Peer Review of Peer Review of NIH NIH Research Grant Research Grant ApplicationsApplications

Center for Scientific ReviewNational Institutes of Health

Review Process for a Review Process for a Research GrantResearch Grant

National Institutes of HealthNational Institutes of Health

Center for Scientific ReviewCenter for Scientific Review

Study SectionStudy Section

InstituteInstitute

Advisory Councils and BoardsAdvisory Councils and Boards

Institute DirectorInstitute Director

School or Other Research Center

School or Other Research Center

ResearchGrant Application

ResearchGrant Application

Submits Application

Allocates Funds

Initiates Research Idea

Conducts Research

Assign to IC & IRG/ Study Section

Review for Scientific Merit

Evaluate for Relevance

Recommend Action

Takes final action

Dual Review System for Grant Dual Review System for Grant ApplicationsApplications

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 MeritProvides Initial Scientific Merit Review of Grant ApplicationsReview of Grant Applications Rates Applications and Makes Rates Applications and Makes

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

Office of the DirectorOffice of the Director

National Instituteon Alcohol Abuseand Alcoholism

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National CancerInstitute

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Child Health

and HumanDevelopment

National Institute onDeafness and Other

CommunicationDisorders

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National EyeInstitute

National HumanGenome Research

Institute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Instituteof Nursing Research

National Libraryof Medicine

National Libraryof Medicine

Center for InformationTechnology

Center for InformationTechnology

Center for Scientific Review

Center for Scientific Review

National Centerfor Complementary

and AlternativeMedicine

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

National Instituteof Allergy and

Infectious Diseases

FogartyInternational

Center

FogartyInternational

Center

National Centerfor ResearchResources

National Centerfor ResearchResources

National Institutes of HealthNational Institutes of Health

Clinical Center

Clinical Center

National Center on Minority Health andHealth Disparities

National Center on Minority Health andHealth Disparities

National Institute of Biomedical Imagingand Bioengineering

National Institute of Biomedical Imagingand Bioengineering

Center for Scientific Review (CSR)Center for Scientific Review (CSR)

Center Center forfor Scientific Scientific ReviewReview

ReferralReferral Central Receipt Point for PHS Grant ApplicationsCentral Receipt Point for PHS Grant Applications Institute Assignment (Potential Funding Institute Assignment (Potential Funding

Component)Component) Assignment to Scientific Review Group in CSR or in Assignment to Scientific Review Group in CSR or in

an Institutean Institute

Scientific ReviewScientific Review More than 100 Study Sections that review:More than 100 Study Sections that review:

Research Grant ApplicationsResearch Grant Applications Postdoctoral Fellowship ApplicationPostdoctoral Fellowship Application Academic Research Enhancement Award Academic Research Enhancement Award

ApplicationsApplications Small Business Innovation Research ApplicationsSmall Business Innovation Research Applications

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 SectionsSections Applications are assigned to Integrated Applications are assigned to Integrated

Review Groups (IRGs) for review. IRGs are Review Groups (IRGs) for review. IRGs are clusters of scientifically-related study clusters of scientifically-related study sectionssections

The IRG assignment is based on specific The IRG assignment is based on specific referral guidelines for each IRGreferral guidelines for each IRG

Each of the 20 IRGs within CSR has 5 - 8 Each of the 20 IRGs within CSR has 5 - 8 standing study sectionsstanding study sections

Biological Chemistry and Macromolecular Biophysics

AIDS and Related Research

Cell Biology

Genes, Genomes and Genetics

AIDS and Related Research

Endocrinology, Metabolism, Nutrition and Reproductive Sciences

Immunology

Infectious Diseases and Microbiology

Digestive Sciences

Integrative, Functional and Cognitive Neuroscience

Cardiovascular SciencesBiobehavioral and Behavioral Processes

Brain Disorders and Clinical Neuroscience

Health of the Population

Surgical Sciences, Biomedical Imaging and Bioengineering

Division of Molecular and Cellular Mechanisms

Division of Biologic Basis of Disease

Division of Physiology and Pathology

Division of Clinical and Population-based Studies

Organization Chart of Review DivisionsCenter for Scientific ReviewNational Institutes of Health

Department of Health and Human Services

Bioengineering Sciences and Technologies

Oncological Sciences

Molecular, Cellular and Developmental Neuroscience

Musculoskeletal, Oral and Skin Sciences

Renal and Urological Sciences

Biology of Development and Aging Hematology

Risk, Prevention and Health Behavior

Revised on April 16, 2003.

