The NIH Peer Review Process

and Grant Writing

Denise Wiesch, Ph.D.

Scientific Review Administrator

Epidemiology of Cancer SRG

Health of the Population IRG

Center for Scientific Review

NIH/DHHS

Outline• NIH Infrastructure

• From Submission to Funding– Electronic submission

• Grant Mechanisms

• Reviewers

• Study Section Meeting

• Role of NIH Program vs. Review staff

• NIH Advisory Councils

• Grant Writing

NIHThe Big Picture

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)

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

NIH Extramural Awarding Components

• National Cancer Institute (NCI)• National Heart, Lung, and Blood Institute (NHLBI)• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)• National Library of Medicine (NLM)• National Institute of Child Health and Human Development (NICHD)• National Institute of Deafness and Other Communication Disorders (NIDCD)• National Institute of Environmental Health Sciences (NIEHS)• National Institute of Neurological Disorders and Stroke (NINDS)• National Institute on Aging (NIA)• National Institute of Allergy and Infectious Diseases (NIAID)• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)• National Institute of Dental and Craniofacial Research (NIDCR)• National Eye Institute (NEI)• National Institute of General Medical Sciences (NIGMS)• National Institute of Mental Health (NIMH)• National Institute for Nursing Research (NINR)• National Institute on Alcohol Abuse and Alcoholism (NIAAA)• National Institute on Drug Abuse (NIDA)• National Center for Complementary and Alternative Medicine (NCCAM)• National Center for Research Resources (NCRR)• National Human Genome Research Institute (NHGRI)• National Institute of Biomedical Imaging and Bioengineering (NIBIB)• Fogarty International Center (FIC) • National Center on Minority Health and Health Disparities (NCMHD)

A Typical Institute/Center

Office of the ICOffice of the ICDirectorDirector

NationalNationalAdvisoryAdvisoryCouncilCouncil

Board ofBoard ofScientificScientific

CounselorsCounselors

ExtramuralExtramural

ScientificScientificProgramsPrograms

GrantsGrants ContractsContracts

IntramuralIntramural

LaboratoryLaboratoryStudiesStudies

ClinicalClinicalStudiesStudies

16% NIH In-House6,000 Scientists6,000 Scientists

TOTAL BUDGET$28.8 Billion

Spending Outside NIH

$24.1

Spending at NIH

$4.7

84% Outside NIH- Supports over 212,000 212,000 Scientists & Other Scientists & Other PersonnelPersonnel- Supports over 3,000 Institutions Nationwide

FY 2005 NIH Funding (dollars in billions)

NIH Funding in FY 2004: By MechanismTotal = $27B

Research Project Grants54%

Research Centers9%

Other Research Grants6%

Research Training3%

R&D Contracts10%

Research Management4%

Nat. Lib. Of Medicine1%

Cancer Prev. & Control

2%

Construction & Facilities

1%

Intramural Research10%

NIH Referral and Review Process

CSR

Review

NIGMS NIANIAAA

NEINIAMS

NIMHNHLBI

NCHGRNICHDNIDDK

Referral

FIC NIDA

Funding Decisions

Scientific Management

Program and Policy Considerations

NCCAMNCRR

NLMNIDCD

NIEHS

NINR

NIDCRNIAID

NINDS

Receipt of Grant Applications at CSR

CSR ReferralApplications Are Assigned to:

• Scientific Review Groups based on:

–Specific referral guidelines for each

scientific review group

• NIH Institutes or Centers based on:

–Overall mission of the Institute or Center

–Specific programmatic mandates and

interests of the Institute or Center

Number of Applications Reviewed by NIH

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

2000 2001 2002 2003 2004 2005

# o

f A

pp

licat

ion

s

Institute reviewCSR review

Where are Applications Reviewed?

• CSR– Research Projects – Academic Research

Enhancement Awards– SBIR & STTR– Shared Instrumentation

– Career Awards– Small Grants– Fellowships– RFAs

• Institutes/Centers– Contracts– Program Projects (most)– Institutional Training Grants– Conference Grants– Centers

– Career Awards– Small Grants– Fellowships– RFAs

CSR Review Divisions

Division of Biologic Basis of DiseaseElliot Postow, Ph.D.

ImmunologyIRG (IMM)

Calbert Laing, Ph.D.

AIDS and RelatedResearch IRG (AARR)

Ranga V. Srinivas, Ph.D.

