Archive for the ‘NIH grant strategy’ 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!

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

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NIH Simplifies Policy on Late Applications

NIH might give you a two-week grace period on late applications. For details, see the Notice issued Dec 2014.

Examples of Reasons Why Late Applications Might Be Accepted

  • Death of an immediate family member of the PD/PI (or MPI).
  • Sudden acute severe illness of the PD/PI (MPI) or immediate family member.
  • Temporary or ad hoc service by a PD/PI on an NIH advisory group during the two months preceding or the two months following the application due date. Examples of qualifying service include: participation in an NIH study section/special emphasis panel, NIH Board of Scientific Counselors, Program Advisory Committee, or an NIH Advisory Board/Council. Qualifying service does not include participation in NIH activities other than those involved in extramural/intramural peer review or NIH Advisory Council/Board service.
  • Delays due to weather, natural disasters, or other emergency situations, not to exceed the time the applicant organization is closed.
  • For PD/PIs who are eligible for continuous submission (http://grants.nih.gov/grants/peer/continuous_submission.htm), the late application policy applies to activities not covered under the continuous submission policy (i.e., other than R01, R21, and R34 funding opportunities that use standard due dates).

 

Examples of Reasons Why Late Applications Will Not Be Accepted

  • Heavy teaching or administrative responsibilities, relocation of a laboratory, ongoing or non-severe health problems, personal events, participation in review activities for other Federal agencies or private organizations, attendance at scientific meetings, or a very busy schedule.
  • Review service for participants other than a PD/PI or MPI, acute health issues or death in the family of a participant other than a PD/PI or MPI.
  • Problems with computer systems at the applicant organization, problems with a system-to-system grant submission service, or failure to complete or renew required registrations in advance of the application due date.
  • Failure to follow instructions in the Application Guide or funding opportunity announcement.
  • Correction of errors or addressing warnings after 5 PM local (applicant organization) time on the application due date. Applicants are encouraged to submit in advance of the due date to allow time to correct errors and/or address warnings identified in the NIH validation process.

– See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html#sthash.flUVBOvk.dpuf

Top Ten Things NIH Reviewers Should NOT Say In A Review

ID-10046929

Credit: Ambro at FreeDigitalPhotos.net

The Center for Scientific Review publishes their Peer Review Notes three times a year, and the most recent issue came out yesterday. The news items are always interesting and it is worth subscribing, if you don’t already. This issue contained an item about things NIH reviewers should not say. I repeat the list in its entirety here—I thought it might be fun for my grantees to see reviewers critiqued for a change.

What do you think of this list? Have you seen one or two of these on your Summary Statements? Me personally? I have seen variations on # 2, 4, and 10 in Summary Statements, and have strongly suspected reviewers of #1 and 5. I almost fell out of my chair laughing when I read # 7, sometimes I think CSR is a little out of touch with what actually happens on Study Sections:

  1. “I didn’t read the application, but I scanned it and saw the applicant said XXX. He doesn’t know what he’s doing.” Damning statements like this can skew a review discussion over something that might be insignificant in the context of the overall application. It’s better for you to ask other reviewers who have read the application carefully what they think about XXX.
  2. “This New Investigator does not appear to be fully independent since he continues to co-publish with his fellowship mentor/department chair, or does not have designated lab space, or has not been promoted in the past several years.”  Academic research organizations have widely diverse policies for faculty advancements and lab space, and many PIs maintain productive and healthy collaborations with mentors for many years after establishing themselves as bona fide investigators. You should focus more on the investigator accomplishments, such as being the first or senior author on a significant publication or giving presentations at major scientific meetings.
  3. “This application is not in my area of expertise . . . “  If you’re assigned an application you feel uncomfortable reviewing, you should tell your Scientific Review Officer as soon as possible before the meeting.
  4. “I don’t see this basic science research affecting my clinical practice any time soon.” An application does not necessarily have to show the potential for clinical or timely impact—if the applicant doesn’t make such claims. Basic research often takes time to pay off, and you’re charged to assess the “likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.” Absence of an effect on public health does not necessarily constitute a weakness in basic science.
  5. “I like this project but I’m giving it a poorer score because the applicant has too much money.” Other funding is not a scoreable matter. You should focus on the application’s scientific and technical merit. However, you can note an excessive budget request in the budget section for NIH to consider.
  6. “This application has 2 great aims and 1 bad one. I would recommend deleting Aim 3, and I can give it a 1 or 2.” You cannot trade aims with scores. The application needs to be evaluated as a whole.
  7. “This R21 application does not have pilot data, which should be provided to ensure the success of the project.” R21s are exploratory projects to collect pilot data. Preliminary data are not required, although they can be evaluated if provided.
  8. “The human subject protection section does not spell out the specifics, but they already got the IRB approval, and therefore, it is ok.” IRB approval is not required at this stage, and it should not be considered to replace evaluation of the protection plans.
  9. “This application was scored a 25 and 14th percentile last time it was reviewed . . . .” You should not mention the previous score an application got, because this could skew the review discussion. Focus on the strengths and weaknesses of the current application as well as the responses to previous critiques.
  10. “This is a fishing expedition.” It would be better if you said the research plan is exploratory in nature, which may be a great thing to do if there are compelling reasons to explore a specific area. Well-designed exploratory or discovery research can provide a wealth of knowledge.

