NIH and the
Grant Review Process
Dawn M Elliott, PhD
BIOMEDICAL ENGINEERING
Outline
• What’s up with the NIH?
• What happens to my grant after it is submitted?
• What happens at a study section?
BIOMEDICAL ENGINEERING
National Institutes of Health (NIH)
 The steward of medical and behavioral research for the
nation
 Composed of 27 Institutes and Centers (ICs)
 Provides leadership and financial support
 NIH Public Health Mission: To enable discovery of
new knowledge that leads to better health for the nation
 Support peer-reviewed scientific research at universities,
medical schools, hospitals, and research institutions
 Train research investigators.
 Develop and disseminate credible health information based
on scientific discovery.
BIOMEDICAL ENGINEERING
NIH = National Institutes of Health
NCI – National Cancer Institute
NEI – National Eye Institute
NHGRI - National Human Genome Research Institute
NHLBI - National Heart, Lung, and Blood Institute
NIA - National Institute on Aging
NIAAA - National Institute on Alcohol Abuse and Alcoholism
NIAID - National Institute of Allergy and Infectious Diseases
NIAMS - National Institute of Arthritis and Musculoskeletal and Skin
Diseases
NIBIB - National Institute of Biomedical Imaging and Bioengineering
NICHD - National Institute of Child Health and Human Development
NIDA - National Institute on Drug Abuse
NIDCD - National Institute of Deafness and Other Communication Disorders
NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases
NIDCR - National Institute of Dental and Craniofacial Research
NIEHS - National Institute of Environmental Health Sciences
NIGMS - National Institute of General Medical Sciences
NIMH - National Institute of Mental Health
NINDS - National Institute of Neurological Disorders and Stroke
NINR - National Institute for Nursing Research
BIOMEDICAL ENGINEERING
A Simple View of the NIH
For help with the
business aspects –
Listed on the eRA
Commons link to your
submitted application
Intramural
Research
Program
About the scientific and
technical aspects –
Listed in FOA and IC’s
programmatic descriptions
For questions
during the review –
Grants
Management
(GMS)
Listed on the eRA
Commons link to your
submitted application
Extramural
Research Scientific
Program Review
Scientific
Program
(PD/PO)
(SRO)
BIOMEDICAL ENGINEERING
Program Director/Officer (PD/PO)
 Scientific Public Face of the Government
• Pre-application and post-review scientific contact
 Responsible Steward of Public Funds
• Monitor award and progress
• Ensure proper use of public fund
 Scientific Portfolio Builder
• Help to set/implement IC priorities
• Design/execute specific initiatives
• Make funding recommendations
BIOMEDICAL ENGINEERING
Scientific Review Officer (SRO)
 Responsible for implementing review policies and
procedures and a fair, unbiased and competent review
 Primary NIH contact with PIs during review phase
 Manager of all aspects of the review process:
• Analyze applications for completeness, scientific content
and determines who will review them
• Manage and oversee scientific peer review meetings to
ensure the fairness and consistency
• Legally responsible for ensuring NIH regulations and
policies are followed
• Prepare summary statements reflecting recommendations
from the review meeting
BIOMEDICAL ENGINEERING
Grants Management Specialist (GMS)



Provide advice on business-related aspects of grants such
as budgets
Monitor the business management practices of grantee
organization to assure awarded funds are spent properly
Assure grantees fulfill requirements regarding laws,
regulations and administrative grant policies
 Pre-Award Steps: Just-in-time (JIT) information




Eligibility verification statement
Human and Animal subjects training and approvals
Other support for key personnel
Consortium/subcontract information
 Post-Award Advice/Guidance
 Annual Progress Reports
 Financial Status Reports
 Closeout activities
GMS issues the
Notice of Award!
BIOMEDICAL ENGINEERING
Who to Contact When?
Application in
Contact YOUR GRANTS
OFFICE, or grant.gov, or
NIH eRA Help for issues
related to submission.
