NIH 101 Primer NCURA 49th Annual Meeting

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NIH 101 PrimerNCURA 49th Annual Meeting

• Rebecca D. Claycamp, CRA
• Chief Grants Management Officer
• National Institute of Mental Health
• rc253d_at_nih.gov

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The Agenda

• Agency Overview
• Roles and Responsibilities
• Award Mechanisms
• Application Development Submission
• Review
• After the Award

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To get started(8 most frequently used acronyms
in this talk)

• IC Institute/Center
• FOA Funding Opportunity Announcement
• PA Program Announcement
• RFA Request for Application
• NoA/NGA Notice of (Grant) Award
• CSR Center for Scientific Review
• OPERA Office of Policy for Evaluation Research
  Administration
• FSR Financial Status Report

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Birthplace of the NIH, ca. 1887
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On October 31, 1940, President Franklin Roosevelt
dedicated the first six buildings of NIH
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The NIH Campus Then
1940 NIH Budget 707,000
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NIH Campus Now
2007 NIH Budget 29.2 Billion
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(No Transcript)
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NIH Institutes and Centers
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Off-Campus Facilities

• All but 3 NIH Grants
• Management offices
• are located in
• facilities away from
• the main campus.
• Most are located in
• the Rockville/
• Bethesda area of
• Maryland which is
• located (approx. 5
• miles away from
• the NIH campus).

Rockledge, Bethesda, MD Home of OPERA, the
Office of Extramural Research, the National
Heart, Lung, and Blood Institutes Grants
Management Branch, and many more.
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Essential Documents

• NIH Guide
• NIH Grants Policy Statement
• SF424 Application from Specific FOA or PHS 398
  Application, as relevant
• PHS 2590 Application
• PHS 416-1 Application
• Relevant FOA (RFA or PA)
• Notice of Award (aka Notice of Grant Award)
• http//www.grants.nih/grants/oer.htm

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NIH RPG Funding Stats

• In FY 2005, the NIH
• Reviewed Awarded Success
  Rate
• New 35,874 6,739 18.1
• Continuation 7,025 2,809 40.0
• Supplements 170 51
  30.0
• __________________________________________________
  ______
• Totals 43,069 9,599 22.3

In FY 2006, the NIH Reviewed
Awarded Success Rate
New 38,220 6,390 16.7 Continuation
7,320 2,694 36.8 Supplements
148 44 29.7 ____________________
____________________________________ Totals 40,8
61 10,052 24.6
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FY 2007 Budget 29.2 Billion
Research Project Grants 55 15.4 billion
Training 3 761 million
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The NIH Extramural Team
Review
Grants Management
Program
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Program Officer

• Responsible for the scientific and/or technical
  aspects of grants
• Important contact for PIs
• Initiates and encourages interest in scientific
  area of importance to match that of Institutes
  mission
• Is familiar with the peer review process
• Prepares funding recommendations
• Reviews annual progress of grants

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Scientific Review Administrator

• Performs administrative technical review of
  applications
• Selects reviewers
• Manages study sections and project site visits
• Prepares summary statements
• Provides any requested information about study
  section requirements

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Grants Management Officer

• Monitors administrative and fiscal aspects of the
  grant
• Assures compliance with Federal laws and NIH
  administrative policies and procedures
• Responsible for maintaining the official grant
  files for grant awards
• Is the only NIH official authorized to obligate
  the NIH to funds or other terms and conditions of
  award

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Grants Management Specialist

• Acts as an agent of the GMO
• Assures compliance with Federal laws and NIH
  policies and procedures
• Analyzes grant applications prior to award
• Prepares award for GMO release
• Reviews and responds to grantee prior approval
  and rebudgeting requests
• Assures documentation of official grant files

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The Grantee Institution Team
Institution
Authorized Institutional Official
Principal Investigator
Research Administrator
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Grantee Institution

• Award made to institution
• Legally responsible for proper
• conduct and execution of the project
• Provides fiscal management of
• the project
• Oversight on allocation decisions
• Assures compliance with Federal laws and
  regulations, and NIH policies and procedures

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Authorized Organizational Representative

• aka Authorized Institutional Official
• Designated representative of the grantee
  organization
• Accountable for information presented in grant
  application, signs all official correspondence.
• Assures compliance with Federal laws and
  regulations, and NIH policies and procedures.