Implications for Grantees of no more “Two Strikes You’re Out”

Credit: adamr at  FreeDigitalPhotos.net

Credit: adamr at FreeDigitalPhotos.net

Ding, dong the evil resubmission policy is dead. What are the implications in terms of your grantsmanship strategy and writing?

The original intent of the ill-fated, much-hated “Two Strikes You’re Out” policy was to reduce the time from first submission to award. According to the statistics and metrics put out by NIH, it was achieving that goal. With the policy change that went into effect last month, grantees still submit an A0 (new application) and an A1 (first resubmission), with no A2 (second resubmission) available. But if they fail at both the A0 and A1, they no longer need to shelve the application forever. They can now submit the application again as an A0 to any IC or study section they choose, and the reviewers will be given no information about earlier versions or summary statements. I have yet to find a grantee who is unhappy about the change of policy. ESI and New Investigator grantees in particular have expressed relief that they will have multiple attempts to “get it right” (the incorrect assumption being that study sections are static entities and that each review will be similar to previous reviews in terms of expectations and criticisms.)

Yet, it seems to me that this resubmission policy will lead to even longer lengths of time from first submission to award than were seen when people were allowed three submissions total. In essence, the very problem that “Two Strikes You’re Out” sought to fix will be made worse than it was prior to the “Two Strikes” policy. Here is my tongue-in-cheek mathematical representation of the new resubmission policy:

(A0, A1) ∞

To my mind, this policy equates not only to longer times to award than ever before, but also to an unprecedented number of NIH submissions going forward. In recent years, the total aggregate number of R01 submissions has been fairly steady at about 28 or 29 thousand per year. I expect we will see a dramatic increase in that number in FY14 and into FY15, as all those shelved, failed submissions go back into circulation. At some point that number will decrease a bit to a steady state that is still significantly higher than 29 thousand applications per year.

Love or hate the new policy (and while I recognize that “Two Strikes” was flawed, I am firmly in the latter camp), how should you fold this information into your approach to grantsmanship?

1. Consider deferring your June 5 A0 to the Oct deadline. I suspect that everyone and his brother will be dusting off an old, unfunded application and submitting an A0 for June 5. I suspect that that will equate to a gigantic number of submissions for this cycle, and my suspicions appear to be supported by the sheer volume of A0s on which I have been contracted to work. (I haven’t seen a crushing number of applications like this since the stimulus money.)

2. Give yourself more time to upload to the grants.gov portal with any R01 deadline going forward, but particularly for the June 5 deadline. As you know, applications must be uploaded and time stamped. When traffic at the portal is heavy, there are delays in your ability to upload. Many grantees have told me they missed a deadline because they waited too long and could not upload due to traffic at the portal, or not enough time to correct error messages received. This problem will be exacerbated by the increased application volume from now on.

3. Format your application with greater care than ever. A sharp increase in submissions will likely mean that reviewers will be even more overworked than ever, and the increased time/cost of reviewing all these extra applications may mean that CSR will step up its experiments with virtual peer review. How should this affect your writing? Use lots of unique identifiers throughout the application (numbering system with multiple subheadings) to help orient reviewers who are exhausted and/or not meeting face to face while discussing your application. Make judicious use of formatting to highlight key words and phrases so that reviewers can skim and quickly grasp your main points.

4. Understand that the time from first submission to funding may be very, very long. Plan your work accordingly. Your career strategy must be able to accommodate long review times at NIH. Your career cannot come to a standstill while you wait years to find out if you will receive NIH funding. Understand that you cannot have the same science in review at two NIH ICs simultaneously. However, you can and should submit the same science to different federal agencies simultaneously (ex- NIH and HRSA, AHRQ, DoD, PCORI, NSF, etc). And of course you can blanket the private foundation landscape with the same project. (Should you receive funding from multiple entities— may you have such a problem—this conundrum can generally be worked out in consultation with the program officers.)

