Working Group 4 - Regulatory and Ethical issues

Initiated by Andrea Antal

Leaders: Andrea Antal & Til Ole Bergman

Aim: Since the FDA approval of rTMS and tDCS for the treatment of some neurological and psychiatric diseases, the methods have also gained increasing importance in clinical practice. As a result, numerous guidelines and safety standards for the use of NIBS have been developed and published by the scientific community. However, clinical research and treatment with NIBS always raised ethical questions for researchers and practitioners. For example, the border between treatment and neuroenhancement is still blurry. Furthermore, it is not clear if the same guidelines apply to treating vulnerable populations, e.g. children and elderly people. Even more complicated is to understand if the same guidelines and ethics apply to people with dementia or other diseases that affect the ability to give consent. A huge financially lucrative market has developed in recent years outside clinical research, where individuals can buy NIBS products and use them at home without any medical supervision. These developments increasingly create serious regulatory problems also for the relevant authorities. 

See also our actions 

EU Reclassification of TMS and tDCS to Class III - Action to be taken