Oncological SciencesIRG (ONC)

Syed Quadri, Ph.D.

Endocrinology, Metabolism, Nutrition and Reproductive

Sciences IRG (EMNR)Sooja Kim, Ph.D.

Infectious Diseases andMicrobiology IRG (IDM)

Alex Politis, Ph.D.

Division of Physiology and Pathology

Michael Martin, Ph.D.

Cardiovascular SciencesIRG (CVS)

Joyce Gibson, D.Sc.

Integrative, Functionaland Cognitive Neuroscience

IRG (IFCN)Christine Melchior, Ph.D.

Renal and Urological Sciences IRG (RUS)

Daniel McDonald, Ph.D.

HematologyIRG (HEME)

Joyce Gibson, D.Sc.

Digestive Sciences IRG (DIG)

Mushtaq Khan, Ph.D.

Division of Clinical andPopulation-Based Studies

Anita Miller Sostek, Ph.D

Surgical Sciences, Biomedical Imaging and Bioengineering

IRG (SBIB)Eileen Bradley, D. Sc.

Health of the Population IRG (HOP)

Robert Weller, Ph.D.

Risk, Prevention, and HealthBehavior IRG (RPHB)Michael Micklin, Ph.D.

Brain Disorders and ClinicalNeuroscience IRG (BDCN)

David Armstrong, Ph.D.

Behavioral & BiobehavioralProcesses IRG (BBBP)Karen Sirocco, Ph.D.

Division of Molecular and Cellular MechanismsDonald Schneider, Ph.D.

Bioengineering Sciences and

Technologies IRG (BST)Sally Amero, Ph.D.

Biology of Development and

and Aging IRG (BDA)Sherry Dupere, Ph.D.

Biological Chemistry and Macromolecular

Biophysics IRG (BCMB)John Bowers, Ph.D.

Cell Biology IRG (CB)Marcia Steinberg, Ph.D.

Genes, Genomes and Genetics IRG (GGG)

Richard Panniers, Ph.D

Molecular, Cellular and Developmental

Neuroscience IRG (MDCN)Carole Jelsema, Ph.D.

Respiratory Sciences IRG (RES)

Mushtaq Khan, Ph.D.

Musculoskeletal, Oral, and Skin Sciences IRG (MOSS)

Daniel McDonald, Ph.D.

Division of Clinical &Population-Based Studies

Surgical Sciences, Biomedical Imaging & Bioengineering

Health of the Population

Risk, Prevention & HealthBehavior

Brain Disorders & Clinical

Neuroscience

Behavioral & BiobehavioralProcesses

Health of the Population (HOP) IRG

Community-Level Health Promotion

Behavioral Genetics and Epidemiology

Social Sciences and Population Studies

Health Services Organization and Delivery

Biostatistical Methods and Research Development

Epidemiology of Cancer

Kidney, Nutrition, Obesity, & Diabetes Epi

Infectious Diseases, Reproductive Health, Asthma and Pulmonary Epidemiology

Nursing Science: Children & Families

Nursing Science: Adults & Older Adults

Community Influences on Health Behavior

Cardiovascular and Sleep Epidemiology

Neurological, Aging and Musculoskeletal Epi

From Submission to Funding

From Submission to Funding: THE PROCESS FOR A RESEARCH GRANT

Principal

InvestigatorSchool or OtherResearch Center

NIH

InitiatesResearch Idea

Conducts Research

Submitsapplication

AllocatesFunds

Center for Scientific Review

Review Group Institute

Advisory Council or Board

Institute Director

Assign to IRG and IC

Review for scientific merit

Evaluate for relevance

Recommend Action

Timeline for Submission to Potential Award

New RO1 Application

Feb. 1

SendAppl. toCSRNew

March 15

AssignmentNotificationSent to PI

May 10

Mail toReviewers

June 24-25

StudySectionMeeting

July 8

ReviewNotificationSent

August 1

SummaryStatementSent

September

CouncilMeets

Dec. 1

EarliestAwardDate

Revised/Competing Continuation/ Supplemental RO1 Application

March 1

SendAppl. ToCSRRevised orContinuation

April 15

AssignmentNotificationSent to PI

May 10

Mail toReviewers

June 24-25

StudySectionMeeting

July 8

ReviewNotificationSent

August 1

SummaryStatementReleased

September

CouncilMeets

Dec. 1

EarliestAwardDate

Who / What Determines which Study Section Reviews your Application?

