[Advocacy] Statement on the revised guidelines for ethics-related problems with “non-invasive research on human brain function”

    The development of technology has led to the invention of methods for measuring the functional neuroanatomy of the living human brain, which was regarded as a “black box” in traditional psychology. Functional magnetic resonance imaging (fMRI) is a leading example, and many other methods are also available: clinical electrophysiological methods including electroencephalography (EEG) and magnetoencephalography (MEG), molecular imaging methods including positron emission tomography (PET) and single-photon emission computed tomography (SPECT), optical imaging using near infrared spectroscopy (NIRS), and non-invasive brain stimulation (NIBS) including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). These methods are collectively called non-invasive methods for measuring human brain functions (“non-invasive brain research methodologies” hereafter) and now widely used in basic and clinical neuroscience research.

    Most non-invasive brain research methodologies use devices approved for medical use, and deal with information, which could be sensitive in terms of medical conditions or privacy, from an individual’s brain. Therefore, it is important for neuroscience researchers to consider ethics for the use of non-invasive brain research methodologies and how to make use of findings from them. To make an active commitment to these issues, the Japan Neuroscience Society has issued Guidelines for Ethics-related Problems with “Non-invasive Research on Human Brain Function” in 2001 and revised the Guideline in 2010.

    Ten years have passed since the last revision of the guidelines. Since then, non-invasive research on human brain function has evolved and began to overlap with medical research as seen in the neurofeedback and the brain-machine interface (BMI) researches. Government policies for medical research have also been revised. “Ethical. Guidelines for Medical and Health Research Involving Human Participants (released in 2014, revised partially in 2017)” have been issued from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and the Ministry of Health, Labour and Welfare (MHLW), Japan. The new guidelines specify the rules that should be followed by all parties involved in medical research conducted in humans.

    Moreover, the Clinical Trial Act, promulgated in 2017, stipulates the procedures and information disclosure systems of clinical trials, defining such trials as research to clarify the efficacy or safety of pharmaceuticals by using these pharmaceuticals in humans. Because the law stipulates only the basic principles regarding various forms of medical research, the establishment of specific and appropriate guides based on these principles is desired for each field. Furthermore, the Act on the Protection of Personal Information was significantly revised in 2015, and the revision took effect in 2017.

    Since the development of guidelines and regulations reflect Japan’s drive to advance brain science research, it has become necessary to clarify management systems for non-invasive human brain research at each facility for gaining social understanding consistent with the standards in each era. Under these circumstances, we have decided to revise the guidelines for ethics-related problems with “non-invasive research on human brain function. We hope that the revised guidelines are of help for basic and clinical neuroscientists, participants, and personnel who are involved in non-invasive research on human brain functions for the further advancement of the research field.

Michisuke Yuzaki, Presiedent, The Japan Neuroscience Society
Takashi Hanakawa, Chair, Ethics Commitee

Ethics Commitee Members for 2018-2019 in charge of the revision
Norihiro Sadato (Chair), Osamu Sakura, Tetsuya Suhara, Takashi Hanakawa, Masaki Fukunaga, Tetsuya Matsuda