5. The standard for quality of a submission is likely to be raised, so you will need to write stronger applications than ever before. Historically, it seemed that if reviewers knew you had a resubmission available to you, they expected you to use it to hone and polish the submission. Because reviewers know you have endless resubmissions available, I wonder if they might raise the bar for quality of the application. They may want you to resubmit until they feel it is just right (which is a moving target, given that your original reviewer(s) may have rotated off the study section before you resubmit.) In addition, a sharp increase in the number of submissions will likely mean that competition will be stiffer, so the quality of the submission will need to be even higher to stand out from the larger crowd. Grantees will need to write their applications more thoughtfully than ever, taking extra time and care.

6. Institutions also will need to step up their game if they want to stay ahead of the competition. If your institution does not do so already, now is the time to implement Chalk Talks and Red Team Reviews (i.e., mock study sections) if you want to help your grantees succeed with the policy change. And of course, hire your grantees a professional grant writer for a few thousand dollars to improve the quality of their R01. It will improve their grantsmanship not just on this submission but on all submissions going forward, and if it helps land even one award it will have paid for itself by many orders of magnitude in the indirects received.

7. Write every submission as if it were your only shot at funding. I am afraid that less savvy grantees may think that they should jump into the game and submit an application that may not represent their best effort. After all, what harm is there in doing so if they can just keep submitting? And wouldn’t it be helpful to have multiple summary statements to hone one’s grantsmanship? Keep in mind that if you are submitting to the same study section repeatedly, they may not formally be given previous submissions and summary statements. But if you have some of the same reviewers, they will remember your past submissions, and it may color their impressions of the current submission. I liken it to a jury who hears testimony and is then instructed by a judge to ignore it in their deliberations. We know from the social psychology literature that despite our best efforts, it is not feasible to act as if we do not know something. If your assigned reviewers still serve on the study section, they may recognize your A0 as something they read in the past, and may recall their reaction to the previous submissions. Reviewers, like jurors, are human. Therefore, I maintain that grantees should write every submission as if it were their only one.

Can you think of other ways you will need to alter your approach to NIH applications because of the new resubmission policy? Do you like or dislike the new policy?

Dr. Bouvier Interviewed on Grantsmanship for the Journal Nature

We invite you to read Dr. Bouvier’s comments on grantsmanship in an article in the latest issue of the journal Nature.

The article, entitled, “Impact: Pack a Punch”, discusses the importance of impact in proposed research projects. It included comments from scientists and funding agency administrators from a wide variety of scientific fields in numerous countries. Dr. Bouvier was the only professional grantwriter who participated in the article.

Nature, a prominent international journal published weekly, remains one of the few journals to publish research spanning all of the scientific disciplines. It is one of the most widely cited journals in science worldwide.

Dr. Bouvier provided permission for her information to be translated for their Japanese and Arabic editions.

Posted October 21, 2013 by Meg Bouvier in Biomedical research, Freelance medical writing, medical grant writing, medical policy writing, NIH grantwriting

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Discussing Your Application’s Review with Your Program Director

NIGMS puts out a nice newsletter with useful articles and information. A recent newsletter contained the below article, which spells out how a Program Officer can help guide your next steps after you receive the Summary Statements on your grant application. I wholeheartedly agree with everything the author suggests. I think Program Officers are a highly under-utilized resource, and I always encourage my grantees to build a strong relationship with their PO.

Discussing Your Application’s Review with Your Program Director – NIGMS Feedback Loop Blog – National Institute of General Medical Sciences.

Reviewers of NIH Grant Submissions May Pay A Heavy Price When Their Own Submissions Are Reviewed

Grant scores are being posted right now. I was at a policy meeting last week with one of my grant clients and we waited with baited breath to see her scores. Although she has had a great deal of success on past NIH submissions, she was worried about this one, and with good reason. She recently agreed to serve as a reviewer on an NIH study section, but quickly realized that it meant that the resubmission of her own R01 competing renewal could no longer be reviewed in the most appropriate study section. Instead, it was assigned to a Special Emphasis Panel, or SEP. My client studied the list of reviewers on the SEP and learned that there was no one on the panel with the expertise needed to review her submission. She informed her SRO of this problem, but was told to sit tight and wait and see how the review went.

