To examine a specific disease in a case report or study for publication in an academic conference or specialized journal, sincere consent, as a rule, should be received from subjects. According to the revised Personal Information Protection Law, medical information should be specially protected as sensitive personal information. However, in reality there exist cases where consent cannot be easily obtained, from those with mental illness for instance. In the past, presumed, fictitious, or proxy consent was obtained to circumvent the consent principle. However, these methods are only for the sake of legal technicality, leading to speculation of the patient's intention. Therefore, I propose that we need to develop a model that circumvents the consent principle from different viewpoints in order to appropriately pave the way for necessary and meaningful academic research, while respecting the human rights of patients. In this paper, I would like to present a draft proposal.
Author's abstract
Difficulty in Obtaining Consent in a Case Report or Research: Lawyer's Viewpoint
Lawyer, Daiichi Tokyo Bar Association
Psychiatria et Neurologia Japonica
123: 349-353, 2021
<Keywords:Personal Information Protection Law, special care-required personal information, consent principle, de-identification, biomedical ethics>