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Principal Investigator(s)

• Designated by grantee institution
• Responsible for scientific and technical aspects
  of proposal
• Assures compliance with Federal laws and
  regulations, and NIH policies and procedures -
  maintains contact with Grants Management
  Specialist
• Assures scientific compliance - maintains contact
  with Program Administrator

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Principal Investigator(s)

• Should work with designated officials within
  grantee organization to
• Create/maintain necessary technical and
  administrative documentation
• Prepare justifications
• Comply with organizational and Federal
  requirements
• Acknowledge Federal support in publications

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Research Administrator

• Acts as a local agent of the Authorized
  Organizational Representative and/or PI
• Is a counterpart to the Grants Specialist
• Provides essential grant-related support
• Cannot assume responsibilities assigned to the
  Authorized Institutional Official or the PI

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The Program Officer can

• find the right program and Institute
• suggest the most appropriate mechanism
• provide technical assistance as the researcher
  develops the application
• help navigate information on study sections

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The Grants Specialist can

• answer questions about completing the SF424(RR)
  and PHS398
• provide guidance on administrative and fiscal
  aspects of applications and awards
• help navigate NIH grants management information
  on the Web

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Who is eligible for an NIH grant?

• Qualified scientist(s) at institution that can
  provide the needed resources
• Except for fellowships, grants are to
  institutions, not individuals Career Awards to
  the institution for a named individual
• Awards to foreign institutions for projects not
  having comparable research in the U.S.
• For most training and career awards, person needs
  U.S. permanent residency

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Multiple PIs

• Available to all research grant applications
  submitted electronically through Grants.gov
• Does not apply to certain mechanisms Ks, Fs,
  R36, DP1, DP2, C06, S10
• Some paper-submitted PHS398 applications will
  allow inclusion of multiple PIs, but only when
  clearly specified in the RFA or PA

http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-07-017.html
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Key Features of the Multiple PI Option

• Applications
• Leadership Plan required describing roles,
  responsibilities, and the working relationship of
  the identified PIs
• All PIs must have PI role NIH still does not
  recognize Co-PI
• Principal Investigators
• The Contact PI will be responsible for
  communication between the NIH and the leadership
  team (and will be listed first on the
  application)
• All PIs share the responsibility authority for
  leading directing project
• New Investigator Policies
• New Investigator box on the application may only
  be checked when all PIs are classified as New
  Investigators
• Awards Involving More than One Institution
• PIs from different institutions will be managed
  though subcontracts until options involving
  linked awards have been developed

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The NIH Commons

• Administration
• Create and maintain institutional profiles (IPFs)
• Create and maintain user accounts and
  professional profiles (PPFs)
• PI must have Commons Account for SF424 submission
• Status
• Display summary and detail grant info, notice of
  grant award and other documents, progress report
  face page, NIH staff contact info
• Link to study section dates and rosters
• Submit Just-in-Time Information
• Enter IACUC and IRB approval dates, other support
  and education info for key personnel involved
  with human subjects

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The NIH Commons

• Internet Assisted Review (IAR)
• Submit Electronic Simple Non-Competing Award
  Process (eSNAP)
• Submit SNAP, non-competing progress reports
• Due 45 days before budget start date (vs. 60 days
  for paper)
• IRB and IACUC approval dates not required with
  submission
• Image stored in electronic grant folder for
  online viewing

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The NIH Commons

• Submit No-Cost Extension Notification
• Automatically updates end dates
• Generates notifications
• Can submit up to the last day of current project
  period (no 10-day window as with hardcopy
  requests)
• Submit Closeout Documents
• Final Progress Report
• Final Inventions Statement
• Links to system for Final FSR

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Mechanisms and Activity Codes

• Terms often used interchangeably, an activity
  code is the three-digit identifier of an grant
  award type--e.g., R01 is a Research Project, P50
  is a Specialized Center. For budgeting purposes
  activity codes are grouped into funding
  mechanisms for example, the training mechanisms
  includes career (K), fellowship (F) and training
  (T) activity codes.

