Archive for the ‘nih grant application’ 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

Tagged with , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

NIH Grantwriting Webinar Series Begins in February 2015!

We are happy to announce that in addition to one-on-one consulting, workshops, and seminars, we are now adding webinars to our menu of options to help NIH grantees. Upcoming webinars:

Mistakes Commonly Made On NIH Grant Applications
Benefit from the knowledge gained by a grantwriter who reads dozens of Summary Statements per year.

Wednesday 4 February, 11am-12:30pm EST or Thursday 12 February, 11am-12:30pm EST

NIH Submission Strategies
Take steps to optimize your chance of success before you write.

Wednesday 11 February, 11am-12:30pm EST or Thursday 19 February, 11am-12:30pm EST

How To Write The Specific Aims Of An NIH R01
Learn how to make the most important section of your submission compelling and persuasive.

Wednesday 25 February, 11am-12:30pm EST or Tuesday 3 March, 11am-12:30pm EST

Learn More!

NIH Funding to Study Sex as a Fundamental Variable in Clinical Research

Credit: Photokanok at FreeDigitalPhotos.net

Credit: Photokanok at FreeDigitalPhotos.net

I am popping up from my mountain of R01 drafts to bring attention to an important NIH news release. Yesterday, NIH announced it has devoted over $10 million in supplemental funding for 82 grantees to explore sex differences in their clinical and pre-clinical research.

The news release states, “These awards are the latest round of funding in a program described in a May 2014 Nature commentary by [Janine Austin Clayton, M.D., NIH associate director for women’s health research] and NIH Director Francis S. Collins, M.D., Ph.D. This commentary informed NIH grantees and other stakeholders of the agency’s intent to develop policies that will require applicants to address the influence of sex in the design and analysis of biomedical research with animals and cells.”

The news release states that the goal of the supplements is to serve as “…a catalyst for considering sex as a fundamental variable in research.”

NIH began this program in FY13, initially funding 50 supplements ($4.6 million total.) The initiative has been led by the Office of Research on Women’s Health. Most of the NIH ICs have funded supplements since the inception of the program.

Historically, medical research has been conducted predominantly on white male subjects. NIH has made efforts to expand the scope of clinical research to include both sexes and to represent multiple races and ethnicities. Grantees who want to succeed in the NIH arena would be wise to incorporate such variables into current and future studies.

 

 

How to Use RePORTER When Preparing New Grant Applications

I love the NIH RePORTER website. One could spend hours on this site, looking at funding trends, levels, priorities, and percentages. If you are considering writing a grant application or contract proposal to NIH, it is well worth spending time on this website to see what NIH is already funding in your topic area.  If you find a similar project, read about it and determine if your proposed project could offer something different. If you find no funding for your topic, it could mean there is a gap in an Institute’s funding portfolio that they might want to fill, or it could mean it is not a funding priority for them at this time. As always, discuss your grantsmanship strategies with your prospective Program Officer(s). NIGMS has a recent post on using RePORTER to search for funded projects in your area:

How to Use RePORTER When Preparing New Grant Applications – NIGMS Feedback Loop Blog – National Institute of General Medical Sciences.

Will NIH Eliminate The Unpopular “Two Strikes You’re Out” Grant Review Policy?

In January 2009, NIH instituted a policy to sunset A2 applications, i.e. to eliminate a second resubmission. Since, investigators submit a grant application (A0) and if the application is unfunded they may submit one revised application (A1), and no more (previously, one could resubmit twice). This policy has been detested among research scientists since its inception and NIH has heard an earful of complaints about it. NIH spoke out recently on this topic. Will they consider eliminating the wildly unpopular policy? The short answer: Not bloody likely.

In a recent blog post, Sally Rockey gives some data NIH has compiled on this policy. One of the goals of the policy was to reduce the time to award, and in fact the time from A0 submission to award has been reduced from 93 weeks to 56 weeks by this policy. It is conventional wisdom that NIH grant applications, if funded, tend to be successful on their final submission, with very few succeeding as an A0. Yet surprisingly, since the policy went into effect, the proportion of funded A0 applications as compared to A1 apps has increased.

One major complaint of the policy is that it favors established investigators over new investigators. The data do not appear to support this idea, because the time-to-award for new applicants is not appreciably longer than for the entire population.

In response to the suggestion that NIH allow A2 applications only from those investigators whose apps fall just outside the payline, NIH modeled the potential impact of such a policy using FY11 data. From their model, NIH concluded that the result would be to shift awards from A0 and A1 apps toward A2 apps, which was what the policy was designed to avoid to begin with (see original blog post for details of their method.)

