As delineated in the “BRAIN 2025: A Scientific Vision” report, crucial scientific knowledge of brain function comes from patients who voluntarily consent to the collection of research data as they undergo diagnostic or therapeutic brain monitoring with recording or stimulating electrodes. Researchers need to access the latest generation of devices to optimize the scientific value of this unique opportunity. Cooperation of clinical and academic research teams with private companies could quickly break down technological barriers and forge a new streamlined path for developing, implementing and integrating new devices for advancing human neuroscience research. Toward this end, NIH is interested in creating public/private partnerships with manufacturers to facilitate broad access to novel intracranial stimulating and/or recording devices for conducting clinical research.
NIH is especially interested in working with manufacturers willing to share their pre-clinical safety and technical data on instruments that fall into the FDA category of “significant risk,” meaning they may be implantable and could pose serious risk to the health, safety, or welfare of subjects. These data can be costly and time-consuming to obtain, but are required for new clinical research protocols using the latest generation of devices. Successful partnerships will facilitate research on human brain function, deepen our understanding of mechanisms and underlying human brain disorders, increase effectiveness of therapies, and enhance the value of diagnostics.
On behalf of the NIH Institutes involved in the BRAIN Initiative, NINDS has issued a Request for Information (RFI) to seek input from interested academic/clinical researchers, regulatory and other government agencies, healthcare professionals, members of the public and potential industry partners, to identify key barriers and potential opportunities for granting NIH investigators earlier access to these significant risk stimulating/recording devices in order to conduct important, ethical human studies research. Small businesses with appropriate technologies are especially encouraged to provide input. This RFI is intended to gather relevant information and identify interested parties to inform a follow-on workshop. The deadline for submitting input is November 21, 2014.
Separate events on Tuesday, September 30 highlighted the awardees of the first round of NIH BRAIN Initiative grants and the additional investments by companies, foundations, patient advocacy organizations, universities, and private research institutions to support the BRAIN Initiative.
At the National Press Club, NIH Director Francis Collins, alongside NINDS and NIMH Directors and representatives from the scientific and advocacy community, congratulated the first 58 NIH BRAIN Initiative grant awardees. Approximately $46 million in federal grants will support the research projects of over 100 investigators in 15 states and three countries. Emphasizing the importance of developing next-generation tools for studying the brain in health and illness, Collins featured several grants when describing the initiative’s overall potential impact. Collins referred to BRAIN as America’s next moonshot on his blog, declaring that the 12-year scientific plan for BRAIN should enable “the next leap in understanding the brain.”
White House Office of Science and Technology Policy Director John Holdren and Deputy Director for Technology and Innovation Tom Kalil later unveiled the broad response to the President’s call for “an all hands on deck” effort to support the BRAIN Initiative at a White House press conference. Major foundations, patient advocacy organizations, universities, and corporations, including the Simons Foundation, GE and Google, will align more than $240 million in research efforts with the BRAIN Initiative. Kalil called for “the emergence of regional technology clusters,” which will form via contributions from several private companies involved in neuro-based technologies.
Additionally, the U.S. Food and Drug Administration (FDA) and the Intelligence Advanced Research Projects Activity (IARPA) have joined the BRAIN Initiative. The FDA, while not directly supplying funds for research, plans to heighten the transparency of the regulatory landscape for medical devices to treat brain disorders. IARPA will be funding a handful of innovative research projects involving machine learning.
More information about the exciting growth of the BRAIN Initiative can be found here.
The first meeting of the NIH BRAIN Initiative Multi-Council Working Group (MCWG) took place on August 25. The working group, co-chaired by NINDS Director Story Landis and NIMH Director Tom Insel, is composed of 14 outstanding extramural neuroscience researchers and a neuro-ethics expert, in addition to three ex officio members representing Defense Advanced Research Projects Agency (DARPA), US Food & Drug Administration (FDA), and the National Science Foundation (NSF). The purpose of the working group is to provide input on a variety of issues to the advisory councils of the 10 NIH Institutes participating in the BRAIN Initiative. The meeting included an overview of the BRAIN Initiative, an overview of the working group’s responsibilities, and a discussion of the applications received in response to the NIH’s initial six BRAIN Initiative funding announcements. In the afternoon, concepts for potential future BRAIN funding announcements were presented for input and approval.
The NIH BRAIN working group presented its long-term vision for the BRAIN Initiative to the NIH Director’s Advisory Committee on June 5, which was enthusiastically endorsed by the Committee and the NIH director. This vision, detailed in the working group’s final report, BRAIN 2025, focuses 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. Check out the NIH director’s statement and the NIH news release to learn more!
The NIH BRAIN working group will present its scientific plan to the Advisory Committee to the Director, NIH, at the June 5-6, 2014 meeting. This plan outlines the scientific vision for the Initiative as well as specific goals, milestones, and deliverables. Related information, webcast link, and materials will be posted to the ACD and BRAINwebsites as they become available.
On May 14, the Commission for the Study of Bioethical Issues issued its first set of recommendations in response to President Obama’s charge to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.” The specific topic of the report is the integration of ethics into neuroscience research across the life of a research endeavor. Read the press release or report for more information.
Last week, President Obama announced his budget proposal to double the Federal investment in the BRAIN Initiative from about $100 million in Fy 2014 to approximately $200 million in FY 2015. Read the fact sheet to learn more about the proposed investments at various agencies to support groundbreaking research and meet the audacious goals of this initiative.
The White House is seeking to further advance the goals of the President’s BRAIN Initiative by mobilizing organizations around the country. Through a Call to Action released on February 24, the White House has asked to hear from companies, health systems, patient advocacy organizations, philanthropists, etc. about the unique activities and capabilities underway that could be leveraged to catalyze new breakthroughs in our understanding of the brain.
Later this year, the White House will hold an event to feature the role of these organizations in achieving the President’s bold vision. Have ideas? Send to email@example.com by May 1, 2014.
When the President launched the BRAIN Initiative in April 2013, he charged his Commission for the Study of Bioethical Issues with exploring the ethical, legal, and societal implications raised by both this research initiative and other recent advances in neuroscience to ensure that this research progresses responsibly. The Commission is currently encouraging the public to weigh in on these topics and individuals interested in submitting comments should refer to the announcement recently posted in the Federal Register.
On January 15, 2014, the President signed the Consolidated Appropriations Act of 2014 (P.L. 113-73.). In this bill, Congress signaled its strong support for the BRAIN Initiative by appropriating funds for NIH Institutes and Centers to begin its implementation in fiscal year 2014. Language also indicates the importance of investing in basic research to advance fundamental knowledge by stating that “This work may take decades before it results in cures or treatments, but it holds promise to unlock the secrets behind diseases such as Alzheimer’s and epilepsy.”
Scientists funded by the NIH BRAIN Initiative hope to diagram all of the circuits in the brain. One group will attempt to identify all of the connections among the retina’s ganglion cells (red), which transmit visual information from bipolar cells (green) and photoreceptors (purple) to the brain.
Credit: Josh Morgan, Ph.D. and Rachel Wong, Ph.D., University of Washington.