2020 Volume 30 Issue 1 Pages 78-85
The Ethical Guidelines for Medical and Health Research Involving Human Subjects calls for “special consideration for vulnerable subjects.” This principle has yet to be examined in detail. Questions remain, such as, what defines a subject as vulnerable? What does special consideration involve? Research ethicists have discussed the meaning of “vulnerability” and “vulnerable groups” for the past two decades, but Ethical Guidelines use little from the discussion. Consequently, the protections for vulnerable subjects laid out in the Guidelines are problematic. This article offers three steps to improve the medical and health research regulations and practices in Japan. First, the history of vulnerability in research ethics is traced back to its original context and premise. Second, three promising approaches to the concept of vulnerability are examined. Finally, relevant conditions in Japan are highlighted to demonstrate the need for a supplementary ethical document regarding special protections for vulnerable subjects. The supplementary document should be analytical and concrete.