• Principal Investigator Letter attached to application; self-referral

• Grant Mechanism

• CSR Referral Staff – determine broad scientific area Scientists, most of whom also serve as Scientific Review Administrators (SRAs) of CSR Study Sections.

• Initial Review Group (IRG) Chiefs and SRAs

IRGs: Clusters of scientifically related study sections IRG Chiefs are also SRAs with own Study Section(s)

• Past review history (if any) of application

Cover Letter• Request study section (optional)

– Be familiar with the study sections and what they review

– CSR website with study section descriptions and rosters

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

– Ask peers

– Contact SRA

– Do not recommend specific reviewers (expertise required

is OK).

• Request an NIH Institute (optional)

Assignment Notification

• Study Section or Special Emphasis Panel

• Scientific Review Administrator– Address, telephone number, etc.

• Institute Assignment– Primary and any dual

– General contact number

• Unique Identifier (1 R01 CA123456-01 A1)

• Request change if assignment is wrong – Contact SRA if assigned to the wrong study section

– Contact Referral office if grant # is wrong (is it really a new application or competing continuation). Is the NIH Institute assignment correct.

– more efficient to include a request in cover letter at submission.

Sample Application Number

Individual Serial Amended Research Number Grant

1 R01 CA 123456 01 A1

New National GrantApplication Cancer Support Institute Year

• Jan 10, May 10, Sept. 10: – Institutional Training Grant Applications

• Feb 25, June 25, Oct 25:– Academic Research Enhancement awards

• Feb 1, June 1, Oct 1:– New Research Grant Applications

• Mar 1, July 1, Nov 1:– Revised, Competing Continuations, Supplemental

• April 1, Aug 1, Dec 1:– Small Business (sbir/sttr)

• April 5, Aug 5, Dec 5:– Fellowship applications

• May 1, Sept 1, Jan 1:– AIDS applications

Receipt DatesDepend on the Type of Application

Electronic Grant Submission!• Soon will be REQUIRED

• Phased in dates by grant mechanism

• Grant opportunities will be posted on Grants.gov

– download and begin working on application package after grant mechanism transition - SF424(R&R) form

• Until a grant mechanism is transitioned - submit on paper PHS 398 forms.

• As mechanisms are transitioned, Funding Opportunity Announcements (PAs, RFAs etc.) will be issued in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/pa-files/) and posted in Grants.gov.

GRANT TYPE Submission DATE

Small Business (SBIR/STTR)R41, R42,

R43, R44

Dec. 1 ‘05

Conferences & Scientific Meetings R13 Dec.15 ‘05

Academic Research Enhancement Award (AREA) R15 Feb. 25 ‘06

Small Grant Programs; Exploratory/Developmental Research Grant Awards

R03, R21 June 1 ‘06

Research Project Grant Program R01 Oct. 1 ‘06

Remaining grant mechanisms   May 2007

Electronic Submission Transition Dates

Where to go for Help• General information on Electronic Submission and the SF424 (R&R):

– http://era.nih.gov/ElectronicReceipt

• Forms transition and questions on NIH’s overall plan for electronic receipt– NIH GrantsInfo.gov

• E-mail: grantsinfo@nih.gov• Phone: 301-435-0714

• eRA Commons registration and post submission questions on Commons functionality– Support Page: http://era.nih.gov/commons/index.cfm – Help Desk

• E-mail: commons@od.nih.gov • Phone: 1-866-504-9552 OR 301-402-7469

• Grants.gov registration and submission questions– Visit: http://www.grants.gov/CustomerSupport– Grants.gov Customer Service

• E-mail: support@grants.gov • Phone: 1-800-518-4726

Grant Mechanisms

Unsolicited vs. Solicited Applications• Unsolicited R01s – Investigator initiated

• Program Announcement (PA): – Funding announcement for grants relating to areas of increased priority and/or emphasis on particular funding

mechanisms for a specific area of science. Applications are usually accepted on standard receipt dates on an on-going basis.

• PAR:– A PA for which special referral guidelines apply (usually special receipt date), as described in the PAR

announcement.

• PAS:– A PA that includes specific set-aside funds, as described in the PAS announcement.

• Request for Applications (RFA): – Funding announcement for grants that identifies a more narrowly defined area for which one or more NIH institutes

have set aside funds for awarding grants. An RFA usually has a single receipt date, as specified in RFA announcement.

