Archive for the ‘medical grantwriting’ Tag

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 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.

Scientists Explore Shared Biology In Human, Fly, and Worm Genomes

 

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Credit: rajcreationzs at FreeDigitalPhoto.net

Researchers analyzing human, fly, and worm genomes have found that these species have a number of key genomic processes in common, reflecting a shared ancestry. Three papers were published in the Aug. 28, 2014 issue of Nature offering insights into embryonic development, gene regulation, and other biological processes vital to understanding human biology and disease.

These studies utilized data generated by the model organism ENCyclopedia Of DNA Elements (modENCODE) and the ENCyclopedia Of DNA Elements (ENCODE) Project, both supported by NHGRI. Launched in 2007, the goal of modENCODE is to create a comprehensive catalog of functional elements in the fruit fly and roundworm genomes for use by the research community. Initial catalogs were published in 2010. The ENCODE Project is building a comprehensive catalog of functional elements in the human and mouse genome.

More than a dozen modENCODE Consortium papers have been or will be published in the journals Nature, Genome Research, Genome Biology, and the Proceedings of the National Academy of Sciences this year. This collection of papers is the culmination of the modENCODE program, for which funding ended in 2012. More than 100 papers using modENCODE data by groups outside of the program have already been published. It is anticipated that the data and resources produced by modENCODE will continue to be used by the broader research community for years to come.

Rapid Advances in Ebola Research

The current Ebola outbreak is by far the largest since this hemorrhagic fever was identified in 1976. Previous outbreaks involved dozens or hundreds of infected people (click here for CDC chronology). Estimates of the current outbreak are 2,473 infections and 1350 deaths thus far. Outbreaks begin by transmission through close contact with infected animals, then rapidly spread through human communities via direct contact with bodily fluids of infected people, or through contact with items contaminated with such fluids. Once infected, case fatality is as high as 90% (click here for WHO fact sheet). There are currently no vaccines, treatments, or cures. Traditionally, outbreaks have been controlled largely by infection control measures (masks, gloves, etc.) and quarantine, and supportive care such as hydration of the infected patient.

 

Experimental Treatments: A promising drug called ZMAPP was given at Emory University to two missionaries who were infected with Ebola. Both have gotten better. The drug was also given to a Spanish priest who died soon thereafter, though the timing of drug delivery may have played a part in the drug’s efficacy in this case. As of this week, it appears to be helping three Liberian health care workers. The drug is manufactured by Mapp Biopharmaceutical Inc. It is not FDA approved at present, nor can this monoclonal antibody be produced quickly in large quantities. Other drugs are in development but have yet to show as much promise as ZMAPP. Ebola is a rare disease and affects poor countries almost exclusively, so limited funding is provided mostly by government agencies (see $28 million consortium led by Scripps and funded by NIH, and the recent $10.8 million initiative announced by Wellcome Trust and the United Kingdom’s Department of International Development.) I generally distrust .com coverage of anything related to medicine (and so should you), but this recent CNN piece on ZMAPP seems reasonable, if you would like more information.

 

Cause of the Current Outbreak: NIH announced this morning that researchers funded by NIH have used advanced genomic analysis to determine the single point of infection from an animal that led to the current outbreak, and that since that initial infection the spread has been solely human to human. Importantly, through their genetic analysis, the researchers can see how the virus has mutated since December to outsmart human immune systems. As we know, viruses are little more than tiny pieces of DNA that can mutate with diabolical speed to outsmart the comparatively slow human immune response. By understanding how infection occurs, how disease is spread, and how viruses are mutating to defy immune attack, these researchers have taken a giant step toward improved treatments and a cure. The team was led by Pardis Sabeti, MD, PhD (who not surprisingly won a highly prestigious NIH Director’s New Innovator award in 2009.)

 

Experimental Vaccines: Next week, NIAID will begin the first of several phase I clinical trials of an Ebola vaccine produced in collaboration with GlaxoSmithKline (for details, click here). They will also test an Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. NIH will partner with a British-based international consortium to test volunteers in the UK, and in the West African countries of Gambia (with approval of local authorities) and Mali. The CDC is in discussion with Nigerian officials about testing vaccines there.

NIH Commits to 12-Year Plan for BRAIN Initiative

Credit: Koratmember at FreDigitalPhotos.net

Credit: Koratmember at FreDigitalPhotos.net

Last month a federal report was released calling for $4.5 billion in funding for brain research over the next 12 years. On June 5th, 2014 the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative was presented to NIH Director Francis Collins by his Advisory Committee to the Director (ACD). The report, drafted by the ACD BRAIN Working Group, maps out a sustained commitment of $4.5 billion in new federal funding over 10 years, beginning in fiscal year 2016, to achieve seven primary goals (see bullets below).