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Award Mechanisms-Contracts

• Contracts
• Acquisition or purchase of services or supplies
  for the direct use or benefits of the federal
  government
• Initiated by NIH
• FEDBIZOPPS
• ExamplesN01, N02, N43, N44

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Award Mechanisms-Grants

• Research Project Grants (RPGs)
• Usually investigator-initiated
• Specifically includes R01, R03, R15, R21, R22,
  R23, R33, R34, R35, R36, R37, R55, R56, RC1, P01,
  P42, PN1, U01, U19, UC1 and NIGMS P41.
• Other R mechanisms termed other research
• Includes R13/U13, R18, R24, R25, SBIR/STTR and
  others

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Award Mechanisms-Grants

• Research Center Grants
• Established by ICs to meet special needs
• Research and core facility
• Examples
• Specialized - P50, U54
• Core grants - P30
• General clinical - M01

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Award Mechanisms-Training

• Training Grants - Institutional NRSA
• Predoctoral and postdoctoral slots
• Fellowships Kirschstein NRSAs
• Individual
• Predoctoral (F31)
• Postdoctoral (F32)
• Career Awards (Ks)

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Award Mechanisms-Cooperative Agreements

• Cooperative Agreements
• ExamplesU01, U13, U19, U24, U54
• Assistance as opposed to acquisition
• Substantial NIH programmatic involvement
• Generally referred to as a grant
• Usually initiated by NIH

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FY2007 Grant Award Facts

• The 24 ICs and the Office of the Director
  awarded grants representing 110 award types
  including
• 8 Fs
• 18 Ks
• 11 Ps
• 20 Rs
• 10 Ts
• 19 Us

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FY2007 Grant Award Facts

• One IC awarded 49 different activity codes (NCI)
  one awarded only 11 (FIC) the median was 36
• 23/24 ICs awarded R01s
• 23/24 ICs awarded Ts
• 22/24 ICs awarded Fs

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FY2007 Grant Award Facts

• Only 30/110 activity codes awarded by 13 or more
  of the ICs
• 45 mechanisms each awarded by only one IC (not
  including DP1 and DP2)
• 11 of these 45 awarded by one IC (NCRR)

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Why are these facts important to note?

• Critical to look at each ICs web page to see
  what grant award programs each supports
• Essential to review relevant PAs and RFAs from
  the NIH Guide
• Invaluable for PIs to talk to Program staff at
  an IC

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Developing the Application

• Identify NIH Program
• Search Institute Web Sites
• ID Pool of Potential Program Staff
• Send Email about Idea
• Identify relevant RFA or PA (FOA)
• Follow-Up

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Finding Funding Opportunities Searching the NIH
Guide
Office of Extramural Research home
pagehttp//grants.nih.gov/grants/oer.htm
Select Funding Opportunities in the NIH Guide for
Grants and Contracts
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Funding Opportunity Announcements (FOAs)

• Most NIH grants are unsolicited. If solicited,
  funding opportunities are published in the NIH
  Guide for 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 (active up to 3 yrs)
  Parent PA for unsolitcited SF424 programs
• 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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Importance of the RFA/PA

• Will define eligible mechanisms
• Will define eligible PIs and institutions
• Will specify budget format
• May dictate budget caps
• May identify certain allowable and/or unallowable
  cost elements

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Proposal Development

• What makes a successful application?
• Science (significance)
• Approach (design, methods, analyses, problems and
  alternatives)
• Investigator (training, suitability for project)
• Innovation (novel concepts or approaches)
• Environment (unique features, collaborations,
  institutional support)
• Review criteria for research grant applications
• Available in PHS 398 instructions

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NIH Currently Has Two Kinds of Application
Processes

• NIH has transitioned many mechanisms to SF424
  (RR) including SBIR/STTR, G07, G08, G11, G12,
  G20, DP1, R01, R03, R13/U13, R15, R18/U18, R21,
  R25, R33, R34/U34, R36, S10, S11, S21, S22, X01,
  X02
• remainder remain on hold, including Ks, Ts, Fs
  and complex mechanisms must use PHS398 or 416-1,
  as appropriate

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When Do I Have to Submit a Modular Grant?

