Informed consent and information security for long-term follow-up research of childhood cancer survivors in Japan (Part 2)

Abstract

Although the approaches to obtaining informed consent in clinical research have diversified, a method for long-term follow-up research of childhood cancer survivors remains to be established. Typically, legal guardians provide consent for children’s participation in childhood cancer research. However, for long-term follow-up research, obtaining informed consent directly from the participants once they have reached the age of autonomous decision-making is essential. Achieving this necessitates considering a method that enables obtaining non-face-to-face informed consent. Specifically, implementing “informed consent by electronic method,” as outlined in the Ethical Guidelines for Medical and Health Research Involving Human Subjects, would be desirable, depending on the research content and security strength of the electronic system used. Moreover, obtaining informed consent through electronic data capture entails the management of personal information within an electronic system, thereby necessitating robust information security infrastructure. In this context, we developed a “Safe Server” to ensure data security. To address the abovementioned issues, we, “the Long-term Follow-up Matsumoto Group,” are in the process of establishing a nationwide long-term follow-up system as part of the Comprehensive Research Project for the Promotion of Cancer Control. In this paper, we propose an approach for obtaining informed consent and describe the information security system that underpins this proposal.