Archive for the ‘nih grant advice’ 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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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

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

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 Issues Draft Policy That Would Require A Single IRB For Multi-Site Clinical Trials

For years, grantees have been encouraged to use a shared IRB in multi-site clinical trials as part of shared research networks at NCI, and it appears to increase efficiency without compromising protection. In early December 2014, NIH released a draft policy proposing that multi-site trials in the U.S. be required to use a single IRB. NCI has already conducted an analysis demonstrating that a single IRB decreases time and costs when compared to having individual IRB at each participating clinical site. To read and comment on the draft policy, click here. NIH is eliciting input until January 29, 2015. A commonly used model of joint IRB review is IRBshare, which according to its website “facilitates the sharing of full board approved documents between IRBs, accelerates the initial review process by enabling a temporary reliance between IRBs, and minimizes the need for all sites to conduct a full board review.” See the IRBshare website for details.

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.

 

 

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*

 

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?

Should You Ask An NIH Grantwriter For Their Success Rate?

The short answer is no. And if you find a grantwriter who maintains and advertises such a thing, you should probably run for the hills. Grantwriting is an iterative process. At NIH, few applications are funded on the first try, and it can take time to titrate a grantee’s submission strategy. Success in one agency, IC, or study section does not mean you will be successful at others. It takes time, patience, legwork, and usually multiple submissions to figure it out. Most of my clients understand this and are willing to invest time and energy in developing their relationship with a given agency over time.

While one should write an application as if it were your only shot at funding, the grantwriter and client must also understand that a first submission to a new agency, study section, or IC will likely wind up being a learning experience. I find it very rewarding to work with a client over time as they develop their understanding of a given IC and study section, and build a relationship with a PO. It is gratifying to help that client grow in terms of their NIH grantsmanship, and hopefully to land their grant on a subsequent submission and launch their relationship with NIH. The same holds true for experienced grantees looking to make the leap into center grants. It usually takes patience, hard work, and multiple submissions to succeed.

No matter how strong the science, NIH statistics show that few funded projects are successful on the A0. Therefore, a grantwriter who maintains their own funding statistics is not likely to accept inexperienced applicants as clients—yet these are the very clients who may benefit the most from your help. If grantwriters only accept projects they know have a strong chance of funding, then who will help inexperienced grantees learn the ropes?

If a grantwriter maintains success statistics, I would question their commitment to their clients. That said, you certainly don’t want to choose a grantwriter who never lands grants! But perhaps the better measure of “success” in this scenario is if their clients feel the grantwriter strengthened their application, educated them on the NIH grant process, and improved their overall approach to grantsmanship—skills they will carry with them throughout their career, whether they are successful on a given submission or not.

I assume I do not need to mention that you should steer clear of a grantwriter who guarantees success. Anyone fool enough to believe such a thing deserves what they get. Great writing and grantsmanship savvy are necessary, but not sufficient, to funding success. A grantwriter cannot change the science, and naturally many projects are not funded because of the science.

What would you look for in an NIH grantwriter? How would you interview one if you wanted help on a submission?

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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