Informed consent in clinical trials using stem cells: Suggestions and points of attention from informed consent training workshops in Japan

Abstract

Informed consent (IC) is an essential requirement of ethical research involving human participants, and is usually achieved by providing prospective research participants (PRPs) with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research, due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators) is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to ensure adequate comprehension of the study and its potential after-effects; judge PRPs’ voluntariness and eligibility; and establish and/or maintain partnerships with PRPs. The workshops used role-playing simulations, to demonstrate how to effectively obtain fuller IC, to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information patients want when considering participation in induced pluripotent stem cell (iPSC) research. The correlated results showed the need for continuous training and education of elucidators in order to make sure that they acquire and maintain IC competency.