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

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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.

 

 

NIH Commits to 12-Year Plan for BRAIN Initiative

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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

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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!