Contact PD/PO for IC
scientific mission
relevance of your
research, and advice on
grant mechanism, IRG
selection and/or
revision; and GMS for
budget related issues.
Contact SRO for any review
related issues such as changing
IRG, sending in supplements,
indicating conflicts etc.
Peer Review
Contact PD/PO for
revision and funding.
Once funded, contact
PD/PO for scientific
relevant issues and GMS
for process and/or policy
issues.
BIOMEDICAL ENGINEERING
NIH New Investigator Policy
 New Investigator (NI): Principal Investigator (PD/PI)
who has not previously competed successfully as PD/PI
for a significant NIH independent research award; but
may have received the following: fellowships (F), career
awards (K), R00, R03, R15, R21, R34, R36, R41, R43
 NIH expects to support NIs at success rates equivalent
to that of established investigators
 This policy applies only to the R01 mechanism
 The NIH strongly encourages NIs to apply for R01
grants when seeking first-time NIH funding
 Advantage at Review – clustered together to be
reviewed
 Advantage at Funding – higher percentile for funding
 All PIs on a Multi-PI application must be NIs
BIOMEDICAL ENGINEERING
Finding NIH Grant Opportunities
 All applications must be submitted in
response to a Funding Opportunity
Announcement (FOA)
 FOAs are posted online in the NIH Guide for
Grants & Contracts and at www.Grants.gov
(under “Find Grant Opportunities”)
– All of the NIH FOAs (unsolicited and solicited) found
at the NIH Guide http://grants.nih.gov/grants/guide/index.html
– Weekly NIH Funding Opportunities and Notices
published
– Sign up at http://grants.nih.gov/grants/guide/listserv.htm
BIOMEDICAL ENGINEERING
Types of NIH Applications
 “Unsolicited” or “investigator-initiated”
– Majority of NIH funded applications
– Research ideas come from PIs
 “Solicited” – NIH publishes Funding Opportunity
Announcement (FOA) to solicit specific research
topics or types
Program Announcement (PA)
Request for Applications (RFA)
BIOMEDICAL ENGINEERING
Some NIH Funding Mechanisms
 Research Project Grants – RPG (R01)
– Requires high likelihood of success and strong
preliminary data
– Under $500,000/year, up to 5 years
– >$500K direct cost requires permission to apply
 NIAMS Small Research Grants (R03)
– New Investigators only, limited to 2 R03 awards/career
– $50,000/yr direct costs, 3 year max, not renewable
 Developmental/Exploratory Grants (R21)
– Ground breaking, potentially high yield research
– $275K direct costs over two years, not renewable
– not recommended for New PIs to obtain prelim data
BIOMEDICAL ENGINEERING
Pathway to Independence (K99/K00)
• Goal of the Pathway to Independence Award
program is to increase and maintain a strong
cohort of new and talented NIH-supported
independent investigators. The program is
designed to facilitate a timely transition from a
mentored postdoctoral research position to a
stable independent research position with
independent NIH or other independent research
support at an earlier stage than is currently the
norm
BIOMEDICAL ENGINEERING
NIH Director’s New Innovator Award
• Open to exceptionally creative Early Stage Investigators
• Early stage investigator – New Investigator within 10
years of terminal degree
• Goal is to fund bold and highly innovative research with
potential to have significant impact on a broad area of
biomedical or behavioral research
• Up to $1.5 million in direct costs over 5 years (300K/yr)
• 537 applications submitted for 2014, 50 awards (9.3%)
• 490 applications submitted for 2015
• Expect to fund ~33 awards in 2015 (6.7%)
https://commonfund.nih.gov/newinnovator/index
CONFIDENTIAL
BIOMEDICAL ENGINEERING
15
New Innovator Award Application
• Applications are shorter than R01s (10 pg) and
Research Strategy includes:
 Project description: scientific problem,
significance, and potential impact; suitability of
planned research for New Innovator Award rather
than a traditional mechanism
 Innovativeness: what makes project
exceptionally innovative; risks and challenges,
