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NINDS Chief: As BRAIN Initiative Moves Forward, Ethical Issues Emerge

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As projects supported by the BRAIN Initiative move forward, they will raise a host of important neuroethical considerations not just for the medical community but also for society as a whole, authors of a new paper wrote.

With the largest neuroscience project in history at its midpoint, a number of neuroethical issues associated with brain research have come of age, according to Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke (NINDs).

Innovative neurological technologies have shown promise in preclinical studies funded by the 2013 National Institutes of Health (NIH) Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, he said.

“Now at the halfway point, we have a clearer sense of many of the near-term ethical issues, and we are identifying issues that can be anticipated over the next decades as BRAIN Initiative technologies begin to permeate the medical and non-medical communities,” Dr. Koroshetz and colleagues wrote in a paper published in the journal AJOB Neuroscience.

“Neurologists can help start the discussion in their communities. Otherwise people are stuck with science fiction,” he told Neurology Today. “If people aren't prepared, they're going to be surprised.”

Dr. Koroshetz pointed to deep brain stimulation studies for Parkinson disease and epilepsy as an example, noting ethical questions remain about whether or not a clinical trial participant implanted with a device is entitled to continue using it after a trial ends, and who is responsible for paying for the continued use and upkeep of it.

“From its inception, [the BRAIN Initiative] has ...made a concerted effort to integrate neuroethics into its science. As these tools mature and move to human applications they will raise a host of important neuroethical considerations not just for the medical community but for society as a whole.”

The BRAIN Initiative and similar large-scale neuroscience efforts hold tremendous potential, but also “probe the very essence of who we are as individuals and will raise profound questions for society in how to utilize them, especially in non-medical situations,” according to the paper.

About the BRAIN Initiative

Launched in 2013, the BRAIN initiative is a collaboration of private partners and other government agencies, including the Defense Advanced Research Projects Agency National Science Foundation, the US Food and Drug Administration, and Intelligence Advanced Research Projects Activity. As of last year, the NIH has made over 700 awards to hundreds of investigators, totaling about $1.3 billion.

“In the past five years, the BRAIN Initiative has given rise to powerful tools and neurotechnologies capable of probing deeply into the brain circuits in animal models. Now marks a pivotal moment to assess the status and consider the future of the BRAIN Initiative's neuroethics efforts,” Dr. Koroshetz and his coauthors wrote.

Shortly after the launch of the BRAIN Initiative in 2013, the NIH BRAIN Initiative's Neuroethics Working Group was formed as a working group of the NINDS Advisory Council to recommend approaches for identifying and addressing ethical questions raised by the development and use of the resulting tools and technologies.

“NIH is leading the way for proactively considering and addressing potential ethical considerations as the BRAIN Initiative leads to novel ways of measuring and influencing the activity of the brain,” said Dr. Koroshetz.

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“Neurologists can help start the discussion in their communities. Otherwise people are stuck with science fiction. If people arent prepared, theyre going to be surprised.”—DR. WALTER KOROSHETZ

Coauthored by Jackie Ward, PhD and Christine Grady, PhD, a senior investigator and chief of the NIH Center for Clinical Center's Department of Bioethics, the new paper describes core issues in neuroscience advances, the state of neurotechnologies in humans, and how ethics will be incorporated into the Initiative as the ten-year project enters its second phase.

The most promising technologies to map, monitor, and modulate neural network activity in mouse studies are presently out of bounds in humans because they are not considered safe or ethically justified at present, according to the NINDS authors.

“As the technologies become more refined and the therapeutic applications in devastating neurological, mental, and substance use disorders, the risk-benefit balance is likely to change.”

Tools developed through the BRAIN Initiative are facilitating a new ability to map brain connections, and to monitor and modulate brain activity. It is now possible to observe in real-time activity patterns in a million mouse neurons as an animal goes about normal behaviors. Also, emerging artificial Intelligence (AI) techniques, including machine learning, are able to analyze large data sets of neural activity to understand the patterns that give rise to behaviors, as are new methods for identifying mouse neurons that are connected to form a memory, an entity called an “engram.”

“The core neuroethical issue in BRAIN revolves around the possibility that these technologies might deconstruct human thoughts, emotions, preferences, intentions, motor programs, learning and more into computational constructs of neural network states, some of which may even become detectable or modulatable,” according to the paper.

“The derivative ethical concerns involve not only the appropriate development and use of such technologies but bleed into age-old philosophical questions about our nature as a species and as individuals.”

Cross-Discipline Discussion

In many respects, the BRAIN Initiative has already fostered greater communication and discussion of ethics between different groups of academics and researchers who in the past have not necessarily talked to each other, commented Joseph J. Fins, MD, professor and chief of the division of medical ethics at Weill Cornell Medical College.

“One of the great things about the BRAIN Initiative is that it provides funding for multidisciplinary discussion of ethical issues. It has created a community of scholars working together. As the initiative enters its second phase, or BRAIN 2.0, it is increasingly clear that our growing understanding of the neurocircuitry and genetics behind different conditions require that ethical considerations keeps pace,” he told Neurology Today.

Neuroethical considerations today are similar to those that were needed when the Human Genome Project began providing unique insights into the genetic variability of different diseases and disorders, he noted

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“As technological innovations in neuroscience evolve, ethical analysis also needs to evolve, especially as these advances offer us a better understanding of the pathology of different neurological disorders and the search for solutions.”—DR. JOSEPH J. FINS

“As technological innovations in neuroscience evolve, ethical analysis also needs to evolve, especially as these advances offer us a better understanding of the pathology of different neurological disorders and the search for solutions,” he said.

Dr. Fins, an expert in the neuroethics of disorders of consciousness, was among a l group of bioethics experts who addressed the Vatican's Pontifical Academy of Sciences workshop on personalized medicine in 2019. At the meeting, he said he discussed research indicating the need to revise definitions and ethical considerations relating to brain injured patients in a vegetative state.

One recent example is a study that found that as many as 41 percent of patients who clinically appear to be in a vegetative state, with no evidence of brain function beyond basic reflexive activity, were in fact minimally conscious, with brain circuitry that revealed awareness.

“With disorders of consciousness, we are in a transition phase between traditional behavioral criteria and a fuller understanding of the circuitry that might better characterize these conditions,” Dr. Fins said.

“Since its inception, the BRAIN Initiative has placed a significant emphasis on embedding ethicists within its projects,” said Michael Rubin, MD, FAAN, associate professor of neurology at the University of Texas Southwestern Medical Center, Dallas,

“While research into technology and our understanding of the complexity of neural networks is fascinating, it should be motivated not only by love of knowledge but by the hope that such knowledge will allow treatment of disease and betterment of all of the society that is funding the research,” he told Neurology Today.

“While this may seem to be obvious, health care disparities are clearly apparent in 2020, making it worthwhile to consider means of promoting accessibility to the knowledge and treatments that are created from the BRAIN initiative, long before they are being implemented,” he said.

“Lack of appropriate attention to distributive justice could inadvertently, in the foreseeable future, lead to widening of health care disparities.”

Disclosures

Drs. Koroshetz, Fins, and Rubin had no relevant disclosures.

Link Up for More Information

• Koroshetz WJ, Warda J, Grady C. Neuroethics and the BRAIN Initiative: Where are we? Where are we going https://www.tandfonline.com/doi/abs/10.1080/21507740.2020.1778119?journalCode=uabn20. AJOB Neurosci 2020;11:140–147.