Japan Association for Medical Informatics

[3-B-2-06] Promotion of Clinical Research Through Preparation of Protocol Template Among Clinical Research Core Hospitals

*Takahiro Imaizumi Imaizumi1 (1. Department of Advanced Medicine, Nagoya University Hospital)

Ethical Guidelines, Real World Data, Template

Clinical research core hospitals are developing a platform to collect and output the relevant medical data accumulated at each facility in response to proposals from researchers. In March 2021, the Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects were amended and the principle of "one study, one review" was stated. However, the implementation of the guidelines has still been a challenge. Therefore, we prepared a template of the research proposal so that researchers could prepare a research protocol by simply filling in the form, and consulted in advance with those involved in the ethical review process at each institution. The template was designed specifically for observational studies using existing medical information. It included all required items in the ethical guidelines, as well as examples and explanations in the margins to facilitate understanding for researchers. The template was then consulted with the ethics committee of each institution to investigate (1) whether it could be used within the institution and (2) whether it would be possible to conduct research based on the protocol reviewed and approved at another institution. While the template was proven to be usable in most institutions, the way each facility accepts the approvals from other facilities varied.