2015 Volume 46 Issue 1 Pages 21-27
An increasing number of clinical trials recently require the submission of examination data as sample to check the feasibility of the study before the trials are started. However, procedures to obtain informed consent have not been standardized. Therefore, we investigated various procedures by reviewing past cases and guidelines on research ethics and personal information protection. Based on this review, we developed the procedures for four types of study classified according to the prospective nature and degree of invasiveness of the examination. In type A, when the sample data is prospective and requires implementation of invasive examination not conducted as part of routine medical care, written informed consent is mandatory and each examination must be approved by the institutional review board (IRB). In type B, when the sample data is prospective and requires implementation of less invasive or non-invasive examination not conducted as part of routine medical care, use of pre-approved template of written informed consent that includes explanations of foreseeable risks and inconveniences accompanying the examination is required. In type C, when the sample data is prospective and uses results of examination conducted as part of routine medical care, informed consent can be obtained either orally or in writing at the discretion of the investigator. In type D, when the sample data uses preexisting medical data, efforts have to be made to obtain oral informed consent as far as possible. However, if informed consent is not possible, individual informed consent can be omitted but general notice should be given to patients regarding use of their medical records for purposes including answering inquires on medical services from other medical institutions. This classification system, which includes flowcharts and templates for informed consent, has been approved by the IRB at the University of Tokyo Hospital and will facilitate proper handling of sample data.
