Japanese MHLW Issues New eConsent Guidelines for Clinical Trials

Up until recently in Japan, most drug applications, informed consent forms, and other drug documents needed to be in hard copy with original personal stamps or signatures. On March 30, Japan’s Ministry of Health, Labor, and Welfare (MHLW) authorized the use of electronic informed consent (eConsent) instead of the use of paper informed consent forms. eConsent was authorized for participants wanting to take part in registered clinical trials or post-marketing studies.

In order for an eConsent to work, patients and doctors must be able to interact through video calls or online Q&A sessions. Such interactions must be similar to face-to-face discussions and follow Japanese GCP guidelines. Such eConsent requires patients to sign forms electronically. The MHLW ER/ES guidelines provide information on how patients can do electronic signatures.