The National Institutes of Health’s Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative represents the next generation of powerful new devices and technologies to monitor and regulate brain activity. They participated in a recent research study offered a discussion of material issues to revolve around these advancements of both invasive and noninvasive neural devices such as ethics.

Published in JAMA Neurology, an elite group of researchers from over a dozen major academic centers and the NIH discussed clinical research considerations.

The Brain Initiative

Launched in 2013, the NIH sought to support the collaboration of neuroscience researchers, clinicians and ethicists all associated with next-generation neuron-based research. Shortly after the launch of the BRAIN initiative, 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 the resulting tools and technologies.

Ethical Challenges Related to Neural Devices

The authors offer three primary ethical elements related to the rapidly advancing neural devices. Two of them build upon established issues while a third element is relatively new for these devices. They include 1) weighting the risks and benefits involved in clinical experimentation and 2) the importance of informed consent—whether a trial participant is provided with enough information, and under the right circumstances to be able to decide on enrolling; and 3) what responsibilities do researchers, manufacturers, and funders have to the research participants once a trial has ended? Unlike drug trial participation, in advanced neuron-based device studies, the implants or devices may have an impact on their (the patient) future. Who is responsible for making sure that the implant or device continues to work properly weeks, months, or years later? The impressive author collective suggests that at a minimum, researchers and sponsors need to anticipate any future care needs of the trial participants, including associated costs.

Co-Author Comments

Khara Ramos, Ph.D., Director of Neuroethics at NINDS and co-author of the research noted “Cutting-edge science required cutting-edge ethics.” She continued “The BRAIN Initiative is moving the field of neuroscience forward at a rapid pace, and we are fortunate to collaborate with experts from diverse backgrounds to help us evaluate and anticipate the ethical implications of that research.”

Source: NIH

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