Archive for the ‘NIH Center For Scientific Review’ Tag

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

The Center for Scientific Review Board Makes Grant Review Suggestions to NIH

The NIH Center for Scientific Review (CSR) publishes Peer Review Notes to inform reviewers, NIH staff, and others interested in news related to grant application review policies, procedures, and plans. The latest issue of Peer Review Notes was sent out last night (they publish three times per year). Here are items that caught my attention:

Dr. Nakamura (new Director of CSR) Lists Some Initial Priorities for CSR:
  • Become more scientific in assessing approaches to improve the efficiency and particularly the quality of NIH peer review.
  • Work hard to understand and address possible disparities in NIH awards.
  • Collaborate with the NIH and scientific communities to identify critical problems, such as the definition of a “new” application, and to develop solutions.
  • Help the public understand the role of NIH peer review in advancing science and health in the United States.

I certainly wanted more clarity on those first three bullets, some of which I found in another article in this issue of Notes, which I have copied below (my comments appear after each numbered suggestion):
CSR’s Council Suggests Five Ways NIH Can Help Applicants CSR’s Advisory Council recently asked NIH to consider five ideas for helping applicants with promising research ideas to stay in the game despite historically low funding rates. Because these ideas deal with trans-NIH policies beyond CSR, Council members asked CSR’s Director to share them with the appropriate NIH officials.

CSR Council Ideas

1. Treat all applications as new and let investigators instead of NIH decide when resubmission is futile. Council members suggested that the resulting reviews would be more independent and simplified since earlier reviews would not be considered. Reviewers might also be more focused on merit because they wouldn’t get sidetracked by considering how investigators responded to previous reviews. Our Council suggested doing a pilot where investigators who opt-in could resubmit any R01 application as many times as they wanted, but they could submit no more than two research project grant applications in any 12 month period. Reviewers would be encouraged to send strong messages about applications that need substantial revision.

          Meg’s comment: I suspect PIs would love to submit an R01 application as many times as they like, though some folks would balk at being limited to two RPGs per 12-month period (I assume they mean any RPG at any IC). Many PIs I know would appreciate a clear message from reviewers about whether they should resubmit. The grant score alone does not always help them decide, as I have seen applications go unscored because the reviewers wanted an entire aim added or taken away, but they were very favorable about the rest of the application (in this instance, clearly the team should resubmit even though the A0 is unscored.)
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2. Encourage more NIH Institutes and Centers (ICs) to allow investigators to respond to their reviews prior to Council consideration so very promising applications that might slip through the system could be identified. Principal investigators (PIs) with “gray zone” applications would be asked to provide a response to their reviews. IC Program staff would submit these comments and applications to their Councils, which provide the second level of peer review.
          Meg’s comment: Again, I can imagine that most PIs would welcome the opportunity to speak persuasively about their project if they score near the funding line, though this strategy adds to the workload for both the PI and PO, which is something NIH has been trying to avoid.
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3. Enhance communications with PIs: Study sections and NIH program staff should do better at communicating to PIs about applications that are unlikely to be successful or, alternatively, are of potential interest.  [See our last PRN newsletter: Make the Best Use of the “Additional Comments to Applicant” Box]
          Meg’s comment: My clients and I spend plenty of time trying to read between the lines of pink sheets to figure out if the reviewers would welcome a resubmission. It can be exceedingly difficult for a PI to read his/her pink sheets, let alone accurately assess the subtleties of the comments. On the one hand, a clear message from the reviewers about resubmission would be welcome. On the other hand, if the PI feels he can address the problems, or feels the review was less-than-fair and s/he would like to wait it out and resubmit to the same study section after there has been some turnover, they should have the opportunity to do so regardless of what the study section said in the pink sheets. Note that this CSR Council recommendation seems to contradict their first recommendation above: “…let investigators instead of NIH decide when resubmission is futile.”
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4. Encourage NIH ICs to take full advantage of the R56 funding mechanism to provide bridge funding to promising investigators. These “High Priority, Short-Term Project Awards” provide 1 year funding for high-priority new or competing renewal R01 applications that score just outside an ICs funding limits.
          Meg’s comment: The little-known R56 funding mechanism is not one for which a PI can apply directly, it is awarded to a PI with a promising application to another grant mechanism. The award is made at the discretion of the Program Officer, which is one of the very many reasons I am a huge advocate of the PI cultivating a relationship with the PO. Note also that I had a client receive an R56 even though his original application was nowhere near the funding line. He had a great relationship with his PO, and the PO believed in him and his work.
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5. Provide longer-term funding for some PIs: For investigators with large and successful programs, NIH should consider offering funding for a longer duration but at a lower overall amount. The savings would be used to fund more applications. Restrictions on participating PIs would be necessary to ensure that the result would be revenue-positive.
          Meg’s comment: This is such a mixed bag I don’t even know where to begin.
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What do you think of the CSR Advisory Board recommendations to NIH?