• Research project grant mechanisms (R01, R03, R15,
  R21) and RFAs with no more than 250,000 direct
  costs/year.
• Requested total direct costs in modules of
  25,000 reflecting appropriate support for
  project. There will be no future year
  escalations in the traditional sense.

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Do I have to contact NIH before I submit a
proposal?

• Always recommend contact with program staff
  during application development
• Must contact IC staff must agree to accept the
  application prior to a submission for any
  investigator-initiated competitive applications
  with gt500,000 direct cost for any single year
• Request must be six weeks before deadline
• Refer to NIH Guide dated 10/16/2001

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When are NIH applications due?

• ALL competitive applications are submitted to CSR
• Unsolicited Applications
• Considered on time if received by or mailed on
  or before the published receipt date
• Solicited Applications
• Must be received by the specified date (or the
  following business day if a weekend or holiday)
• On time Grants.gov applications must be
  accepted by 500pm local time on the submission
  date
• No request for waiver of a receipt date will be
  considered in advance

http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-06-030.html
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Change in Standard Receipt Dates Effective
January 1, 2007

• Receipt for different mechanisms spread over
  multiple dates virtually no more Feb 1, Jun 1,
  Oct 1
• For all submissions paper or electronic
• RFAs and PAs with special receipt dates continue
  to be due on the specified date listed in the
  FOA.
• e.g., New R01s due Feb 5, Jun 5, Oct 5
  renewals/ resubmissions/revisions due Mar 5, Jul
  5, Nov 5

NIH Guide, October 6, 2006 http//grants2.nih.gov/
grants/guide/notice-files/NOT-OD-07-001.html
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CSR Application Receipt Center
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Where Are Applications Reviewed?

• GROUPS
  APPLICATIONS REVIEWED
• CSR Research projects
• Study Sections Academic Research
  Enhancement Awards
• Special Emphasis Panels Postdoctoral
  Fellowships
• Small Business Innovation Research
• Institutes Shared Instrumentation
• Scientific Review Program Projects
• Committees Centers
• Institutional Training Grants
• Conference Grants
• Career Awards
• Small Grants
• RFAs
• Contract Review Committees Contracts

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What happens when CSR receives a grant?

• Assessed for completeness and eligibility
• Referral Officer
• Assigns to a SRG for initial peer review
• Assigns to a primary and multiple secondary IC
  for potential funding and secondary review
  (advisory council/board)
• Application number assigned
• Notice of assignment sent in 4-6 weeks

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Who reviews grants?

• Scientific Review Administrator recruits and
  selects reviewers
• Some reviewers charter others ad hoc or
  temporary
• Reviewers are scientists with appropriate
  expertise
• Specific grant review assignments based on
  expertise of reviewers and their knowledge of the
  field

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What review criteria are used?

• Depends upon mechanismfor R01 applications, NIH
  uses five review criteria
• Significance
• Approach
• Innovation
• Investigator
• Resources and Environment
• Also will be detailed in the RFA/PA.

http//grants.nih.gov/grants/guide/notice-files/NO
T-OD-05-002.html
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How is an application reviewed?

• Each reviewer typically is asked to be primary
  reviewer on 6-12 applications for a round
• Each application typically has two primary
  reviewers and a secondary reviewer
• A standing study section may have some 60-100
  applications per round

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What is Streamlined Review?

• The process by which applications judged by the
  reviewers to be in the lower half of those
  assigned for review are not discussed at the SRG
  meeting. aka triage.
• Any member can object to streamlining an
  application
• Streamlined applications still receive written
  critiques from reviewers
• Allows more time for discussion of more
  meritorious applications
• Shortens meetings and some persons more willing
  to serve

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What are the results from peer review?

