The NIH Scientific Review Process

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The NIH Scientific Review Process Janice Benson
Allen, PhD Scientific Review Officer Division
of Extramural Research and Training
(DERT) National Institute of Environmental
Health Science (NIEHS) National Institutes of
Health (NIH) Dept of Health Human Services
(DHHS)
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I am from the Government and am here to help you!
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The NIH Grant Process

• Overview of NIH
• Funding Mechanisms
• Important Personnel
• Overview of NIH Grant Process
• Submission
• Referral
• Review
• Award
• Post-award

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NIH consists of 27 Institutes and Centers
NHLBI
NINR
OD
NCCAM
NIEHS
NCI
NIAMS
CIT
NIDA
NEI
NIMH
CC
NIDDK
NLM
NINDS
NHGRI
NIDCR
NCMHD
NIBIB
NIA
NIDCD
NIAAA
NICHD
NIAID
NIGMS
NCRR
CSR
FIC
Extramural only
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NIH Institutes
Within most ICs, there are separate and distinct
Extramural and Intramural components. At NIEHS,
these are the Division of Intramural Research
(DIR) Division of Extramural Research and
Training (DERT)
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NIEHS -- National Institute of Environmental
Health Sciences

• Human health and human disease result from three
  interactive elements
• environmental factors
• individual susceptibility
• age
• The mission of the NIEHS is to reduce the burden
  of human illness and dysfunction from
  environmental causes by understanding each of
  these elements and how they interrelate.

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Assistance (Grant) Mechanisms

• Grants Assistance mechanism to stimulate
  research, often unsolicited. If solicited,
  published in the NIH Guide to Grants and
  Contracts as
• RFA Request for Applications one receipt date
  and funds set aside to fund (grants)
• RFP Request for Proposal (contracts)
• PA Program Announcement
• PAS Program Announcement with set aside funds
• PAR Program Announcement reviewed by the
  Institute/Center not Center for Scientific Review
  (CSR)

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Grant Mechanisms
R Research Project R01 Reseach Grant R03 Small Research Grants R15 AREA Grants R21 Exploratory/Developmental Grants R43 Small Business Innovation Research
P Multi-component projects P01 Program Projects P30 P50 Center Grants
T Institutional Training T32 Institutional Training Grants T35 Short-term Training
F Individual Fellowships (NRSA) F30 MD/PhD Predoctoral Fellowship F31 Diversity Predoctoral Fellowship F32 Postdoctoral Fellowships
K Career Development K99/R00 Pathways to Independence Award K08 Mentored Clinical Scientist Develop Award K12 Institutional Career Develop Program
Not all mechanisms are available at all
Institutes under all circumstances.
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R01 Characteristics

• Traditional Research Grant- supports a
  discrete, specified project to be performed by
  the Principal Investigator
• Up to five years of support
• Budget potentially unlimited- modular up to 250K
  per year
• CSR or IC (Institute/Center) review

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R03 - Small Grants

• Provision of limited funding for a short period
  of time
• Types of projects may be
• Pilot or feasibility studies
• Secondary analysis of existing data
• Small, self-contained research projects
• Development of research methodology
• Development of new research technology
• Up to 2 years, up to 50,000/ year

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R13 Conference Grants

• A scientific meeting is defined as a gathering,
  symposium, seminar, conference, workshop or any
  other organized, formal meeting where persons
  assemble to coordinate, exchange, and disseminate
  information or to explore or clarify a defined
  subject, problem, or area of knowledge.focus
  must be scientific.
• 3000-10,000 support provided
• Apply 9 months prior to meeting
• Contact Jerry Heindel heindelj_at_niehs.nih.gov

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R21 Exploratory/Developmental Grant

• NIH seeks to foster the introduction of novel
  scientific ideas, model systems, tools, and
  technologies that have the potential to
  substantially advance biomedical research.
• The R21 mechanism is intended to encourage new
  exploratory/developmental research projects by
  providing support for the early stages of their
  development
• Supports small research projects that can be
  carried out in a short period of time (2 years),
  with limited resources

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R15 AREA GrantsResearch Grants for non
research Intensive Institutions