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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Learn About The NIH Application Review Process

Most grant applications and contract proposals to NIH are reviewed in the Center for Scientific Review. The CSR puts out a newsletter periodically with updates and tidbits for NIH applicants. It is well worth subscribing to this newsletter, as well as spending some time perusing past issues. Here is the link to the latest edition:

Latest Issue of the Peer Review Notes

http://internet.csr.nih.gov/WebAnalytics/QRRedirect.aspx?param=PRNSep12Listserv

*   How Well Is NIH Identifying and Advancing Innovative Research?

*   Former Study Section Chairs Share Advice for New Reviewers

*   Make the Best Use of the “Additional Comments to Applicant” Box

*   Who Are the Other People in Your Review Meetings?

*   CSR Reviews for the NIH-FDA Collaboration on Tobacco Control Regulatory Research

What is the NIH R15 Grant Application?

I find that few of my clients are even aware of the R15 grant application. Apparently they are not alone. CSR recently took it upon themselves to remind reviewers what the R15 was:

“NIH recently posted a reviewer’s guide to R15 grant applications to help reviewers fully appreciate the unique goals and policies that govern this grant program. The “Academic Research Enhancement Award” (AREA) grant program was designed to support small-scale research projects at educational institutions that have not been major recipients of NIH grants but provide baccalaureate or advanced degrees for a significant number of students who may become research scientists. In addition to the usual goal of supporting meritorious research, this program was designed to strengthen the research environment and expose students to research at these targeted institutions. Applications should include plans to expose students to research but should not include training plans like traditional training or fellowship applications. Enhancing research environment and student exposure to research currently are not specific review criteria, but reviewers are asked to consider these issues when they assess “overall impact” and the “investigators” criterion.

“AREA grants are limited to institutions that receive a total of $6 million or less in research and training grants in 4 of the last 7 years. Awards are limited to 3 years and $300,000 in direct costs over the entire project period.”

NOTE that I do know of one client who was told this spring by a program officer that she was eligible for an R15– her academic institution does not fit the criteria, but her particular school within that institution did. As always, check with your program officer as such interpretations of these policies may vary from IC to IC.

Click HERE to learn more about the review of R15 applications by viewing the R15 Guide for Reviewers on the NIH Web site.


 

The State of 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 proposal 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. Proposal writing 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 proposal submission. Your energy is best spent on improving your proposal and your grantsmanship on that submission, to the best of your ability.

Center for Scientific Review’s “Peer Review Notes” is out!

I’m emerging briefly from my grantwriting fog to remind people that the NIH’s Center For Scientific Review, which oversees the peer review portion of the extramural grants, publishes a newsletter three times a year. The latest issue is out. If you don’t already subscribe, I strongly encourage you to do so.

I’ll be posting more when I emerge from the hell of impending Cycle II grant deadlines. (WHY do so many people apply for Cycle II grants? Does anyone know?)

What Does the NIH FY12 Appropriations Report Actually Say?

Why should we follow the Appropriations process? Aside from the obvious reason—to know how big the pot of extramural money will be next year and to understand the government’s commitment (or lack thereof) to science funding—there is another important reason: If you know the language worked into Appropriations testimony you can strategically design your research and incorporate key language and ideas into your NIH proposal in order to improve your odds of funding. (In these competitive funding times, every little advantage helps.) So without further ado, here are some key concepts from the NIH FY12 Appropriation report:

