Medical AI Promotion Institute Establishes Ethics Review Board Specialized in Medical AI and Data

– Now accepting applications for ethical review of clinical trials involving medical AI –

Medical AI Promotion Institute, Inc. (Head Office: Chuo-ku, Tokyo; Director General: Yuki Shimahara; Representative Director: Sho Kawabe; hereinafter “MAPI”) has established an independent Ethics Review Board (hereinafter “MAPI Ethics Review Board”), a third-party committee to conduct ethical reviews of clinical trials and research protocols involving medical AI, and has begun accepting applications.

Background

In recent years, while clinical trials and research utilizing medical AI have been advancing, the development of ethical review systems and specialized human resources that adequately address the unique characteristics of AI remains in progress (Note 1).

The Ministry of Health, Labour and Welfare’s “Ethical Guidelines for Medical and Biological Research Involving Human Subjects” require the establishment of independent and impartial ethics review boards to ensure both respect for human rights and scientific validity (Note 2).

However, there is a shortage of experts capable of appropriately evaluating AI algorithm structures and the validity of training data, making it a challenge to establish review systems specialized for AI clinical trials.

MAPI established this Ethics Review Board following its experience in undertaking clinical trials involving medical AI, bringing together experts with deep knowledge of both AI technology and medical ethics.

Features of the MAPI Ethics Review Board

MAPI’s core activities include medical data services, AI research and development, and commercialization support, with participation from diverse experts including physicians, legal professionals, and AI engineers.

Leveraging this expertise, the MAPI Ethics Review Board conducts ethical reviews that address AI-specific issues such as algorithm transparency, bias, and data management.

The Board specializes in ethical review of research related to medical AI and medical data. The scope of review includes:

• Research related to medical AI
  Studies involving development, implementation, and evaluation
• Research related to medical data
  Studies involving collection, management, analysis, and utilization

MAPI provides an independent and specialized ethical review platform to support medical institutions, AI developers, universities, and other organizations in conducting clinical trials with confidence.

Future Plans

MAPI will accept ethical review applications from organizations conducting clinical trials and research in the medical AI field and will build a fair and transparent review system.

In addition, MAPI aims to serve as a foundational organization supporting the reliability and social implementation of medical AI through ethics awareness initiatives and collaboration with the medical, academic, and industrial sectors.

Contact Information

Medical AI Promotion Institute, Inc.
Ethics Review Board Secretariat
E-mail: irb@mapi-jp.org
Details: https://mapi-irb-yagvm92.gamma.site/

Note 1: Ministry of Health, Labour and Welfare, “Summary of Discussions and Future Directions of the Healthcare AI Development Acceleration Consortium” (June 28, 2019)
Note 2: Ministry of Health, Labour and Welfare, “Ethical Guidelines for Medical and Biological Research Involving Human Subjects” (2021)