2020 Volume 69 Issue 3 Pages 243-252
Objectives: Regarding the application of the laws and regulations on case reports, we outlined the current regulatory framework in Japan and other countries, focusing on the distinction concerning research with human subjects, and discussed the future challenges regarding case reports.
Methods: We reviewed the relevant laws and guidelines of Japan and other major developed countries, including the United States (US), the United Kingdom (UK), France, and Germany, policies of academic institutions and academic societies, editorial policies of major medical journals, and the academic literature. We then described and summarized the current situation of the regulatory framework for case reports (whether they were applicable to research), and the regulations and requirements related to the protection of personal information in case reports, in each country.
Results: Case reports were considered to represent “medical care” or “activity other than research” in Japan, US, and the UK, according to legislation/guidelines, and were not regarded as research. In France and Germany, there were no explicit references to case reports in the legislation/guidelines. In all countries, when conducting case reports, regulations on research, including approval by a research ethics committee, were not applied, in general. However, the application status of the rules varied depending on the purpose of the case report (whether or not it was for research purposes) and the policy of the facility. Regarding the protection of patient personal information, the process of de-identification and consent was stipulated by laws and relevant guidelines in all countries. Similar procedures were also applied to academic journals and societies.
Conclusion: While case reports were generally conducted without applying regulations concerning research, in some cases, they may be undertaken for research purposes. It is desirable to define and classify case reports in light of the environment surrounding medical care and research, in order to establish a regulatory framework that considers the aims and content of case reports.