• Request for Proposals (RFP): – Solicits contract proposals. An RFP usually has one receipt date, as specified in RFP solicitation.

• Request for Applications (RFAs)

• PARs (program announcements with special receipt dates)

• Success Rates

R01• Can submit without PA etc.

• Need preliminary/pilot data

• Up to 5 years of funding

• Need to obtain approval from program staff prior to submission of proposal costing $500,000 or more in direct costs in any one year

• R21 - Exploratory/Developmental Grants

– Feasibility/New Technology/ Innovative High Risk

– Pilot studies

– Preliminary data for a R01

– 2 years with a maximum of $275K total

– Need Program Announcement specific to appropriate

funding Institute

Mechanisms for Preliminary Studies

Mechanisms for Preliminary Studies

• R03: Small Grants –Feasibility (for those without preliminary

data)

–Development of pilot / preliminary data

–2 years with a maximum of $50,000 per year

–Need Program Announcement specific to

appropriate funding Institute

Other Grant Mechanisms

• Grant mechanisms supported by different NIH

Institutes:

http://grants.nih.gov/grants/guide/notice-files/

not94-003.html

• General information about different grant

mechanisms:

http://grants2.nih.gov/grants/funding/phs398/

instructions2/p3_general_info_mechanisms.htm

for Grants

NIH GUIDE and ContractsU.S. Department of Health and Human Services

• Announces NIH Scientific Initiatives

• Provides NIH Policy and Administrative Information

• Available on the NIH Web Site http://grants1.nih.gov/grants/guide/index.html

(can search for grant mechanism and specific NIH Institute using ‘Advance Search’)

Reviewers

Criteria for Selection of Peer Reviewers

Scientific Community Active and Productive Researchers

Non-Doctoral

Non-Research

Active & Productive Researchers

Research Capability

Doctoral or Equivalent

DegreeInterest

in Serving

Expertise in Discipline of Review Group and

Specialization Needed

Meet Internal Administrative Considerations

•Geography•Institutional

 Affiliation

  •Gender &

EthnicStatus

Criteria for Selection of Peer Reviewers

• Active and productive researchers

• Demonstrated scientific expertise

• Mature and impartial judgment

• Work effectively in a group context

• Breadth of perspective

• Interest in serving

• Adequate representation of women and minority scientists

Process for Nominating Chartered Study Section Members

• SRAs solicit names from ICs, societies, former and current members

• Try out potential nominees as temporary members

• Contact potential members to see if they are willing to serve if

nomination is approved

• SRA drafts nomination package

• Submission to IRG Chief and Division Director

• CSR CMO sends copies to ICs for concurrence (3-week hold)

• CSR Director’s approval

• NIH Director’s approval

• New members start July 1 and typically serve a four-year term

Study Section Meeting

CSR Study Sections• Each CSR standing study

section has 12-28 regular members who are primarily from academia

• Ad Hoc members

• CSR standing study sections convene face-to-face meetings

• As many as 60-100 applications are reviewed by each study section

Pre-Meeting Activities• Reviewers receive applications and assignments 4-6

weeks prior to meeting

– Identify conflicts of interest

– Generally assigned between 8-14 applications

– Write critiques prior to the meeting

• Post preliminary scores and critiques on secure

meeting website

• Read written critiques of other reviewers a few days

before the meeting

What Happens at the Study Section Meeting• Closed Meeting• Orientation

– Conflict of Interest– Confidentiality– Developments of interest to the study section– Changes in policy or procedure– Roles of the persons present

• Chair and other Reviewers• Program Officers (Observers)• SRA

• Streamlining• Application by Application review

Certification of No Conflict of Interest

This will certify that in the review of applications and proposals by (study section) on (date), I did not participate in the evaluation of any grant or fellowship applications from (1) any organization, institution or university system in which a financial interest exists to myself, spouse, parent,child, or collaborating investigators; (2) any organization in which I serve as officer, director, trustee, employee or collaborating investigator; or (3) any organization which I am negotiating or have any arrangements concerning prospective employment or other such associations.

__________________ __________________ __________________ __________________ __________________ __________________ __________________ __________________

SIGNATURESSIGNATURES

Confidentiality• Review materials and proceedings of review

meetings represent privileged information to be used only by reviewers and NIH staff.

• At the conclusion of each meeting, reviewers will be asked to destroy or return all review-related material.