NIH has already announced an investment of $40 million in fiscal year 2014 and President Obama has made a request for $100 million for NIH’s component of the initiative in his fiscal year 2015 budget. The working group emphasized in its report that its cost estimates assume that the budget for the BRAIN Initiative will supplement — not supplant — NIH’s existing investment in the broader spectrum of basic, translational, and clinical neuroscience research.

The NIH efforts on the BRAIN Initiative will focus on mapping the circuits of the brain, measuring the fluctuating patterns of electrical and chemical activity flowing within those circuits, and understanding how their interplay creates our unique cognitive and behavioral capabilities.

The following seven scientific goals were identified as high priorities for achieving this vision:

  • Identify and provide experimental access to the different brain cell types to determine their roles in health and disease.
  • Generate circuit diagrams that vary in resolution from synapses to the whole brain.
  • Produce a dynamic picture of the functioning brain by developing and applying improved methods for large-scale monitoring of neural activity.
  • Link brain activity to behavior with precise interventional tools that change neural circuit dynamics.
  • Produce conceptual foundations for understanding the biological basis of mental processes through development of new theoretical and data analysis tools.
  • Develop innovative technologies to understand the human brain and treat its disorders; create and support integrated brain research networks.
  • Integrate new technological and conceptual approaches produced in the other goals to discover how dynamic patterns of neural activity are transformed into cognition, emotion, perception, and action in health and disease.

The BRAIN Initiative is jointly led by NIH, Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, National Science Foundation, and Food and Drug Administration. Private organizations are also committed to ensuring success through investment in the initiative.

About the ACD:

The ACD advises the NIH Director on policy matters important to the NIH mission of conducting and supporting biomedical and behavioral research, research training, and translating research results for the public. For more information on the ACD and the full agenda of this meeting, visit: http://acd.od.nih.gov/index.htm

 

 

Seven-Year, Multi-Center Clinical Trial Award 2014

Credit: terapun at FreeDigitalPhotos.net

Credit: Teerapun at FreeDigitalPhotos. net

Meg Bouvier Medical Writing is pleased to announce that our client has been awarded a seven-year Cooperative Agreement from the National Institutes of Health (NIH). The team, working at four participating medical centers, will conduct clinical trials to accelerate the discovery of treatments for critically ill patients. The work will be conducted as part of a highly prestigious, multidisciplinary clinical research consortium at NIH. While the size of the award will depend on the clinical protocols chosen, a typical seven-year clinical trial award runs in the tens of millions of dollars. Dr. Bouvier was the lead writer, editor, and advisor on the U01 submission team from Meg Bouvier Medical Writing.

NIH Common Fund Celebrates 10th Anniversary

Credit: Stuart Miles at FreeDigitalPhotos.net

Credit: Stuart Miles at FreeDigitalPhotos.net

This month the NIH celebrates the 10th anniversary of the NIH Common Fund, a funding mechanism created to support cross-cutting, trans-NIH programs that require participation by at least two NIH Institutes or Centers (ICs). These large collaborative, multi-disciplinary research projects often have the potential to encourage the development of innovative technologies and research tools that, until the development of the Common Fund, would have had difficulty meshing with the plans of any single one of the existing 27 NIH Institutes or Centers.

Over the last decade, the Common Fund has supported significant and transformative research, including the Human Microbiome Project, Big Data to Knowledge (BD2K), Extracellular RNA, Nanomedicine, Epigenomics, Undiagnosed Diseases Program, as well as the High-Risk, High-Reward Research Program that funds individual scientists with particularly innovative ideas or transformative technologies that may lack the preliminary data typically used to evaluate NIH grant applications.

To celebrate this significant milestone in the program’s history, on July 19th the NIH hosted the Common Fund Symposium featuring talks by Dr. Zerhouni, former director of the NIH (2002-2008), as well as many of the remarkable scientists who have led research projects supported by the NIH Common Fund. For those unable to attend the symposium, an archived version of the webcast is accessible to the public here. In addition, over the course of the Symposium, the winners of the first-ever Common Fund video competition were unveiled. This competition encouraged researchers to describe their work to the public utilizing wonderfully creative and often humorous methods, and are well worth a look!

 

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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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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