Peer Review of NIH Research Grant Applications

1
New form New process
Electronic R01s February 2007
The time is now to find out how http//era.nih.g
ov/ElectronicReceipt/
2
Big Changes for R01 Applicants

• For the February 5, 2007 R01 receipt date and
  beyond
• NIH will require electronic application
  submission for all R01 applications NO MORE
  PAPER!
• NIH welcomes unsolicited, investigator-initiated
  applications - use Parent Announcements listed
  at http//grants.nih.gov/gran
  ts/guide/parent_announcements.htm
• All applications must be in response to a Funding
  Opportunity Announcement

3
Learn More

• Start now!
• Work with your central grants office to learn how
  your institution is handling the changes.
• Join us live or via webcast on Dec 5 for training
  http//era.nih.gov/training/esub_120506/
• Training will be archived for later viewing
• Check out the training resources on
  http//era.nih.gov/ElectronicReceipt/training.htm
  

For full details on the new process, go to
http//era.nih.gov/ElectronicReceipt/
4
NIH Funding Mechanisms for Early Career Research
SupportWhat you need to know
Critical Research Issues in Latino Mental Health
2006 Grant Workshop Michael A. Sesma,
Ph.D. Office for Special Populations National
Institute of Mental Health
5
Finding the Right Grant Mechanism

• Match where you are in your career
• Pre-doc, Post-doc, New faculty member
• Match the type of research
• e.g. basic, risk and protective factors, pilot
  data, intervention development, secondary
  analyses, treatment, efficacy/effectiveness
• Match what types of funds are needed
• e.g how much , over how many years

6
Take-Home Message

• Communicate
• with NIH staff
• with investigators
• with institutional administrators
• http//www.nih.gov

7
NIMH Mission

• Reduce the burden of mental illness and
  behavioral disorders through research on mind,
  brain and behavior

8
NIMH Research Mission
The NIMH Directors Page http//www.nimh.nih.gov/a
bout/director.cfm
NIMH Strategic Plans and Priorities http//www.nim
h.nih.gov/council/advis.cfm

• National Advisory Mental Health Council Reports
  http//www.nimh.nih.gov/council/advis.cfm

9
How do we get there from here ?
psychiatric syndromes
Cells multiple subtle abnormalities
Genes multiple susceptibility alleles each of
small effect
Systems abnormal information processing
Behavior complex functional interactions and
emergent phenomena
10
Genes x Environment
11
?
Genes x Environment
12
Genes x Environment
13
Genes Environment
Development
Behavior Emotion Cognition Perception
14
How do we set priorities?

• Relevance what do we need?

• Traction where are the opportunities?

• Innovation what is new?

Relevance Traction Innovation IMPACT
15
New NIH Research Objectives for Biomedical and
Behavioral Science

• NIH Roadmap http//nihroadmap.nih.gov/
• New Pathways to Discovery
• Research Teams of the Future
• Re-Engineering the Clinical Enterprise
• National Advisory Mental Health Council Reports
  http//www.nimh.nih.gov/council/advis.cfm
• Setting Priorities for Basic Brain Behavioral
  Science Research at NIMH
• Mental Health for Lifetime Research on Mental
  Health Needs of Older Americans

16
Changing Practices at NIMH

• New priorities
• Reorganized for translation
• Supporting practical clinical trials
• New initiatives

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Strong Basic Science Strong Clinical Trials Are
Fundamental to Translational Research
Translation
Basic Neurosci Behavior
Trials Services
18
Two Kinds of Translation
Bench
Bedside
Pathophysiology Diagnostic tests Biomarkers New
treatments
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The NIMH Model
Translational Research - adult
Bench
Trials Services
Translational Research - child
Basic
Health Behavior
Practice
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Your Research Training should enable you to Mine
the Gap between basic and clinical science

• Unprecedented progress in human biology
  neuroscience

• Urgent need for effective diagnosis, prevention,
  treatment, and health care services

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What Do I Need To Do?

• Interdisciplinary Training - Learning and
  integrating the theories, models, and techniques
  of more than one science/discipline in your own
  research
• By
• Choosing your moves strategically
• Learning - coursework
• Doing - research
• Thinking communicate, present, and write
• Collaborating - team science

22

• Who Can
• Help Me?

