The NIH, NIDA, and the Review Process: Focus on Undergraduate Institutions and Students

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The NIH, NIDA, and the Review Process Focus on
Undergraduate Institutions and Students
Jose Ruiz, Ph.D. Scientific Review
Officer, Office Of Extramural Affairs, National
Institute on Drug Abuse, NIH, DHHS May 28, 2008
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NIH Mission

• NIH is the steward of medical and behavioral
  research for the Nation
• Our mission is to is to uncover new knowledge
  that will lead to better health for everyone

• At a glance
• One of 11 agencies in the Department of Health
  and Human Services (HHS)
• 27 Institutes and Centers (IC)

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FY 2007 29.228 Billion
Training 2.7 764 Million
Research Project Grants 52.7 15.417 Billion
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NIH
NCI
NIBIB
NCMHD
NIDDK
NCRR
NIDA
NIAID
NIAAA
NICHD
NIEHS
NIGMS
NCCAM
NIMH
NINDS
NIDCD
NHGRI
NIA
NEI
FIC
NHLBI
NIAMS
NIDCR
NINR
NLM
CIT
CSR
CC
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National Institute on Drug Abuse

• Supports a great majority of the worlds research
  on the health aspects of drug abuse and addiction
• Has an annual budget of about 1 billion
• Is a leading supporter of behavioral research on
  HIV/AIDS
• Supports primarily extramural, investigator
  initiated research
• Supports research across the disciplines

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NIDA Funding Strategy

• Congressional Justification
• Initiatives Requests for Applications Program
  Announcements (RFAs Pas)
• Strategic Plan

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NIDA BUDGET
(Thousands)
2006Actual
2008Est.
2009P.B.
2007Budget Authority
698,976
699,168 301,532 1,000,700 0.1
700,140 301,532 1,001,672 0.1
NonAIDS
699,852 300,162 1,000,014
299,882
AIDS
998,858
TOTAL
Increase Over Prior Year
0.6
-0.8
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Addiction is a complex behavioral,
neurobiological, and genetic disorder
DEVELOPMENTAL, ENVIRONMENT (e.g. Social)
DRUG EXPOSURE
SYNAPTIC PLASTICITY
BRAINCHANGES
GENETIC VARIANTS
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NIDAs Extramural Programs

• Division of Basic Neurosciences Behavioral
  Research
• Division of Pharmacotherapies Medical
  Consequences of Drug Abuse
• Division of Epidemiology, Services Prevention
  Research
• Division of Clinical Neuroscience and Behavioral
  Research
• Center for Clinical Trials Network
• AIDS Research Program

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DBNBR supports basic research on the behavioral,
neurobiological, genetic developmental and social
cognitive factors associated with drug abuse and
addiction
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Modeling the Addiction Process
V. Deroche-Gamonet, D. Belin, P. V. Piazza,
Science 305, 1014 (2004) L. J. M. J.
Vanderschuren, B. J. Everitt, Science 305, 1017
(2004)
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NIH Grant Award Mechanisms
R21
R01
K08
F32
R03
T32
K23
R43
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Research Project Grants

• Traditional R01
• Exploratory/Developmental/Planning Grants
  R03/R21/R33/R34
• Program Project P01
• Research Center Grants P20, P30, P50, P60
• Small Business R41, R42, R43, R44
• AREA Grants R15

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Finding Grant Opportunities

• How Do You Find 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)

NIH Guide http//grants.nih.gov/grants/guide/inde
x.html
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NIH webpage http//www.nih.gov/
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Office of Extramural Researchhttp//grants.nih.go
v/grants/oer.htm
New Parent FOA page added for quick reference
to unsolicited applications.
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So What Type of GrantIs Right for Me?
Stage of research career? - experience and
expertise? Research needs? - mentors or
collaborators? - size of project?
Talk with staff Program Officers at NIDA. NIDA
will help you find the right funding mechanism.
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R01

• Original and historically oldest grant mechanism
  used by NIH
• Used to support a discrete, specified,
  circumscribed project to be performed by the
  named investigator(s) in an area representing the
  investigator's specific interest and
  competencies, based on the mission of the NIH
• Not limited in dollars
• Generally awarded for 1-5 budget periods, each
  normally 12 months in duration
• Can be renewed by competing for an additional
  project period
• Supplements are allowed