• Enable scientists at eligible institutions to
  receive support for small research projects,
  which might include, feasibility studies, pilot
  studies, and other small-scale research programs
• Maximum of 150,000 in direct costs plus
  facilities and administrative costs at the rate
  negotiated for the institution may be awarded for
  a period of up to three years
• Contact Mike Humble humble_at_niehs.nih.gov

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Assistance (Grant) Mechanisms

• Mentored Career Awards (Ks)
• K01 Mentored Research Scientist Development
  Award
• K07 Academic Career Award
• K08 Mentored Clinical Development Scientist
  Award
• K12 Institutional Clinical Scientist
  Development Program Award
• K22 Career Transition Award
• K23 Mentored Patient-oriented Research Career
  Development Award
• K25 Mentored Quantitative Res Career
  Development Award
• Mentored career awardees may now hold concurrent
  support from an NIH career award and an NIH
  research grant
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-04-007.html

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PURPOSE OF CAREER AWARDS

• Provides support/protected time to junior,
  mid-career and established investigators to
  develop/further develop their research careers.
• Provides bridge support to transition from
  mentored to independent career phases.

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Ruth L. Kirschstein National Research Service
Awards

• Training Grants - T32, T35
• Institutional
• Predoctoral and postdoctoral
• Fellowships
• Individual
• Predoctoral (F30, F31)
• Postdoctoral (F32)
• Senior (F33)
• http//grants.nih.gov/training/extramural.htm

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Exciting Opportunities - 1
Outstanding New Environmental Scientist (ONES)
NIEHS. Highly selective for most talented new
scientists Long term commitment to EHS research
lt 8 years postdoctoral experience Junior
Faculty Evidence of independent productivity
and facilities First R01 Support Statement of
Career Goals Discussion of research experience
and achievements External Advisory Committee
Institutional Commitment to PI (gt50 research
time) Research focus on human disease, defined
impact in environmental health research. Annual
submission. Only at NIEHS now (3rd release).
K99/R00 NIH-wide. Candidate Potential of
independent research, based on experience level,
research training, potential to contribute to
health-related research field, evidence of
research productivity (quality of peer-reviewed
scientific publications), research creativity
reference letters, mentors (sponsors)
statement, and statement from institutional
training grant director (if applicable). Career
Development Plan Appropriateness of career
development plan and likelihood that award will
contribute substantially to the scientific
development. Research Plan Scientific and
technical merit of the research question, design
and methodology. Mentor Appropriateness of the
mentors research qualifications, scientific
stature, experience and mentoring track record
for career development needs. Environment and
Institutional Commitment to the Candidate
Adequacy of facilities, availability of
appropriate educational opportunities, and
strength of institutional commitment to fostering
career development of the candidate. Training in
the Responsible Conduct of Research.
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Exciting Opportunities - 2

• Loan Repayment NIH-wide. NIH Loan Repayment
  Programs Help Desk answers questions about
  programs/eligibility/benefits and provides
  assistance with online application. In exchange
  for a two-year research commitment, NIH will
  repay qualified educational debt up to 35,000
  per year reimburse Federal/state taxes resulting
  from repayment award repay qualified educational
  debt after completion of the two-year commitment
  through competitive renewals - if you have
  student debt remaining at the completion of your
  award, you can apply for a competitive renewal
  provided you continue to meet NIHs eligibility
  requirements. Applicants must have a Doctoral
  degree (M.D., Ph.D., or equivalent), funding for
  research at any domestic nonprofit, university,
  or government organization, educational loan debt
  equal to at least 20 of annual salary, conduct
  research an average of 20 hours/week, and be a US
  Citizen or permanent resident. (http//www.lrp.nih
  .gov)
• ViCTER NIEHS. The proposed new Virtual Program
  will allow researchers at remote locations to
  form a Virtual Consortia via an integration of
  their research and the identification of a center
  director who houses the ViCTER and coordinates
  monthly conference calls and annual update
  meetings. Any R01 ES funded researcher can
  develop a collaborative and integrative
  transdisciplinary and/or translational program
  with a focus on the role of environmental
  stressors in the etiology, trajectory and outcome
  of human disease and disorders with 2-3 other
  scientists. The Competitive Supplement mechanism
  will be used. PAR ES-10-030)

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Important Personnel

PROGRAM ADMINISTRATOR
SCIENTIFIC REVIEW OFFICER
GRANTS MANAGEMENT SPECIALIST
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When should/can I contact NIH/NIEHS Staff? ANY
TIME!

