Archive for the ‘NIH funding’ Tag

NIH Awards $31M To Increase Diversity in The Biomedical Research Workforce

Credit: Photokanok at FreeDigitalPhoto.net

Credit: Photokanok at FreeDigitalPhoto.net

In late October, NIH issued a news release stating that it will award $31 million to enhance diversity in the biomedical research workforce in FY14. The award will go to over 50 recipients who will be part of the national Diversity Program Consortium, established to engage researchers from underrepresented backgrounds. Award recipients work at geographically diverse institutions across the country that serve underrepresented communities. Members of the consortium will develop, implement, and evaluate methods for encouraging individuals to pursue careers in biomedical research and remain in this field.

Research shows that economic, social, and cultural factors significantly influence the pursuit of science careers. Dr. Hannah Valentine, NIH chief officer for scientific workforce diversity, asserts, “These awards represent a significant step toward ensuring that NIH’s future biomedical research workforce will reflect the unique perspectives found within the diverse composition of our society.”

The Diversity Program Consortium is part of a five-year plan with three major initiatives. The goal of the first initiative, BUILD, is to explore new approaches to attract students from diverse backgrounds to the biomedical science workforce. The goal of the second initiative, the National Research Mentoring Network (NRMN), is to develop best practices for mentoring individuals from underrepresented groups. Finally, work carried out as part of the Coordination and Evaluation Center is designed to assess the effectiveness of the training and mentoring approaches developed by BUILD and NRMN. It will also establish short- and long-term methods for measuring the effectiveness of both training and mentoring programs.

Top Ten Things NIH Reviewers Should NOT Say In A Review

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Credit: Ambro at FreeDigitalPhotos.net

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

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

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

NIGMS To Dramatically Limit Funding for Scientific Meetings

In a December blog post, NIGMS states it will “accept very few R13 or U13 applications in the future. We strongly encourage potential applicants to contact us before requesting approval to submit an application.” Associate Director for Extramural Activities at NIGMS, Ann Hagan PhD, explains further:

“We understand the importance of these meetings, but we receive a large number of requests to support them and have concluded that it is not cost-effective to consider most of these requests. The numerous applications for small conference grants are costly to process and review, and the funds used for them compete directly with research project grants, including R01s. Our priority is to use our resources in the ways that most directly promote research and training, which already include mechanisms to allow students and fellows to attend scientific meetings.”

For the full blog post, click here. Note the comments below the post from the President of Cold Spring Harbor Lab and the Chair of an upcoming Gordon Research Conference, as well as Dr. Hagan’s reply about the use of the R25 mechanism to fund courses and training workshops.

NIH Releases Info For Grantees on Government Shutdown

As expected, with no Congressional agreement on FY14 funding, and with too much Obamacare-related animosity for Congress even to agree to a temporary bill to fund at FY13 levels, the US federal government shut down at midnight last night. This morning the NIH released a notice to grantees concerning the government shutdown. Highlights include the following:

SUBMISSION OF GRANT APPLICATIONS: For the duration of the funding lapse, applicants are strongly encouraged not to submit paper or electronic grant applications to NIH during the period of the lapse.  Adjustments to application submission dates that occur during the funding lapse will be announced once operations resume.  For any applications submitted immediately prior to or during the funding lapse, here is what will happen.

  1. For electronic submissions through Grants.gov: Grants.gov will be open and can accept electronic applications.  However, applications will not be processed by NIH until the eRA Systems are back on-line.  NIH will ensure that all applications submitted within the two business days before or during the funding lapse will receive the full viewing window once the systems are back on-line.
  2. For electronic submission of multi-project applications through NIH’s ASSIST system: The ASISST system will not be available until NIH systems are back on-line.
  3. Paper Submissions: Staff will not be available to receive paper applications during a funding lapse.

The safest course is to wait to submit any application to NIH until after operations resume and a Notice in the NIH Guide concerning adjusted submission dates is posted.

CONTACT WITH NIH STAFF: For the duration of the funding lapse, NIH extramural employees will be prohibited from working (remotely or in the office).

PEER REVIEW AND COUNCIL MEETINGS: For the duration of the funding lapse, the NIH will not be able to conduct initial peer review meetings – whether in-person or through teleconferences or other electronic media. Also during this time, the NIH staff will not be able to send or receive email messages, or update website information, and NIH computer systems that support review functions will not be operational.

