Rebecca Wagenaar-Miller, PhD Scientific Review Officer National Institute of Dental and Craniofacial...

Rebecca Wagenaar-Miller, PhDScientific Review Officer

National Institute of Dental and Craniofacial Research

NIH

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PhD Vanderbilt University Department of Cancer Biology (2002) Matrix Metalloproteinase-7 in Mouse Models of

Intestinal Tumorigenesis Vanderbilt University Postdoctoral

Fellow (2002-2003) MMP-7 in pre-clinical model of colorectal cancer

NIH, NIDCR Postdoctoral Fellow (2003-2007) Type II transmembrane serine proteases MMP-mediated and uPARAP-mediated collagen

degradation in development Scientific Review Officer (SRO), NIDCR,

NIH (2007-present)

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Give a brief look into the NIH peer review process

Update you on changes in NIH peer review Discuss strategies for a successful

application Provide a few resources

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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

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To ensure that grant applications and contract proposals are evaluated by qualified scientific peers in a fair, objective, and timely manner.

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Conducted according to the Federal Advisory Committee Act

o Meetings are closed to the public

o All materials and discussions – strictly confidential

Over 80,000 applications reviewed per year

Almost 18,000 reviewers

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80% of applications are reviewed by CSR in Scientific Review Groups (SRGs) that are part of Integrated Review Groups (IRGs)

The rest are reviewed by individual ICso Requests for Applications (RFAs)o Program Announcements with IC

Review (PARs)o Training Applications (F, K’s)o ‘Complex’ Applications (P, U’s,

Clinical Trials)o Contract Proposals

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The legal summary of the review meeting

Includes all three reviewer critiques, largely unedited

Includes a resume, which is a summary of the discussion of the meeting, focusing on the major strengths and weaknesses that resulted in the overall impact score

Used by council, applicants, program staff

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Applications Arrive

Peer Review Meeting

Summary Statement Council

One month

2-6 weeks

2-3 months

Pre-application

Programand GM

Peer Review Council

Award and Post Award

Program Scientific Review Officer

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To Request a Scientific Review Group Cover letter of application

o Application titleo FOA# and titleo Request:– Assignment to particular SRG or study section–Assignment to particular IC for funding consideration– Disciplines involved, if multidisciplinary– Explanation for late application

Not all requestscan be honored.

SRG rosters are posted 30 days before the SRG meeting:http://era.nih.gov/roster/index.cfmhttp://www.csr.nih.gov/committees/rosterindex.asp

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Reviewer Assignments• For each application: – ≥ Three qualified reviewers are assigned (“2 + 1”)– Assignments are made by the SRO • Based on the scientific content of application• Expertise of the reviewer• Suggestions from the PI on types of expertise –

not names!• Suggestions from Program staff

Assignments areconfidential!

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Impact Score Descriptor Additional Guidance on Strengths and Weaknesses

High Impact

1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with only negligible weaknesses

3 Excellent Very strong with only some minor weaknesses

Moderate Impact

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weaknesses

Low Impact

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

Non-numeric score options:  NR = Not Recommended for Further Consideration, DF = Deferred, AB = Abstention, CF = Conflict, NP = Not Present, ND=Not Discussed

•Minor Weakness: An easily addressable weakness that does not substantially lessen impact•Moderate Weakness: A weakness that lessens impact•Major Weakness: A weakness that severely limits impact

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NIH Scoring System Preliminary scores (before the meeting)– Entered by assigned reviewers and discussants in secure website– Made available to other SRG members

Final overall impact/priority scores (at the SRG meeting)– Voted by private ballot– All eligible members vote Reviewers are instructed to revise their criterion scores after the meeting.

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Post-submission Materials Applications submitted for Sept. 25th, 2010 and later:– Will only accept administrative materials resulting from

unforeseen administrative issues, such as– Revised budget page(s) (e.g., due to new funding)– Biographical sketches (e.g., due to the loss of an

investigator)– Letters of support or collaboration (e.g., due to the

loss of an investigator)– Adjustment resulting from natural disaster (e.g., loss of

animal colony)– Adjustments resulting from change of institution (e.g.,

PI moves to another university)– News of an article accepted for publication (do not

sent article) Special provisions for training grants and certain

FOAs Notice OD-10-11518

SRG Meeting Procedures Discussion format –Members with conflicts excused – Initial levels of enthusiasm stated(assigned

reviewers and discussants)– Primary reviewer - explains project, strengths,

weaknesses–Other assigned reviewers and discussants

follow–Open discussion (full panel)– Levels of enthusiasm (assigned reviewers)

restated– Individual SRG members vote–Other review considerations discussed

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NEW Sections OLD Sections

INTRODUCTION-Revision (1 page) INTRODUCTION-Resubmission (3 pages)