alternatives if approaches not successful
 Investigator Qualifications: evidence to support
claim of creativity and innovativeness
• Biographical Sketch – 2 pages
• List of current and pending research support
CONFIDENTIAL
B I O M E D I C16
AL ENGINEERING
•
•
•
•
New Innovator Award Application
Applicant must be an Early Stage Investigator
(no multiple PI)
Must propose bold highly innovative new
approaches to high impact problem
Innovation and impact expected to be
significantly greater than in typical R01
Preliminary data not required but allowed
CONFIDENTIAL
B I O M E D I C17
AL ENGINEERING
New Innovator Award Review Process
• Phase 1 -- mail review (January)
 Assignments made by broad scientific area:
 Instrumentation and Engineering;
Behavioral and Social Sciences; Chemical
Biology; Clinical and Translational Research;
Immunology; Molecular and Cellular Biology;
Neuroscience; High Throughput and
Integrative Biology; Quantitative and
Computational Biology
• Phase 2 – on-site review meeting (April)
 Different reviewers
BIOMEDICAL ENGINEERING
New Innovator Award Review Criteria
Scientific Problem (Significance):
• Does the project address an important scientific
problem or critical barrier in the field?
• How will scientific knowledge, technical
capability and or clinical practice be improved?
• If the proposed research is completed, will the
project have a major impact on a broad area of
biomedical or behavioral research?
CONFIDENTIAL
B I O M E D I C19
AL ENGINEERING
New Innovator Award Review Criteria
Innovativeness of the research proposed:
• Does the application challenge or seek to shift
current research or clinical practice?
• Are the proposed scientific problem, concepts,
approaches or instrumentation or interventions
significantly more innovative, bold and creative
than would normally be expected from an early
stage investigator?
• Is it evident from research strategy that the
investigator has considered and addressed the
potential risks and challenges?
• Is the proposed project unusually innovative?
BIOMEDICAL ENGINEERING
New Innovator Award Review Criteria
Investigator Qualifications
• Is the investigator well suited to the project?
• Is the investigator appropriately trained to
independently carry out the project?
• Is there any evidence of the investigator’s potential
to do creative and innovative research?
• Is there any evidence of investigator’s inclination to
challenge paradigms and take intellectual risks?
Overall Impact: assessment of the likelihood for the
project to exert a sustained, powerful influence on the
research field(s) involved, in consideration of the three
core review criteria.
CONFIDENTIAL
BIOMEDICAL ENGINEERING
21
Outline
• What’s up with the NIH?
• What happens to my grant after it is
submitted?
• What happens at a study section?
BIOMEDICAL ENGINEERING
Review Process for a Grant
BIOMEDICAL ENGINEERING
NIH Dual Level Review System
First Level – Peer Review
Scientific Review Group (SRG)
 Independent outside review
Output: Priority Score
 Evaluate scientific merit, significance
and Summary Statement
 Recommend length and level of funding
Second Level – Council Review
3-7 months
Scientific Advisory Council
 Assesses Quality of SRG
Review of Grant Applications
 Makes Recommendations to the
Institute/Center (IC) on Funding
 Evaluates Program Priorities and
Relevance
1-3 months
Output: Funding
Recommendations
NIH IC Director
Output: Awards or Resubmission
BIOMEDICAL ENGINEERING
Two Level Review Process
 Center for Scientific Review (CSR) Receipt, Referral, &
Review
– Receives all grant applications
– Assigns (“Refers”) to
o study sections for review
o ICs for potential funding
– Reviews most of the NIH grant applications
– CSR does not fund grants
 NIH Institutes and Centers (ICs): Secondary Review,
Funding Decisions, Management, & Oversight
– Program Directors, Grants Management Specialists, and
IC specific Scientific Review Officers
– Fund and manage grants and contracts
BIOMEDICAL ENGINEERING
Who Makes Final Funding Decisions?
