News Release

Monday, October 30, 2017

NIH announces awards for BRAIN Initiative neuroethics research

Grants aim to address neuroethical issues associated with human brain research.

As scientists develop powerful neurotechnologies to monitor and regulate brain activity, ethical questions arise about how these new tools should be incorporated into medical research and clinical practice. To inform this discussion, the National Institutes of Health has awarded grants to five teams of experts who will study the neuroethical issues surrounding the use of deep brain stimulation in neuropsychiatric and movement disorders and appropriate consent for brain research. The grants are part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

“Neuroscience is rapidly moving toward a new frontier of research on human brains that may have long-lasting and unforeseen effects. These new awards signal our commitment to research conducted in a responsible way as to anticipate all potential consequences, and to ensure that research subjects have a clear understanding of the potential benefits and risks of participating in studies,” said Walter Koroshetz, M.D., director of NIH’s National Institute of Neurological Disorders and Stroke.

The BRAIN Initiative was launched in 2013 with the goal of developing the tools to see the brain in action, and leveraging this knowledge to reduce the burden of illness due to brain disorders. Shortly after the initiative was announced, efforts began to identify potential ethical questions that may be raised by new investigations on the human brain, including those that involve invasive brain surgery. NIH formed the BRAIN Multi-Council Working Group Neuroethics Division to assist the advisory councils of participating NIH institutes and centers to recommend approaches for identifying and addressing neuroethics questions related to BRAIN Initiative research. 

The grants are:

• Neuroethics of aDBS Systems Targeting Neuropsychiatric and Movement Disorders
  Principal Investigator: Gabriel Lazaro-Munoz, Ph.D., Baylor Medicine, Houston
  MH114854 — Deep brain stimulation (DBS), a neurosurgical procedure in which probes are inserted into the brain to modulate circuit activity in specific brain regions, has become widely used to help treat several movement and neuropsychiatric disorders. Adaptive DBS (aDBS) is a relatively new technology that enables recording of brain cell activity that is then used to regulate the brain in real time. As these techniques are applied to treat neuropsychiatric disorders, such as depression or obsessive-compulsive disorder, there are special ethical questions that come to the forefront. Dr. Lazaro-Munoz and his team plan to identify the most critical neuroethics issues related to aDBS research. They will examine neuroethical concerns by closely observing researchers conducting aDBS studies and administering in-depth interviews to study participants, their caregivers, researchers as well as individuals who declined to participate in aDBS studies. A better understanding of neuroethical concerns associated with aDBS may help researchers create plans to ensure responsible research in this area.&
• Ethics of Patients and Care Partners Perspectives on Personality Change in Parkinson’s Disease and Deep Brain Stimulation
  Principal Investigator: Cynthia Kubu, Ph.D., Cleveland Clinic Lerner College of Medicine, Cleveland
  MH114853 — Individuals affected by neurological disorders are often afraid that the disease or treatment may change their personality and sense of their identity. Dr. Kubu and her colleagues will conduct a series of interviews with people with Parkinson’s disease to learn what personality characteristics patients and their caregivers are most afraid of losing. Dr. Kubu’s team will also examine ways in which personality features are affected by DBS for Parkinson’s disease. More knowledge about patient concerns about personality changes and DBS-related effects on personality may allow researchers to ease the fears of patients receiving DBS and may help enhance the informed consent process.
• Achieving Ethical Integration in the Development of Novel Neurotechnologies
  Principal Investigator: Winston Chiong, MD/Ph.D., University of California, San Francisco
  MH114860 — New technologies that adjust brain function by assessing neural activity and stimulating specific regions have the potential to help individuals with neuropsychiatric disorders. However, these treatment strategies also raise a number of concerns regarding control of an individual’s thoughts and emotions as well as how they see themselves. Dr. Chiong will lead a multidisciplinary team, including experts in neuroscience, law and philosophy, that will work closely with researchers who are creating devices to regulate brain activity. This innovative collaborative approach to research will ensure that the ethical concerns of patients, caregivers and clinicians are addressed from the initial phases of the research plan and may help enable acceptability of new treatments for neuropsychiatric disorders.
• Enabling Ethical Participation in Innovative Neuroscience on Mental Illness and Addiction: Towards a New Screening Tool Enhancing Informed Consent for Transformative Research on the Human Brain
  Principal Investigator: Laura Roberts, Ph.D., Stanford University, Stanford, California
  MH114856 — Cutting-edge tools and neurotechnologies are being developed that may help people affected by mental illnesses and addiction. As researchers begin testing new technologies in people, concerns arise regarding ethical participation in these studies. Dr. Roberts’ group will work with brain researchers, neuroethicists and members of institutional review boards to identify ethical issues raised by novel research related to mental illness. Dr. Roberts and her team will also examine how people with mental illness, as compared with healthy controls, decide whether to participate in neuroscience research studies. Recognizing potential ethical concerns and understanding how people make decisions regarding research participation may improve informed consent for studies and may help to safeguard study volunteers.
• Ethical Safeguards for Exit and Withdrawal from Implanted Neurotechnology Research
  Principal Investigator: Lauren Sankary, J.D., Cleveland Clinic Lerner College of Medicine, Cleveland
  F32MH115419 — Patients who participate in a research study of a new brain technology can face difficult decisions regarding exiting the study and whether to have implanted devices removed. Ms. Sankary and her colleagues will conduct a detailed review of current regulations and practices relating to individuals ending their participation in research studies that used novel neuroscience tools. Ms. Sankary’s group will also interview research participants to learn about their experiences after their participation in the study and concerns regarding device removal. A better understanding of issues related to research subjects’ exit from studies will help support development of safeguards to protect study volunteers and ensure their concerns are addressed in design of research protocols.

In addition to funding grants in neuroethics, the NIH hosted a workshop on October 26, 2017, entitled “Ethical Issues in Research with Invasive and Non-Invasive Neural Devices in Humans”, which explored ethical issues and practical approaches specific to research with invasive and non-invasive neural devices. The workshop will result in a publication outlining factors for researchers to consider around neuroethics. To view a recording of the workshop, go to: https://braininitiative.nih.gov/about/neuroethics.htm

The NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

About the National Institute of Mental Health (NIMH): The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit https://www.nimh.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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