Abstract
Informed consent (IC) is an essential ethical requirement for conducting clinical trials. This study aimed to investigate changes in research on IC for clinical trials and compare the trend in Japan with that overseas.
In February 2010, the electronic databases, PubMed and Japana Centra Revuo Medicina were searched for studies on IC for clinical trials both in and outside Japan.
The literature search identified 89 Japanese studies and 401 overseas studies concerning IC for clinical trials. In Japan, these articles were first published in 1993, and the number increased remarkably from 2002. Many of these articles discussed the contribution of a clinical research coordinator or the understanding of the information by trial subjects. The overseas studies were first published in the early 1980s, and the number increased remarkably in the 1990s.
Since, the enforcement of the new Good Clinical Practice in 1998, observational studies on IC for clinical trials have been conducted in Japan. However, most of these studies applied a quantitative approach, and qualitative analysis is limited. In Japan, IC is not focused exclusively on the protection of trial subjects, but also serves as the basis for an important encounter to build the physician-patient relationship. Therefore, investigations of the IC process by qualitative and quantitative approaches are necessary.