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Small Grants R03

• Support small research projects that can be
  carried out in a short period of time with
  limited resources
• Project period of up to two years and a budget
  for direct costs of up to 50,000 per year
• For new projects only competing continuation
  applications will not be accepted
• Types of projects that ICs support with the R03
• Pilot or feasibility studies
• Secondary analysis of existing data
• Small, self-contained research projects
• Development of research methodology
• Development of new research technology

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Small Grants R21

• Intended to encourage exploratory/developmental
  research projects by providing support for the
  early and conceptual stages of development
• Ex Assess the feasibility of a novel area of
  investigation or a new experimental system that
  has the potential to enhance health-related
  research
• may involve considerable risk but may lead to a
  breakthrough in a particular area, or to the
  development of novel techniques, agents,
  methodologies, models or applications that could
  have major impact on a field of biomedical,
  behavioral, or clinical research
• long-term projects, or projects designed to
  increase knowledge in a well-established area
  will not be considered
• Project period of up to two years with a combined
  budget for direct costs not to exceed 275,000
• For new projects only competing continuation
  applications will not be accepted
• Preliminary data not required

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Other Funding Opportunities
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NIH Academic Research Enhancement Awards (AREA)
R15
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ACADEMIC RESEARCH ENHANCEMENT AWARD(AREA) or
R15 Program

• PURPOSE
• Strengthen the research environment at
  institutions that are not research intensive
• Exposing students, especially undergraduates, at
  such institutions to biomedical and behavioral
  research
• Providing support for meritorious research at
  these institutions

http//grants1.nih.gov/grants/funding/area.htm
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Features of the AREA Grant

• FEATURES
• Duration - Up to 3 yrs
• Mentor - No
  
• Res. Costs - 150,000
• Renew - Yes
• Pages - 25 pgs.
• Receipt Dates-Feb 25, June 25, Oct 25

• Small-scale Research support
• pilot research projects and feasibility studies
• development, testing, and refinement of research
  techniques
• secondary data analysis
• similar discrete research projects that
  demonstrate research capacity
• Eligible institutions with less than 3M total
  costs in NIH support in each of 4 or more of the
  last 7 years

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NIH AREA /R15 FEATURES

• Only 1 AREA grant at a time per PI/PD
• PI cannot hold another active NIH research grant
  at the time of award
• Eligible organizations include domestic public
  private institutions that offer at least a
  baccalaureate degree in the sciences
• Majority of research should be done at the home
  institution
• R15 grants eligible for administrative
  supplements for underrepresented students
• Online application submission through
  www.grants.gov

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R15 FUNDING

• Multi-year Funding
• R15 is a RESEARCH grant, not training
• Specific funds available and research objectives
  at NIH ICs
• http//grants.nih.gov/grants/funding/area_objectiv
  es.doc
• Success rates for AREA applications are
  competitive

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AREA Application Award Data
Rev
Awarded
Funds
Rate
IC
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AREA Specific Review Criteria-Facilities and
Other Resources

• A profile of available students and outcomes
  (degree and graduate school)
• Special characteristics of the school/academic
  component that make it appropriate for an AREA
  grant
• Brief description of resources that will be used
  at another institution, if relevant
• Statement of institutional support for the
  proposed research project, if relevant

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AREA Specific Review Criteria

• INVESTIGATOR Is the principal investigators
  experience appropriate for supervising available
  students in research?
• ENVIRONMENT Assess the suitability of the
  applicant school/academic component for an award
  in terms of the likely impact that an award will
  have on strengthening the research environment
  and exposing available students to research.

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AREA Application Receipt, Referral and Review
Cycles
 http//grants.nih.gov/grants/funding/submissionsc
hedule.html
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CRISP Check out potential opportunities and
competition

• Search CRISP (Computer Retrieval Information on
  Specific Projects) for abstracts of funded
  projects
• Get to know projects that are ongoing in your
  research area
• Know potential collaborators and/or competition
  in the field
• Determine if there are any potential projects
  eligible for supplement opportunities.
• http//www.crisp.cit.nih.gov/

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PubMed www.pubmed.gov
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RePORT Webpage -
http//report.nih.gov/
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Scientific Review Process
National Institutes of Health
School or Other Research Center
Research Grant Application
Center for Scientific Review
Assign Inst. Study Section

