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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)




                                                  The National Institute of Environmental Health Sciences
                                                  The National Institutes of Health
I am from the Government and am here to
                help you!




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

           CSR                                                             NCRR         NIGMS
 FIC
                                     = Extramural only
            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)
         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.
       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)
                     Grant Mechanisms
“R”: Research Project R01: Reseach Grant
                       R03: Small Research Grants
                       R15: AREA Grants
                       R21: Exploratory/Developmental Grants
                       R43: Small Business Innovation Research
Not all mechanisms are available at all Institutes under all circumstances.
“P”: Multi-component P01: Program Projects
   projects          P30 & P50: Center Grants
“T”: Institutional      T32: Institutional Training Grants
    Training            T35: Short-term Training
“F”: Individual         F30: MD/PhD Predoctoral Fellowship
    Fellowships         F31: Diversity Predoctoral Fellowship
    (NRSA)              F32: Postdoctoral Fellowships
“K”: Career             K99/R00: Pathways to Independence Award
    Development         K08: Mentored Clinical Scientist Develop Award
                        K12: Institutional Career Develop Program
      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
         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
         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@niehs.nih.gov
   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
   R15 – AREA Grants…Research 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@niehs.nih.gov
           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/NOT-OD-04-007.html
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.
       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
Exciting Opportunities - 1
Outstanding New Environmental Scientist (ONES): NIEHS. Highly selective for most
talented new scientists; Long term commitment to EHS research; < 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 (>50% 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, mentor’s (sponsor’s) 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 mentor’s 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.
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 NIH’s 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)
  Important Personnel


  PROGRAM                 SCIENTIFIC
ADMINISTRATOR              REVIEW
                           OFFICER




              GRANTS
            MANAGEMENT
             SPECIALIST
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.
The NIH Grant Process


         NIH Grant Process




    What happens in the Black Box ?
Overview of NIH Grant Process
      Submission


      Referral


      Review

      Award


      Post-award
     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
                 Submission Dates
Standard Deadlines:
   http://grants.nih.gov/grants/funding/submissionschedule.htm

R01 (new Research Grants): SF424 (R&R)
  February 5, June 5, October 5

R01 (renewal, resubmission, revision): SF424 (R&R)
  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
         Where To Go For Help…
   General information on Electronic Submission and the SF424 (R&R):
    http://era.nih.gov/ElectronicReceipt

   Grants.gov registration, submission and ADOBE questions: Visit:
    http://www.grants.gov/CustomerSupport
        Grants.gov Customer Service
             E-mail: support@grants.gov
             Phone: 1-800-518-4726
   eRA Commons registration and post submission questions on Commons
    functionality
        Web Support: http://ithelpdesk.nih.gov/eRA
        eRA Commons Help Desk
             E-mail: commons@od.nig.gov
             Phone: 1-866-504-9552 OR 301-402-7469
   Forms transition and questions on NIH’s overall plan for electronic receipt
        NIH Grants Information
             E-mail: grantsinfo@nih.gov
             Phone: 301-435-0714
        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!
Overview of NIH Grant Process
      Submission


      Referral


      Review

      Award


      Post-award
 ENHANCING PEER
REVIEW – CHANGES
  IMPLEMENTED
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/index.htm
        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/NOT-OD-09-155.html
           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/not-od-09-016.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html
      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/not-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
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.
 ENHANCING PEER
REVIEW – UPCOMING
     CHANGES
NEW FORMS, FORMAT, PAGE LIMITS

   Applies to paper and electronic submissions (PHS 398
    and SF 424 R&R)
   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.
         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/NOT-OD-09-149.html
       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
                APPENDIX MATERIALS

Appendix requirements; Notice OD-07-018
http://grants1.nih.gov/grants/guide/notice-files/NOT-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)
               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.
        New Research Plan Components

Introduction
Specific Aims                                                   Research
Background and Significance                                     Strategy
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
         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
     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
    Enhanced Review Criteria for FY2010
Core Review Criteria
                                          Significance
 For research grant applications and
                                           Investigator(s)

                                       
cooperative agreements

 Received for potential FY2010           Innovation
funding
                                          Approach
Will receive individual criterion
scores from assigned reviewers &
discussants                               Environment
   Enhanced Review Criteria for FY2010
Core
Review
               Does the project address an important problem or a
Criteria       critical barrier to progress in the field?

               If the aims of the project are achieved, how will
Significance   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?
   Enhanced Review Criteria for FY2010
Core         Does the application challenge and seek to shift
Review       current research or clinical practice paradigms by
Criteria     utilizing novel theoretical concepts, approaches
             or methodologies, instrumentation, or
             interventions?
Innovation
             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?
     Enhanced Review Criteria for FY2010
Core Review       Are the PD/PIs, collaborators, and other
                  researchers well suited to the project?
Criteria
                  If Early Stage Investigators or New Investigators,
Investigator(s)   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)
   Enhanced Review Criteria for FY2010
Core
Review
              Will the scientific environment in which the work
Criteria      will be done contribute to the probability of
              success?
Environment
              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?
     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
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 ⅓ 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***
             New Scoring Procedures
New Scoring Procedures for Evaluation

http://grants.nih.gov/grants/guide/notice-files/NOT-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




                                                                           50
9-point Scoring Descriptions




                      Weaknesses
    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.
                                                          52
             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




                                                           53
                 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
    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
       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 can’t
    change the score.
Overview of NIH Grant Process
   Submission

   Referral

   Review

   Award

   Post-award
     Funding Considerations

Recommendations from DERT are based on:

   Summary Statement: Score and review
    narratives

   Programmatic Priorities

   Budgetary Considerations
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)
Overview of NIH Grant Process

    Submission

    Referral

    Review

    Award

    Post-award
                 Post-Award
   Yearly Progress Reports

   Competitive Renewal (for some mechanisms –
                   not K99/R00)


           Fame and Fortune
                       Summary of NIH Grant Process


                                         Initiates Research                                     Conducts

                                         Idea and Prepares                                      Research

                                              Application

                                                                            INVESTIGATOR



                                                                                GRANTEE
                                  Submits                                                                       Manages

                                Application                                                                      Funds




                                                   THE NATIONAL INSTITUTES OF HEALTH

                       IRG Evaluates                          Institute Evaluates           National Advisory              Institute Makes
    CSR Assigns
                        for Scientific                 for Program Relevance                 Council or Board             funding Decisions
to IRG and Institute
                              Merit                                 and Need               Recommends Action                  and Awards
  Thank you. QUESTIONS / INFORMATION

       JB Allen, PhD    919-541-7556
                        allen9@niehs.nih.gov

   http://www.niehs.nih.gov/dert/home.htm
http://www.niehs.nih.gov/dert/dertsrb/srb.htm

				
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