Respiratory Sciences

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)

The Musculoskeletal, Oral and Skin Sciences [MOSS] IRG will consider research applications The Musculoskeletal, Oral and Skin Sciences [MOSS] IRG will consider research applications that address structural systems that are prerequisite for physical form, mechanical function, that address structural systems that are prerequisite for physical form, mechanical function,

movement, and integrity of the body. These structural systems and their components are movement, and integrity of the body. These structural systems and their components are the basis for the organization of the study sections of this IRG and are described according the basis for the organization of the study sections of this IRG and are described according

to the following topical areas: skeleton, spine, bone, connective tissue, extracellular to the following topical areas: skeleton, spine, bone, connective tissue, extracellular matrix, and their related diseases/disorders; dental/oral and craniofacial and their related matrix, and their related diseases/disorders; dental/oral and craniofacial and their related diseases/disorders; skeletal muscle, limb, and their related diseases/disorders; joints and diseases/disorders; skeletal muscle, limb, and their related diseases/disorders; joints and

their related diseases/disorders, including rheumatic diseases; skin and its related their related diseases/disorders, including rheumatic diseases; skin and its related diseases/disorders. Autoimmune diseases are specifically included. For these topical areas, diseases/disorders. Autoimmune diseases are specifically included. For these topical areas,

the studies considered range from molecular genetics and stem cell research to animal the studies considered range from molecular genetics and stem cell research to animal models and clinical trials. For each major topical area, the research applications may include models and clinical trials. For each major topical area, the research applications may include

studies of: basic biology, including growth, development, maturation, and aging; studies of: basic biology, including growth, development, maturation, and aging; biomaterials for prostheses/orthotics and implants; pathogenesis and therapeutics; physical biomaterials for prostheses/orthotics and implants; pathogenesis and therapeutics; physical

rehabilitation; exercise; mechanobiology/biomechanics; injury and repair, including rehabilitation; exercise; mechanobiology/biomechanics; injury and repair, including adaptation, plasticity, degeneration, and regeneration; diagnostic markers and biomarkers; adaptation, plasticity, degeneration, and regeneration; diagnostic markers and biomarkers;

cell and gene-based therapies; and clinical outcomes and trials.cell and gene-based therapies; and clinical outcomes and trials.

The following Study Sections are included within the MOSS IRG: The following Study Sections are included within the MOSS IRG:

Oral, Dental and Craniofacial Sciences [ODCS]Oral, Dental and Craniofacial Sciences [ODCS]Skeletal Biology Development and Disease [SBDD]Skeletal Biology Development and Disease [SBDD]

Skeletal Biology Structure and Regeneration [SBSR]Skeletal Biology Structure and Regeneration [SBSR]Skeletal Muscle Biology and Exercise Physiology [SMEP]Skeletal Muscle Biology and Exercise Physiology [SMEP]

Musculoskeletal Rehabilitation Sciences [MRS]Musculoskeletal Rehabilitation Sciences [MRS]Arthritis, Connective Tissue, and Skin [ACTS]Arthritis, Connective Tissue, and Skin [ACTS]

General Medicine B Study Section [GMB]General Medicine B Study Section [GMB]Chronic Fatigue Syndrome/ Fibromyalgia Syndrome Special Emphasis Panel [CFS SEP]Chronic Fatigue Syndrome/ Fibromyalgia Syndrome Special Emphasis Panel [CFS SEP]

Urology Study Section [UROL SEP]Urology Study Section [UROL SEP]Bioengineering Research Partnerships/Grants Special Emphasis Panel [SSS-M]Bioengineering Research Partnerships/Grants Special Emphasis Panel [SSS-M]

MOSS Small Business Activities [SBIR/STTR SEPs]MOSS Small Business Activities [SBIR/STTR SEPs]

Musculoskeletal, Oral and Skin Sciences IRG [MOSS]

Assignment to Assignment to InstitutesInstitutes

Applications are referred to an Institute or Applications are referred to an Institute or Center as the potential funding component:Center as the potential funding component:

