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Posted February 16, 2015 by Meg Bouvier in Freelance medical writing

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.

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


Posted February 5, 2015 by Meg Bouvier in Freelance medical writing, medical grant writing, NIH grantwriting

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New Webinar: “Mistakes Commonly Made on NIH Grant Applications”

In an effort to provide cost-effective training to the broadest group possible, I am launching a series of webinars in the upcoming months. The first of these will be in early February, and the goal will be to help grantees recognize and correct common submission mistakes.

Unlike many who conduct NIH submission training programs, I myself work on NIH submissions full time. I see clients make the same types of mistakes repeatedly– mistakes that are easily avoided.

Each year I am fortunate to have dozens of clients share their Summary Statements with me. Because I regularly read reviewer comments from a multitude of study sections, I can easily identify trends in pink sheets. I also keep track of evolving trends at NIH based on information I find in FOAs, Notices, and Appropriations Testimony. Study sections change, funding priorities evolve. It is important to understand NIH’s priorities right now.

I have helped clients land over $200 million in federal funds in the past five years. Your NIH submission will entail several hundred hours of work by you and others. Why not learn strategies to optimize your success on this and future submissions?

What: Webinar entitled “Mistakes Commonly Made on NIH Grant Applications

Who: Ideal for faculty preparing to submit a K, R21, R03, or R01 in an upcoming cycle, and the senior faculty and administrators who advise them.

When:Wednesday 4 February 2015, 11am-12:30pm EST or
Thursday 12 February 2015, 11am-12:30pm EST
Cost: $149
Takeaways: At the end of this 90-minute session, participants will be able to:
1) Predict some key criticisms reviewers may make
2) Identify problems in their or their colleague’s draft applications
3) Utilize that information to write stronger drafts

NIH Simplifies Policy on Late Applications

NIH might give you a two-week grace period on late applications. For details, see the Notice issued Dec 2014.

Examples of Reasons Why Late Applications Might Be Accepted

  • Death of an immediate family member of the PD/PI (or MPI).
  • Sudden acute severe illness of the PD/PI (MPI) or immediate family member.
  • Temporary or ad hoc service by a PD/PI on an NIH advisory group during the two months preceding or the two months following the application due date. Examples of qualifying service include: participation in an NIH study section/special emphasis panel, NIH Board of Scientific Counselors, Program Advisory Committee, or an NIH Advisory Board/Council. Qualifying service does not include participation in NIH activities other than those involved in extramural/intramural peer review or NIH Advisory Council/Board service.
  • Delays due to weather, natural disasters, or other emergency situations, not to exceed the time the applicant organization is closed.
  • For PD/PIs who are eligible for continuous submission (http://grants.nih.gov/grants/peer/continuous_submission.htm), the late application policy applies to activities not covered under the continuous submission policy (i.e., other than R01, R21, and R34 funding opportunities that use standard due dates).


Examples of Reasons Why Late Applications Will Not Be Accepted

  • Heavy teaching or administrative responsibilities, relocation of a laboratory, ongoing or non-severe health problems, personal events, participation in review activities for other Federal agencies or private organizations, attendance at scientific meetings, or a very busy schedule.
  • Review service for participants other than a PD/PI or MPI, acute health issues or death in the family of a participant other than a PD/PI or MPI.
  • Problems with computer systems at the applicant organization, problems with a system-to-system grant submission service, or failure to complete or renew required registrations in advance of the application due date.
  • Failure to follow instructions in the Application Guide or funding opportunity announcement.
  • Correction of errors or addressing warnings after 5 PM local (applicant organization) time on the application due date. Applicants are encouraged to submit in advance of the due date to allow time to correct errors and/or address warnings identified in the NIH validation process.

– See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html#sthash.flUVBOvk.dpuf

NIH Grantwriting Webinar Series Begins in February 2015!

We are happy to announce that in addition to one-on-one consulting, workshops, and seminars, we are now adding webinars to our menu of options to help NIH grantees. Upcoming webinars:

Mistakes Commonly Made On NIH Grant Applications
Benefit from the knowledge gained by a grantwriter who reads dozens of Summary Statements per year.

Wednesday 4 February, 11am-12:30pm EST or Thursday 12 February, 11am-12:30pm EST

NIH Submission Strategies
Take steps to optimize your chance of success before you write.

Wednesday 11 February, 11am-12:30pm EST or Thursday 19 February, 11am-12:30pm EST

How To Write The Specific Aims Of An NIH R01
Learn how to make the most important section of your submission compelling and persuasive.

