医薬品GCP省令における同意説明および同意取得について　― 緊急状況下の治験における同意取得を制度面から考える ―

抄録

Clinical trials of pharmaceutical products conducted in Japan are subject to stringent regulatory requirements including the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Ministerial Ordinance on Good Clinical Practice for Drugs (J–GCP), and the associated guidance documents (such as the J–GCP Guidance). This regulatory framework is designed to ensure that the protection of participants' rights, safety, and wellbeing are accorded the highest priority, while ensuring scientific quality and the reliability of clinical trial results. These regulations require that investigators shall explain trial–related information appropriately to prospective participants (or their legally acceptable representatives) and obtain written informed consent prior to their trial participation.

However, in life saving clinical trials conducted in emergency situations ―where time is critically limited and the prospective participant is at life–threatening risk ―it may be impracticable to obtain prior informed consent from the participant, and the participant's legally acceptable representative may not be immediately available. Article 55 of the J–GCP sets forth specific provisions the conduct of clinical trials in such cases.

This paper discusses, with reference to the J–GCP and the J–GCP Guidance, the fundamental principles of providing trial–related information and obtaining informed consent before participating in clinical trials, as well as the regulatory considerations applicable to life saving clinical trials conducted in emergency situations when the enrollment proceeds without prior consent from the participant or the participant's legally acceptable representative. To ensure that life–saving clinical trials in emergency settings are implemented in Japan without an undue delay, it is essential to establish a shared understanding among all stakeholders involved in such trials. It is anticipated that this paper will contribute to enhanced understanding among stakeholders engaged in the planning, review, and conduct of such trials.