• PA As soon as you begin to THINK of preparing an
  NIH application (or even sooner!) when receive
  summary statement after Council meets after
  award is made during administration of project.
• SRO As soon as you receive an email from CSR as
  to which SRO is assigned to your application (CSR
  review) or when preparing your application (name
  provided in FOA).
• GMS When have budgetary/JIT (Just-in-Time)
  questions preparing application questions on
  summary statement (or contact PA) clarifications
  on FOA JIT submissions fiscal administration
  during award period.

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The NIH Grant Process
NIH Grant Process
What happens in the Black Box ?
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Overview of NIH Grant Process
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WHAT IS AVAILABLE?
To find out about Funding Opportunity
Announcements (FOA)
NIH Guide for Grants and Contracts http//grants.
nih.gov/grants/guide/index.htm
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Submission Dates

• Standard Deadlines
• http//grants.nih.gov/grants/funding/submissionsc
  hedule.htm
• R01 (new Research Grants) SF424 (RR)
• February 5, June 5, October 5
• R01 (renewal, resubmission, revision) SF424
  (RR)
• March 5, July 5, November 5
• T Series (Training) PHS 398
• January 25, May 25, September 25
• K (new Career Grants) (PHS 398)
• February 12, June 12, October 12
• K (renewal, resubmission, revision) (PHS 398)
• March 12, July 12, November 12
• Solicited Applications See PA/RFA

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Where To Go For Help

• General information on Electronic Submission and
  the SF424 (RR) http//era.nih.gov/ElectronicRece
  ipt
• Grants.gov registration, submission and ADOBE
  questions Visit http//www.grants.gov/CustomerS
  upport
• Grants.gov Customer Service
• E-mail support_at_grants.gov
• Phone [phone]
• eRA Commons registration and post submission
  questions on Commons functionality
• Web Support http//ithelpdesk.nih.gov/eRA
• eRA Commons Help Desk
• E-mail commons_at_od.nig.gov
• Phone [phone] OR 301-402-7469
• Forms transition and questions on NIHs overall
  plan for electronic receipt
• NIH Grants Information
• E-mail grantsinfo_at_nih.gov
• Phone [phone]

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CRITICAL MESSAGE

• If you do not see the application image in
  eRA Commons, the NIH does not see it either. Be
  sure to follow up on the process and use eRA
  Commons to check. We need to know you have
  submitted an application in order to assign,
  review and award!

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Overview of NIH Grant Process
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ENHANCING PEER REVIEW CHANGES IMPLEMENTED
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NEW EARLY STAGE INVESTIGATORS

• New PI Status calculated by IMPAC
• Early Stage Investigator Status
• Subset of NI
• Within 10 years of last research degree/end of
  residency
• Extension possible
• Appropriate reasons for extension include
  clinical training, military service, family
  responsibilities, payback obligations, illness,
  disability, natural disasters
• Reasons not appropriate include change of field,
  work in industry, visa complications
• http//grants1.nih.gov/grants/new_investigators/in
  dex.htm

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MODIFIED SUBMISSION, REFERRAL, REVIEW

• Eligible appointed members of study sections
  (CSR and IC), NIH Boards of Scientific
  Counselors, NIH Advisory Boards or Councils, and
  the NIH Peer Review Advisory Committee, and
  reviewers with recent substantial service
• R01, R21, and R34 applications for standard due
  dates may be granted extensions no other
  activities no RFAs or PARs with special dates
• If multi-PI, only one need be a member
• CSR or IC review within 120 days
• http//grants1.nih.gov/grants/guide/notice-files/N
  OT-OD-09-155.html

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RESUBMISSION POLICY

• A0 applications submitted for October 2009
  council and beyond, only allowed an A1
• Applications from submissions prior to October
  2009 council are allowed A2 by January 7, 2011
  (AIDS date for May 2011 council)
• Applies to all activity codes no exceptions
• Applies to new (type 1), renewal (type 2), and
  revision (type 3) applications no exceptions.
• Earliest could see inappropriate A2s is for May
  2010 council (September 2009 to January 2010 due
  dates).
• First major wave will be for October 2010 council
  (January to May 2010 due dates).
• http//grants1.nih.gov/grants/guide/notice-files/n
  ot-od-09-016.html
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-09-003.html

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WHAT CONSTITUTES A NEW APPLICATION?