The Institute or Center Director
Taking the recommendations from the Council and
Program Directors, consider the following factors:




Scientific Merit
Contribution to Institute Mission
Program Balance
Availability of Funds
BIOMEDICAL ENGINEERING
NIH Grant Application Process – Summary
 Grant application in the CSR; is logged in and given a unique ID
number
 application assigned to an integrated review groups (IRG) and to a
Study Section for initial peer review.
 application also assigned to NIH IC based on research topic
 PI can log in to the eRA Commons to get assignment
information within 6 weeks after the CSR receives application
 SRO sends applications to reviewers 1 month prior to the Study
Section meeting for their review and preliminary scores
 Application is either discussed (if score is in top ~50%) or not
discussed (if scores is in bottom ~50%) at the Study Section meeting
(View mock study section at http://www.csr.nih.gov/Video/Video.asp)
BIOMEDICAL ENGINEERING
NIH Grant Application Process – Summary
 2 days after review meeting, PI can see priority score or that
application was not discussed in the Commons
 Roughly 4 weeks after review, summary statement will be posted
on the NIH Commons, or 1-2 weeks for new PI
 Applications undergo second-level review by the Institute
advisory Council
 IC will request “Just In Time“(JIT) materials if application is within
an IC’s pay line or close to it
 All administrative issues raised in the summary statement must
be addressed prior to funding
 For most to-be-funded applications, you will receive Notice of
Award (NoA or NGA) within 6 to 8 weeks of Council meeting
 First time applications that are not funded can be revised based
on feedback from the review and resubmitted for reconsideration
BIOMEDICAL ENGINEERING
Relevant Scientific Review Groups
One of the five divisions – the Division of Translational
and Clinical Sciences includes:
Musculoskeletal, Oral & Skin Sciences (MOSS) IRG reviews applications on structural
systems prerequisite for physical form, mechanical function, movement, & integrity of the
body. Some study sections are:
•
•
Oral, Dental and Craniofacial Sciences Study Section [ODCS]
Skeletal Biology Development and Disease Study Section [SBDD]
•
Skeletal Biology Structure and Regeneration Study Section [SBSR]
•
•
•
Skeletal Muscle Biology and Exercise Physiology Study Section [SMEP]
Musculoskeletal Rehabilitation Sciences Study Section [MRS]
Arthritis, Connective Tissue and Skin Study Section [ACTS]
•
Musculoskeletal Tissue Engineering Study Section [MTE]
Surgical Sciences, Biomedical Imaging, and Bioengineering (SBIB) IRG
review applications for research grants that address topics in a variety of areas at
the interface between a physical science or engineering and biomedical or clinical
research. Some study sections are:


Bioengineering, Technology, and Surgical Sciences [BTSS]
Medical Imaging Study Section [MEDI]
BIOMEDICAL ENGINEERING
Center for Scientific Review
• The CSR study section rosters are public
• You can request that your proposal be
reviewed by a particular study section
• Program officers from several institutes
attend each study section
• A few grants are not reviewed by CSR, but
are reviewed by institute-run committees
 training grants, K-awards, some R03s, and
special initiatives
BIOMEDICAL ENGINEERING
Final thoughts
• Good luck!
• Grant writing can be the most intellectually
engaged part of your job
• The review process is not perfect, but it is pretty
good and pretty fair
BIOMEDICAL ENGINEERING
BIOMEDICAL ENGINEERING
Outline
• What’s up with the NIH?
• What happens to my grant after it is submitted?
• What happens at a study section?
