The R21 Mechanism

Your guide through the R21 jungle* Patricia Parmelee, PhD (Pat to you) * jun’ gle, n.: a confused or disordered mass of objects; something that baffles or frustrates by its tangled or complex character; a place of ruthless struggle for survival Merriam-Webster Online Dictionary

Your guide through the R21 jungle* Patricia Parmelee, PhD (Pat to you) Qualifications: Years & years & years reviewing R21s on various NIH study sections Previously PI on an R21 (AG026121) Several R21 applications in various stages of development/revision

What’s an R21? According to US DHHS PA , A grant mechanism that is “…intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects.”

What’s an R21? Explores Novel concepts or methods Previously un- or understudied issues Feasibility/applicability of a research idea Develops New techniques and approaches New models, methods or applications

R21 applications : the basics Two years’ funding Up to $275,000 TDC Maximum $200,000 in a given year Modular budget 7-page limit for research plan Adobe e-submission One revision permitted Due Feb June 16 - Oct. 16

Who supports R21s? Just about all NIH branches… NCCAM NEI NHLBI NHGRI NLM NIA NIAAA But not FIC, NCI, NCMHD, NCRR NIGMS NIAID NIAMS NIBIB NICHD NIDCD NIDA NIDCR NIDDK NIEHS NIMH NINDS NINR

Characteristics of a successful R21 that have the potential to substantially advance biomedical science.” “By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets and technologies that have the potential to substantially advance biomedical science.” US DHHS PA

Characteristics of a successful R21 Innovative High risk Innovative Potentially big pay-off Innovative Rigorous Did I mention “innovative”?

Some examples of successful R21s Developing materials and methods for a translational intervention Using existing large data sets to develop statistical techniques for modeling change in health status Finding genes for alcohol-related behaviors & risk for alcoholism Improving the trauma system response to disaster

What isn’t an R21? A “mini R01” A “maxi R03” A training grant

Preparing an R21 Some frequently asked questions about R21s Does the research plan follow the same format as an R01? Do I need pilot data? Do I need to have clear, testable hypotheses? The answer? It depends!

Preparing an R21 Some frequently asked questions about R21s Does the research plan follow the same format as an R01?

Preparing an R21 Some frequently asked questions about R21s Does the research plan follow the same format as an R01? Do I need pilot data?

Preparing an R21 Some frequently asked questions about R21s Does the research plan follow the same format as an R01? Do I need pilot data? Do I need to have clear, testable hypotheses?

Preparing an R21 Points to ponder as you write What truly new knowledge might this yield? What’s unique about how I’m going about generating that knowledge? How will this work prepare me to conduct similar, larger-scale research? Do I have a clear game plan for next steps once the R21 is completed?

Preparing an R21 Some common “errors” in writing R21 applications Not conveying how the work is exploratory/developmental Trying to do too much Too much structure (the “mini R01”) Too little structure (“trust me”)

How do reviewers ideally view R21s? “reviewers will focus their evaluation on the conceptual framework the level of innovation, and the potential to significantly advance our knowledge or understanding.” Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluation the scientific merit of R01 applications, including supportive preliminary data.” US DHHS PA

How do reviewers actually view R21s? Sometimes appropriately… Excellent “first step” for new investigators with a clear long-range research plan Good for forays into less well-studied areas Sometimes not… Not accepting “exploratory” nature Holding to R01-level methodological standard Unfamiliar with the research area

Dealing with an overly zealous reviewer Be respectful… “We appreciate your thorough critique…” “The reviewers correctly pointed out…” but stand your ground “… is not feasible at this first, exploratory stage” “Inherent limitations of the R21 mechanism preclude…” “This study addresses feasibility, not hypothesis-testing.” “… but will certainly be included in our future, full-scale intervention efforts.”

In summary…. R21 is a great “foot in the door” Not always well understood by investigators… OR study section! Work closely w’ program officer to determine if it’s appropriate for your research