the nih peer review process and grant writing denise wiesch, ph.d. scientific review administrator...
Post on 25-Dec-2015
221 Views
Preview:
TRANSCRIPT
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
top related