BIOMEDICAL ENGINEERING
NIH Study Section Meeting
• Each Study Section has 12-23 members
 university, government, industry scientists
 “regular” and “ad hoc”
• One regular member is chair
• Scientific Review Administrator (SRA) is
NIH’s overseer and works for CSR
• Up to 60-100 proposals reviewed in a session
BIOMEDICAL ENGINEERING
NIH study section meeting
BIOMEDICAL ENGINEERING
NIH Study Section Meeting
• Each proposal is assigned to
 a primary reviewer
 a secondary & usually a tertiary reviewer
 can have 1-3 “readers”
• Each reviewer has about 10 reviews to write and
several proposals to read
• Everyone is free to discuss/comment
• Everyone scores every proposal
BIOMEDICAL ENGINEERING
Review Formats
OVERALL IMPACT
Reviewers will provide an overall impact score to reflect their
assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of
the following five scored review criteria, and additional review criteria.
SCORED REVIEW CRITERIA
Reviewers will consider each of the five review criteria in the
determination of scientific and technical merit, and give a separate
score for each. Strengths and weaknesses will be identified for each of the
five review criteria
1. Significance
2. Investigator(s)
3. Innovation
4. Approach
5. Environment
BIOMEDICAL ENGINEERING
NIH Scoring System
Impact Full Description
Score – Descriptor
High
Exceptionally strong with essentially no weaknesses
1 – Exceptional
Extremely strong with negligible weaknesses
2 – Outstanding
Very strong with only some minor weaknesses
3 – Excellent
Medium Strong but with numerous minor weaknesses
Low
4 – Very Good
Strong but with at least one moderate weakness
5 – Good
Some strengths but also some moderate weaknesses
6 – Satisfactory
Some strength but with at least one major weaknesses
7 – Fair
A few strengths and a few major weaknesses
8 – Marginal
Very few strengths and numerous major weaknesses
9 – Poor
Minor weakness: Easily addressable weakness that does not substantially
lessen impact.
Moderate Weakness: Impact lessened.
Major Weakness: Impact severely limited.
Overall Impact Score = Panel Average x 10
BIOMEDICAL ENGINEERING
Reviewers
• Reviewers are not blinded to the applicants
 because they must assess their
qualifications
• The applicants will be told who was on the
review panel
• Reviewers leave the room during the
discussion if they
 work at the applicant’s institution
 are otherwise close to the applicant
BIOMEDICAL ENGINEERING
NIH study section meeting
• “Streamlining” or triage
 at start reviewers provide list of proposals
they reviewed that were in bottom half
 if assigned reviewers agree and no one
objects, proposal not scored or discussed
 anyone can object, no argument necessary
• Usually < half streamlined
• Norm is ~10-20 min. per discussed proposal
BIOMEDICAL ENGINEERING
NIH study section meeting
• Initial level of enthusiasm (score)
• Primary reviewer presents the proposal
 description
 positive and negative aspects
• Secondary & tertiary reviews follow
 detail depends on extent of agreement
• Readers comment, general discussion
• Reviewers give final scores (often change)
• Everyone writes down their own score (must
be within range OR write down why scoring
outside the range)
BIOMEDICAL ENGINEERING
Ethics, Etiquette, and Politics
• The SRA, chair are ethics watchdogs
 no conflicts of interest, real or perceived
 no discussions of application between
reviewer and applicant, before or afterward
 all discussions of applications between
reviewers must occur in session
• The mood of the room is professional
• Other NIH administrators present
BIOMEDICAL ENGINEERING
Summary Statement
Review results are documented by the Scientific Review Officers
(SROs) in a summary statement and made available to the PI
and NIH Institute/Center where a funding decision is made. A
priority score and, in some cases, a percentile will be posted on
Commons account if application is discussed.
Proposals will receive a summary statement that contains:
– Impact/Priority Score and possibly a Percentile Ranking and overall
Resume and Summary of Discussion (if discussed)
– Essentially Unedited Critiques from individual reviewers (2-4)
– Budget Recommendations
– Administrative Notes (animal, human, overlap, etc.)
For questions on the summary statement, applicants should contact the
Program Director, NOT Scientific Review Officer!
BIOMEDICAL ENGINEERING