Initiates Research Idea
Study Section
Submits Application
Review Scientific Merit
Institute
Evaluate for Relevance
Advisory Councils and Boards
Allocates Funds
Conducts Research
Recommend Action
Institute Director
Takes final action
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Dual Review System for Grant Applications

• First Level of Review
• Scientific Review Group (SRG)
• Provides Initial Scientific Merit Review of Grant
  Applications
• Rates Applications and Makes Recommendations for
  Appropriate Level of Support and Duration of Award

• Second Level of Review
• Council
• Assesses Quality of SRG
• Review of Grant Applications
• Makes Recommendation to Institute Staff on
  Funding
• Evaluates Program Priorities and Relevance
• Advises on Policy

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grants1.nih.gov/grants/grant_tips.htm
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NIH Two System Process

• Grants.gov
• Grants.gov hosts standardized federal forms SF424
  (RR) and agency-specific forms (PHS 398)
• Electronic application through Grants.gov using
  these forms is mandatory for most FOAs.
  Grants.gov checks the application for
  federal-wide requirements.

• eRA Commons
• NIH retrieves the data from Grants.gov and checks
  the application against NIH-specific requirements
• eRA Commons allows applicants to electronically
  track the status of submissions and to
  receive/transmit application and award information

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Registration

• Grants.gov
• Be sure your organization is registered! (one
  time)
• U.S. organizations obtain EIN from IRS (foreign
  applicants see next slide)
• Request DUNS from Dun Bradstreet
• Register with Central Contractor Registry (CCR)
  identify the eBiz Point of Contact (POC)
• Register the Authorized Organization Reps (AORs)
  who can officially sign the application and
  submit
• Visit http//www.grants.gov/applicants/get_regist
  ered.jsp

Grants.gov registration can take up to 8 weeks
for international organizations. START NOW!
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Registration

• eRA Commons PD/PI Registration
• The PD/PI needs to work with the SO to get
  registered in the eRA Commons
• The PI and SO need separate accounts because each
  has different privileges
• PIs have one account that follows them throughout
  their careers. They can view all applications
  where they are listed as PI. The same account
  may be affiliated with multiple organizations.
• SOs can view all applications submitted on behalf
  of the organization

Allow 4 5 business days to complete PI
registration in the eRA Commons
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Software Requirements

• Grants.gov Forms Viewer Software (Free)
• PureEdge Forms Viewer
• New Adobe Acrobat Viewer coming this Fall
• http//www.grants.gov/resources/download_software
  .jsp
• PDF generation software list provided on
  Grants.gov website http//www.grants.gov/agencies/
  software.jsp3

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Preparing Your Application

• Download the Application Package and Instructions
  at the same time. NIH-specific instructions are
  denoted by the HHS logo
• Save the application to your hard drive
  remember to save it after each change
• The application includes specific data fields as
  well as multiple attachments
• All attachments must be saved as PDF documents

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Create a checklist

• Extract all of the requirements from the FOA
• Note what is required, including page limits
• Pay attention to formatting guidelines (margins,
  font size)
• Determine who will submit letters of
  recommendation
• Create a timeline to help manage your application
  process

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Preparing Your Application

• Avoiding Common Errors
• NIH requires all application attachments to be in
  PDF format
• The eRA Commons Username must be entered in the
  Credential, e.g. agency login field for each
  PI. This field is located on the RR Senior/Key
  Person Profile(s) form.
• The Organization Name must be included for all
  Senior/Key Persons listed
• Senior/Key Person effort listed on the RR Budget
  form must be greater than zero

For more information visit http//era.nih.gov/Ele
ctronicReceipt/avoiding_errors.htm
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Some key considerations

• Never assume that reviewers will know what you
  mean
• Tell a coherent and consistent story
• Write for a multidisciplinary audience
• Place your project in a larger scientific/public
  health context
• Create a cohesive application package
• Conduct a mock review with colleagues

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Submit Your Application

• Registration with Grants.gov and eRA Commons must
  be complete prior to submission
• Only the AOR may sign submit the application on
  behalf of the organization
• Grants.gov provides a Tracking Number and a
  Date/Time stamp when you click Submit save
  this information

