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R21s just may be NIH's own riddle wrapped in a mystery inside an enigma.
NIH designed R21s for high-risk exploratory research, yet most people use them for other purposes.
Preliminary data are not required, yet people generally include them, and reviewers seem to be on board either way.
And despite a recent surge in applications, some institutes and centers have decided not to sign on to the R21 parent program announcement for various reasons, including data indicating that a large percentage of R21s do not result in an R01, and success rates for new investigators are low.
Altogether, four institutes (NCI, NHLBI, NIDDK, and NIGMS) and three centers (NCMHD, NCRR, and FIC) do not support R21s through the parent PA (they do use R21s for their own opportunities).
Getting to the Plus Side
At NIAID, we're in the stay-with-the-program camp. We believe the R21 fills a valid need for funding exploratory research and in other circumstances, for example, for investigators who want to break into a new area of research.
If R21s have somewhat lower success rates, we expect it because the research supported is riskier. And, some of our data differ from some of the NIH assessments.
But while we will continue to use R21s, questions abound on their purpose and success both for the R21 program as a whole and for PIs individually.
For those of you who found our previous article interesting—see the April 11, "New Sample R21s—Can They Help You?", linked below—we continue that conversation here.
We have some new data to share, but first let's recap some of the main points of our previous article to help put some of the issues in perspective.
Ambiguities in the status quo raise key questions about the nature and purpose of the R21, including:
Since we are continuing to support R21s, we want PIs to have the best shot at success. To gain some insight into the second two questions, we looked at the correlation of the presence of preliminary data to success in getting a grant.
That connection is broadly relevant. It applies to anyone who may not have preliminary data: from new investigators who don't have the opportunity to conduct preliminary studies to experienced PIs who want to propose high-risk research or are entering a new field.
For our study, we randomly selected and reviewed 200 scored R21 applications (roughly 25 percent of scored 2011 R21 applications assigned to NIAID), counting resubmissions once, to assess the presence or absence of preliminary data. To count as having preliminary data, the application had to include actual data, not just a reference to earlier studies.
Starting with the big picture, our cohort had the following characteristics:
These data show that people overwhelmingly (93.5 percent) describe preliminary data in their R21 applications.
We don't know why. Perhaps they believe that, regardless of requirements, preliminary studies strengthen their case, or they are meeting reviewers' expectations.
Whatever the rationale, the behavior speaks for itself. And that behavior is supported by the differential success rates shown in the bullets above.
Insights for New Investigators
Next we looked at the fate of new investigators submitting an R21 application and the relationship between preliminary data and success. (Note that officially NIH new investigator status—never funded with an R01 equivalent grant—applies only to R01s; we are using it here as an analysis factor only.)
First observation: the R21 is popular with new PIs.
In our 200-application cohort, 69 (34.5 percent) of scored applications were from PIs (or sets of investigators) that qualified as an NIH new investigator.
In data from another study that included unscored applications from new PIs, that number was 50 percent. For the sake of comparison, NIH 2010 data show that new investigators submitted 31.8 percent of competing R01 applications.
But closer scrutiny reveals a negative for new PIs: in our R21 cohort, success rates were considerably lower.
Was the absence of preliminary data a significant factor?
Though the numbers are small, a greater proportion of applications from new PIs lacked preliminary data, compared to the cohort as a whole. Out of the 13 applications that had no preliminary data, 7 (53.8 percent) were from new investigators, none of which were funded.
Our comparison of success rates is particularly salient because it counters a belief among some new investigators that seeking an R21 as a first grant is an easier route than applying for an R01.
In fact, R01s are a better choice for a first independent grant. You benefit from a special payline for new investigators, and the R01 is a more robust award.
Homing in on Multiple PI Applications
We then assessed how well multiple PI applicants fared in their bid for R21 funding. In our cohort of 200 applications, 47 ( 23.5 percent) were from multiple PIs, and they did roughly as well as single PI applications.
Next we looked at the effect of new versus experienced investigators on a multiple PI application's success. Though the numbers are very small, the presence of one or more experienced investigators had a positive impact.
For this group, the effect of preliminary data is hard to determine because only four multiple PI applications did not have preliminary data, none of which were funded.
If you plan to apply for an R21, you now know for sure the importance of including preliminary data since it correlates to funding success. And if you decide to submit an application that does not have preliminary data—for whatever reason—you are now aware that you may have a greater hurdle to overcome to get that grant.
At NIAID, we will continue to support the R21. We know it's important to our extramural research community, so don't hesitate to consider using an R21 if it meets your goals.
Before you apply, remember to discuss your R21 application with one of our program officers to make sure it fits our mission so we can accept it. Read our February 1, 2012, article "Will Your R21 Application Be Homeless?" for details.
Learn more about R21s in our April 11, 2012, article "New Sample R21s—Can They Help You?"
Speaking of R21s, we've posted two new R21 samples as a guide to the strategies successful PIs used to create their applications.
The new ones are more in the vein of exploratory, high-risk research than our previous four, which fit the small R01 model.
And we have our first sample application and summary statement for an R21/R33 Phased Innovation Award. In case that doesn't ring a bell, the R21/R33 is a two-phased award, with both phases described in the application. The transition to the second phase depends on several factors, including the achievement of negotiated milestones.
