In 2021, new ethical guidelines for life science and medical research involving human subjects were established. The author examined the anxiety and expectation about medical research experienced by patients and their family members and the adherence to the new guidelines from the perspective of the author as a member of the ethics committee.
The author asked members of the National Federation of Mental Health and Welfare Associations about their concerns and opinions regarding medical research and found that, along with having hopes for research, there was anxiety that stemmed from unfamiliarity with the research as well as concern about research funds, actual research methods, and utilization of results.
The three main revisions in the new guidelines are "integrated ethical review for multi-institutional research", "establishment of new research collaborating institutions", and "establishment of electromagnetic informed consent". However, it is necessary to consider the concerns and anxieties of patients and their families.
As one of the measures, the author would like to propose that patients join the ethics committee. The participation of patients and family members as lay persons, in addition to the researchers, in the ethics committee can help ensure its quality. In the area of the "establishment of new research collaboration institutions", the facilitation of communication among research institutions and the establishment of an all-Japan system that includes private clinics and psychiatric hospitals are challenging. "Electromagnetic informed consent" has both advantages and disadvantages and requires more careful explanations and responses to questions about the research than those required with face-to-face informed consent. As for the integration of the medical and genomic guidelines, the author agrees with the integration because genomic medicine has become familiar to us, and there are many common points between the two guidelines. Having said this, there is a shortage of specialists who are able to conduct genetic counseling on incidental findings.
If science and ethics do not work together, both will fail. In order to not lose sight of the question, "Research for What, Research for Whom?", the author strongly hopes that the new guidelines will speed up research and promote mutual understanding and cooperation between patients, family members, citizens, and researchers.
Author's abstract
Concerns and Expectations of Patients and Families about Psychiatric Research in the Context of Revised Ethical Guidelines
Yakitsubeno-Michi Clinic
Psychiatria et Neurologia Japonica
124: 479-486, 2022
<Keywords:research ethics, patient and public involvement, ethics review, genetic counseling>