The NIH Peer Review Process

Sally A. Amero, Ph.D.

NIH Review Policy Officer Office of Extramural Research 2010 NIH Regional Seminars

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The NIH Peer Review Process

Two-tiered Process

• • •

Mandated by law

– PHS Health Act

Defined in federal regulation

– 42 CFR 52h

Further defined in NIH policy

•

Per year:

–

Nearly 80,000 applications

–

Over 18,000 reviewers

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The NIH Peer Review Process

• •

Initial peer review

– Recommendations on scientific and technical merit – Scientific Review Groups (SRGs or “Study Sections”) •

Advisory Council or Board

– Recommendations to the ICs on funding, appeals, program priorities – “Council”

Final funding decisions

– IC Director

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The NIH Peer Review Process

Application received – CSR* Assignments made  

Initial peer review Funding considerations

SRG; study section IC or CSR* Scientific Review Officer 

Second level of review

Council or Board (IC)  Institutes or Centers (ICs) Duals possible Program Officer 

Funding decisions

IC Director 

Award!

*

CSR = NIH Center for Scientific Review

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The NIH Peer Review Process

5 Referral to an SRG CSR Review

• Most R01s, fellowships, and small business applications • Some Program Announcements (PAs, PARs) • Some Requests for Applications (RFAs)

Institute/Center Review

• IC-specific features • Program projects • Training grants • Career development awards • RFAs

The review locus is stated in the Funding Opportunity Announcement.

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The NIH Peer Review Process

To Request a Scientific Review Group

•

Cover letter of application

– Application title – FOA # and title – Request:

Not all requests can be honored.

– Assignment to particular SRG or study section – Assignment to particular IC for funding consideration – Disciplines involved, if multidisciplinary – Explanation for late application

SRG rosters are posted 30 days before the SRG meeting:

http://era.nih.gov/roster/index.cfm

http://www.csr.nih.gov/committees/rosterindex.asp

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The NIH Peer Review Process

Scientific Review Officer (SRO)

•

First level of peer review

– Designated Federal Official – Extramural scientist administrator – Identifies and recruits reviewers – Manages conflicts of interest – Oversees arrangements for review meetings – Presides at review committee meetings – Prepares and releases summary statements

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The NIH Peer Review Process

Peer Reviewers

•

Recruitment

– Expertise – Stature in field – Mature judgment – Impartiality – Ability to work well in a group – Managed conflicts of interest – Balanced representation • Gender • Geography • Diversity • Seniority – Availability

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The NIH Peer Review Process

Types of Scientific Review Groups (SRGs)

•

“Chartered” SRGs

– Multiyear terms – Formal appointment process – May include temporary members for special expertise •

Special Emphasis Panels (SEP)

–

Ad hoc

membership – Often meet only once

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The NIH Peer Review Process

Types of Reviewers

•

Regular reviewers – permanent and temporary

– Preliminary impact/priority scores, criterion scores, written critiques – Final impact/priority scores •

Other Contributing Reviewers (“mail” reviewers)

– Written critiques, criterion scores, preliminary impact/priority scores –

Cannot

submit final impact/priority scores

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The NIH Peer Review Process

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 • Suggestions from SRG members • Managing conflicts of interest • Balancing workload

Assignments are confidential!

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The NIH Peer Review Process

Conflicts of Interest (COI)

•

COI between a reviewer and an application:

– Financial – Employment – Personal – Professional – SRG membership – Other interests

Two COI vouchers are submitted by each SRG member.

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The NIH Peer Review Process

Scientific Review Groups (SRGs) 13

•

Make recommendations on merit - not funding!

– Scientific and technical merit – Budget and project duration – Protection of human subjects, inclusion plans, vertebrate animals, biohazards – Resource Sharing Plans – Other administrative factors  

Impact/priority scores Criterion scores



Written critiques

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The NIH Peer Review Process

Confidentiality

• All confidential materials, discussions, documents are deleted, retrieved, or destroyed • Reviewers sent guidance with applications • Application information provided on secure websites or protected portable devices • All questions must be referred to SRO • SRG meetings are closed to the public • Program staff may observe SRG meeting

Do not contact reviewers directly!