• Notice OD-07-015 Limits on Resubmission of an
  Application Clarification of NIH Policy
  http//grants1.nih.gov/grants/guide/notice-files/n
  ot-od-07-015.html
• A new application must have
• Substantial changes in content and scope more
  significant differences than a resubmitted
  application.
• Fundamental changes in the questions being asked
  and/or the outcomes examined.
• Insufficient change for a new application
• Rewording of the Title and Specific Aims
• Changes in response to previous Summary Statement
• Request for review by a different committee or
  funding consideration by a different NIH
  institute
• Change of PA/PAS/PAR

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HOW WILL PROBLEM CASES BE HANDLED?

• Applications may be identified at many steps in
  the referral/review process DRR, SROs,
  Reviewers, Program or other IC
• DRR will analyze each case.
• Straightforward cases handled directly
• Knowledge management program is available to
  provide analysis
• Additional input may be sought from CSR and/or IC
  staff.
• The PD/PI may be asked to provide input.
• Final determination of new or virtual A2/A3 made
  by the DRR
• When an application cannot be accepted or needs
  to be withdrawn the PD/PI and AOR will be
  notified.

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ENHANCING PEER REVIEW upcoming changes
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NEW FORMS, FORMAT, PAGE LIMITS

• Applies to paper and electronic submissions (PHS
  398 and SF 424 RR)
• Applies to applications intended for due dates of
  January 25, 2010.
• For non-AIDS continuous submission change over
  date is January 25, 2010.
• For AIDS continuous submission change over date
  is February 7,2010.
• Not tied to a specific council round.
• Cannot mix two types of applications in the same
  meeting.

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NEW APPLICATION FORMAT

• Specific Aims 1 page (all activities)
• Research Strategy generally 6 or 12 pages 30
  page option needs OEP approval
• Training applications (Ts, K12) - 25 pages
• Multi-component applications use 6 or 12 page
  limit for cores, projects, etc.
• Introduction is 1 page for applications 12 pages
  or less 3 pages for others
• Personal statement in Biographical sketch
  encouraged to limit publications to 15
• eRA validations will be set to check compliance
• No grandparenting clause renewal and
  resubmission applications must use new format
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-09-149.html

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RECEIPT/REVIEW/AWARD CYCLES

• Receipt Dates January May
• May - September
• September January
• Review Dates May - June
• September/October
• January/February
• Council August - October
• January
• May

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APPENDIX MATERIALS

• Appendix requirements Notice OD-07-018
• http//grants1.nih.gov/grants/guide/notice-files/N
  OT-OD-07-018.html
• If publications allowed, only 3 non-publicly
  available may be included
• No submitted manuscripts
• Surveys, questionnaires, consent forms, protocols
  allowed
• Color/glossy figures for paper submission only
• 5 CDs only for paper submissions (these are not
  encrypted)

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COVER LETTER

• The cover letter should be used for a number of
  important purposes
• Suggest Institute/Center Assignment
• Suggest review assignment
• Identify individuals in conflict
• Identify areas of expertise needed to evaluate
  the application
• Discuss any special situations
• Required for an electronic changed/corrected
  submission
• It is not appropriate to use the cover letter to
  suggest specific reviewers.

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New Research Plan Components

• Introduction
• Specific Aims
• Background and Significance
• Preliminary Studies/Progress Report
• Research Design and Methods
• Inclusion Enrollment Report
• Bibliography and References Cited
• Human Subjects Sections.
• protections, women/minorities, enrollment,
  children
• Other Research Plan Sections.
• animals, select agents, multi PD/PI, consortium,
  support, resource sharing
• Appendix

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Changes to Biographical Sketch

• Personal Statement added
• Briefly describe why your experience and
  qualifications make you particularly well-suited
  for your role in the project
• Publications revised
• Limit the list of publications or manuscripts to
  no more than 15
• Applicant is encouraged to make selections based
  on recency, importance to the field, and/or
  relevance to the application

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Changes to Resources and Facilities