23
NIMH Research Training Contacts

• Division of Neuroscience and Basic Behavioral
  Science
• Nancy Desmond, Ph.D.
• Division of Adult Translational Research
  Treatment Development
• Mark Chavez, Ph.D.
• Division of Pediatric Translational Research
  Treatment Development
• Cheryl Boyce, Ph.D., Courtney Ferrell, Ph.D.
• Division of AIDS Health and Behavior Research
• Donna Mayo, Ph.D. and David Stoff, Ph.D.
• Division of Services and Intervention Research
• Enid Light, Ph.D.
• Office of Special Populations
• Robert Mays, Ph.D. and Michael Sesma, Ph.D.

24
National Institute of Mental Health Research
Training and Career Development Timetable
Mechanism of Support

Predoctoral Institutional Training Grant (T32)
Predoctoral Individual NRSA (F31) Predoctoral
Individual MD/PhD NRSA (F30) Research
Supplements Mental Health Dissertation Research
Grants (R36)
GRADUATE/ MEDICAL STUDENT
Postdoctoral Institutional Training Grant (T32)
Postdoctoral Individual NRSA (F32) Research
Supplements
POST DOCTORAL/ CLINICAL RESIDENCY
Approximate Stage of Research Career Development
Pathway to Independence Award (K99-R00) Mentored
Research Scientist Development Award
(K01) Mentored Clinical Scientist Development
Award (K08) Mentored Patient-Oriented Research
Career Development Award (K23) Research
Supplements
EARLY
Small Grant B/START (R03) Exploratory/Developmen
tal Grant (R21/R34) Research Project Grant (R01)
Independent Scientist Award (K02)
CAREER
MIDDLE
Midcareer Investigator Award in Patient-Oriented
Research (K24)
Senior Scientist Award (K05)
SENIOR
NIMH http//www.nimh.nih.gov/grants/training.cfm
25
Research Scientist Development One Step at a
Time!
Faculty
Tenure R01 Mentor
New Faculty
K01, R21, R03
Post-Doc
e.g.Fellowship, Training Grant, Min Supplement,
e.g. Training Grants, Fellowships Min Supp.
Graduate
Undergrad
e.g. Supplements, T34 COR Stipends
High School
e.g. Collaborative Networks, R25, COR Stipends
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NIH Research Training and Career Development
Programs

• Ruth L. Kirschstein National Research Service
  Awards (National Research Service Awards)
• Career Development Awards (K Awards)
• Opportunities to Increase Diversity in the
  Biomedical Workforce
• Extramural Loan Repayment Programs

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National Research Service Awards

• Established by the NRSA Act of 1974
• Replaced All Previous NIH Training Authority
• Supported by All NIH Institutes and Centers
• Established 2 Types of Awards
• Institutional Training Grants (T32, T34, T35)
• Individual Fellowships (F30, F31, F32, F33)

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National Research Service Awards

• Provisions
• - 5 Years of Support at the Predoctoral Level
• - 3 Years of Support at the Postdoctoral Level
• - Service Payback Obligation for First Year
  Postdocs
• - Stipends, Tuition, Fees, Health Insurance,
  Trainee
• Travel, Institutional Allowance, 8 Percent
  Indirect
• (Institutional Only)

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NIMH Postdoctoral Awards

• Individual Postdoctoral Fellowships (F32)
• Institutional Research Training Grants (T32)

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National Research Service Awards

• Individual Postdoctoral Fellowships (F32)
• Individual Applications Prepared in Collaboration
  
• with Sponsor
• Fellow/Trainee Must be a Citizen, Non-citizen
  National, or
• Permanent Resident
• All Institutes and Centers Participate
• Reviewed by CSR
• Stipend (from 35,568 up to 51,036)
• Institutional Allowance (Including Health
  Insurance
• up to 6,500)

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Review Criteria for NRSA Fellowships

• CANDIDATE
• TRAINING PLAN
• RESEARCH PLAN
• MENTOR

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National Research Service Awards

• Institutional Training Grants (T32)
• - For Domestic, Educational Institutions
• - Institution Selects and Appoints the Trainee
• Trainee Eligibility Criteria
• - Must be a Citizen, Non-citizen National, or
  Permanent Resident
• - Must be One of the Following
• - Enrolled in a Program Leading to a Research
  Doctorate or
• a Combined M.D./Ph.D. Degree
• - Doctoral Degree Holders (M.D. or Ph.D.) Engaged
  in
• Full-Time Postdoctoral Research Training
• - Health Professional Students Engaged in
  Full-Time Research Training During Summers or
  Off-Quarters

