Archive for the ‘new NIH grant format’ Tag

New Webinar: NIH Submission Strategies — Register Now!

You have a cool idea for a research project, now what? The second in my new webinar series addresses NIH Submission Strategies. As a person who works on NIH submissions full time, I know there are certain steps you can take before you write a single word that correlate with better scores and outcomes.

Some of these steps include the following: taking the time to understand the priorities of the stakeholders involved, including reading Appropriations Reports; learning which projects are already in the NIH funding portfolio to ascertain how you might adjust your idea to fit in; identifying multiple ICs (not just an obvious one) and shopping around different versions of your Specific Aims to gauge enthusiasm; building a relationship with the all-important Program Officer, who will help guide questions related to study design, FOA, ESI status, and study section; and understanding the review process and audience before you write.

Your team will invest hundreds of hours in your submission. Why not spend 90 minutes learning some tried-and-true strategies to use before you write that will optimize your chance of success? I probably work on more NIH submissions in a month than you will work on across your entire career. I’ve helped clients land over $200 million in federal funds, and I can help strengthen your submission and improve your grantsmanship as well.

REGISTER FOR ALL 3 WEBINARS AND SAVE!
Bundle with two more webinars and save! Three webinars for $499.

Read about all three webinars, including “Mistakes Commonly Made on NIH Grant Applications” and “How To Write The Specific Aims.”

NIH Submission Strategies

Who: Essential for grantees planning to submit an R01, R21, or R03 in an upcoming cycle, and the senior faculty and administrators who advise them.
When: Wednesday 11 February 2015, 11am-12:30pm EST or
Thursday 19 February 2015, 11am-12:30pm EST
Cost: $199; Or register for all three webinars this month for $499
Takeaways: At the end of this 90-minute session, participants will be able to:

1. Utilize the Reporter website to identify their niche in the funding portfolio
2. Identify likely ICs, POs, and FOAs
3. Write several drafts of their Aims to send to POs
4. Choose the most appropriate IC, FOA, and study section with PO guidance

REGISTER NOW!

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Posted February 5, 2015 by Meg Bouvier in Freelance medical writing, medical grant writing, NIH grantwriting

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New Webinar: “Mistakes Commonly Made on NIH Grant Applications”

In an effort to provide cost-effective training to the broadest group possible, I am launching a series of webinars in the upcoming months. The first of these will be in early February, and the goal will be to help grantees recognize and correct common submission mistakes.

Unlike many who conduct NIH submission training programs, I myself work on NIH submissions full time. I see clients make the same types of mistakes repeatedly– mistakes that are easily avoided.

Each year I am fortunate to have dozens of clients share their Summary Statements with me. Because I regularly read reviewer comments from a multitude of study sections, I can easily identify trends in pink sheets. I also keep track of evolving trends at NIH based on information I find in FOAs, Notices, and Appropriations Testimony. Study sections change, funding priorities evolve. It is important to understand NIH’s priorities right now.

I have helped clients land over $200 million in federal funds in the past five years. Your NIH submission will entail several hundred hours of work by you and others. Why not learn strategies to optimize your success on this and future submissions?

What: Webinar entitled “Mistakes Commonly Made on NIH Grant Applications

Who: Ideal for faculty preparing to submit a K, R21, R03, or R01 in an upcoming cycle, and the senior faculty and administrators who advise them.

When:Wednesday 4 February 2015, 11am-12:30pm EST or
Thursday 12 February 2015, 11am-12:30pm EST
Cost: $149
Takeaways: At the end of this 90-minute session, participants will be able to:
1) Predict some key criticisms reviewers may make
2) Identify problems in their or their colleague’s draft applications
3) Utilize that information to write stronger drafts

Update on the New NIH Biosketch Format

Credit: adamr at  FreeDigitalPhotos.net

Credit: adamr at FreeDigitalPhotos.net

There are changes pending for the NIH biosketch format, and I think it is good news for NIH grantees. The new NIH biosketch format will allow up to five pages for the entire biosketch, as opposed to the current four-page limit. Even better, rather than simply listing publications, the new format will give researchers the opportunity to highlight the magnitude and significance of the scientific advances associated with their discoveries and the specific role they played in those findings.

Grantees will be permitted to describe up to five of their most significant contributions to science, the influence of their contributions on their scientific field, and any subsequent effects of these contributions on the fields of medicine or technology. This will help reviewers better focus on the applicant’s most important contributions to science. Researchers also will be able to include a link to their complete list of publications in SciENcv or My Bibliography.

