Igaku-Kenkyu / Rinsho-Shiken no Rinri (Ethics in Medical Research and Clinical Trials: Lessons from Historical Japanese Case Studies)

As advancements are being made in the regulation of medical research, several questions need to be answered moving forward. For instance, how can medical research be conducted appropriately while protecting test subjects? In order to come up with ideal ways to conduct medical research, it is important not only to study the discussions and cases in other countries, but also to better understand the issues within our own. This book examines 15 incidences that occurred in Japan, not as past “scandals” but rather as educational materials, from which we can identify problems and can draw lessons. The book was mainly authored by early-and mid-career researchers, who discussed various issues as they wrote. The issues presented are yet to be resolved and still have a certain rawness that deserves to be considered from a new perspective. The supplemental materials provided at the end of the book introduce 66 Japanese cases involving ethics.
 
The book consists of three sections. Section I presents basic information on “research ethics” and “protection of test subjects” in the context of medical research/clinical trials needed to read this book. It also provides an overview of how these have been implemented in Japan and in other developed countries (INOUE Yusuke).
 
Section II examines the 15 case studies mentioned below, which are grouped into four parts. After a description of each case, various points of discussion are identified and explored with reference to the case studies.
 
Part 1. Clinical Studies and Experimental Medicine
    Case 1: Implementation of a clinical trial without consent from human subjects (YAMAMOTO Keiichiro)
    Case 2: Ethical and Legal status of protocols (FUNABASHI Akiko)
    Case 3:“Experimental” surgery (Innovative therapy) (TASHIRO Shimon)
    Case 4: First-in-human medical equipment trials and effectiveness of consent (MATSUI Kenji)
 
Part 2. Issues and Circumstances Requiring Careful Consideration
    Case 5: Inhumane military medical research during World War II (TSUCHIYA Takashi)
    Case 6: Research on mentally handicapped patients (NAKAZAWA Eisuke)
    Case 7: Research on children (NAGAMIZU Yuko)
    Case 8: Research involving pharmaceutical industry workers (YOKONO Megumu)
 
Part 3. Acquisition, Storage, and Use of Human Tissue Samples and Data
    Case 9: Research on the residents living in a community (SUDA Eiko)
    Case 10: Research using human tissue samples collected in clinical settings (TAKASHIMA Kyoko)
    Case 11: Autopsies and collection of human tissue samples (SATO Yuichiro)
 
Part 4. Neutrality in Research Administration and Honest Reporting of Results
    Case 12: Responsibilities of pharmaceutical companies and researchers in new drug development (IKKA Tsunakuni)
    Case 13: Participation of commercial entities in research and resulting conflicts of interest (ISOBE Tetsu)
    Case 14: Clinical trials coordinator and fraud (INOUE Yusuke)
    Case 15: Scientific misconduct and problems related to authorship (IBUKI Tomohide)
 
In addition to the cases above, Section II also features commentaries (PlusOne) that provide supplementary information.
    PlusOne 1: Conditions for allowing “innovative therapy”—exploring the boundary between research and medical care (TASHIRO Shimon)
    PlusOne 2: Research that uses prisoners as human subjects (OKITA Taketoshi)
    PlusOne 3: Research ethics and large-scale natural disasters (IIJIMA Yoshihiko)
    PlusOne 4: Origin and development of ethical review boards in Japan (AIZAWA Kuniko)
 
Section III chronologically summarizes the historical evolution of research ethics (important dates, regulations, etc. in Japan and abroad) in a table and provides synopses of various medical research-related incidences (66 cases) that actually occurred in Japan (IZUMISAWA Chie, IKKA Tsunakuni, INOUE Yusuke, KOKADO Minori).
 

(Written by INOUE Yusuke, Associate Professor, Graduate School of Frontier Sciences, The Institute of Medical Science / 2021)