• Decision as to whether or not an application will
  be scored
• Based on this, each assigned reviewer gives a
  preliminary score of 1 (best) to 5 (worst) to
  each application assigned to him/her
• After discussion, all reviewers give a final
  score
• Score converted to priority score and percentiled
  (if applicable)
• Summary Statement sent to the PI whether scored
  or unscored

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What does Council do?

• Conducts second level peer review
• Selected Pay (HPPs, foreign grants, human
  subjects/animal welfare concerns, PI appeals)
• En bloc approval of all other applications
• Approval of new program initiatives and concept
  clearances
• Consideration of policy issues

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Funding Factors ICConsiders In Making Awards

• Scientific Merit
• Contribution to the Mission of the Institute
• Program Balance
• Availability of Funds/Funding Strategy

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Research grants, revised RFAs others
PI can request IRG and IC
NIH Application Process Overview
RFAs others
Application to CSR
CSR assigns to IRG, IC
CSR sends to IC
Summary Statement to PI
Review by CSR IRG
Review by IC
Second Level Council Review
Fundable
Not Fundable
PI Notified, Given Feedback
IC Negotiates Award
PI Evaluates Feedback
Revised Application
Grant Ends, Renewal
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Study Sections Do Not Fund
INSTITUTES/CENTERS FUND!

• Study sections judge applications scientific and
  technical merit
• Institute/Centers take these evaluations very
  seriously
• Institute/Centers also consider relevance of
  application to the Institutes research priorities

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Funding Timeline
Submission
Review
Post-Review Phase
Oct 1/Nov 105
Feb Mar 06
Mar-Jun 06
May/Jun 06
Jul 1 06
Feb 1/Mar 1 06
Jun Jul 06
Sep 30 06
Sep/Oct 06
Dec 1 06
Jun 1/Jul 1 06
Oct Nov 06
Nov-Feb07
Jan/Feb 07
Apr 1 07
Standard Receipt Date (new/revised and
continuation)
Initial Peer Review
Council Meeting Funding Approved for en bloc
and Special Actions
Earliest Start Date
Funds Released for Payline Grants Chosen for
Expedited Second-Level Review
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Are there limits to resubmitting a proposal?

• Application modified following initial review and
  resubmitted for consideration
• Maximum of two revised applications
• (limit within two years no longer applies)
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-03-041.html

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Sample Application/Award Number
Suffixes
Activity Code
Serial Number

• 1 R01 GM 012345 01 A1/S1

Application Type
Institute/Center
Year of Support
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Types of NIH Application/Award

• New Competing - Type 1
• Renewal/Competing Continuation - Type 2
• Supplement - Type 3
• Competitive - outside original scope
• Administrative - within the original scope
• Extension (limited use) - Type 4
• Noncompeting Continuation - Type 5
• Successor-In-Interest/Name Change Type 6
• Change of Grantee Institution Type 7
• Change of Institute, Noncompeting Type 8
• Change of Institute, Competing Type 9

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Just-In-Time Information

• Other Support of Key Personnel
• IACUC Approval Within 3 Years
• IRB Approval Within 1 Year
• Certification of Education on Human Subjects

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What is in the Notice of Award? (aka NGA)

• Legally Binding Document
• Establishes funding level
• Establishes period of support
• Sets forth terms and conditions
• NIH Contact Information
• Program Director
• Grants Management Specialist

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What is in the Notice of Award?

• Notice of Award Letter
• Is sent to the business official and is in the
  Commons
• Identifies name of institution, PI, budget
  period, project period, amount of award, issue
  date, title of project
• Specifies that the award terms are accepted once
  funds are drawn or obtained from the payment
  system

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What is in the Notice of Award?

• NoA Section I
• Award Data
• Provides a categorical breakdown of the budget
  (unless modular or SNAP award) for current and
  future years
• Indicates whether an unobligated balance has been
  applied to the award amount
• Fiscal Information

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What is in the Notice of Award?

• NGA Section II
• Grant Payment Information
• OIG Hotline Information
• NGA Section III Terms and Conditions
• Grant Program legislation and regulations
• Restrictions on the expenditure of funds in
  appropriation acts
• 45 CFR 74 or 92, as applicable
• NIH Grants Policy Statement
• Standard terms and conditions

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What is in the Notice of Award?