CURRENTLY ACTIVE GRANT AWARDS:  For the duration of the funding lapse, all work and activities performed under currently active NIH grant awards may continue.  However, see Notice for limits on performing many of the reporting requirements associated with NIH grant funding.

Looking For Good NIH Funding News? Check Out FY12 SBIR/STTR Funding Levels

With all the despondency over the NIH budget situation, I feel the need to broadcast some good news. Last year I blogged on the plummeting funding levels for SBIR and STTR grant applications. I am happy to report that FY12 numbers are out and they may be a lone bright spot on an otherwise bleak NIH funding landscape. What do you think? Good news or too little, too late? Does it make you want to run out and write a Phase II SBIR?:

SBIR ONLY:

YEAR Phase I Phase II Fast Track
2008 27.1% 47.7% 31.4%
2009 21.9% 40.5% 23.1%
2010 13.7% 33.5% 15.6%
2011 11.5% 29.8% 10.3%
2012 15.6% 39.9% 15.9%
YEAR Total # SBIR/STTR Applications Reviewed Total # SBIR/STTRApplications Awarded Total Funding SBIR/STTR
2008 4356 1242 $341,059,957
2009 4529 1108 $339,594,601
2010 6338 1079 $334,370,963
2011 6415 902 $311,127,665
2012 5847 1095 $366,812,604

Significant Budget Cuts Imminent For the National Institutes of Health

Guest Blog by Luke Bouvier, PhD

In a notice issued a few days ago on February 21, the NIH released some additional details about its contingency plans if sequestration goes into effect this Friday, March 1, as scheduled.  In order to hit the mandated 5.1% budget cut, the NIH “likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards.”  Non-competing continuation awards, which have generally been funded this year at 90% of the previous commitment level because of the ongoing budget uncertainty, may see some restoration above the current level “but likely will not reach the full FY 2013 commitment level described in the Notice of Award.”  The NIH also confirmed that in the event of the budget sequester, each of the 27 NIH Institutes and Centers will detail its own approach to meeting the reduced budget level.

Science likewise reported that a press conference held at the NIH last week confirmed the bleak budget outlook.  NIH Director Francis Collins and Senator Barbara Mikulski (D-MD) warned that the coming sequester cut of $1.57 billion to the NIH’s $31 billion budget would “slow scientific progress, delay clinical trials, and put a generation of young researchers at risk.”  Collins reported that “everything will take a hit,” though Institute directors will be able to use their discretion in allocating cuts among programs such as single-investigator grants, centers, and intramural research.  Referring to NIH staff and intramural researchers, Collins added that “we will do everything we can to try not to furlough or to lay off employees.”  Nobel Prize winner Carol Greider, chair of the Department of Molecular Biology and Genetics at Johns Hopkins University, also appeared at the press conference and lamented that the looming cuts could reduce NIH’s grant success rate from an already-low 17-18% down to 15%, which would translate to a reduction of grants in the hundreds, forcing cutbacks in biomedical labs throughout the country.  Collins confirmed that many high-scoring grant proposals have not received any funding yet at all because of the lack of budgetary clarity, adding that “some of that science is being held up as we try to figure out what resources we actually have in fiscal year ’13.”  Though few observers now believe that the sequester cuts can still be averted by March 1, Senator Mikulski, chair of the Senate Appropriations Committee, hopes that the NIH cuts will eventually be remedied in a budgetary deal to fund the federal government through the remainder of the current fiscal year.  That deal would have to be reached before the current Continuing Resolution expires on March 27, or else a government shutdown could result.

Posted February 25, 2013 by Meg Bouvier in Biomedical research, medical grant writing, medical policy writing, NIH grantwriting

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Sequester Cuts to the NIH Budget Look Increasingly Likely

Guest Blog by Luke Bouvier, PhD

The day of reckoning is fast approaching as concerns the sweeping federal budget cuts known as “sequestration,” scheduled to go into effect on March 1.  Originally slated for January 1, 2013, the cuts were mandated by the Budget Control Act of 2011, which was enacted as part of that year’s fight over the increase in the federal debt ceiling.  In the hope that a long-term budget deal would make the automatic cuts unnecessary, their implementation was postponed by the New Year’s Day deal that averted the so-called “fiscal cliff,” but most observers now agree that there is little appetite for a political compromise that could avoid them once again.  On January 24, incoming chair of the Senate Budget Committee Senator Patty Murray (D-WA) released a memo outlining the history of the budget deals reached over the past two years as well as the current state of affairs.  The details are messy, but the consequences for the NIH are clear:  a cut of approximately 5.1% to the current year’s budget, or $1.57 billion, which would be all the more severe in that it would have to be squeezed into the remaining seven months of the fiscal year.

