Archive for the ‘NIH grantwriting’ Category

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!

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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

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.

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.

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.”

Top Ten Things NIH Reviewers Should NOT Say In A Review

ID-10046929

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.

NIH Funding to Study Sex as a Fundamental Variable in Clinical Research

Credit: Photokanok at FreeDigitalPhotos.net

Credit: Photokanok at FreeDigitalPhotos.net

I am popping up from my mountain of R01 drafts to bring attention to an important NIH news release. Yesterday, NIH announced it has devoted over $10 million in supplemental funding for 82 grantees to explore sex differences in their clinical and pre-clinical research.

The news release states, “These awards are the latest round of funding in a program described in a May 2014 Nature commentary by [Janine Austin Clayton, M.D., NIH associate director for women’s health research] and NIH Director Francis S. Collins, M.D., Ph.D. This commentary informed NIH grantees and other stakeholders of the agency’s intent to develop policies that will require applicants to address the influence of sex in the design and analysis of biomedical research with animals and cells.”

The news release states that the goal of the supplements is to serve as “…a catalyst for considering sex as a fundamental variable in research.”

NIH began this program in FY13, initially funding 50 supplements ($4.6 million total.) The initiative has been led by the Office of Research on Women’s Health. Most of the NIH ICs have funded supplements since the inception of the program.

Historically, medical research has been conducted predominantly on white male subjects. NIH has made efforts to expand the scope of clinical research to include both sexes and to represent multiple races and ethnicities. Grantees who want to succeed in the NIH arena would be wise to incorporate such variables into current and future studies.

 

 

Update on the New NIH Biosketch Format

Credit: adamr at  FreeDigitalPhotos.net

Credit: adamr at FreeDigitalPhotos.net

There are changes pending for the NIH biosketch format, and I think it is good news for NIH grantees. The new NIH biosketch format will allow up to five pages for the entire biosketch, as opposed to the current four-page limit. Even better, rather than simply listing publications, the new format will give researchers the opportunity to highlight the magnitude and significance of the scientific advances associated with their discoveries and the specific role they played in those findings.

Grantees will be permitted to describe up to five of their most significant contributions to science, the influence of their contributions on their scientific field, and any subsequent effects of these contributions on the fields of medicine or technology. This will help reviewers better focus on the applicant’s most important contributions to science. Researchers also will be able to include a link to their complete list of publications in SciENcv or My Bibliography.

NIH recently launched a new round of pilot tests (here and here) to make sure the new format will work well for both applicants and reviewers. The pilot will involve surveys of both reviewers and applicants to help NIH fine tune the application instructions and guidance to reviewers. NIH plans to roll out the modified biosketch for all grant applications received for FY 2016 funding and beyond (which generally refers to applications submitted in early 2015).

To learn more about the NIH’s new Biosketch format click *here*

 

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

 

 

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