The R21 MechanismThe R21 Mechanism

Your guide through the R21 jungle*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 Dictionaryhttp://merriam-webster.com/dictionary/jungle

Your guide through the R21 jungle*Your guide through the R21 jungle*Patricia Parmelee, PhD

(Pat to you)

Qualifications:Years & years & years reviewing

R21s on various NIH study sectionsPreviously PI on an R21

(AG026121)Several R21 applications in various

stages of development/revision

What’s an R21?What’s an R21?According to US DHHS PA-06-181,

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?What’s an R21? Explores

Novel concepts or methodsPreviously un- or understudied issuesFeasibility/applicability of a research

idea

Develops New techniques and approaches New models, methods or applications

R21 applications : the basicsR21 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. 16 - June 16 - Oct. 16

Who supports R21s?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 successfulCharacteristics of a successful R21R21

“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 that have the potential to substantially potential to substantially advance biomedical scienceadvance biomedical science.”.”

US DHHS PA-06-181

Characteristics of a successfulCharacteristics of a successful R21R21 Innovative High risk Innovative Potentially big pay-off Innovative Rigorous Did I mention “innovative”?

Some examples of successfulSome examples of successful R21sR21sDeveloping 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 What isn’tisn’t an R21? an R21?

A “mini R01”

A “maxi R03”

A training grant

Preparing an R21Preparing an R21Some 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 R21Preparing an R21Some frequently asked questions about R21s

Does the research plan follow the same format as an R01?

Preparing an R21Preparing an R21Some frequently asked questions about R21s

Does the research plan follow the same format as an R01?

Do I need pilot data?

Preparing an R21Preparing an R21Some 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 R21Preparing an R21Points to ponder as you writeWhat 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 R21Preparing an R21Some 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 How do reviewers ideally ideally view R21s?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-06-181

How do reviewers How do reviewers actually actually view R21s?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 reviewerDealing with an overly zealous reviewerBe 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….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