Japan ’s New Pharmaceutical Affairs Law, effective as of April 1, 2005, outlines new Good Clinical Practice (GCP) guidelines, including the specific requirements for informed consent and privacy statements. Previously, a verbal informed consent by the study participants was acceptable, but the new GCP now requires that the informed consent must be a written document. Clinicians must thoroughly explain the purpose and procedure of the trials to make sure the subject understands and consents to participate . The new GCP requirements on informed consent were developed from the ethical standards in the Declaration of Helsinki.
In addition to written informed consent, physicians conducting the clinical trials are now required to provide the study subjects with written explanatory documents. The documents must include the purpose of the trial, contact information of the physician, how the trial will be conducted and what treatments will be involved, potential side effects, and information on the research institutions conducting the studies. It is also required that the participant be provided with written documents which grant permission for the subject to withdraw from the trial, which state that no harm will result to the subject if participation is stopped, and which ensure that the subject’s privacy information will be kept confidential. Information on adverse events must also be provided to the patient, including the name of the research institute to contact, what measures to take, and compensation information. In order to facilitate the patient’s clear understanding of these documents, physicians are encouraged to avoid using technical vocabulary. The MHLW hopes that this new regulation will help to increase the understanding and agreement of the study participants before they engage in clinical trials.