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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.

Objectives: In this study, we surveyed the methods of subject recruitment used in medical institutions and investigated the appropriate methods for each type of clinical study or medical institution.Methods: We conducted a questionnaire survey regarding the methods of subject recruitment used in four medical institutions (Department of Clinical Research, National Cerebral and Cardiovascular Center; Clinical Trial Center, Shiga University of Medical Science Hospital; Center for Drug & Food Clinical Evaluation, Osaka City University Hospital; Translational Research Center, Kyoto University Hospital) in November 2009. We listed the methods of subject recruitment indicated in the responses and determined the suitability for specific target diseases or medical institutions based on the possibility of increasing the number of subjects or promoting registration of subjects.Results: Different methods aiming at facilitating recruitment were used depending on the target disease and the situation of the medical facility. These methods include advertising within the institution using audiovisual materials, putting information of the study on a web page, forming a volunteer group, and explaining the clinical study separately from outpatient consultation.Conclusion: It is necessary to select and combine methods of subject recruitment depending on target disease and situation of the medical facility.