The new ethical guidelines came into effect on June 30,2021. The main revisions are as follows: (1) the introduction of the principle of "central ethical review" (one research, one review), (2) the establishment of "research collaborating institutions," and (3) the establishment of "e-consent" (electronic informed consent).
 Regarding (1), a central ethical review could be conducted based on a request from the head of the research institution, and the operation of such a review was limited to cases where the institution did not have its own ethical review committee. In addition, the ethical review committee was positioned as an advisory body to the head of the research institution who then had the final responsibility. Under the new ethical guidelines, as in the case of the Clinical Trials Act, the principal investigator will apply to the ethical review committee, and after its review, the head of the research institution will grant permission for the research to be conducted at each research institution.
 Concerning (2), when new samples and information were obtained for research purposes, it was necessary to develop a system similar to that of a researcher/research institution, such as applying for ethical review, attending research ethics education, and managing conflicts of interest. Under the new ethical guidelines, it is possible for an institution to be positioned as a "research collaborating institution", which is not a researcher/research institution, even in cases where samples and information are newly obtained or provided.
 As for (3), the new ethical guidelines recognize the use of information and communication technology to obtain informed consent for research participation. It is expected that multimedia-based explanations and electronic signatures would facilitate research participation from remote locations.
 In this paper, I would like to introduce the response to the new ethical guidelines at National Center of Neurology and Psychiatry, focusing on the case of the Mental Illness Registry, and to consider strategies for the smooth implementation of the new ethical guidelines and further promotion of non-interventional clinical trials.
 Author's abstract