NIH has requested $31.987B for FY12. In the cover letter for the report from the Office of the Budget, Francis Collins states: “The requested funding will enhance NIH’s ability to support research that prolongs life, reduces disability, and strengthens the economy. NIH-funded research contributes to economic growth, produces well-paying jobs, and helps to keep the United States competitive on the global stage.” He continues: “For the FY 2012 budget request, NIH has identified one major area of extraordinary opportunity and three other themes that are exceptionally ripe for investment and integral to improving the health of the American people.” The one major area of opportunity of course is the proposed highly-controversial National Center For Advancing Translational Science (NCAT), which Collins refers to as “a new paradigm for turning lab discoveries into cures and treatments through targeted investments in translational science and medicine.” The three themes that NIH has deemed “instrumental in paving the way for more rapid scientific advances across all areas of human health and disease, including global applications”:

 1) Technologies to Accelerate DiscoveryThis area focuses on genes and the environment (I guess we will see more of those FOAs), and directly lists advanced technologies such as DNA sequencing, microarray technology, nanotechnology, new imaging modalities, and computational biology.

2) Enhancing the Evidence Base For Health Care Decisions. Language here includes “comparative effectiveness” and “personalized medicine.” He also cites the new HMO Research Network, which “will bring together HMOs caring for more than13 million patients for the purpose of accelerating research in the high priority areas of epidemiological studies, clinical trials, and electronic-health-record-enabled health care delivery.”

3) New Investigators, New Ideas. Here Collins mentions two programs: “the NIH Director’s New Innovator Award, which supports new investigators with potentially high-impact projects, and the Early Independence Award, which enables our most talented young scientists to move directly from a doctoral degree to an independent research career.”

If you write NIH grants, I strongly encourage you to spend some time with the full Appropriations report put out by the NIH Office of the Budget. (click here)

The Administration requested $31.829B for NIH FY12. Here are highlights that the Administration pulled from the NIH report (and therefore deem important):

*The FY12 budget proposes to support a total of 9,158 competing Research Project Grants (RPGs), a reduction of 228 from FY10. In total, NIH projects it will support 36,582 RPGs (competing and non-competing) in FY12, an increase of 43 grants from 2010.

*The budget also proposes a 4 percent increase in stipends under the Ruth L. Kirschstein National Research Service Award (NRSA) program. The goal is to “improve NIH’s ability to attract high-quality research investigators to the field of biomedical research.” This will result in an increase in NRSA funding of $19 million over FY10, for a total of $794 million.

*The Cures Acceleration Network would receive $100 million in FY12; it is included in the budget of the Office of the Director.

*As in previous years, $300 million is transferred out of the budget of the National Institute of Allergy and Infectious Diseases (NIAID) for the Global Fund to Fight HIV/AIDS, Malaria, and TB.

*Although the budget narrative specifically mentions implementation of the National Center for Advancing Translational Sciences (NCATS), the National Center for Research Resources (NCRR) remains a line item in the FY12 budget.

*At a briefing of NIH advocates, NIH Director Francis Collins said that within the next month, the agency expects to file a budget amendment detailing the movement of NCRR programs into NCATS or other NIH institutes and centers.

*The National Children’s Study would receive $194 million, the same level as FY10; the Common Fund would receive $557 million, an increase of $13 million.

*NIH intramural research would increase by $50 million, to a total of $3.382 billion, which is approximately a 1.4 percent increase.

*NIH estimates it will be able to save more than $15 million in administrative costs in FY12. The agency plans to do so through such means as using technology to save study section travel costs by holding virtual peer review sessions.

To illustrate the achievements of NIH, Dr. Collins used two particularly compelling examples at the budget briefing:

*A 21-year-old diagnosed today with HIV/AIDS has a life expectancy of 70 years, thanks to the anti-retroviral         therapy made possible by NIH funding.

*Gains in life expectancy supported by NIH-funded research result in $3.2 trillion in annual savings.

NIH identified in its FY12 budget justification priority areas and initiatives related to the following diseases: autism; cancer; Alzheimer’s disease; type 1 diabetes; and HIV/AIDS.

Some scientific program areas of accomplishment or special emphasis provided by NIH include: bioinformatics and computational biology; National Technology Center for Networks and Pathways programs; epigenomics; genotype-tissue expression; global health; Gulf oil spill long-term follow-up; health economics; high-risk, high-reward investigator initiated research; the HMO research collaboratory; the human microbe project; and nanomedicine.

Posted April 27, 2011 by Meg Bouvier in Biomedical research, medical grant writing, medical policy writing

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