Yuki Kuroda, Goshiro Yamamoto, Tomohiro Kuroda
Vol. 11 (2022) p.48-57

In addition to traditional clinical research, advances in information communication technologies facilitates new medical research using internet of things devices and other cutting-edge technologies. Such medical research also simplifies the collection of data on research subjects in their daily lives internationally. In this context, medical research is increasingly required to comply with rules protecting patients’ personal data. This study proposes a model to enable researchers and other stakeholders including ethics committees in such international medical research to easily verify whether the planned processing of patient data complies with relevant legal and ethical rules. The model proposed in this study consists of (1) how patient information is processed, (2) the rules that are relevant to the processing, and (3) the analysis of whether the processing complies with the rules. This study suggests that the model should describe the aspects of data processing that are subject to many rules, such as the location of the processing, categories of data, purposes of the processing, and the storage period. Thus, using the information described in the model as a guide, stakeholders can determine which national and international legal/ethical rules apply to the planned processing. Then, they can use the model to verify and document whether the processing complies with the specific regulatory rules. The use of the model in this study enables stakeholders in medical research to comply with the rules related to patient data more effectively than without using the model.