In an interview with Politico last month, NIH Director Francis Collins called the impending cuts “a profound and devastating blow” to medical research, adding that “there’s no sort of lever you can pull and all of a sudden everything will be fine” in the face of a cut of that magnitude.  Collins noted that over the past ten years, the NIH budget has been essentially flat, which means that inflation has whittled away about 20% of its value.  The looming cuts would greatly exacerbate that trend, at a time when cancer research is “just exploding with potential,” Collins said.  “We could go faster and faster; … it’s an incredibly exciting science, but it will go slower.”

Nature reported last week that scientists are already cutting back expenditures in anticipation of the cuts.  Senior officials at the science agencies are under White House orders not to discuss specific plans for implementing the cuts, but the Office of Management and Budget has directed them to minimize the impact of the cuts on their core missions and to give priority to concerns over life, safety, or health.  Nature reports that the cuts to the NIH budget would be spread over all of its 27 institutes and centers, with only its Clinical Center spared in order to avoid putting patients’ lives in danger.  Directors would have some discretion in apportioning the cuts, as long as the total adds up to 5.1%.  Given the uncertainty, the NIH has been paying only 90% of the promised amounts for previously awarded grants; if the sequester goes into effect, the final 10% of these grants would almost certainly suffer a significant cut, leaving principal investigators with difficult spending decisions to make.

As if sequestration weren’t enough, looming right behind it is another impending budget crisis, as the current fiscal year’s Continuing Resolution expires on March 27.  If no budget deal is reached by then, a government shut-down is a real possibility.  And following along close behind that deadline is the expiration of the debt ceiling suspension on May 19, which could lead to a US government default on its payment obligations in the absence of congressional action.

Posted February 17, 2013 by Meg Bouvier in Biomedical research, Freelance medical writing, medical grant writing, medical policy writing, NIH grantwriting

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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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NIH To Limit Money To Well-Funded Investigators?

Dr. Sally Rockey, Deputy Director for Extramural Research at NIH, posted in her blog “Rock Talk” about the possibility of NIH limiting funds to already funded investigators. Decisions were to be made at September Council, so we should be getting some information about this program soon. From the original blog post:

“It’s been three months since I discussed how, during May Advisory Council meetings, NIH would pilot a new Special Council Review process for particularly well-funded applicants (NOTE that they have now dropped the amount to $1M in directs to trigger a council review). Since that time, we ran the pilot and carefully considered all the great feedback we received from Advisory Council members and staff. We are now ready to implement the final policy on Special Council Review.

“The new special review process will be in effect for the 2013 fiscal year, beginning with September 2012 Council meetings. The new policy will provide additional consideration of new and renewal applications from well-supported investigators who currently receive more than $1 million or more in direct costs. I want to remind you that this policy does not cap the total amount of funds an investigator may receive from NIH, but rather is a special review to complement existing NIH policies that require monitoring all investigators’ activities for overlapping support, and determining whether additional funds should be awarded to well-supported investigators.”

For the full blog post and all comments, click here: NIH Extramural Nexus.

How The Continuing Resolution Affects The NIH Budget– And Your Grant Award

The NIH issued this announcement yesterday:

“The Department of Health and Human Services (HHS), including NIH, operates under a Continuing Resolution (CR) (H. J. Resolution 117) that was signed by President Obama as Public Law 112-175 on September 28, 2012.  The CR continues government operations through March 27, 2013 at the FY 2012 level plus 0.6 percent.

“Until FY 2013 appropriations are enacted, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). This is consistent with our practice during the CRs of FY 2006 – 2012. Upward adjustments to awarded levels will be considered after our FY 2013 appropriations are enacted but NIH expects institutions to monitor their expenditures carefully during this period.  All legislative mandates that were in effect in FY 2012 remain in effect under the CR, including the salary limitation set at Executive Level II of the Federal Pay Scale ($179,700), which was effective with grant awards with an initial Issue Date on or after December 23, 2011 (see NOT-OD-12-034 and NOT-OD-12-035).”

For grant applications that have just been reviewed, look for a delay (possibly lengthy) in funding decision pending the FY13 Appropriation (unless you are lucky enough to have a priority score well within the funding range.) For those in the gray zone (perhaps 7-16%, depending on your funding mechanism and your ESI status), you can expect a lengthy delay in the funding decision. Discuss your specific circumstances with your program officer.

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