SPECIFIC AIMS (1 page) SPECIFIC AIMS (1 page)

RESEARCH STRATEGY (R01-12 PAGES)

R01 25 pages

Significance Background and Significance

Innovation

Approach- Research Design and Methods

-(preliminary studies-part of approach)

Preliminary Studies

-(progress report-part of approach) Progress report

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Impact Score

Do not Impact Score

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Research Project Grant (RPG): likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the five core review criteria, and additional review criteria

Fellowship (F): likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria

Career Development (K): likelihood for the candidate to maintain a strong research program, taking into consideration the criteria in determining the overall impact/priority score

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Background:o Concern about the number of New Investigators

(NI) and the increasing age at first award

Goals: o Enrich the applicant pool with enough Early

Stage Investigator (ESIs) to reduce the average age at first award

o Accelerate the period of training leading to independence

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NIH created a new ‘Early Stage Investigator’ (ESI) category designed to accelerate the early transition of new scientists to research independence by receiving their first R01 earlier. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html

A PD/PI who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). 

NOT-OD-08-121 September 26, 2008

New Investigator Policies are limited to applications for traditional research project grant (R01) support.

All New Investigators are encouraged to apply for NIH R01 awards.

During Peer Review:o NI/ESI applications will be clustered during

reviewo Consider the career stage of the PD/PI when

evaluating elements of the applications, such as the availability of preliminary data

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The NIH modified the collection of information on degree dates and medical residency within the personal profile of the eRA Commons.

PD/PIs must update their personal profile in the eRA Commons in order to be considered for the ESI classification.  Investigators who enter degree and residency completion dates will be notified of their ESI status by email.

A procedure and guidelines for requesting an extension of the period of ESI eligibility is in place to accommodate individuals with various medical concerns, disability, pressing family care responsibilities, or active duty military service (instructions in Commons).

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NOT-OD-10-039,January 8, 2010

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-039.html

Over the past three years, about 25 percent of all competing R01 awards have gone to New Investigators

Continue to equilibrate success rates for established and New Investigators submitting new R01 applications

Should permit the NIH to support 1,650 or more New Investigators

A majority of the New Investigators will be Early Stage Investigators

http://grants.nih.gov/grants/oer.htm

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Start early Start with a good idea Talk to your NIH Program Official(s) Remember review criteria Show you draft application to colleagues

o who do not already know what you intend to do

o who are not your best friend

o who has/had the same type of grant

Follow instructions carefully

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Propose experiments that take advantage of o YOUR trainingo YOUR expertiseo YOUR environment

Don't say that you're going to learn a sophisticated new technique and then apply it in later yearso If you need a collaborator(s), get a strong one

who publishes in peer-reviewed journals and who has a grant

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A major problem with applications from first time investigators is being overly ambitious.

Focus Focus Focus Did I remember to say “Focus”?

o Be certain every aim and experiment is clearly related to the overall goal of the application.

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grants1.nih.gov/grants/guide/listserv.htm

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Late submission policy for NIH study section service for any PI/PD of grant application (NOT-OD-08-027)o Standard receipt dates (1 or 2 weeks late)o “Late applications have been accepted for reasons such

as…temporary or ad hoc service on a NIH extramural peer review group”

o “No NIH staff member whether in the Center for Scientific Review or any of the other Institutes/Centers has the authority to give permission in advance for a late application.”

Cover letter importanto Identify study sectiono Identify areas of expertise neededo Can list conflicts that should not review application (but

be prepared to justify) Submit to R01 to take advantage of NI/ESI mandate Submit to RFAs if possible… free review of

application

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A Searchable database of federally supported biomedical research

Access reports, data, analyses, expenditures, results of NIH supported research activities

Identify, Analyze IC(s) research portfolios, funding patterns, funded investigators:o Identify areas with many or few funded projectso Identify NIH-funded investigators and their

researcho Identify potential mentors/collaborators

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NIH Guide: http://grants.nih.gov/grants/guide/ NIH Office of Extramural Research

http://grants.nih.gov/grants/oer.htm NIAID “how to” website for developing a grant application:

http://www.niaid.nih.gov/ncn/grants/default.htm Writing a Grant: A Technical Checklist from NINDS:

http://www.ninds.nih.gov/funding/grantsmanship_checklist.htm

 NIH RePorter: database of all funded grants including abstracts, funding amounts, study section, PI, and much more info: http://projectreporter.nih.gov/reporter.cfm

NIH Peer Review Policies and Practices http://grants.nih.gov/grants/peer/peer.htm

Changes to Peer Review (and applications) http://enhancing-peer-review.nih.gov/docs/application_changes.pdf

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