NIH recently launched a new round of pilot tests (here and here) to make sure the new format will work well for both applicants and reviewers. The pilot will involve surveys of both reviewers and applicants to help NIH fine tune the application instructions and guidance to reviewers. NIH plans to roll out the modified biosketch for all grant applications received for FY 2016 funding and beyond (which generally refers to applications submitted in early 2015).

To learn more about the NIH’s new Biosketch format click *here*

 

The Importance of the “Approach” Criterion On NIH Grant Scores

Sally Rockey, Deputy Director of Extramural Research at NIH, posted data on her blog concerning reviewer behavior on proposals reviewed in 2010. Recall that with the new NIH grant format, NIH implemented scores of one to five (lower is better) in each of five categories: Significance, Innovation, Approach, Investigators, and Environment, as well as the overall impact score. Of 54,727 applications reviewed in FY10, 32,546 were discussed and received overall impact scores. The NIH generated some data on these scores. Among their findings:

*While reviewers used the full scoring range (one through five) for each of the five review categories, their scores were distributed more widely for the Approach category.

*Criterion scores are moderately correlated with each other and with the overall impact score.

*Of the five scoring categories, the one best able to predict the overall impact score was the Approach section (followed by significance, innovation, investigators, environment.)

The language surrounding the changes to the NIH grant format in Zerhouni’s efforts to enhance peer review stressed the importance of Impact, Significance, and Innovation. And in the new format, the length of the Research Strategies was halved, forcing grantees to compress “Approach” sections such as the exhaustive literature review and the detailed methodologies. However, from the data in Rockey’s blog post, we might surmise that reviewers still heavily weigh the Approach category. And based on my own experience with pink sheets in the new format, reviewers’ nearly-insatiable desire for preliminary data appears to continue unabated, despite the reduced page limits on proposals.

Multiple Regression To Predict Impact Scores Using Criterion Scores

Criterion Regression Weight
Approach

6.7

Significance

3.3

Innovation

1.4

Investigator

1.3

Environment

-0.1

NIH “Two Strikes You’re Out” Rule, Two Years Later

Once upon a time, one was allowed three submissions on an NIH grant application—your initial submission (A0), and two resubmissions after review (A1 and A2). In January 2009 NIH did away with the second resubmission, giving rise to what the scientific community not-so-fondly dubbed the “Two Strikes You’re Out” rule. This policy was instituted under the leadership of previous NIH Director Elias Zerhouni as part of the effort to Enhance Peer Review. The goal was to fund the best science in the shortest time period possible.

So two years out, how successful has this policy been? Today NIH released a letter it composed in response to one it received from members of the scientific community. Before the policy went into effect, funding for A0s had dropped dramatically, despite the fact that applications that initially scored in the top 20% were eventually funded (they went on to be funded as A1s and A2s after having to wait 1-2 years.) This trend appears to have reversed: The proportion of funded A1 applications has remained constant while the proportion of funded A0s has increased dramatically. The NIH letter goes on to supply data demonstrating that the policy has not had a negative effect on R01 funding for New and Early Stage Investigators. Read more, and if you haven’t already subscribed to NIH Deputy Director Sally Rockey’s blog “Rock Talk”, I highly recommend you do so.

NIH Funding Advantages to New and Early Stage Investigators

Between 1980 and 2001, the average age at which an investigator first obtained NIH R01 funding rose by almost 6 years (I won’t tell you what that age currently is, because I don’t want to depress you.) Yet the NIH website states,

“New investigators are the innovators of the future – they bring fresh ideas and technologies to existing biomedical research problems, and they pioneer new areas of investigation. Entry of new investigators into the ranks of independent, NIH-funded researchers is essential to the health of this country’s biomedical research enterprise.”

So what is NIH doing to help New Investigators break into the field? And what the heck IS a New Investigator, anyway?

The NIH defines a “New Investigator” as a Program Director/Principal Investigator (PD/PI) who has not previously competed successfully as PD/PI for a substantial NIH independent research award. (i.e., R01s, but not R03s and R21s.) During the hay day from 1998-2003, when the NIH budget doubled, 25% of R01 recipients were New Investigators. That number has been steadily declining since 2003. In order to address that decline, one of the policies NIH implemented concerns how New Investigators are treated at scientific review. The NIH website states,

“In order to address both the duration of training and to protect the flux of new investigators, the NIH announced a new policy in fiscal year 2009 involving the identification of Early Stage Investigators (ESIs). ESIs are New Investigators who are within 10 years of completing their terminal research degree or within 10 years of completing their medical residency at the time they apply for R01 grants.  Applications from ESIs will be given special consideration during peer review and at the time of funding. Peer reviewers will be instructed to focus more on the proposed approach than on the track record, and to expect less preliminary data than would be provided by an established investigator.”

