know

what you mean”what you mean” Refer to literature thoroughly Refer to literature thoroughly State rationale of proposed investigationState rationale of proposed investigation Include well-designed tables and figuresInclude well-designed tables and figures Present an organized, lucid write-upPresent an organized, lucid write-up Obtain pre-review from faculty at your Obtain pre-review from faculty at your

institutioninstitution

Common Problems in Common Problems in ApplicationsApplications Lack of new or original ideasLack of new or original ideas Absence of an acceptable scientific rationaleAbsence of an acceptable scientific rationale Lack of experience in the essential methodologyLack of experience in the essential methodology Questionable reasoning in experimental approachQuestionable reasoning in experimental approach Uncritical approachUncritical approach Diffuse, superficial, or unfocused research planDiffuse, superficial, or unfocused research plan Lack of sufficient experimental detailLack of sufficient experimental detail Lack of knowledge of published relevant workLack of knowledge of published relevant work Unrealistically large amount of workUnrealistically large amount of work Uncertainty concerning future directionsUncertainty concerning future directions