• reviewers should not discuss review proceedings with anyone except the SRA.

• Questions concerning review proceedings should be referred to the SRA.

K185pp.46

Streamlining• The process by which applications judged by the

reviewers to be in the worse half are not discussed at the

the study section meeting (identification of “unscored”)

• Purpose is to allow more time for discussion of more

meritorious applications

• Shortens meeting time from 3 days to 1.5 days

• Pre-meeting - identification of unscoreds

• Meeting – unanimous voting of unscoreds (any member

can object to streamlining an application)

• Unscored applications receive written critiques

• Unscored vs. NRFC

Review of Each Application• Reviewers with conflicts leave room

• Assigned reviewers state preliminary scores

• Discussion of scientific and technical merit – Based on the 5 review criteria

– Assigned reviewers first then open discussion to whole committee

• Discussion of Protection of Human Subjects and Inclusion criteria

• Assigned reviewers state final score – range of scores is set

• Every member scores each application

• Budget and Administrative concerns

• Ideal time for each application - 15 to 20 minutes

Review Criteria• SIGNIFICANCE: Does the study address an important

problem? How will scientific knowledge be advanced by the proposed project?

• APPROACH: Are design and methods well-developed, appropriate, and feasible? Are problem areas addressed?

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

• INVESTIGATORS: Is the investigator appropriately trained? Is the investigative team strong in necessary areas?

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

Inside the NIH Grant Review Process Video

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

CSR has developed a video CSR has developed a video of a mock study section of a mock study section meeting to show how NIH meeting to show how NIH grant applications are grant applications are reviewed. reviewed.

Post Meeting: Results of Review

• Unscored (approximately bottom half) • Score (generally between 100 and 300)• Percentile ranking (if scored)• Deferral (rare)• NRFC - Not Recommended for Further Consideration (very

rare; serious concerns)

• Notification of Principal Investigator – NIH Commons

• Summary Statement– NIH Commons

Summary Statement• Study Section Recommendation – Score, Unscored

• Resume and Summary of Discussion (if scored)

• Description (Abstract)

• Essentially unedited comments of reviewers– Organized by review criteria

• Administrative notes

• Budget Recommendations

• Coding for human subjects, animals, gender, minorities,

children

• Institute/Center contact information – Program Director

Role of Program vs. Review Staff

Separation of Funding and Review

Review Staff:-Manage study section meetings to

evaluate scientific and technical merit

-Provide a fair, thorough and

competent review for each application

-Work with applicants before review

Program Staff:-Identify and promote research priorities

-Recommend projects for funding (based on score, budget, priorities)

-Manage portfolio of projects

-Work with applicants up to review and after review

Review Process for a Research Grant

Not Funded

Grant

Application N I H Referral Review Program

Principal Investigator

Study Section Meeting

Review Staff –Scientific Review Administrators (SRA)

• Designated federal official responsible for ensuring that the grant applications are reviewed in an impartial environment.

• Responsible for overseeing the scientific peer review of applications

• Managing study section meetings

• Prepare summary statements

• Communicate with program staff on review issues

• Discuss review issues and policies with applicants

Program Officers (PO)• Interface between NIH funding Institute and the

extramural research community

• Serve as a resource and advocate

• Monitor research progress via annual reports

• Discuss other research opportunities (e.g.

competing supplements, minority supplements)

PO Assistance: Pre-Application

• Point of contact for investigators

• Assist with identifying appropriate

mechanism of support

• Clarify policy requirements

• Discuss budget plans

PO Assistance - After the Review Meeting

• Review summary statement with PI

• Obtain additional information regarding:

– gender / minorities / children

– human subjects

– budget

• Explore funding opportunities with other

Institutes / Centers

• Work with grants management to make award

Role of Program vs. Review • Program Officers

– Contact for scores and other funding issues after SS meeting– Advocate

• at Council meetings - Funding for borderline applications in some ICs

– Observe study section meetings– Help with revised application– Contact after grant is funded

• Progress reports • Oversight of funded grants

• Review – SRAs– Contact for review issues – before SS meeting

• (e.g. study section assignment, supplemental review material)

– Unbiased treatment for all PIs –• Assure a fair, thorough, competent review of all applications

– Supplemental data for applications

NIH InstituteAdvisory Councils

Dual Review System for Grant Applications

Second Level of Review

Council Assesses Quality of SRG Review of Grant Applications Makes Recommendation to Institute Staff on Funding Evaluates Program Priorities and Relevance Advises on Policy

