4. Ethical characteristics and testing guidelines for each non-invasive research method
G. Brain Machine Interface (BMI)
Brain Machine Interface (BMI) is a form of technology that uses a computer to analyze information received from the human brain and (if possible) aims to achieve bidirectional communication. Technology that directly links humans and machines is generally categorized as within the field of Neural Modulation and Neural Prosthesis. The former refers to technology that controls abnormal nerve activities, or compensates for or stimulates dysfunctional nerve circuits through intervention at the level of the central nervous system (such as Deep Brain Stimulation (DBS) used for the treatment of Parkinson’s disease). On the other hand, Neural Prosthesis refers to technology that accesses the central nervous system in order to compensate for the dysfunction of the sensory or motor systems. Neural Prosthesis applied to motor function, such as in development of prosthetic limbs driven by brain-derived information, is called BMI in a limited sense.
Two types of BMI are defined depending on the method used to record brain-derived information: non-invasive BMI, which collects information e.g. by recording brain wave from the scalp; and invasive BMI, which uses a probe placed in the central nervous system through surgery.
It is advisable that non-invasive BMI follow each of the items listed in these current guidelines according to the recording method used. Although our current guidelines do not cover invasive BMI, since invasive and non-invasive studies are carried out within the same projects in many cases, it is necessary to be careful that appropriate measures for the protection of test subjects or criteria for reviewing ethical issues remain consistent.