NIH Challenge Grants in Health and Science Research

RFA OD-09-003

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

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

Useful websites

• http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-003.html

• http://grants.nih.gov/recovery/faqs_challenge.html

Useful (?) websites

• http://grants.nih.gov/grants/funding/challenge_award/Omnibus.pdf --a 181 page document

• http://www.niehs.nih.gov/recovery/challengegrants.cfm --NIEHS Challenge topics

• http://grants.nih.gov/grants/funding/challenge_award/IC_ChallengeWebPage.htm

--all institutes

Review Criteria

• The new (2010) criteria will be used for Recovery Act FOAs.

• http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-025.html

• For comparison of current and new criteria

• http://grants.nih.gov/grants/peer/side_by_side_comparison.doc

Grant preparation

• Project summary / abstract

• Bibliography and references – 1 page

• Biosketch – 2 pages. Limit publications to TEN (10)

• Specific Aims – 1 page

• Research plan—12 pages

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

Research Plan

• Research area and project title

• The challenge and potential impact

• Approach

• Timeline and milestones

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?

The Challenge / Potential Impact

• Which community will be affected?

• What is the size of the community?

• Will the potential impact be major?

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?

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?

The Approach •Provide enough information that reviewers can determine what, in general, you areproposing to do, but do not include a detailedexperimental plan.

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?

Timeline and Milestones•Why is the proposed research uniquely suited to the stated goals of the challengeinitiative?

•What is the likelihood of success?

•Provide a timeline for the proposed research.

•To facilitate evaluation of progress reports,describe when you anticipate that essentialcomponents of the project will be completed.

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”

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.

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» What’s the importance of cost?

• Public-Private Partnerships http://ppp.od.nih.gov/

Caveats!

No plan survives contact with the enemy

“High achievement always takes place in the framework of high expectation.”

–Charles Kettering