33
National Institute of Mental Health Research
Training and Career Development Timetable
Mechanism of Support

Predoctoral Institutional Training Grant (T32)
Predoctoral Individual NRSA (F31) Predoctoral
Individual MD/PhD NRSA (F30) Research
Supplements Mental Health Dissertation Research
Grants (R36)
GRADUATE/ MEDICAL STUDENT
Postdoctoral Institutional Training Grant (T32)
Postdoctoral Individual NRSA (F32) Research
Supplements
POST DOCTORAL/ CLINICAL RESIDENCY
Approximate Stage of Research Career Development
Pathway to Independence Award (K99-R00) Mentored
Research Scientist Development Award
(K01) Mentored Clinical Scientist Development
Award (K08) Mentored Patient-Oriented Research
Career Development Award (K23) Research
Supplements
EARLY
Small Grant B/START (R03) Exploratory/Developmen
tal Grant (R21/R34) Research Project Grant (R01)
Independent Scientist Award (K02)
CAREER
MIDDLE
Midcareer Investigator Award in Patient-Oriented
Research (K24)
Senior Scientist Award (K05)
SENIOR
NIMH http//www.nimh.nih.gov/grants/training.cfm
34
Mentored Career Development Awards (AKA
Mentored - Ks)

• K01 Mentored Research Scientists Award
• K08 Mentored Clinical Scientist Development Award
• K23 Mentored Patient-Oriented Research Career
  Development Award
• K99-R00 Pathway to Independence Award

35
What Are They?
Mentored Career Development Awards are designed
for basic and clinical research scientists who
are in the initial phases of establishing their
research careers and who need to pursue an
additional period of supervised career
development beyond postdoctoral training in order
to become an independent scientific
investigators A Mentor is an mid-level or senior
investigator established in their field of
research
36
Who Can Apply?

• US Citizen, Non-Citizen National, or Permanent
  Resident
• Research Doctoral Degree (K01)
• Clinical Doctoral Degree (K01/K08/K23)
• Current PI of PHS Career Development (K) and
  Research (R) Awards Ineligible
• Former PI of PHS Career Development (K) and
  Research (R) Awards Ineligible (Except R03, R21)

37
New Investigator Career Awards

• Mentored Research Scientist Development (K01)
• Mentored Clinical Scientist Development Award
  (K08)
• Mentored Patient-Oriented Research Career
  Development (K23)
• NIH Pathway to Independence (PI) Award (K99/R00)

• FEATURES
• Duration - 3 to 5 years
• Mentor - Yes
• Salary - Up to 90,000
• Effort - 75 minimum
  
• Res. Costs - Up to 50,000
• Renew - No
  

38
K01 Mentored Research Scientist Development Award

• Provides a mentored research experience for
  research scientists who needs to gain additional
  expertise in a new research area, or one in which
  an additional supervised research experience will
  substantially add to the research capabilities of
  the applicant.

39
K08 Mentored Clinical Scientist Development Award

• Provides a Mentored Research Experience for
  clinically-trained professionals to establish
  independent careers in basic and/or clinical
  research

40
K23 Mentored Patient-Oriented Research Career
Development Award

• Provides a Mentored Research Experience for
  clinically-trained professionals to establish
  independent careers focusing on patient-oriented
  clinical research

41
What is Patient-Oriented Research?

• Research Conducted With Human Subjects (or on
  Material of Human Origin Such As Tissues,
  Specimens and Cognitive Phenomena) for Which an
  Investigator Directly Interacts With Human
  Subjects.
• This Area of Research Includes
• Mechanisms of Human Disease
• Therapeutic Interventions
• Clinical Trials
• The Development of New Technologies

42

• A New Grant Mechanism Pathway to Independence
  Award (K99/R00)
• A hybrid mechanism
• Five years of support consisting of two phases
• Phase I 1-2 years of mentored support for
  advanced postdoctoral fellows
• Total cost of 90,000 per award including 8 FA
• Phase II up to 3 years of independent research
  support contingent upon securing an
  independent research position and administrative
  review.
  
• Total cost of 249,000 per award including full
  FA
• U.S. citizens and non-citizens are eligible to
  apply

43
NIH Pathway to Independence (PI) Award (K99/R00)

• http//grants.nih.gov/grants/guide/pa-files/PA-06-
  133.html
• http//grants1.nih.gov/grants/new_investigators/Qs
  andAs.htm

44
How are Career Applications Reviewed?

• Candidate Commitment to and Potential as an
  Independent Investigator
• Career Development Plan Scientific Development
• Research Plan Vehicle for Developing Enhancing
  Research Skills
• Mentor Qualifications and Commitment
• Institutional Commitment

45

• Review of K99/R00 Applications
• IC-centered locus of review
• Clustered review encouraged where feasible
• Similar review considerations as Career Grants
  (Ks)
• Review process will emphasize the weight of the
  commitment and support provided by the institution

