Archive for the ‘nih grant policy’ 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

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?

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

 

TOP TEN TIPS for Writing an NIH Center Grant Application

We just staggered over the finish line of another massive NIH grant application. These monster applications exact their toll on everyone, always leaving the entire team feeling completely drained. Having now been involved in developing a number of large-format NIH grant applications (P-series and U-series), I have begun to compile a list of things that go into making not just a successful application, but a good experience for everyone:

 

1. It takes a village. Or rather, a small city. Trite I know, but let me tell you, these applications will demand the availability and input of dozens of people. In addition to the PIs, the grant application writers will need unfettered access to the myriad investigators involved in the project (including co-Is, PIs on subcontracts, consultants, etc.) as well as budget people, grant administrators, hospital/university administrators, policy wonks, etc. I once needed eleventh-hour input from a team of upper-level administrators from a major medical center who were all traveling to the same conference; They teleconferenced in to me from an airport terminal in the eight minutes it took for them to be called to board their flight. All hands on deck. Kiss your families goodbye. Everyone hand over your off-hours contact info.

 

2. Within that village there must be one Chief. And that point person must be willing to seriously put him/herself in the red zone for the application. S/he will be at least as sleep-deprived as we are by submission. I have worked on center grant applications where there was a single point person who was willing to turn him/herself inside out for the application, a person who was available 24/7 if I had questions, someone who was willing to jump into the fray and resolve any and all issues that might arise. This person is involved in every aspect of the project from concept development, strategic planning, and kick-off meeting to final manuscript review. This person reviews every word of every draft of every section of the application, and does not sign off until someone hits the “Upload” button to the portal (or you hear the engine fade as the FedEx truck drives off with your paper submission.) In contrast, I have been involved in center grant applications where no one assumes this responsibility. Guess which applications fare better? My take-home message here is to upper-level administration: If you want to improve your odds of landing a center grant, choose a capable person (often one of the PIs, but not always) and free up that person’s schedule for a few months so s/he can dedicate him/herself to the task. Yes, really.

 

3. Kids don’t try this at home. Hire yourself a full-service team to develop the grant application. These large-format grants tend to start at around $8-$10 million, and go up from there. Beyond the dollar award, the benefits of landing such a prestigious award are numerous and not always tangible or quantifiable. If you are serious about improving your odds of funding, invest up front in a skilled and experienced team to help you navigate the process. On that team one should have several experienced and highly-skilled writers, a dedicated budget person, and a project coordinator who will help run teleconferences, create timelines, organize support letters, etc. The project coordinator also can help on the other end with formatting, pagination, and uploading (believe me, this part takes a lot longer than you ever think, especially for these gigantic applications. The devil is in the details.)

 

4. Plan the project well in advance. Projects work best if you can identify an FOA, assemble a team, and meet to brainstorm and strategize about how to proceed. I have posted previously about my feeling that center grant applications work best when the host institution invests significant money beforehand to launch some of the projects/cores that will go into the application. That sort of up-front investment goes a long way toward showing reviewers that the projects are feasible and also demonstrates a high level of commitment on the part of the institution.

 

5. Recognize that most groups don’t plan well in advance. Apply anyway.  Very few center grant applications are written under ideal circumstances. For many groups, the project takes shape as part of the writing process. While this scenario is not ideal, it is not uncommon. So don’t panic when things seem chaotic, even as you approach the submission deadline.  That said, please also recognize that while your writers are there to help you write up your ideas, they cannot design the project for you (though we certainly will offer opinions and advice.)

 

6. Do your policy homework, then apply anyway. Most large institutions have a team of policy wonks who can dig up some “intelligence” on the competition and the review process. While this process generally yields extremely valuable information for the writing team, be careful how you use it. The largest grant I ever landed was meant to be an earmark for another group. In fact, the anticipated recipient got at least as much press for their failure to land the grant as the awardee got for their success.

 

7. Respond to the funding opportunity announcement. Another obvious suggestion but you would be amazed how in the process of writing a lengthy application, the group can lose sight of the purpose of the FOA and veer instead toward their own interests. Sometimes a group has an idea for a center design that does not exactly fit the purpose of the FOA. Get out your shoehorn and make it fit. If you have an innovative model for medical care but the FOA is designed to expand access to or reduce the cost of care, figure out a way to spin the write-up so it fits the FOA. This is where a skilled writer can be invaluable.

 

8. You name it. If you are presenting a business plan for a multi-million dollar center, don’t you think that center ought to have a name? In addition to the fact that it will be easier to discuss in the application and in review, naming a center also lends credibility and validity to an entity. Names are often acronyms (or portions of it are acronyms.) Sometimes they are named after people (no, not the Program Officer, as one client recently quipped.) The advantage of naming after a person is that it can instantly create an image for the center if the person’s reputation or qualities are known within the field. It also can help with fundraising efforts down the line. Don’t be afraid to name after a living individual, if they are in the field they will understand if the project is not funded.

 

9. It takes a resubmission.  Please remember that the vast majority of NIH grants, including center grants, are awarded to applications on a second submission. So when the pink sheets come in and you want to commit hari-kari, try to remember this fact. Give yourself a few days to cry in your beer and contemplate a career change, then pull yourself and your team together and start planning your resubmission.

 

10. Tips for the application development team. I will conclude with a few words to the beleaguered application development team. I generally serve as lead writer on these teams so my advice is from that perspective: Implement a system for “version control”, as the document will be written by committee and you will need to incorporate input from dozens of people on numerous rounds of revisions for dozens of sections; Create clear timelines for intermediate milestones in the writing process, then recognize that you may not hit them and that you may need to adjust as you go along (within reason); Learn to delegate, both to members of your application development team and to members of the research team, and know when to bring in more writing help; Make clear to the research team when you are switching to “edit only” mode (i.e., no more sourcing and writing), and again when you have switched over to “formatting only” mode (no more edits thank you). Otherwise they will edit ‘til the cows come home, whether they have had a week or a year to write the damn thing. Applications can always be improved and editing is never actually “done”. Respect the timeline to submission and know when to cut the cord.

 

A final note…

Writing a center grant application is an arduous process and it will go much more smoothly if everyone in the trenches maintains a sense of humor. I don’t know where I would be without my team members making jokes at 4am when we are on our umpteenth straight night of minimal sleep. If you are on the writing team, try to keep everyone’s spirits up as you near submission. Remember that while this is your day (night, weekend) job, the researchers are working on the application in addition to their day job. Show patience and forbearance and heap on the encouragement as everyone staggers toward the finish line. And don’t wait for the funding decision—celebrate the submission itself! (Then go hang out with your family before they disown you. My delightful urchins have been known to come up to me after submission, shake my hand, and reintroduce themselves.)

 

 

 

 

 

 

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