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The NIH Peer Review Process

Overall Impact:

Likelihood for the project to exert a sustained, powerful influence on the research field(s) involved

•

In consideration of:

– At least five scored criteria • Receive individual, numerical scores • Additional criteria in certain announcements – Additional review criteria • As applicable for the project proposed • Do not receive individual, numerical scores • Additional criteria in certain announcements

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The NIH Peer Review Process

16 Scored Review Criteria

•

Applications for:

– Research grants – Cooperative agreements •

Other criteria apply to other mechanisms

• • • • •

Significance Investigator(s) Innovation Approach Environment

•

(FOA-specific criteria)

See “Review Criteria at a Glance”

(http://grants.nih.gov/grants/peer/reviewer_guidelines.htm)

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The NIH Peer Review Process

Scored Review Criteria

Does the project address an important problem or a critical barrier to progress in the field?

Significance

If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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The NIH Peer Review Process

Scored Review Criteria

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project?

If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?

If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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The NIH Peer Review Process

Scored Review Criteria

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Innovation

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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Scored Review Criteria

Approach

The NIH Peer Review Process

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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Scored Review Criteria

Approach

The NIH Peer Review Process

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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Scored Review Criteria

Environment

The NIH Peer Review Process

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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The NIH Peer Review Process

Additional Review Criteria 23

As applicable for the project proposed, reviewers: • Consider in determining scientific and technical • merit

Do not

give separate scores for these items.

• • • • • • • •

FOA-specific criteria Protections for Human Subjects Inclusion of Women, Minorities, and Children Vertebrate Animals Resubmission Applications Renewal Applications Revision Applications Biohazards

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The NIH Peer Review Process

Additional Review Considerations

• As applicable for the • project proposed, reviewers: • Address each item

Do not

give scores for these items • S

hould not

consider them in providing an overall impact/priority score.

• • •

FOA-specific considerations Select Agent Research Applications from Foreign Organizations

• •

Resource Sharing Plans Budget and Period Support

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The NIH Peer Review Process

NIH Scoring System

•

Numerical scores

– 1.0 (exceptional) to 9.0 (poor) – Final impact/priority score - average of individual scores x 10 – Individual criterion scores – Ranked by percentile for certain mechanisms – Not Discussed (ND) - streamlining – Other designations (NR, DF, AB, NP, etc.)

Final impact/priority scores range from 10 through 90.

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The NIH Peer Review Process

NIH Scoring System

• •

Preliminary scores

(before the SRG 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 SRG members vote

Reviewers are instructed to revise their criterion scores after the meeting.

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The NIH Peer Review Process

Score Descriptors Impact High Impact Moderate Impact Low Impact Score Descriptor 1 2 Exceptional Outstanding 3 4 Excellent Very Good 5 6 7 8 9 Good Satisfactory Fair Marginal Poor 27 27

The NIH Peer Review Process

Streamlining

•

Allows discussion of more meritorious applications

– Less meritorious applications tabled at the – SRG meeting, designated Not Discussed (ND) – Requires full concurrence of the entire SRG – Summary statement: • Reviewer critiques • Individual criterion scores • No numerical, overall impact/priority score

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The NIH Peer Review Process

Streamlining

•

Score order of review

– SRG discusses most meritorious applications first – Entire SRG decides when to stop, which applications will not be discussed in panel •

Other order of review (e.g., IC assignment, mechanism)

– SRO prepares a list of average preliminary scores – Distributes to SRG – Entire SRG decides which applications to discuss

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The NIH Peer Review Process

Pre-Meeting SRG Procedures

•

SRO

– Performs administrative review of applications – Recruits reviewers, arranges for meeting date and site – Assigns 3 SRG members to each application – Makes applications available to reviewers • Internet Assisted Review (IAR) site or on CDs • Usually about six weeks before the SRG meeting – Instructs reviewers in review procedures – Monitors posting of initial scores and critiques in IAR

Documents for Reviewers are available at:

http://grants.nih.gov/grants/peer/reviewer_guidelines.htm#general_guidelines

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The NIH Peer Review Process

Structured Critiques

•

New summary statement format

– Bulleted comments from reviewers, less text – Criterion scores from assigned reviewers – Decreases variability – Increases quality of information in critiques – More succinct, better organized – Encourages evaluative statements – Ensures that reviewers address all review criteria and considerations

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Critique templates are available at: http://grants.nih.gov/grants/peer/reviewer_guidelines.htm#general_guidelines

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The NIH Peer Review Process

Templates for Reviewers

Links to definitions of review criteria

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The NIH Peer Review Process

Pre-Meeting SRG Procedures

•

Reviewers

– Examine assignments – Submit Conflict of Interest and Confidentiality voucher – Read applications, prepare written critiques in templates – Enter preliminary scores into IAR – Read and consider other critiques and preliminary scores – Make travel and hotel arrangements

Preliminary scores and critiques may be due several days or a week in advance!