46
NIH Institutes and Centers have committed to 171
awards in the first year, assuming budget permits
and sufficient numbers of quality applications
are received

171 K/R awards per year for 5 years
2007 2008 2009 2010 2011 2007
cohort 15.4M 15.4M 42.6M 42.6M 42.6M 2008
cohort 15.4M 15.4M 42.6M 42.6M
2009 cohort 15.4M 15.4M 42.6M
2010 cohort 15.4M 15.4M 2011
cohort 15.4M 15.4M 30.8M
73.4M 116.0M 158.6M 394.2M Total
171 K/R awards per year for 5 years
2007 2008 2009 2010 2011 2007
cohort 15.4M 15.4M 42.6M 42.6M 42.6M 2008
cohort 15.4M 15.4M 42.6M 42.6M
2009 cohort 15.4M 15.4M 42.6M
2010 cohort 15.4M 15.4M 2011
cohort 15.4M 15.4M 30.8M 73.4M
116.0M 158.6M 394.2M Total
171 K/R awards per year for 5 years
2007 2008 2009 2010 2011 2007
cohort 15.4M 15.4M 42.6M 42.6M 42.6M 2008
cohort 15.4M 15.4M 42.6M 42.6M
2009 cohort 15.4M 15.4M 42.6M
2010 cohort 15.4M 15.4M 2011
cohort 15.4M 15.4M 30.8M 73.4M
116.0M 158.6M 394.2M Total
Notes Phase I, K portion total cost per year,
per award 90.K (salary-50K fringe-25
20K research support 83K x 8 FA)
Phase II, R portion total cost per year, per
award 249.K (salary fringe research
support 175K x 42 estimated FA)
47
FY 2007 IC commitments for Pathway to
Independence Awards, budget permitting and
sufficient numbers of meritorious applications
received
25

20
20
18
15
15
12
12
K/R awards
10
10
8
10
7
7
6
6
5
5
5
4
4
4
5
3
3
3
2
1
1
0
NEI
NIA
NIAID
NIMH
NIBIB
NHLBI
NCRR
FIC
NCI
NIEHS
NIDCR
NICHD
NIAMS
NIDCD
NIGMS
NLM
NCCAM
NIDA
NINR
NIAAA
NIDDK
NINDS
NHGRI
NCMHD
Institute or Center
48
Which One is Right for You?

• K01 Mentored Research Scientists Award
• K08 Mentored Clinical Scientist Development Award
• K23 Mentored Patient-Oriented Research Career
  Development Award
• K99-R00 Pathway to Independence Award

49
What Determines Which Awards Are Made?

• Scientific merit
• Program Considerations
• Availability of funds

50
Research Awards (R03)
NIMH Small Grants Program

• Provides support for any of the following three
  categories
• Newer, less experienced investigators
• Investigators at institutions without well
  developed research traditions and resources
• More experienced investigators who want to pursue
  exploratory studies that represent a significant
  change in direction for them, or who want to test
  new methods or techniques

51
Research Awards

• NIMH Small Grants Program (R03)

FEATURES Duration - 2
years Mentor - No
Res. Costs - Up to 50,000
per year Renew - No Pages - 10

52
Research Awards

• NIMH R21 Program (R21)
• Exploratory/Developmental research grant

FEATURES Duration - 2
years Mentor - No
Res. Costs - Up to 100,000
per year Renew - No Pages - 10-25
Check with Inst.

53
Research Awards

• NIMH R34 Program (R34)
• Exploratory/Intervention Development Grant

FEATURES Duration - 3 years
maximum Mentor - No
Res. Costs - Up to 450,000 total in direct
costs over 3 years (no more than 225,000 in a
year) Renew - No Pages - 25

54
Research Awards

• FEATURES
• Duration - Up to 5 years
• Mentor - No
  
• Res. Costs - Not limited
• Modular grants up to 250,000
• Permission and data sharing if gt 500,000
• Renew - Yes
• Pages - 25 pgs.
  

• Regular Research Awards (R01)

The RO1 is the Gold Standard Grant
55
How are R-Mechanism Grants Reviewed?

• Standard Review Criteria
• Significance - why is this important research?
• Approach - how are you going to do the research?
• Innovation - what is innovative about the
  hypotheses or approach?
• Investigator - do you have the expertise to do
  the work?
• Environment - do you have the resources and
  support necessary to do the work?