Rockey concludes: “Overall, these data indicate that the policy to sunset A2 applications continues to achieve the stated goals of enabling NIH to fund as much meritorious science as possible in as short a time period as possible. Any revision to the policy to allow additional resubmissions of all or a subset of A2 applications will displace equally meritorious A0 and A1 applications, and increase the time to award for many applications. For these reasons, we have decided to continue the policy in its current form.”

Sorry folks, it’s here to stay.

FAQs on NIH Application Review

Another useful post on a recent NIGMS Feedback Loop Blog – National Institute of General Medical Sciences (Can you tell by the number of recent posts that we are past most of the Cycle III deadlines and I can finally catch up on reading/posting??)

FAQs on Application Review, Next Steps – NIGMS Feedback Loop Blog – National Institute of General Medical Sciences.

Questions include:

NIH Grantwriting Circles of Hell

T.S. Eliot says that “April is the cruellest month”, but if you work on NIH grant applications for a living, April’s got nothing on May. For those of us whose professional lives largely revolve around the NIH grant cycles, May is the month leading up to all those dreaded deadlines in June. Forget Eliot, this feels more like Dante’s Inferno:

First Circle: LIMBO. This is where the guiltless damned reside. Sounds about right. It is when a client sends you a dreadful first draft of their Research Strategy and you read and re-read it, and think, “I don’t even know where to begin.”

Second Circle: LUST. Where your appetite sways your reason, and you are consumed with fantasies of eight- and nine-figure grant awards.

Third Circle: GLUTTONY. You are at your computer at 2am. For the ten thousandth time this month, you do a global find-and-replace to change “data is” to “data are”.  With red-rimmed eyes, you decide to crack open your fifteenth bag of peanut M&Ms. Large bags of potato chips wait nearby.

Fourth Circle: GREED. When you lose your ability to understand why any other person’s grant applications should ever be funded.

Fifth Circle: ANGER. May is not the month to spend time looking at funding statistics on the NIH Reporter website.

Sixth Circle: HERESY. You start to believe that other federal funding agencies, such as Department of Defense or NSF, are evil or satanic because you believe their funding levels are better than those at NIH. You generally find yourself in this circle of hell after a conversation with a grantwriting colleague who has recently landing a DoD or NSF grant.

Seventh Circle: VIOLENCE.

Outer Ring: You fantasize about sabotaging the grants.gov portal.

Middle Ring: You fantasize about being transformed into a gnarled thorny bush and being fed upon by Harpies, because anything would be better than spending one more minute creatively formatting to meet a page limit.

Outer Ring: You shake your fist at God and rue the day you ever applied to a biomedical research graduate program.

Eighth Circle: FRAUD. You tell your client their R01 will not be competitive with so little preliminary data. They miraculously return two weeks later with seven more figures. You say nothing.

Ninth Circle: TREACHERY. You recall the client who first talked you into trying your hand at grantwriting and remember how he recommended you to all his research colleagues. At the time you were grateful for his having launched this lucrative segment of your business portfolio, but you now recognize it for the act of treachery that it truly was. You recall the day he kissed you on the cheek at a department-wide meeting in front of the faculty, and kick yourself for having missed the symbolism.

The Centre of Hell: SATAN. Satan is portrayed by Dante as ignorant and full of hate—i.e., a Study Section. He has three faces: one represents basic science, one clinical science, and one translational science. He is waist-deep in applications, entrapped and weeping tears from his six eyes as he shouts, “You have given poor consideration to alternative hypotheses! You have not run the appropriate controls! Your ideas are not innovative! Your diffuse study design has dampened our enthusiasm for your project! You did not cite me in your references!” The icy winds of bureaucracy ensure his continued imprisonment in the Pooks Hill Marriot. Each of his mouths chews on an unscored grantee, as he rakes his hideous claws over the applications, reducing them to shreds. And just when you cannot stand one more moment…

You reach COB June 5. And your phone starts ringing for help on the Cycle III apps…

How Cover Letters Aid NIH Application Reviews

I am often asked whether one should write a cover letter to accompany an application. Many of my clients feel it is a waste of time. I completely disagree. Here is a section on the topic from the May 2011 “Peer Review Notes”, a newsletter put out by the Center for Scientific Review:

NIH encourages applicants to submit cover letters to help guide applications to our review groups and give us other information that will help us review them. A majority of applicants now take advantage of this opportunity.