My client is considered an eminence in her field. She chairs a nationally-ranked academic department in her area, has landed numerous R01s, a U01, ARRA funding, and more. On her R01 competing renewal she scored in the 20th percentile, but the problems identified by the reviewers were certainly fixable and she resubmitted with hope, if not confidence. Then she accepted the position on the study section and the resubmission went to the (underqualified) SEP. The results of the resubmission were posted: Unscored.

It is hardly the first time I have heard such a story, it is just the most recent. It is considered an honor to be invited to serve on a study section. Many, like my client, choose to do so despite the time and effort involved because they feel they should give back for the many years of funding they have received from NIH. But the inadvertent result may be that the reviewer’s own submissions must be reviewed elsewhere, often on a panel that lacks the necessary expertise. As a result, my client and others have decided to terminate their service on study sections, which has the result of denying other NIH grantees reviews from those deemed the most qualified to provide them.

The current policy creates a situation where reviewers of a study section may be unable to get a fair review of their own grant applications at the most appropriate study section, thereby essentially penalizing them for service to NIH.

When discussing this problem last week in Washington with an NIH program officer, I was told to contact my local congressman. The PO felt that if we wanted to effect change to this NIH policy, the only approach was to inform a congressman that his constituents were not receiving millions in federal funding due to this policy. I plan to do so, and urge you all to do the same.

Posted October 30, 2012 by Meg Bouvier in Biomedical research, medical grant writing

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How The Change in Fiscal Year May Affect your NIH Grant

NIGMS puts out a nice blog that often has information that is applicable to NIH grants in general. I subscribe to it and often mine out grantsmanship gems from it. In the latest issue, NIGMS discusses how the change in fiscal year (FY13 is meant to begin on Oct 1, 2012) may affect your funded NIH grant:

How the Change of Fiscal Year Affects Your NIGMS Grant – NIGMS Feedback Loop Blog – National Institute of General Medical Sciences.

Topics include:

*September Council’s over. My application did well in review. When is my grant going to get funded?

*Would my grant application be funded more quickly if it went to a different Council round?

*Why can’t I activate my NRSA fellowship in October or early November?

*I’m moving from one institution to another on October 1. Can my grant or fellowship be transferred when I move? I want it to start on the day that I arrive or, if that’s not possible, later in October.

*I’ve applied for a diversity supplement for an individual who’s arriving on October 25. Will the supplement be available on the day that she arrives?

*My grant’s anniversary date is December 1. Why are the awards late most years?

*Why was my continuation budget reduced? Is the likelihood of a budget cut higher if my grant’s anniversary date is in the winter? Will the cut funds ever be restored?

Most Provocative Post of 2011

Of all the blog posts I wrote last year, this one provoked by far the most feedback. Posted last June after a particularly disturbing trip to D.C., I got many emails and phone calls about it in the weeks following. While I wouldn’t call it controversial, it seemed to hit a nerve for a great many people:

The State if Despair Among Many NIH Grantees

I am on a flight returning from a trip to Washington DC. I was visiting friends and former colleagues from my days at NIH. Several of my friends are now running research labs at medical centers, one of whom has served on several study sections. Another former colleague has gone on to become a Program Officer at NIH. One person does public health education at NIH, and another is running a successful freelance business. Each of them was interested in discussing the state of NIH grantwriting, especially given that the preliminary summary statements from the previous grant cycle have just become available on eCommons. We are all disturbed by the pervasive feeling of despair that I hear among NIH grantees.

One concern I hear repeatedly from both grantees and NIH program staff is concern about the quality of the review process on study sections. There are those who feel that regardless of the quality of the proposal, the best scores tend to go to the big-name labs who already are flush with funding. (I have heard it suggested by more than one person that reviews would work better if proposals were submitted anonymously.) Some feel that while New and Early Stage Investigators are given better opportunities to obtain funding, mid-career researchers are left in the cold because of the tendency to dole out money for the big-name labs. Another concern I often hear is that there are “cliques” within a given field, and the power to award great scores rests in the hands of the “in group” in a study section, while those outside the clique remain unscored and unfunded. I sometimes hear grantees and even program staff at NIH complain that the Summary Statements are illogical or contradictory– or worse, unintelligent. (When I see Summary Statements that are illogical or contradictory, often it is because the grant was confusing. Poor writing is not always the cause of such reviewer responses. But you can decrease your odds of a confused or ill-informed reviewer by writing more clearly and concisely.)

