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The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated Review Group National Cancer Institute-NCI New Grantee Workshop Bethesda, MD October 18, 2010 National Institutes of Health U.S. Department of Health and Human Services

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Page 1: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

The Grant Renewal Review Process

Nywana Sizemore, PhD

Scientific Review Officer

Molecular Oncogenesis - MONC

Oncology I - Basic Translational - OBT

Integrated Review Group

National Cancer Institute-NCI New Grantee Workshop

Bethesda, MD

October 18, 2010

National Institutes of HealthU.S. Department of Health and Human Services

Page 2: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

National Institutes of Health

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

Page 3: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

National Institutes of Health

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 Instituteon Drug Abuse

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteon Aging

Eunice KennedyShriver National Institute

of Child Health andHuman Development

Eunice KennedyShriver National Institute

of Child Health andHuman Development

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 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 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

John E. FogartyInternational

Center

John E. FogartyInternational

Center

National Centerfor ResearchResources

National Centerfor ResearchResources

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

Office of the DirectorOffice of the Director

Center for InformationTechnology

Center for InformationTechnology

National Heart,Lung, and Blood

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Dental andCraniofacial

Research

National Instituteof Dental andCraniofacial

Research

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

Page 4: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

• Receives all NIH applications

• Refers them to NIH Institutes/Centers and to scientific review groups

• Reviews majority of grant applications for scientific merit

Your Application Goes to the NIH Center for Scientific Review (CSR)

Focal Point for Initial Review at NIH

Page 5: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

CSR Mission Statement

To see that NIH grant applications receive fair, independent, expert, and timely reviews – free from inappropriate influences – so NIH can fund the most promising research.

Page 6: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

First Level of Review

CSR or Institute Review

Scientific Review Group

(Study Section)

First Level of Review

CSR or Institute Review

Scientific Review Group

(Study Section)

Second Level of Review NIH Institute/Center Council

Second Level of Review NIH Institute/Center Council

Scientific Review Process

Dual Review System for Grant Applications

Page 7: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

National Institutes of Health

Center for Scientific Review

Study Section

Institute

Advisory Councils and Boards

Institute Director

Assigns to IC & IRG/Study Section

Reviews for Scientific Merit

Evaluates for Relevance

Recommends Action

Takes Final Action

ResearchGrant Application

School or OtherResearch Center

InitiatesResearch Idea

ConductsResearch

Allocates Funds

Submits Application

Review Process for a Research Grant

Page 8: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul

Cycle 1

Receipt

Referral

CouncilReview

Award

Cycle 2

Receipt

Referral

CouncilReview

Award

Cycle 3

Receipt

Referral

CouncilReview

Award

There are three overlapping cycles per year

Overall Timeframe from Submission to Award

Page 9: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Divisions and Integrated Review Groups (IRGs)

Translational and Clinical Sciences

Cardiovascular and Respiratory Sciences

Surgical Sciences, Biomedical

Imaging and Bioengineering

Musculoskeletal, Oral & Skin Sciences

Oncology 2: Translational Clinical

Vascular and Hematology

Physiological and Pathological Sciences

Endocrinology, Metabolism, Nutrition & Reproductive Sciences

Immunology

Infectious Diseases& Microbiology

Digestive, Kidney &Urological Systems

Neuroscience, Development and Aging

Brain Disorders &Clinical Neuroscience

Molecular, Cellular &Developmental Neuroscience

Integrative, Functional & Cognitive Neuroscience

Emerging Technologies &Training in Neuroscience

Biology of Development & Aging

Biobehavioral & Behavioral Processes

Risk, Prevention & Health Behavior

Population Sciences & Epidemiology

Healthcare Delivery & Methodologies

AIDS & AIDSRelated Research

AIDS, Behavioral and Population Sciences

Basic and Integrative Biological Sciences

Biological Chemistry & Macromolecular

Biophysics

Bioengineering Sciences& Technologies

Genes, Genomes & Genetics

Oncology 1: Basic Translational

Cell Biology

Interdisciplinary Molecular Sciences

& Training

Page 10: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Integrated Review Groups

Biological Chemistry & Macromolecular Biophysics

Bioengineering Sciences & Technologies

Oncology 1: Basic Translational

Cell Biology

Genes, Genomes & Genetics

Interdisciplinary Molecular Sciences & Training

Division of Basic and Integrative Biological Sciences

Cancer Molecular Pathobiology (CAMP)

Cancer Etiology (CE)

Cancer Genetics (CG)

Molecular Oncogenesis (MONC)

Tumor Cell Biology (TCB)

Tumor Microenvironment (TME)

Tumor Progression & Metastasis (TPM)

CSR Study Sections

Page 11: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Referral Officers

Professional scientists, most of whom also serve as scientific review officers of CSR study sections

Applications Are Assigned by:

Page 12: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

• Institutes or Centers based on─Overall mission and guidelines of the Institute or Center

Specific programmatic mandates and interests of the Institute or Center

• Integrated Review Groups based on─Specific review guidelines for each Integrated Review Group (IRG)

Applications Are Assigned to:

Page 13: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Get Your Application to the Right Study Section!

• Review CSR Integrated Review Group and Scientific Review Group (Study Section) guidelines to identify a home for your application.

• Submit a Cover Letter!

Page 14: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Help Your Application Get to the Right Study Section

http://www.csr.nih.gov/

Page 15: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Cover Letter

The cover letter should be used for a number of important purposes:

•Suggest Institute/Center assignment

•Suggest review assignment

•Identify individuals in conflict

•Identify areas of expertise needed to evaluate the application

•Discuss any special situations

•Required for an electronic changed/corrected submission

It is NOT appropriate to use the cover letter to suggest specific reviewers.

