NIH Peer Review Process – Grant Renewal

Angela Y Ng, MBA, PhD

Scientific Review and Referral Officer

Center for Scientific Review

NCI DCB New Grantee Workshop

March 18, 2015

National Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National Instituteof Arthritis and

Musculoskeletaland 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 Advancing

Translational Research

National Centerfor Advancing

Translational Research

Clinical Center

Clinical Center

National Institute on Minority Health andHealth Disparities

National Institute 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

NIH Peer Review System for Grant Applications

First Level of ReviewScientific Review Group (Study Section)

Second Level of Review NIH Institute/Center CouncilSecond Level of Review NIH Institute/Center Council

• 86,000 applications received

• 16,000 reviewers

• 237 Scientific Review Officers

• 1,500 review meetings

CSR Peer Review – Fiscal Year 2014

Electronic Application Process

• Register with Grants.gov & eRA Commons

• Submit in response to Funding Opportunity Announcement (FOA)

• Follow Application Guide & Instructions

• Submit via your organizational representative

• Use eRA Commons to view & track

Prepare to Apply & Register

Find Opportunity Prepare Application

Submit, Track & View

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

Help Your Application Get to the Right Study Section

http://ProjectRePORTER.NIH.gov

Match your application to NIH:• Projects: related research on the same scientific topic• FOAs: Funding Opportunity Announcements for the topic area• Institutes: Programs that are funding research in this topic area

Help Your Application Get to the Right Institute

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

• Suggest Institute/Center assignment• Suggest review assignment• Identify individuals in potential conflict and explain why• Identify areas of expertise needed to evaluate the application • Discuss any special situations

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

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

Cover Letter

• Performs administrative review of applications to ensure completeness and accuracy

• Selects reviewers based on broad input

• Manages study section meetings

• Prepares summary statements

Designated Federal Official with overall responsibility for the review process

Role of the Scientific Review Officer

Review Criteria

• Overall Impact –Assessment of the likelihood for the project to exert a

sustained, powerful influence on the research field(s) involved

• Core Review Criteria–Significance–Investigator(s)–Innovation–Approach–Environment

Review criteria each scored from 1-9

9-Point Scoring Scale

Impact Score Descriptor

High Impact

1 Exceptional

2 Outstanding

3 Excellent

Medium Impact

4 Very Good

5 Good

6 Satisfactory

Low Impact

7 Fair

8 Marginal

9 Poor

For Renewal R01 Application

Review includes:

• The application as submitted, including Progress Report ( in “Approach” )& Progress Report Publication List ( Attachment )

Additional Criteria Contribute to Overall Impact Scores

• Protections for human subjects

• Inclusions of women, minorities, and children

• Appropriate use of vertebrate animals

• Management of biohazards

• Resource Sharing Plans: –Data–Model Organisms

− Genomic Data (Human and nonhuman)

• Foreign Organizations• Select Agents• Budget

Other Considerations that Do Not Affect Overall Impact Scores

NIH’s Resubmission Policy

After an unsuccessful new (A0) application or an unsuccessful resubmission (A1) application, you may submit a new (A0) application with the same idea as long as your summary statement has been issued.

NIH Guide Notices• NOT-OD-14-074• NOT-OD-14-082

Resubmission FAQshttp://grants.nih.gov/grants/policy/resubmission_q&a.htm

Your New Application Must Be Written as New

Your new (A0) application should not contain information that might bias the review or provide a competitive advantage:

You Cannot Refer to a Previous Review• No mention of previous score• No mention of previous reviewer comments• No mention of how the A0 is responsive to previous review• No marks in text to indicate changes

You Cannot Submit Elements of a Renewal• No Progress Report• No Progress Report Publication List

NIH Will Not Accept

• An A0 or A1 application that overlaps a funded application• Simultaneous submissions of overlapping applications• An A0 or A1 application before NIH issues the summary

statement of an earlier, overlapping application.

Recent NIH New Policies

• NOT-OD-14-124: Genomic Data Sharing Policy (effective Jan 25, 2015) (NOT-OD-15-027: reminder)

• NOT-OD-15-030: Modification on Marking Changes in Resubmission Applications (effective Dec 4, 2014)

• NOT-OD-15-032: New Biosketch Format Required After May 25, 2015

• NOT-OD-15-039: Late Submission Policy (uniform 2 weeks of consideration for all types of applications; with some RFAs or PARs specific exception in which NOT-OD-11-035 applies)

Insider’s Guide to Peer Review for Applicants: http://www.csr.nih.gov/applicantresources/insider

• Read instructions• Never assume that reviewers will know what you mean• Refer to pertinent literature • Don’t overstate the significance of your research• State rationale of proposed investigation• Include well-designed tables and figures• Present an organized, lucid write-up• Don’t be overly ambitions• Obtain pre-review from colleagues at your organization

When Preparing an Application

• Significance and impact• Exciting ideas• Clarity • Ideas they can understand -- Don’t assume too much• Realistic aims and timelines -- Don’t be overly

ambitious• Brevity with things that everybody knows• Noted limitations of the study• A clean, well-written application

What Reviewers Look for in Applications

Insider’s Guide to Peer Review for Applicants: http://www.csr.nih.gov/applicantresources/insider

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

• NIH Peer Review Revealed

• Jumpstart Your Research Career with CSR’s Early Career Reviewer Program

• NIH Tips for Applicants

• What Happens to Your NIH Grant Application

View the Videos

www.csr.nih.gov/webinar

For Researchers Seeking: • R01 Grants• Fellowship Awards• AREA/R15 Grants• Small Business Grants

Meet the Experts in NIH Peer Review Webinars

Early Career Reviewer Program

• Train and educate qualified scientists to become critical and well-trained reviewers

• Expose investigators to the peer review experience to help make them more competitive as applicants

• Enrich the existing pool of NIH reviewers

Information available at www.csr.nih.gov/ECR