• Standard Terms and Conditions
• Included or excluded from carryover as
  appropriate
• Streamlined Noncompeting Award Process (SNAP)
• Program income

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To SNAP or Not to SNAP

• Awards typically not SNAPed
• Cooperative Agreements
• Clinical Trials
• Centers
• Training Grants

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What is in the Notice of Award?

• NGA Section IV Special Terms and Conditions
• Restrictive terms
• Informational Terms
• Terms for a revised award
• Terms for a supplemental award
• Cooperative agreement terms

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What can slow down the award process

• Lack of or slow response to inquiries
• Delays sending JIT info
• IRB approvals
• IACUC approvals
• Certification of Education on Human Subjects
• Other Support
• Info sent without identification
• Lack of institutional signatures

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What can slow down the award process

• Budgets with inadequate justification
• Other support for an individual that adds up to
  more than 100/12 months
• Missing information for Key Personnel
• Checklist FA that doesnt make sense
• Out of date IRB/IACUC approvals
• Lack of population data for clinical grants

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What can slow down the award process

• Being on Continuing Resolution
• Required Congressional notification
• Request for carryover without justification
• A noncompetitive renewal missing interim required
  prior approvals
• Submitting a change of institution in August or
  September

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After award, when do we need to contact to NIH?

• Noncompeting Progress Report
• due two months prior to anniversary date45 days
  for eSNAP
• SNAP and non-SNAP processes

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Administrative and Fiscal Monitoring

• SNAP (Streamlined Non-Competing Award Process)
• Award in total direct and indirect costs
• Total costs as commitment base
• Modified financial reporting FSR only due at
  the end of the competitive segment
• Three questions in noncompeting applications

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Administrative and Fiscal Monitoring

• SNAP Questions
• Change in Other Support key personnel?
• Change in the level of effort for key personnel
  named in the NoA?
• Estimated unobligated balance greater than 25 of
  current years total budget?

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Administrative and Fiscal Monitoring

• Traditional/ Non-SNAP
• Submit complete non-competing continuation
  application (PHS 2590)
• detailed budget and updated other support
• Categorical awards
• Total Costs as commitment base
• Annual Financial Status Reports

85
Key Elements of the Progress Report

• Specific Aims as funded
• Studies and results
• Significance
• Plans
• Inclusion Enrollment Report Table (clinical)
• Publications
• Personnel Report

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After award, when else do we need to contact to
NIH?

• Change in Scope
• Preaward Costs gt90 Days Prior to Effective Date
  of New or Competing Award
• Change in Key Personnel named in NoA
• Change in Grantee Institution
• Addition of a Foreign Component
• Second No-Cost Extension

87
After award, when else do we need to contact to
NIH?

• Changes in Grantee Organizational Status
• Changes to Award Terms and Conditions or
  Undertaking Any Activities Disapproved or
  Restricted as a Term of Award
• Retention of Research Grant Salary/ Fringe
  Benefit Funds When a K Award is Made
• Transferring Costs from Trainee Costs

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Rule of Thumb

• Whenever a PI contemplates post-award changes and
  is uncertain about the need for prior approval,
  consult, in advance, with
• Written policies and regulations, e.g., NIH
  Grants Policy Statement
• Sponsored Program Office
• Grants Management Specialist named in the Notice
  of Award or in the NIH Commons

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Award Closeout

• Final Reports Grantees are required to submit
  90 days after the end of the project period
• Final Financial Status Reports
• Final invention statement and certification
• Final Progress Report

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Five Helpful Addresses

• NIH Guide for Grants and Contracts
  http//grants.nih.gov/grants/guide/
• eSubmission http//era.nih.gov/ElectronicReceipt/
  
• Grants Policy Information (including GPS)
• http//grants.nih.gov/grants/policy/policy.htm
  
• NIH Regional Seminar Information
• http//grants.nih.gov/grants/seminars.htm
• List of GMOs
• http//grants.nih.gov/grants/stafflist_gmos.ht
  m