56
Diversity Supplements

• For all stages of the research career from high
  school to assistant professor/research associate
• Support for Minority, Disadvantaged and Disabled
  individuals
• Additional funds are awarded to a Principal
  Investigator to include a minority researcher on
  their existing project
• Great way to join a research project and
  successful research team
• Also, provides funds for equipment to allow
  reasonable accommodations for to disabled
  individual

57
Supplements

• Search CRISP (Computer Retrieval Information on
  Specific Projects) for abstracts of funded
  projects that would be eligible for a supplement
  opportunities on the NIH website.
• www.nih.gov
• Contact institutes to learn how supplements are
  evaluated and awarded practices vary
• http//www.nimh.nih.gov/grants/supplement.cfm

58
Loan Repayment Program

• Program repays up to 35,000 of educational loans
• Must be doing patient-oriented clinical work
• Must be U.S. citizen, national or permanent
  resident
• Must have advanced degree
• Must be affiliated with NIH as postdoc, K
  awardee, first-time PI on R01, R03, R21 or U01,
  or first-time director on certain sub-projects
• More information at http//grants.nih.gov/grants/g
  uide/notice-files/NOT-OD-01-064.html

59
What should I do to get funding and other support?
60
Prepare Yourself to Seize NIH Opportunities

• Become knowledgeable about research and
  researcher development activities at NIH but
  particularly the ICs that support work related to
  your interest (e.g., NIMH, NIDA, NIAAA).
• Read the web pages
• Know program officials at the ICs especially
  people in Special Populations type offices
• Prepare a short concept paper (1-5 pages) on your
  research ideas
• Contact program officials before you put pen to
  paper or hit the save key

61
Prepare Yourself to Seize NIH Opportunities

• Know who will likely review your application
• Never submit an application without conferring
  with program
• Do not expect to be funded the first time around
  its not the norm
• Be ready to start research if funded its likely
  to happen
• Cultivate a strong support system that
  understands the process

62
Read the PAs and RFAs

• Program Announcements and
• Requests for Applications
• Explain the purpose, eligibility, objectives,
  interests of an NIH institute(s)
• Identify the mechanism(s) to be used
• Provide application receipt dates
• List participating ICs
• Identify program contacts
• Identify review criteria
• May provide some background and source material

63
Choosing a Grant Mechanism

• Determine the feasibility of your first choice
  mechanism given your research objectives,
  experience and resources
• If limited or no independent research experience,
  consider the RO3 small grant
• If using RO1, may need to collaborate
• To gain experience quickly, apply for Diversity
  Supplement
• To gain experience, consider Career Development
  Award
• (Is there a way to accomplish your long-term
  goal in smaller developmental steps building on
  available mechanisms?)

64
National Institute of Mental Health Research
Training and Career Development Timetable
Mechanism of Support

Predoctoral Institutional Training Grant (T32)
Predoctoral Individual NRSA (F31) Predoctoral
Individual MD/PhD NRSA (F30) Research
Supplements Mental Health Dissertation Research
Grants (R36)
GRADUATE/ MEDICAL STUDENT
Postdoctoral Institutional Training Grant (T32)
Postdoctoral Individual NRSA (F32) Research
Supplements
POST DOCTORAL/ CLINICAL RESIDENCY
Approximate Stage of Research Career Development
Pathway to Independence Award (K99-R00) Mentored
Research Scientist Development Award
(K01) Mentored Clinical Scientist Development
Award (K08) Mentored Patient-Oriented Research
Career Development Award (K23) Research
Supplements
EARLY
Small Grant B/START (R03) Exploratory/Developmen
tal Grant (R21/R34) Research Project Grant (R01)
Independent Scientist Award (K02)
CAREER
MIDDLE
Midcareer Investigator Award in Patient-Oriented
Research (K24)
Senior Scientist Award (K05)
SENIOR
NIMH http//www.nimh.nih.gov/grants/training.cfm
65
NIH Resources

• CRISP data retrieval information system provides
  information on funded research,
  http//crisp.cit.nih.gov/
• Strategic Plan on Health Disparities each NIH
  institute has a plan
• The NIH Grants Home Page provides access to all
  relevant information for new and continuing
  applicants including application forms,
  instructions and explanations http//grants1.nih.
  gov/grants/oer.htm
• NIH is not the only player in federal grants
  http//www.grants.gov/Find

66
Take-Home Message

• Communicate
• with NIH staff
• with investigators
• with institutional administrators
• http//www.nih.gov
• http//www.nimh.nih.gov

67
Who do you know at NIH who can help you get
started?

• Michael A. Sesma, Ph.D.
• Office for Special Populations
• National Institute of Mental Health
• msesma_at_mail.nih.gov
• 301-443-2847