Page 16: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Please assign this Phase I SBIR “Drugs for Retinoblastoma Treatment” to the following:

Institutes/Centers

National Cancer Institute – NCI

National Eye Institute – NEI

Scientific Review Group

Oncology Translational and Clinical IRG - OTC

Please do not assign this application to the following:

Scientific Review Group

Biological Chemistry and Macromolecular

Biophysics - BCMB

This study focuses on a new in vitro model for testing drugs for treatment of retinoblastoma, not the synthesis of new chemotherapeutic agents.

Sample Cover Letter

Page 17: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Peer Review in CSR

• CSR Study Sections are managed by a Scientific Review Officer (SRO) who is a doctoral-level professional, whose scientific background is close to the focus of the study section.

• Each CSR standing study section has 12-25 regular members who are primarily from academia.

• About 60-100 applications are normally reviewed at each study section meeting.

Page 18: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Role of the Scientific Review Officer

• Performs administrative and technical review of applications to ensure completeness and accuracy

• Selects reviewers based on broad input

• Manages study section meetings

• Prepares summary statements

• Provides any requested information about study section recommendations to Institutes/Centers and National Advisory Councils/Boards

Designated Federal Official with overall responsibility for the review process

Page 19: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Enhancing Peer Review Overview and Timeline

January 2009 May/June 2009

ReviewsJanuary 25, 2010

Submissions

• Phase out A2 resubmission of applications

• Identification of Early Stage Investigator (ESI) R01 applications

• Enhanced review criteria

• New 9-point scoring system

• Criterion scoring

• Structured critiques

• Score order review

• Clustering of New Investigator (NI) R01 & clinical applications

• Discussed/Not-discussed Applications

• Restructured applications to align with review criteria

• Shortened page limits and new instructions

Page 20: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Where Do We Find Reviewers?

• CSR Registry for Volunteer Reviewers?

• Successful applicants

• Recommendations from reviewers and NIH staff

• NIH RePORTER (http://projectreporter.nih.gov/reporter.cfm)

• Internet

• Scientific conferences

Page 21: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

How Reviewers Are Selected for Study Section Service

• Demonstrated scientific expertise/research support

• Doctoral degree or equivalent

• Mature judgment

• Work effectively in a group context

• Breadth of perspective

• Impartiality

• Representation of women and minority scientists

• Geographic distribution

Page 22: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Before the Study Section Meeting

• Each application is assigned to 3 or more reviewers 5-6 weeks in advance

• Reviewer assess each application by providing: A preliminary Overall Impact score Criterion Scores for each of the 5 Core Review Criteria using the 1 - 9 scaleA written critique

Page 23: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

At The Meeting • Order of Review

– The average of the preliminary Overall Impact score from the assigned reviewers determines the review order

– Discussions start with the application with the best average preliminary Overall Impact score

• Clustering of Review– New Investigator R01 applications are clustered– Clinical applications & other mechanisms may be clustered

(n ≥ 20)

• Not Discussed Applicationso About 50% applications will be discussedo Applications unanimously judged by the review committee to

be less competitive are not discussed.

Page 24: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Scoring

• Score applications on five review criteria using a scale of 1-9

• Preliminary overall impact/priority score using 1-9 scale

• Discussed applications receive an overall score from each eligible (i.e., without conflicts of interest) panel member, and these scores will be averaged to one decimal place, and multiplied by 10. The 81 possible priority scores will thus range from 10-90.

• All applications will receive scores:

Not discussed applications will receive initial criterion scores from the three assigned reviewers.

Page 25: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

• Scores for each review criterion

• Critiques from assigned reviewers

• Administrative notes if any

If your application is discussed, you also will receive:

• An overall impact/priority score and percentile ranking

• A summary of review discussion

• Budget recommendations

Your Summary Statement

Page 26: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Summary Statement

New Indicator for Early Stage Investigators

Percentile: 29 Percentile in whole numbers

Impact/Priority Score in 10-90

range

Page 27: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

A Window to Your Application: eRA Commons

eRA Commons is an online interface where a grant applicant can:

•Check submitted grant application for errors and warnings and view final image•Track review assignment, view review outcomes (score, summary statements), find contact info•Update Personal Profile to ensure Early Stage Investigator eligibility is in place•Submit pre-award information (just in time)•View Notice of Award and other key documents

And much more! https://commons.era.nih.gov/commons/

Page 28: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Check the Status of Your Application in NIH Commons

Summary Statement

Additions for Review

Page 29: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Preparing an Application

• Register with

Grants.gov & eRA

Commons

• Submit in response to

PA

• Follow Application Guide & Instruction

s

• Submit via your

organizational

representative

• Use error correction

window• Use eRA

Commons to track

Prepare to Apply & Register

Find Opportunity

Prepare Application

Submit, Track & View

Electronic Application Process

Page 30: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Who Can Answer Your Questions?

Before You Submit Your Application

• A Program Officer at an NIH Institute or Center• Scientific Review Officer

After You Submit

• Your Scientific Review Officer

After Your Review

• Your Assigned Program Officer

GrantsInfo: [email protected] – 301 435-0714

Page 31: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

View the Videos

• NIH Peer Review Revealed

• NIH Tips for Applicants

http://www.csr.nih.gov/video/video.asp

Page 32: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

• About CSRAbout CSR

• News and ReportsNews and Reports

• Peer Review Meetings

• Resources for Applicants Resources for Applicants

CSR Web Site: http://www.csr.nih.gov

Page 33: The Grant Renewal Review Process Nywana Sizemore, PhD Scientific Review Officer Molecular Oncogenesis - MONC Oncology I - Basic Translational - OBT Integrated

Key NIH Review and Grants Web Sites

NIH Center for Scientific Review

http://www.csr.nih.gov

NIH Office of Extramural Research

http://grants.nih.gov/