Researchers that conduct psychiatric studies, including genetic analysis studies, have to comply with the Ethical Guidelines for Medical and Health Research Involving Human Subjects, as enforced in June 2021. New policies such as central ethical review, one protocol per a multi-center study, and e-consent have been introduced in this new regulatory framework. These new guidelines will increase the efficiency of research practice as long as the researchers conduct their research with a stronger sense of responsibility and adherence to the regulations.
Researchers have to ensure the privacy of study participants and consider the impact of the research results on society because of personally identifiable preparation and information in psychiatric studies. They must examine and determine the conditions for obtaining agreements with study participants, instructions on the use of genome information, the security requirements and management of personal information protection, the conditions for commercial use, among others, based on the laws and guidelines related to research ethics.
This paper clarifies the points needed for high-quality psychiatric research by overviewing the new guidelines and examining discussions of the ethical review committee of the Japanese Society of Psychiatry and Neurology (J. S. P. N. ).
Author's abstract
New Ethical Guidelines for Psychiatric Research Involving Human Subjects
Fujita Health University, Bioethics, School of Medicine
Psychiatria et Neurologia Japonica
124: 457-462, 2022
<Keywords:psychiatric research, research ethics, ethical guidelines, central ethical review, e-consent>