Informed Consent and Clinical Trials in Japan

Informed consent is a concept that requires physicians to share decision-making power regarding medical treatment with their patients. This concept originated in the U.S. and there is no history of informed consent in Japan. Thus, the vast majority of Japanese are not aware of the importance of informed consent. In Japanese, informed consent is translated as “explanation and consent.” This translation does not fully explain the right of patients to be active decision makers in deciding their course of treatment.

However, even if Japanese physicians and patients were to fully understand the concept of informed consent, traditional relationships between Japanese patients, physicians, and family members may be the strongest barrier to the application of this principle. Physicians in Japan have a “doctors know best” mentality. Family members also want to protect their loved ones. Once a family member becomes ill, they are often treated as incompetent and incapable of making their own decisions regarding treatment. Paternalistic physicians and protective family members would often counteract informed consent and try to make medical decisions to promote a patients’ well being independent of his/her wishes and values.

A survey conducted by the Ministry of Health and Welfare (MHW, now the Ministry of Health, Labor and Welfare – MHLW) revealed that 40% of 1600 physicians deemed it appropriate to decide how much medical information should be given to patients while only 26% felt that patients should be given as much information as they want.

Due to the lack of informed consent and patient decision-making power, patients are often unaware of their eligibility to participate in clinical trials. Those that do participate may not be aware of the full implications of the study or its purpose. The Japanese government has taken steps in recent years to educate the public regarding the benefits of clinical trials and the importance of patient participation. However, without proper informed consent during clinical trials, it is unlikely that significantly more Japanese patients will choose to participate in such clinical research.

The following are some general recommendations to carry out effective informed consent for clinical trials:

  • Clearly and simply explain the purpose of the study
  • Distinguish the investigational treatment from standard care
  • Avoid overstating the potential benefit of the investigational treatment
  • Keep focus on the physical and non-physical risks associated with the investigational treatment as a whole
  • Broadly estimate the likelihood of the risks associated with the investigational treatment
  • Provide supplementary and readable documents that are culturally sensitive and provide these materials throughout the lifetime of the study