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On Time Submission

• All registrations with Grants.gov eRA Commons
  must be complete
• Initial submission must have a Grants.gov
  timestamp on or before 500p.m. local time of
  submitting organization on the receipt date
• Errors in the application must be corrected
  within 5 business days of the receipt date

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Errors Warnings

• Errors stop processing and will keep your
  application from being accepted by NIH
• Warnings provide caution for you to ensure the
  item is correct, but will not stop processing
• Changed/Corrected applications may be submitted
  to Grants.gov again to address errors/warnings in
  the five business days after the receipt date.
• Initial application must have been on time
• you must include a cover letter explaining
  your changes

Limited Time!
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Tracking Your Application

• It is the applicants responsibility to track the
  application
• Grants.gov will send status emails to the AOR.
  eRA Commons will send status emails to the
  Signing Official, PI Person to be contacted
  listed on the application
• Log into eRA Commons to check application status
  do not rely on emails. If it is error-free, you
  will have an assembled application to view

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Application Viewing Window

• Applicants have two weekdays (M-F, not including
  U.S. federal holidays) to view the assembled
  application. If no action is taken, it
  automatically proceeds to NIHs Division of
  Receipt and Referral.
• Signing Official has option to Reject
• PI will receive e-mail notification if SO rejects
  application
• If Rejected after receipt date for any
  reasonother than a Grants.gov or NIH system
  issue, the submission is subject to the NIH late
  policy

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Release of scores and summary statements

• Within 1 3 days, final priority scores are
  released to the PI and/SO in eCommons
• In about 1 6 weeks summary statements are
  released to eCommons
• Summary statements for new investigator
  applications are released within 30 days
• Program seeks NIDA Council concurrence on
  funding recommendations
• PI work with PO to discuss critiques and re-work
  application in time for the next round

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How did the committee arrive at its evaluation of
your application?

• Assignments to reviewers based on expertise and
  avoiding conflicts
• Initial review conducted individually and
  preliminary scores and critiques posted to IAR
• Review meeting in person, or by teleconference,
  also Asynchronous Electronic Discussion
• Meeting facilitated by the Chair with SRO as the
  DFO
• Discussion of applications at meeting led by
  assigned reviewers (R1, R2, R3)
• Assigned reviewers set the range for final scores
• All reviewers score based on the discussion
• Critiques revised and uploaded after the meeting

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Streamlining or UN

• Based on preliminary scores, the committee
  categorizes each application as either highly or
  less meritorious
• Any reviewer (if not in conflict) can champion
  the full discussion of an application
• Applications designated as less meritorious are
  unscored (UN) and are not discussed
• About 50 of applications are unscored

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In-house opportunities for undergrads

• NIDA Summer Scholars
• NHLBI St. Marys College of Maryland student in
  Summer 2008 group

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Summer Research with NIDA

• Supported by Diversity Supplement Program
• Summer program for undergraduates and high school
  students from racial/ethnic minority groups
• 8-10 week research placement with NIDA
  investigator

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Post-bac Opportunities

• AAAS
• NIH Tech Transfer
• Other NIH Post-bac opportunities

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Online Resources

• Overview of Electronic Submission
  http//era.nih.gov/ElectronicReceipt/
• Frequently Asked Questions http//era.nih.gov/Elec
  tronicReceipt/faq.htm
• Avoiding Common Errors http//era.nih.gov/Electron
  icReceipt/avoiding_errors.htm
• Training Resources, Videos, Quick Reference
  Materials http//era.nih.gov/ElectronicReceipt/tra
  ining.htm

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Where to find information about trends and
success rates

• Award Trends (http//grants.nih.gov/grants/award/a
  wardtr.htm)
• Success rates (http//grants.nih.gov/grants/award/
  success.htm)

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Finding Help

• eRA Commons Help Desk Online Help Ticket
  http//ithelpdesk.nih.gov/eRA/
• Phone [phone] or 1-866-504-9552
• Hours Mon-Fri, 7a.m. to 8 p.m. EST
• Support for Commons Registration, Application
  Status, Post-submission questions
• Grants.gov Contact Center Toll-free
  1-800-518-4726Hours Mon-Fri, 7 a.m. to 9 p.m.
  ESTEmail support_at_grants.gov
• Support for PureEdge Forms, PureEdge with a
  Mac, Grants.gov Registration