This assignment is based on a match between This assignment is based on a match between the research proposed and the overall mission the research proposed and the overall mission of the Institute or Centerof the Institute or Center

Where applications are appropriate for more Where applications are appropriate for more than one Institute or Center, multiple than one Institute or Center, multiple assignments are madeassignments are made

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

Selection of Peer Selection of Peer ReviewersReviewers

Non-Doctoral

Scientific Community

Non-Research

ResearchCapability

Active and ProductiveResearchers

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

Review Review Process for a Process for a Research Research Grant Grant ApplicationApplication

Review of Research Review of Research GrantsGrants

REVIEW CRITERIA:REVIEW CRITERIA: Significance Significance ApproachApproach InnovationInnovation InvestigatorInvestigator EnvironmentEnvironment

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

Review Criteria Review Criteria (continued)(continued) Significance: Significance: Does the study address an important Does the study address an important

problem? How will scientific knowledge be advanced?problem? How will scientific knowledge be advanced?

Approach: Approach: Are design and methods well-developed Are design and methods well-developed and appropriate? Are problem areas addressed?and appropriate? Are problem areas addressed?

Innovation: Innovation: Are there novel concepts or approaches? Are there novel concepts or approaches? Are the aims original and innovative?Are the aims original and innovative?

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

Environment: Environment: Does the scientific environment Does the scientific environment contribute to the probability of success? Are there contribute to the probability of success? Are there unique features of the scientific environment?unique features of the scientific environment?

Research Involving Human Research Involving Human SubjectsSubjects

Important Important ConsiderationsConsiderations

Is the proposed study exempt from Is the proposed study exempt from human subject review?human subject review?

Are there any apparent risks* to the Are there any apparent risks* to the human subjects?human subjects?

Are the protections adequate?Are the protections adequate? What are the potential benefits to the What are the potential benefits to the

subjects and to mankind?subjects and to mankind? Are the inclusions of minorities and both Are the inclusions of minorities and both

genders adequately addressed?genders adequately addressed?*”Risks” include the possibility of physical, psychological, or social injury resulting from research.

Research Involving Research Involving ChildrenChildren

Effective for all new applications received Effective for all new applications received after October 1, 1998after October 1, 1998

Child is defined as an individual under age 21Child is defined as an individual under age 21 If children are included, Investigator must If children are included, Investigator must

addressaddress age rangeage range expertise of investigative teamexpertise of investigative team facilitiesfacilities sufficient numberssufficient numbers

Children must be considered for inclusion in all human subject research supported by NIH

Animal WelfareAnimal Welfare Important ConsiderationsImportant Considerations Will the anticipated results be for the Will the anticipated results be for the

good of society?good of society? Will the work be planned and Will the work be planned and

performed by qualified scientists?performed by qualified scientists? Will the animals be treated so as to Will the animals be treated so as to

avoid any unnecessary discomfort, avoid any unnecessary discomfort, pain, anxiety, or poor health?pain, anxiety, or poor health?

Species chosenSpecies chosen Animals in short supplyAnimals in short supply

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

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

Information on the World Wide Information on the World Wide WebWebSelected Sites of InterestSelected Sites of Interest National Institutes of Health (http://www.nih.gov)National Institutes of Health (http://www.nih.gov)

Office of Extramural Research Office of Extramural Research (http://www.nih.gov/grants/oer.htm)(http://www.nih.gov/grants/oer.htm)

Grants Policy Grants Policy (http://www.nih.gov/grants/policy/policy.htm)(http://www.nih.gov/grants/policy/policy.htm)

Center for Scientific Review (http://www.csr.nih.gov)Center for Scientific Review (http://www.csr.nih.gov)

Referral and Review (http://www.csr.nih.gov/refrev.htm)Referral and Review (http://www.csr.nih.gov/refrev.htm) Overview of Peer Review Process (http://www. Overview of Peer Review Process (http://www.

csr.nih.gov/review/peerrev.htm)csr.nih.gov/review/peerrev.htm)

CSR Study Section Rosters CSR Study Section Rosters (http://www.csr.nih.gov/committees/rosterindex.asp)(http://www.csr.nih.gov/committees/rosterindex.asp)

NIH Peer Review Notes NIH Peer Review Notes (http://www.csr.nih.gov/prnotes/prnotes.htm)(http://www.csr.nih.gov/prnotes/prnotes.htm)