Archive for the ‘medical policy writing’ Category

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.

 

 

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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

 

 

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!

 

Patient-Centered Clinical Research Network (PCOR-net)

As we all know, comparative effectiveness research is smokin’ hot right now. We are all anxious to see what PCORI funding produces in the upcoming years. In December they unveiled PCOR-net, a highly innovative, clinical data sharing network. In a recent blog post, Dr. Francis Collins (who sits on PCORI Board of Governors) stated, “This initiative will provide an unprecedented opportunity to streamline clinical trials, empower patients, and build a solid foundation for personalized medicine.” He goes on:

“PCORnet will be made up of two types of data networks: Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). CDRNs include academic health centers, community hospitals, health plans, inpatient and outpatient hospitals and providers, Veterans’ Administration clinics, pediatric hospitals and providers, private electronic health record companies, and many other health care groups. Utilizing electronic medical records, all of these organizations will build patient databases and a clinical trial infrastructure that can be accessed by researchers from many different organizations (including NIH), while protecting patient privacy and confidentiality.

“As the name suggests, PPRNs are patient-oriented groups united by a certain disease or condition. The successful groups receive support from PCORnet, and are charged with outreach, expanding networks of patients, and collecting standard patient data—all of which are critical for researchers looking to recruit volunteers for a clinical trial.”

In December, PCORI distributed $93.5 million to 11 CDRNs and 18 PPRNs who will conduct pilot studies on data models over the next 18 months.

If successful, this single, overarching network has the potential to include over 100 million people across the US of all ages, ethnicities, and SES who have agreed to participate in clinical research.

Read the complete blog post here.

NIH Tests a New Tool For Creating Biosketches

NIH has worked with six other federal agencies to develop a tool that they hope will reduce the burden of applying for research support. Designed by NCBI, the Science Experts Network– or SciENcv –links with PubMed and eRA Commons, and will eliminate the need to manually enter redundant information. It has been available as a beta version since September. Read more here.

2013 Year In Review at NIH

Here is a link to a useful blog post written by NH Deputy Director Sally Rockey. It summarizes some of the main activities at NIH during the course of 2013. While it begins with a depressing recap of the far-reaching effects of the budget situation, it goes on to highlight some of the main goals and programs of the year. Major themes continue to include data science and efforts to diversify the scientific workforce. The blog is chock-full of hyperlinks to more information on numerous topics. If you plan to develop a long-term relationship with a federal funding agency, it is important to know its mission and funding priorities, and to familiarize yourself each year with the goals identified in the director’s appropriation report, and the suggestions made by the advisory council to the director. Read the full blog post here.

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.

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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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.

With No Agreement on FY14 Budget, A Government Shutdown Looms…

Here we go again folks.  Fiscal year 2014 begins at midnight and once again there is no budget agreement. Normally when this happens, Congress votes to temporarily continue operating the federal budget at the levels from the previous fiscal year, as they continue to duke it out over funding issues. But this year, Obamacare has stirred up so much bipartisan animosity that a shutdown appears increasingly likely.

 

As I have written previously, I know only too well what happens during a government shutdown, as it happened in my first month of being a federal employee many years ago. All non-essential federal employees are furloughed. They may not work or travel for work, therefore all imminent trips planned by federal employees must be canceled. At NIH, the clinical center continues to operate and, for better or worse, we can still submit those R01s for the October 5 deadline. However, NSF has issued an announcement that while grants.gov may be operational,  “FastLane proposal preparation and submission will be unavailable”.

And while NIH will be accepting those Oct 5 new R01 submissions, no doubt we can look forward to hideous delays in funding decisions in the upcoming months. Read more in an article posted this afternoon, on the eve of a likely government shutdown, from Science Insider.

 

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