NIH Challenge Grants in Health and Science Research

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NIH Challenge Grants in Health and Science
Research

• RFA OD-09-003

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Background

• New funds to NIH for 2009 and 2010 as part of the
  ARRA
• Challenge areas should have a high impact
• Novel research that addresses knowledge gaps,
  opportunities, new technologies, data generation,
  or research methods

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Nuts and Bolts

• Deadline is April 27, to DEH by April 13th!
• Non-modular budget up to 500,000 / year total
  cost for two years
• Earliest start date 9/30/09
• Research plan is limited to 12 pages
• NO resubmissions

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Useful websites

• http//grants.nih.gov/grants/guide/rfa-files/RFA-O
  D-09-003.html
• http//grants.nih.gov/recovery/faqs_challenge.html
  

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Useful (?) websites

• http//grants.nih.gov/grants/funding/challenge_awa
  rd/Omnibus.pdf --a 181 page document
• http//www.niehs.nih.gov/recovery/challengegrants.
  cfm --NIEHS Challenge topics
• http//grants.nih.gov/grants/funding/challenge_awa
  rd/IC_ChallengeWebPage.htm
• --all institutes

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Review Criteria

• The new (2010) criteria will be used for Recovery
  Act FOAs.
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-09-025.html
• For comparison of current and new criteria
• http//grants.nih.gov/grants/peer/side_by_side_com
  parison.doc

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Grant preparation

• Project summary / abstract
• Bibliography and references 1 page
• Biosketch 2 pages. Limit publications to TEN
  (10)
• Specific Aims 1 page
• Research plan12 pages

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Additional sections

• Inclusion Enrollment Report
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• MPI Leadership Plan
• Consortium/ Contractual Arrangements
• Letters of Support
• Resource Sharing Plans Data Sharing Plan,
  Sharing Model Organisms, and Genome-Wide
  Association Studies

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Research Plan

• Research area and project title
• The challenge and potential impact
• Approach
• Timeline and milestones

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The Challenge / Potential Impact

• What is the research opportunity, scientific
  knowledge gap or technology that will be
  addressed?
• How broad is the potential impact in science
  and/or health?

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The Challenge / Potential Impact

• Which community will be affected?
• What is the size of the community?
• Will the potential impact be major?

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The Challenge / Potential Impact

• What is the disease or condition that will be
  studied ?
• What is the hypothesis to be tested concerning
  mechanisms underlying this disease/condition?

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The Challenge / Potential Impact

• How will the work disrupt the standard paradigm
  or create a paradigm where none exists?
• How will the results transform our understanding
  of this disease/condition?

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The Approach

• Provide enough information that reviewers
• can determine what, in general, you are
• proposing to do, but do not include a detailed
• experimental plan.

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The Approach

• If your methodology is novel, what is
  unconventional and exceptionally innovative
  about your approach?
• How does your approach differ from what other
  investigators have attempted to do?

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Timeline and Milestones

• Why is the proposed research uniquely
• suited to the stated goals of the challenge
• initiative?
• What is the likelihood of success?
• Provide a timeline for the proposed research.
• To facilitate evaluation of progress reports,
• describe when you anticipate that essential
• components of the project will be completed.

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New Scoring System

• 9-point scale (1 exceptional 9 poor)
• Before review meeting, reviewers and discussant
  will give a 1 9 for each area
• Significance
• Investigator(s)
• Innovation
• Approach
• Environment

You will receive the scores for these criteria,
even if your grant is triaged
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New Scoring System (cont)

• Priority Scores Before the review meeting, each
  reviewer and discussant will give a preliminary
  impact score for that application.
• This score is evaluation of the overall impact,
  rather than a weighted average to previous review
  criteria.

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Other ARRA Concepts

• Comparative Effectiveness Research (CER)
• Role of trials versus observational studies
• Establishing priorities
• Optimally using existing resources
• Coordinating federal agencies and other research
  collaborators
• Improving research methods
• Whats the importance of cost?
• Public-Private Partnerships http//ppp.od.nih.gov/
  

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Caveats!

• No plan survives contact with the enemy
• High achievement always takes place in the
  framework of high expectation.
• Charles Kettering