Wednesday 25 February, 11am-12:30pm EST or Tuesday 3 March, 11am-12:30pm EST

Learn More!

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

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

Ketamine — A New Drug Treatment For Depression?


Credit: Koratmember at FreeDigitalPhotos.net

Remember ketamine, the old veterinary (and sometimes street) drug? Apparently it rapidly and significantly reduces anhedonia in those with treatment-resistant bipolar disorder, according to a new study.

Anhedonia, which is a lack of interest in activities that once gave a person pleasure, is a key feature of treatment-resistant bipolar disorder. According to a recent NIH-funded clinical trial, ketamine restored pleasure-seeking behavior independent of its other antidepressant properties in these patients. What’s more, it did so about 40 minutes after a single infusion, and the effect lasted as long as 14 days.

To me the most interesting part of this study is that ketamine did not act on the midbrain areas typically involved in depressive symptoms. Rather, PET scans on patients in the depressive phase of bipolar disorder showed that after ketamine infusion, there was activity in the dorsal anterior cingulate cortex (dACC). This region lies deep within the brain, resting on the medial surface of the frontal lobes. Its precise role remains somewhat elusive, though it is thought to govern conscious control of goal-directed behavior. The most recent significant study I could find on its function was a 2012 paper in Nature suggesting that the dACC is involved in optimizing behavioral adaptations to continuously evolving demands by predicting the difficulty of a task.

“Our findings help to deconstruct what has traditionally been lumped together as depression,” explained Carlos Zarate, M.D., of NIMH. “We break out a component that responds uniquely to a treatment that works through different brain systems than conventional antidepressants — and link that response to different circuitry than other depression symptoms.”

Imaging studies similar to the one just published are underway in patients with major depression, though results are not yet available. Other studies have suggested that ketamine may be exerting these effects through glutamate and dopamine pathways. Research is underway to explore easier methods of drug delivery, such as nasal spray.

Of late, ketamine has been studied for its rapid antidepressant properties, providing relief within hours rather than the weeks required for traditional medications to work. At present, ketamine is not FDA approved for treatment of depression and it is still used primarily in a veterinary setting.

Ketamine is an NMDA receptor antagonist, though it also inhibits reuptake of dopamine, serotonin, and norepinephrine. It was developed in 1962 and has been used in both humans and animals. It is categorized as a dissociative agent. It has been used for general anesthesia, sedation, and as a pain killer. Side effects include amnesia and agitation, and its street use has led to hallucinations, delirium, and death.

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



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.

World RePORT: A Worldwide Health Research Database

Credit: Stuart Miles at FreeDigitalPhoto.net

Credit: Stuart Miles at FreeDigitalPhoto.net

An article recently published in the September 12th issue of  Science discusses the necessity of creating a global map of    health R&D activities. The goal is to improve coordination  of research and create a “global observatory” for health research.

The Science article states, “How to finance research and   development where normal market forces are absent has been the focus of a number of studies organized by the World Health Organization (WHO), culminating in 2012 with a report that assessed the strengths and weaknesses of more than 100 new financing mechanisms (1). One of the issues that became clear in compiling this report was the absence of good data. There is no global health R&D map that provides a comprehensive picture of research funding, ongoing research, and results that could be used to guide the allocation of the limited available funding. Consequently, the member states of WHO have called for the establishment of a global observatory on health R&D to address this lack of information (2).”

While a truly comprehensive global health observatory is still years away, the World Health Organization recently created a database, the World Research -Portfolio Online Reporting Tool (World RePORT), which constitutes an important first step toward this goal. Released last year, the beta version of World RePORT was initially limited to research conducted in sub-Saharan Africa. However since then, a new funding organization has been added (the European & Developing Countries Clinical Trials Partnership; EDCTP) and coverage has been expanded to include NIH projects funded in 2013 and projects emanating from South Asia and East Asia/Pacific regions of the world.

As existing funders update the database with projects funded in 2013 across this expanded set of regions, the hope is that the database will help researchers build more effective networks and allow governments and donors to invest their time and money more strategically. Complete information from all ten current funders, as well as information on new organizations joining the World RePORT, will be available on the site soon.

As to the question of funding, the article explains: “As with many WHO projects of this type, it is a new activity and will require new and additional funding outside of its existing budget. A conservative estimate is that $11.5 million will be needed in the first 5 years to cover project staff and software development and to build capacity in those countries (the majority) that do not report health R&D data.”

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