It is difficult to find language on the NIH website that provides an operational definition of “special consideration during peer review and at the time of funding.” But word on the street is that the funding line can be as much as five percentile points higher for ESIs. So, for example, if a given Institute is funding 12% of applicants on a specific FOA, then 17% of ESIs will be funded. The original NIH Notice concerning the creation of ESI status and the favored position they would enjoy at review states, “Early Stage Investigators should comprise a majority of the New Investigators supported” under this policy. “Where possible, New Investigator applications will be clustered during review.”

Naturally it pays to take advantage of this window of opportunity in your career and work to land an R01 before your ESI status runs out. Conventional wisdom states that ESI status is eliminated after you land your first R01. So if you are lucky enough to be within 10 years of your terminal degree when writing a competing renewal (ie, your first R01 has run out and you are trying to land another one), supposedly you will be thrown into the pool with the big sharks and will have to compete like everyone else, with the same funding lines. However, last year I had a client who was in just that situation—writing an R01 competing renewal, but also less than ten years from her terminal degree. Her R01 competing renewal score was 16%. As a non-ESI at her primary Institute, she was not eligible for funding. However, this shrewd investigator found out that another major institute that was relevant to her work recognized ESI status on R01 competing renewals—so she switched assignment and obtained funding as an ESI at that institute.

The take-home message, as always: It pays to call around and speak to Program Officers at NIH. Many “rules” are not consistent across institutes, and a great many within Institutes are not written in stone. You never know unless you ask…

For more information about New Investigators and Early Stage Investigators, visit: NIH’s Frequently asked questions about NI/ESI.

How To Write an NIH Grant in the “New” Format

I put “new” in quotes because the revised NIH grant format went into effect last January, 2010. We are now into our fourth grant cycle with this format. In addition, we have seen pink sheets for two of those cycles, so we know what’s getting funded, what isn’t, what reviewers love and what they hate. I still get asked all the time about the new NIH grant format—it’s the most common question after funding rates (see blog entry from January 10.) So what do you need to know as you embark upon writing an NIH grant in the new format?

It’s all about impact. If you remember nothing else, please remember to emphasize the impact of your work. Remember the NIH mission statement: to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. Make sure the reviewers are abundantly clear how your work will reduce human suffering or improve health. Talk about it in the Summary, in the Specific Aims, and in the Significance section. Highlight it with formatting (bold, italics, underline—but please only one of these, not all three!)

The format aligns with the review criteria. Yea! It seems like a no-brainer that the two ought to be parallel. But the old format was not aligned with the review criteria. What are the review criteria, you ask?

1. Significance . Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach . Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation . Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators . Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment . Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Less real estate. The page length has been halved in the new format: R01s are 12 pages and R03s and R21s are a mere six pages. That means you need to get to the point. This shorter page limit together with the switch to only one resubmission means that you have fewer opportunities to be convincing. But one’s best, most persuasive writing ought to be brief anyway.

Lose the exhaustive literature review. One of the casualties of the shorter format is the lengthy lit review. Save that for your publications.

Ditto the extensive experimental detail. You simply do not have enough space in a 12-page R01 to go on at length about every single solitary detail concerning your methods. Save that for your publications.

Publish in peer-reviewed journals as much as humanly possible. Given the two aforementioned items, one can see that it is now more important than ever to publish in peer-reviewed journals. To a certain extent, you need to demonstrate your grasp of the literature and your experimental expertise in peer-reviewed journals rather than in NIH proposals. For these reasons, I feel the new format favors established investigators over newbies.

Write carefully the narrative overview in the biosketch. That’s right: your NIH biosketch no longer can sit in an obscure file on your computer desktop, ready to be dusted off when you submit a proposal. Now you must write the four-page biosketch anew with each submission. Of particular importance is the brief personal statement in the beginning, where you state how you are uniquely qualified to contribute to this particular project; and the publications, which are limited to 15 and must be chosen to reflect your qualifications for this particular project.

Choose your mentor(s) carefully. If you are a newbie with few publications, it is critically important that you choose a stellar mentor(s). If you are not writing a mentored (K-series) proposal, be sure to bring someone more experienced on as a consultant or key personnel, but not as a multi-PI, or their credentials will eclipse yours and defeat the purpose of writing your own R-series grant. Choose someone with an extensive publication list in solid peer-reviewed journals. Preferably, the person will have a track-record of landing grants at the NIH institute to which you are applying. This mentor’s endorsement of you as a new investigator serves in essence as another type of “peer review” in the eyes of the reviewers.

Still feel overwhelmed and confused? You can always hire yourself an experienced grantwriter!

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