R21/R33 applications are often challenging to prepare, so we thought a sample would be particularly helpful to people applying for this type of support.
They are solicited only, i.e., you must respond to a program announcement or request for applications. You can look for our R21/R33 PAs and RFAs on the NIAID Funding Opportunities List.
To review the samples, go to R21 Sample Applications and Summary Statements and R21/R33 Sample Application and Summary Statement on Sample Applications and Summary Statements.
As funding gets more and more competitive, we don't have to tell you how important it is to explore multiple avenues of potential funding.
If you're looking in NIAID's areas of science, our NIAID's List of Foundations and Other Funding Sources can help. It pulls together relevant opportunities from organizations outside NIH in one handy spot.
On the list you can find timing information for open and expected opportunities, information about the target audience, and links to sign up pages to get automatic notifications from organizations.
Funding sources run the gamut from big to small, global to domestic, and broadly focused to single-issue.
Here's a question we'd like feedback on: do you find it helpful to see foreign organizations that accept applications only from their own citizens?
To send us your thoughts or suggest a foundation for the list, email email@example.com.
Are you wondering about the impact on your award of the recently-issued United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern?
We have some news.
If you haven't heard from us, it means we have not identified concerns with your research. We have already placed new terms of award on a very small number of grants and contracts that may have dual use concerns.
Those terms require an institution to assess the dual use implications of its research and send us a risk mitigation plan. They also ask investigators to share manuscripts with their program officers or contracting officer's representatives before submitting to a journal.
We'll review new applications and proposals as well as changes in funded research and add terms as necessary to comply with the new policy.
Look for further guidelines, including standard operating procedures and possible requests for public input, in the coming months.
For more information, visit the National Science Advisory Board for Biosecurity (NSABB) Web site on Dual Use Research to read Educational Materials and NSABB Documents.
Well-supported investigators who are slated for new awards will get a special Council review (SCR), as required in the FY 2013 President's Budget for HHS.
"Well-supported" describes people with existing NIH grants of $1.5 million or more in annual total costs from NIH.
Council members have the option of discussing unsolicited applications from these PIs and making a funding recommendation to the institute. Members will take into account whether a project offers a unique opportunity to advance research and if it's distinct from the PI's other funded work.
Keep in mind that SCR does not represent a cap on total NIH funding for any one investigator and that a relatively small number of applications will be subject to SCR.
For further details, including what will and won't require SCR, see the May 18, 2012, Guide notice.
You may also want to read the May 18 blog post "Piloting the $1.5M Special Review" from NIH's Office of Extramural Research.
Here's news from around NIH.
May 2013 Council: Plan for June. We moved next year's "May" Council to June 3, 2013. It had been scheduled for May 20, 2013. See the dates for other Council meetings on our Advisory Council portal.
Give Feedback on Small Business Rules. The Small Business Administration proposed new regulations on size and eligibility, including ownership, control, and affiliation for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. To learn more and submit a comment by July 16, 2012, see the SBA Federal Register Notice and go to Submit a Comment.
CCR Will Move to SAM. By the end of July, Central Contractor Registration services will relocate to a still-under-construction System for Award Management (SAM). CCR will migrate your information automatically; if it requires action on your part, it will email you. Learn more about the new system at System for Award Management.
If your organization uses a proprietary system to assemble and submit electronic applications, be alert for how the timing and instructions may differ from NIH's description for Adobe forms.
For example, you may need extra lead time for training on how to use your organization's system. And your business office's role might require additional or different internal due dates for you to finish your part of the application.
Keep in mind that some of NIH's instructions may not match how your organization's system works. NIH describes applying directly to Grants.gov using the grant application package. Your proprietary system may have its own forms, layouts, or form fields.
The differences we describe above aren't barriers to your success, however. NIH data indicate that system-to-system applications tend to need fewer attempts to pass eRA Commons validations.
Number of Attempts Required for Error-Free* Commons Validation in FY 2011
*A passing application may be free of errors but still receive warnings.
If you need help troubleshooting the application process, talk to staff in your business office. Your business official should be able to answer the question directly or know whether you should contact a system provider, the Grants.gov helpdesk, or the eRA helpdesk.
Not using a system like this yet? Your organization may start soon. The system-to-system approach is increasingly popular, used by 38 percent of all electronic R01 applications in FY 2011, up 6 percent from 2010.
Feel free to send us a question at firstname.lastname@example.org. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
"Can a PI submit two renewal applications to follow-up on a single R01?"—Paige McDonald, National Cancer Institute
No, but you can submit one as a renewal and another as a new application that's significantly different.
Be aware that there are different submission dates for non-AIDS-related new and renewal applications. You may also want to read our advice on renewals—go to How to Renew Your Application in the Strategy for NIH Funding.
"Does a grant renewal have to go to the same study section as its original R01?"—Dan Rudic, Georgia Health Sciences University
No. You can request any study section in your cover letter if it’s relevant to the science. However, keep in mind that there’s no guarantee your application will go there.
See these and older announcements at NIAID Funding Opportunities List.
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Last Updated June 06, 2012
Last Reviewed June 06, 2012