First Level of ReviewScientific Review Group Scientific Review Group

(SRG)(SRG)• Provides Initial Scientific MeritProvides Initial Scientific Merit Review Review

of Grant Applicationsof Grant Applications• Scores Applications and Makes Scores Applications and Makes

Recommendations for Appropriate Recommendations for Appropriate Level of Budget Support and Duration Level of Budget Support and Duration of Awardof Award

Council Actions

• Concurrence with study section action

• Modification of study section action

• Deferral for re-review

STUDY SECTIONS DO NOT FUND

INSTITUTES FUND!

• Study sections judge application’s scientific

and technical merit

• Institutes take these evaluations very seriously

• Institutes also consider relevance of

application to the Institute’s research priorities

What Determines Which Awards Are Made?

• Scientific merit (score)

• Program considerations

• Availability of funds

Grant Writing

When Preparing an Application• Read PHS398 instructions

• Consider the review criteria

• Consider your primary audience - Reviewers

• Never assume that reviewers “will know what you mean”

• Refer to literature thoroughly and update when

submitting revised application

• Clearly state rationale of proposed investigation

• Include well-designed tables and figures

• Present an organized, lucid write-up

• Obtain pre-review from other faculty at your institution

Common Problems in Applications

• Lack of new or original ideas

• Absence of an acceptable scientific rationale

• Lack of experience in the essential methodology

• Questionable reasoning in experimental approach

• Uncritical approach

• Diffuse, superficial, or unfocused research plan

• Lack of sufficient experimental detail

• Lack of knowledge of published relevant work

• Unrealistically large amount of work

Additional Considerations

• Research involving human subjects

– Protection from risks

– Inclusion of women, minorities, children

• Animal Welfare

• Biohazards

• Data Sharing Plans

• Appropriateness of Budget

Revised Applications• 2 amendment limitation (no time limit any more)

• Must have received summary statement

• Cycle designed to submit every other round

(this may change- see NIH Guide notice on pilot study to shorten

cycle for New PIs http://grants.nih.gov/grants/guide/notice-

files/NOT-OD-06-013.html )

• Be calm and respectful of reviewers

• Be responsive to reviewer’s specific critiques

• Need to include Introduction and clearly mark text to

show changes

• Next review usually the same study section.

– Continuity of review is goal.

• Don’t give up!

Other Grant Writing Tips• Follow format rules (don’t squeeze, don’t cheat!)

– At least 11 pt font smallest allowed

– No more than 15 characters per inch and 6 lines per inch

– At least ½” margins

• Take time– avoid sloppy errors

– Give to colleagues for feedback

• Write clearly for whole review committee (they are your main

audience as well as judge and jury)– Well-written applications are noticed and appreciated

• You are not anonymous – don’t embarrass yourself with a

sloppy application.

Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications

To qualify for this expedited resubmission all of the following conditions must all be met:

• The PI must meet the NIH definition of a new investigator (see webiste below).

• A new or first resubmission of an R01 application must be submitted for the February 1 or March 1, 2006 date.

• The application must be reviewed in one of the participating Study Sections listed in the Notice at website below.

• The Summary Statement must have the special note indicating eligibility to participate in the pilot.

• The Principal Investigator must determine that it is reasonable to prepare a resubmission application in a short time.

• The Principal Investigator must agree that the resubmitted application be assigned to the same Study Section; no change in review venue is permitted for the resubmission.

• The July 20, 2006 receipt date must be met; late applications will not be considered.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-013.html

Volunteer To Review!• Junior Investigators

– Ad hoc reviewer

– Learn process – do’s and don’ts

• Senior Investigators

– Contribution is vital to peer review process

– Consider the debt to the scientific community

– Be constructive instead of complaining

• You are the “Peer” in Peer Review!

The NIH Commons

• https://commons.era.nih.gov/commons/

• Register in the Commons

• Individual Profile

• Obtain priority score, summary

statement, notice of grant award

• Reviewer can post critiques

Websites

WWW.NIH.GOV NIH homepage; directories; information; gateway to parts of NIH

WWW.NIH.GOV/ICD Information about Institutes

WWW.CSR.NIH.GOV/REFREV.HTM

Application forms, rosters, policies

www.csr.nih.gov/review/irgdesc.asp#hop

Information about HOP IRG