Almost certainly, there is some element of truth to each of these concerns. But I hate to see such talk discourage promising researchers from entering or remaining in the field. One could speculate endlessly about how to game the system when it comes to NIH grantsmanship. I think a great deal of such speculation is wasted energy. I hear a lot of stories from people in the field about what has gone wrong with their career, their proposals, the myriad ways in which they have been screwed. Being a proposal writer is a bit like being a bartender at times. And I see grantees making a lot of poor choices that are directly within their control to change. Here are some suggestions based on the mistakes I see:

When it comes to interacting with your colleagues, do your level best not to make enemies. Areas of biomedical research expertise have become so narrow and esoteric that you cannot afford to antagonize anyone in the handful of researchers in your field. That said, given the level of desperation over the current funding climate, you probably also should play your cards close to the vest. Be careful with whom you discuss your ideas. Your draft Aims may be best discussed at departmental chalk talks, where you can elicit great feedback while also divulging your ideas to a larger group who may serve as witnesses later on that the ideas were indeed yours. (Yes, I hear lots of talk of researchers stealing each other’s ideas.) Be assertive. It pays to ask for everything and anything you need, as the worst you will hear is no. I have a client who requested funds for application writing support from everyone—her Chair, the Dean, anyone who would listen. She got a little money from each source that, together with a little money from her start-up, helped pay for help on a K01 and a Robert Wood Johnson proposal (she landed both.) Her colleagues have whined about the help she has gotten, and why haven’t they been offered such help? (The answer: They never asked.) More examples: If you have done the work, insist on being first or last author on the manuscript. Conversely, if you are not the PI on a grant, do not do all the work. You will get no recognition. Above all, behave with integrity– even when your colleagues do not.

I have a great deal of respect for researchers who remain in the trenches of biomedical research, continuing to apply for grants even in the current funding climate. Such work is much more difficult than what I do. Increasingly, medical research facilities are shifting toward the elimination of tenure while demanding that their faculty rely 100% on soft money. It is not for the faint of heart.

But if you choose to remain, you must work to develop an extraordinarily thick skin. Writing a grant application is an iterative process. With each submission, you use the Summary Statements to hone your grantsmanship. You work to find a great Program Officer in an institute that is a good fit for your work, and then you work with the PO to figure out how to tailor your research to fit the funding priorities and interests of the institute. If you are suspect of the quality of your study section, shift your focus and request a different one. There is little use in dwelling on your fears (real or not) about the inequities and injustices in the review process, at least not while you are putting together a grant application submission. Your energy is best spent on improving your application and your grantsmanship on that submission, to the best of your ability.

Are R03s and R21s Disappearing from NIH?

In a previous post I reported that NIDDK is the latest IC to pull out of the R21 program. My colleagues and I have been discussing (read: bemoaning) the demise of the small grant programs at NIH for some time, so it got me wondering about the actual numbers. Below is a table I created of data on the total number of awards and total funding under the R01, R03, and R21 programs over the past ten years. Below the table is a link to three line graphs I created from these data.

The R03 program appears to have peaked in 2004, with 1,632 awards and about $131.3M in funding. That number has been trending downward ever since, with 2010 numbers dipping to 1,058 awards and $87.3M in funding. Both of these R03 2010 numbers are about 65% of what they were at their peak in 2004.

The R21 program looks like it peaked in 2008 (3,649 applications and $678M in funding), with the numbers trending down since.

The number of R01 awards peaked in 2004 and have gone down each year since, dropping from 29,060 (2004) to 26,752 (2010). However the total R01 funding has remained relatively constant over the same time period and was actually at its highest in ten years in 2010 ($10.6B).

 

Click here for line graphs comparing R03 and R21

 

  R01- # awards R01- total funding R03- # awards R03- total funding R21- number awards R21- total funding
2001 26,173 $8,092,593,805 1250 $85,588,331 1279 $222,627,134
2002 27,568 $8,985,081,987 1378 $100,859,126 1822 $334,251,476
2003 28,698

$9,742,052,935 1506 $119,237,600 2464 $463,441,579
2004 29,060 $10,176,053,099 1632

$131,256,249

2934 $565,855,342
2005 28,622 $10,288,217,875 1603

$129,112,877

3056 $590,944,052
2006 28,192 $10,121,779,877 1409

$110,742,609

3126 $599,204,776
2007 27,850 $10,045,800,665 1430

$107,986,148

3453 $676,573,619

2008 27,012 $9,956,033,585 1479

$107,464,019

3649 $736,213,063

2009 26,580 $10,261,795,174 1284

$99,073,147

3271 $678,182,707

2010 26,752 $10,641,893,906 1058

$87,331,891

3124 $658,330,834

Source: NIH Reporter website. Total # awards excludes number of awards for noncompeting supplements 

Click here for line graphs comparing R03 and R21

 

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