• Instructions added to Resources
• Provide a description of how the scientific
  environment will contribute to the probability of
  success of the project
• For Early Stage Investigators (ESIs), describe
  the institutional investment in the success of
  the investigator

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Enhanced Review Criteria for FY2010
Core Review Criteria For research grant applications and cooperative agreements Received for potential FY2010 funding Will receive individual criterion scores from assigned reviewers discussants Significance Investigator(s) Innovation Approach Environment
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Enhanced Review Criteria for FY2010
Core Review Criteria Significance Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
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Enhanced Review Criteria for FY2010
Core Review Criteria Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
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Enhanced Review Criteria for FY2010
Core Review Criteria Investigator(s) Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise are their leadership approach, governance and organizational structure appropriate for the project? (Moved from Approach)

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Enhanced Review Criteria for FY2010
Core Review Criteria Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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Enhanced Review Criteria for FY2010
Overall Impact/Priority Score
Reflects the reviewers assessment of the
likelihood for the project to exert a sustained,
powerful influence on the research field(s)
involved

• In consideration of
• Core criteria
• Additional review criteria (RFA or PAR)
• Additional review criteria as applicable

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Streamlining of Applications prior to or at
beginning of review meeting

• Purpose to identify applications that are least
  likely to be funded so that more time can be
  spent on the most scientifically meritorious
  applications
• Goal Identify lower ? to ½ applications
• Conducted by review committee prior to review
• Decision to streamline must be unanimous
• Streamlined applications do not get discussed and
  scored at full review meeting, but do receive a
  written critique

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New Scoring Procedures

• New Scoring Procedures for Evaluation
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-09-024.html
• The new scoring system will utilize a 9-point
  scale (1 exceptional, 9 poor)
• This scale will be used for overall
  impact/priority scores and for individual
  criterion scores
• Implemented for reviews of applications under
  funding consideration beginning FY2010

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9-point Scoring Descriptions
Weaknesses
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Impact on applicants or PI/PDs

• The scores provided for criteria that will
• 1. emphasize areas of greatest strengths and
  weaknesses.
• 2. provide more information to aid in
  interpreting reviewer narratives especially
  when the application was not discussed during the
  review meeting.
• For a while, there may be confusion regarding the
  criterion scores vs. the impact/priority score.

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Key Facts- Final Scores

• Final score provided by all eligible committee
  members (i.e. not in conflict), as is presently
  done
• Overall impact/priority score is the mean score
  from all eligible reviewer scores, multiplied by
  10
• Final scores will range from 10 to 90, reported
  in whole numbers

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End of Review

• Summary Statement
• Written report compiled by SRA from written
  comments of the Reviewers and discussions at
  review meeting. (Pink sheets) shows score,
  reviewers comments, and summary of discussions
• Streamlined applications also get summary
  statements, with critiques of assigned reviewers
  (no scores)
• Available to applicant on COMMONS (hard copy no
  longer mailed)
• Made available to members of the National Council

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What to do if disagree with Summary Statement

• For a review issue Contact SRO
• For a scientific issue Contact PA
• For a budgetary issue Contact GMS or PA
• PA will advise as to what occurs at this point
• Make plans for resubmission
• Discuss other opportunities
• Send a rebuttal letter to NAHSC

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Second Level of Review

• National Advisory Health Sciences Council
• (Secondary Review)
• Council accepts or rejects review of the study
  section
• If recommendations are rejected, the Council may
  defer for a re-review. It cant change the score.

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Overview of NIH Grant Process
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Funding Considerations

• Recommendations from DERT are based on
• Summary Statement Score and review narratives
• Programmatic Priorities
• Budgetary Considerations

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If the application is approved for funding
there are negotiations between NIH and applicant,
if necessary, and an award is made. If the
application is not approved for funding,
applicant can revise and resubmit (up to 1 more
time, usually)
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Overview of NIH Grant Process
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Post-Award

• Yearly Progress Reports

• Competitive Renewal (for some mechanisms not
  K99/R00)

• Fame and Fortune

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Summary of NIH Grant Process
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Thank you. QUESTIONS / INFORMATION JB Allen,
PhD 919-541-7556 allen9_at_niehs.nih.gov
http//www.niehs.nih.gov/dert/home.htm http//www.
niehs.nih.gov/dert/dertsrb/srb.htm