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The NIH Peer Review Process

Post-submission Materials

•

Applications submitted for Sept. 25 th , 2010 and later:

– Will only accept administrative materials resulting from unanticipated events, 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) – News of an article accepted for publication •

Special provisions for training grants and certain FOAs 34 34

The NIH Peer Review Process

SRG Meetings

•

Agenda

– Call to Order - Chairperson – Policy and instructions - SRO – Discuss applications one at a time – Where feasible: • In score order • Cluster New Investigator (NI) applications • Cluster clinical applications – Score each application by private ballot after its discussion – Discuss other considerations • Budget • Resource Sharing Plans

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The NIH Peer Review Process

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) re-stated – Individual SRG members vote – Other review considerations discussed (budget)

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The NIH Peer Review Process

SRG Meeting Procedures

•

If 60 applications/SRG meeting

~ 50% streamlined, 30 applications to discuss and score •

If 9 hour SRG meeting

~ ½ hour introduction, streamlining ~ 1 hour lunch, 2 x 15 minute breaks •

Leaves

~ 14 minutes on average/application ~ 3 - 4 minutes/reviewer

Clarity and brevity are essential!

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The NIH Peer Review Process

After the Review

•

eRA Commons

( http://era.nih.gov/commons/index.cfm

) – Final Impact/Priority Score available three days after the SRG meeting – Summary statement available 4 – 8 weeks after meeting • Available also to Program Officers at that time • Confidential document • Available to: – PD/PIs – NIH officials – Advisory Council members

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The NIH Peer Review Process

Summary Statement

•

First page

– NIH Program Officer (upper left corner) • Name • Contact information – Final Impact/Priority Score or other designation – Percentile (if applicable) – Codes • Human subjects • Vertebrate animals • Inclusion plans – Budget request

A favorable score does not guarantee funding!

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The NIH Peer Review Process

•

Summary Statement - continued Subsequent Pages

– Description (provided by applicant) – Resumé and Summary of Discussion (if discussed) – Reviewer critiques – essentially unedited • Follow review criteria for mechanism • Protections for Human Subjects • Inclusion Plans • Vertebrate Animals • Biohazards • Budget – Administrative Notes – Meeting roster

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The NIH Peer Review Process

Appeals Process

•

NIH Program Officer = Point of Contact

– If the outcome is unfavorable, consider your options: • Revise and resubmit application – Consider critiques in summary statement – Address critiques in introduction and text • Appeal the review outcome – Procedural deficiencies – Factual errors – May result in re-review of same application by the same or different SRG

Discuss your options with your Program Officer!

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The NIH Peer Review Process

Appeals Process

•

Unresolved appeals are presented to the IC Council

– Council options: • Support the SRG review • Support the appeal, recommend a re-review – Application could be deferred for next round – Application cannot be modified or updated – Results of a re-review cannot be appealed further – Council cannot overturn the SRG review or impact/priority score

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The NIH Peer Review Process

Advisory Council/Board

•

Second level of review – recommendations on:

– Research priority areas – Policy – Appeals – Funding – Quality of SRG review •

Members

– Scientists from the extramural research community – Public representatives – Appointed to multi-year terms – Appointed as Special Government Employees

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The NIH Peer Review Process

Advisory Council/Board

•

Balanced representation

– Expertise – Stature in field – Mature judgment – Impartiality – Managed conflicts of interest – Balanced representation • Gender, Diversity • Geography, Seniority

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The NIH Peer Review Process

Funding Considerations

•

Authority of the IC Director

– Scientific and technical merit (initial peer review) – Council recommendations – Relevance to program priorities in IC – Compliance with policies – Number of meritorious applications received – Availability of funds – Advice of IC Program Staff

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The NIH Peer Review Process

Additional Information

• Enhancing Peer Review Initiative http://enhancing-peer-review.nih.gov/ • Office of Extramural Research Peer Review Process http://grants.nih.gov/grants/peer_review_process.htm

• Peer Review Policies & Practices http://grants.nih.gov/grants/peer/peer.htm

• Center for Scientific Review http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/

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The NIH Peer Review Process

Contact Information Sally Amero, Ph.D.

NIH Review Policy Officer Extramural Research Integrity Liaison Officer Office of Extramural Programs Office of Extramural Research National Institutes of Health [email protected]

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