 

Popular Reasons to Use a Cover Letter

• Suggest we assign your application to a review group you think is best.

• Suggest we assign your application to an NIH institute(s) or center(s) you think would be interested in your research.

• Describe the kinds of expertise needed to review your application.

• Let us know about potential reviewers who you think might be in conflict with your application.

Our scientific staff members make the final decisions after they carefully consider your suggestions and explanations.

 

Suggesting a Study Section

We designed our study sections with a deliberate amount of overlap, so more than one study section may have the expertise to review your grant application. You may express a preference, and we will work to accommodate you if possible.

 

• Check our online study section descriptions to identify a review group you think is best suited to review your application. Last year, this area of our Web site registered nearly 1.7 million page views.

• Examine recent study section rosters to help you gauge the scope of our study sections. But note that CSR study section rosters can change significantly from round to round since we recruit reviewers for a meeting based on the specific scientific content of the applications to be reviewed.

• Consider seeking guidance from a CSR scientific review officer overseeing a study section you think could best review your application. Program officers can also give guidance on suitable study sections.

 

Requesting Assignments to NIH Institute(s) and Center(s)

You can also request that your application be assigned to one or more NIH institutes or centers you think would be interested in your research. It’s usually a good idea to contact one or more NIH program officer(s) to get guidance. You can identify program officers via the NIH Institute and Center staff listings on their respective Web sites.

 

Helping Ensure Your Review is Appropriate and Unbiased

 

• Note essential expertise needed to evaluate your application in your cover letter. You

should not, however, list the names of potential reviewers.

• Identify reviewers who you think could be in conflict with your application. Learn

about these conflicts here.

 

Your scientific review officer (SRO) will consider the situation and make the final decision. If he/she agrees there is a conflict, the reviewer will not be assigned to your application and will not be in the room when it is discussed. Rosters are typically posted online 30 days before your review meetings, and if you see a reviewer on it who could be biased, contact your SRO as soon as possible.

 

Notifying NIH that You Are a Reviewer Eligible to Submit an Application Without a Deadline

Learn more about this and other uses of cover letters by checking out our new cover letter Web page.

 

 

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.

Comparison of NIH Small R-Series Research Grants (R03 vs. R21)

In preparation for discussing the fate of small research grant awards at NIH, I decided first to give a brief overview of the R03 and R21 programs, including a list of which ICs participate in these programs, both under the parent FOA and outside the parent FOA:

Small Research Grant Program (R03)

Maximum two-year award, $50K per year in directs (Six-page application.)

Eleven of the 27 NIH ICs currently participate in the parent award: NHGRI, NIDA, NIA, NIAAA, NIAID, NIBIB, NICHD, NIEHS, NIMH, NINDS, and NINR. (Some of the ICs that are not listed may have R03 programs that fall outside these guidelines that are announced in specific RFAs or PAs issued by the IC.  In other words, they are not investigator-initiated, but rather are tied to specific priority areas for the IC.)

 Purpose: The R03 grant mechanism supports different types of projects including:

  • Pilot or feasibility studies
  • Secondary analysis of existing data
  • Small, self-contained research projects
  • Development of research methodology
  • Development of new research technology

Because the research plan is restricted to six pages, an R03 grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies. (But lets face it, you really have to include preliminary data if you want the reviewers to take the application seriously.)

NIH Exploratory Developmental Research Grant Program (R21)

Maximum two-year award, $275K in directs total (no more than $200K in any one year) (Six-page app)

Out of 27 ICs, 19 (soon to be 18) currently participate, and that number is expected to drop: NEI, NHLBI, NHGRI, NLM, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDA, NIDCR, NIDDK (leaving soon), NIEHS, NIMH, NINDS, NINR, NCCAM.

ICs that do not participate in the parent FOA but accept R21 applications in response to their specific FOAs: FIC, NCI, NCMHD, NCRR, NIGMS. For example: NCI reports that they currently have 59 R21 FOAs, 34 of which they initiated. They awarded 229 new R21s in 2010 (as compared to 850 new R01s). They fund a total of 592 R21s (compared to 3998 R01s).

 Purpose of Parent FOA: The Exploratory/Developmental Grant (R21) mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. Such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research.  Another example could include the unique and innovative use of an existing methodology to explore a new scientific area.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. (may submit without preliminary data. NOT.)

(Data and most of the text have been taken from the NIH website. Italics for emphasis, as well as any/all sarcasm, are strictly the author’s.)

%d bloggers like this: