Applying to the National Institutes of Health NIH

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Applying to the National Institutes of Health
(NIH)

• Peter Vanable, Dept. of Psychology and Center
  for Health Behavior
• Trish Lowney, OSP
• October 14, 2005

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About the NIH

• Mission - making important medical discoveries
  that improve health and save lives.
• 27 Institutes Centers (I/C)
• Diseases conditions, infrastructure
• www.NIH.gov
• Intramural and extramural research

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About the NIH contd

• Budget 27B
• 80 competitive grants
• 10 intramural
• Budget doubled 1998 2003
• 2004 present flat
• Decline in real dollars
• Future ????

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Applying to the NIH

• Public health relevance of your project?
• I/C strategic plans or Advisory Council concept
  clearance (minutes)
• IOM reports
• NIH road map initiative
• CRISP (award history)
• The NIH Guide (current interests)
• Program announcements, Requests for Applications

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Applying to the NIH contd

• Funding for Individuals
• Research Projects (R01, R03, R15 (not AS folks),
  R21, R25)
• Career Development (K01, K02, K08)
• Fellowships (F31, F32)
• Funding for Groups
• P01, P30, U01, U24
• Conferences
• R13, U13
• http//grants2.nih.gov/grants/funding/funding_prog
  ram.htm

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Applying to the NIH contd

• Confirm that what you want to do is of interest
  to who will fund
• Contact C/I program manager early!
• 6 months 1 yr before submit
• Who will review?
• Identify/select study section (if not RFA)
• http//cms.csr.nih.gov/
• http//crisp.cit.nih.gov/

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Reminder

• Who will review and who will fund are two
  distinct groups and processes
• Center for Scientific Review manages most reviews
  (study sections)
• I/C fund
• You have to appeal to both audiences

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Applying to the NIH contd

• When to submit (R01, R21, R03)
• New Feb 1, June 1, October 1
• Revised March, July, November 1
• http//grants2.nih.gov/grants/funding/submissionsc
  hedule.htm
• How
• Paper unless grants.gov mandated
• 6/1/06 R03s grants.gov
• 10/1/06 R01s grants.gov
• Guidelines 398(9/04 version)
• http//grants2.nih.gov/grants/funding/phs398/phs39
  8.html

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PHS 398http//grants2.nih.gov/grants/funding/phs3
98/phs398.pdf

• Read and follow instructions
• Use correct forms (9/04), font etc.
• Ask OSP for help with administrivia
• Research Plan
• a) specific aims
• b) background significance
• c) preliminary data
• d) research design methods

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Add any typically unallowable budget items and
justify, e.g., office supplies, alcohol for
research purposes (!), etc. Contact OSP
foradvice. There needs to be a detailed budget
that results in the modulesrequested OSP is
available to help!
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Additional Components

• Human Subjects information
• Women and children
• Animal Subjects
• Consortium/contractual arrangements

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To apply..

• Obtain an eRA commons user name from T. Lowney
  (plowney_at_syr.edu)
• Contact your Research administrator for
  assistance
• (a detailed budget is required for internal
  purposes, even if applying with modular budget)
• Follow guidelines.

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Resources

• Office of Extramural Research
• http//grants1.nih.gov/grants/oer.htm
• NIAID All about grants tutorials (Great site!)
• http//www.niaid.nih.gov/ncn/grants/default.htm
• Annotated R01
• http//www.niaid.nih.gov/ncn/grants/app/app.pdf
• Especially for new investigators
• http//grants1.nih.gov/grants/new_investigators/in
  dex.htm
• Institute Budgets/historical information
• http//officeofbudget.od.nih.gov/UI/SpendingHistor
  y.htm
• Success rates
• http//grants1.nih.gov/grants/award/success.htm

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Perspectives from a New Investigator
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Broad Interests Psychological Aspects of Health
Illness

• How do people successfully self-regulate their
  behavior to promote sustained health?
• How do psychological processes contribute to
  health-compromising behaviors and poor adjustment
  in response to illness?

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Public Health Emphasis

• Health promotion interventions for HIV-positive
  men and women
• Primary prevention to reduce risk for HIV among
  adolescents and adults

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Current NIH Awards
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R21 Exploratory / Development Grant

• Reducing High Risk Behavior among HIV Men
• 562,000 in total costs for 3 year award
• Good funding mechanism for advancing new program
  of research

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Aims

• Develop / refine an intervention to reduce sexual
  risk behavior among HIV gay men
• Pilot test the intervention provide feasibility
  and effectiveness data for larger trial
• Two phases
• Formative (qualitative) research
• Intervention trial
• Partnership with Upstate Medical University

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U01 NIMH Cooperative Agreement

• A Multilevel Prevention Strategy for High-Risk
  Youth
• 5 year project 2.3 million in total costs for
  Syracuse site, 10 million across sites
• Collaboration with four other universities
• Local partnerships with Southwest Community
  Center, Boys and Girls Club, and the Dunbar
  Association

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Major Aim

• To investigate the impact of a small group
  intervention and a mass media campaign on HIV
  risk behavior among African-American teens.
• Two phases
• Formative mass media campaign development.
• Randomized trial Enrolling 1600 youth in four
  cities.

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Lessons learned along the way
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1 Obtaining NIH funding typically takes years of
hard work and perseverance.
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Timeline for R21 funding

• 1996-2002
• Published like crazy, made a (small) splash in
  good journals that grant reviewers care about
• Gained experience on extant NIH grants
• Fostered collaborations with established
  NIH-funded researchers

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Timeline for R21 funding

• 2000-2001
• Identified a fundable idea in an area that
  matches expertise and can be achieved in local
  research setting
• Thought a lot about the feasibility of the idea
  refined plans.
• Gathered input from other experts

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Timeline for R21 funding

• Summer 2001
• Worked for three solid months to craft a
  thoughtful, compelling proposal that reviewer
  couldnt say no to

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Timeline for R21 funding

• Fall, 2001
• Cope with massive disappointment
• Score 350
• Spring, 2002
• Gathered strength to revise and resubmit
• Summer, 2002
• Worked for three solid months to revise the
  application in response to reviews
• Planned for success

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Timeline for R21 funding

• Fall, 2002
• Cope with massive disappointment
• Score 250
• Fall, 2002 Fight back
• Successfully appealed review (long story)
• Spring, 20003
• Re-reviewed by new SRG
• Score 140 ? FUNDED!

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2 Find the right funding mechanism to match your
research goals and level of experience.
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What mechanism is right for you?

• If you have no track record at NIH, dont begin
  with a multimillion dollar proposal
• BSTART, R03, R21, R34, R01
• K series (career development)
• Large scale multisite / cooperative agreements
  (e.g., U awards series)

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3 Find a mentor who can help you develop a
winning proposal and lend credibility to your
research plans.
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The importance of mentoring

• Having a colleague who is already a household
  name at NIH is a big plus
• As appropriate, spell out a plan for how a senior
  colleague will help with mentoring in your
  preliminary studies section

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4 Good science is critical.
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Good science

• Must propose
• Important, testable hypotheses
• Coherent methodology
• Data analysis plan that is clearly linked back to
  the proposed hypotheses
• Must demonstrate statistical prowess

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5 Your track record matters a whole lot
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Track record

• History of strong, peer reviewed pubs in good
  journals
• More high quality pubs better reception as
  potential grant recipient
• Preliminary studies are critical
• Sing the praises of your team and its
  qualifications to conduct the proposed work
• Demonstrate that your methods are feasible by
  reviewing prior success with related work

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6 The proposal must be a joy to read.
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Writing

• Cant be a last minute job
• If collaborators are contributing to specific
  sections, PI must take responsibility for
  insuring overall flow
• Strong, declarative sentences generate
  excitement for the work!
• Use headline headers that walk your reader
  through the grant

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7 Be mindful of the major review criteria for
all NIH grants.(Help your reviewers write their
review)
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Review Criteria

• Significance
• Approach
• Innovation
• Investigator
• Environment
• And what about budgets? Important to do ask for
  enough support.

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8 Take human subjects / IRB concerns very
seriously.
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9 Be mindful of the political climate
surrounding your proposed topic.
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10 Be careful of what you ask for you may
actually have to do the work!