Grant Review Process Dawn M Elliott PhD Outline Whats up with the NIH What happens to my grant after it is submitted What happens at a study section National Institutes of Health NIH The steward of medical and behavioral research for the ID: 557825
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Slide1
NIH and the Grant Review Process
Dawn M Elliott, PhDSlide2
Outline
What’s up with the NIH?What happens to my grant after it is submitted?
What happens at a study section?Slide3
National Institutes of Health (NIH)
The steward of medical and behavioral research for the
nation
Composed of 27 Institutes and Centers (ICs)
P
rovides
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.Slide4
NIH = National Institute
s 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 ResearchSlide5
A Simple View of the NIH
Grants
Management
(GMS)
Scientific
Program
(
PD/PO)
Scientific
Review
(SRO)
Intramural
Research
Program
About the scientific and technical aspects –
Listed in FOA and IC’s programmatic descriptions
For questions during the review –
Listed on the eRA Commons link to your submitted application
For help with the business aspects – Listed on the eRA Commons link to your submitted application
Extramural
Research
ProgramSlide6
Program Director/Officer (PD/PO
)
Scientific Portfolio Builder
Help to set/implement IC
priorities
D
esign
/execute specific
initiatives
M
ake
funding
recommendations
Responsible Steward of Public FundsMonitor award and progress
Ensure proper use of public fundScientific Public
Face of the GovernmentPre-application and post-review scientific contact Slide7
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 meetingSlide8
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!Slide9
Who to Contact When?
Pre-Review
Post-Review
Pre-Submission
Contact
your grants office
, or grant.gov, or NIH eRA Help for issues related to submission.
Contact SRO for any review related issues such as changing IRG, sending in supplements, indicating conflicts etc.
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 PD/PO for revision and funding.
Once funded, contact PD/PO for scientific relevant issues and GMS for process and/or policy issues.
Application in
Peer ReviewSlide10
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 NIsSlide11
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.htmSlide12
Types of NIH Applications
“
U
nsolicited” 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)
Slide13
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
dataSlide14
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 normSlide15
NIH Director’s New Innovator Award
15
CONFIDENTIAL
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 2015Expect to fund ~33 awards in
2015 (6.7%)https://commonfund.nih.gov/newinnovator/indexSlide16
New Innovator Award Application
A
pplications 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 pagesList of current and pending research support
CONFIDENTIAL
16Slide17
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
17Slide18
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 Slide19
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
19Slide20
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?Slide21
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
21Slide22
Outline
What’s up with the NIH?What happens to my grant after it is submitted?
What happens at a study section?Slide23
Review Process for a GrantSlide24
NIH Dual Level Review
System
Output:
Awards or Resubmission
3-7 months
1-3 months
First Level – Peer Review
Scientific Review Group (SRG)
Independent outside review
Evaluate scientific merit, significance
Recommend length and level of funding
Output:
Priority Score and Summary Statement
Second Level –
Council Review
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
Output:
Funding Recommendations
NIH IC DirectorSlide25
Two Level Review Process
Center for Scientific Review (CSR) Receipt, Referral, & Review
Receives all grant applications
Assigns (“Refers”) to
study sections for review
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 contractsSlide26
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 FundsSlide27
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 scoresApplication is either
discussed (if score is in t
op ~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
)Slide28
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 itAll
administrative issues raised in the summary statement must be addressed prior to fundingFor 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 reconsiderationSlide29
Relevant Scientific Review Groups
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]
One of the five divisions – the
Division of Translational and Clinical Sciences
includes:
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]Slide30
Center for Scientific Review
The CSR study section rosters are public
You can request that your proposal be reviewed by a particular study section
P
rogram
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 initiativesSlide31
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 fairSlide32Slide33
Outline
What’s up with the NIH?What happens to my grant after it is submitted?
What happens at a study section?Slide34
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 CSRUp to 60-100 proposals reviewed in a sessionSlide35
NIH study section meeting
Slide36
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 Slide37
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 Slide38
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
4 – Very Good
Strong but with at least
one
moderate
weakness
5 – Good
Some strengths but also
some moderate
weaknesses
6 – Satisfactory
Low
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.
O
verall
I
mpact
S
core
=
Panel
A
verage
x
10Slide39
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 applicantSlide40
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 proposalSlide41
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)Slide42
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 presentSlide43
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.
P
roposals will receive a
summary statement that contains:
Impact/Priority Score and possibly a Percentile Ranking and o
verall
Resume and Summary of Discussion
(if discussed)
Essentially Unedited Critiques from individual reviewers (2-4)
Budget RecommendationsAdministrative Notes (animal, human, overlap, etc.)
For questions on the summary statement, applicants should contact the Program Director,
NOT Scientific Review Officer!