Drug Evaluation Committee 2021-31 Obtaining Consent on and after April 1, 2022
Related classification: Obtaining consent
Date of first publication: Sep. 2021
Question
Under the revised Civil Code that will go into effect on April 1, 2022, the age of majority will change to 18 years of age. If there is no specific provision in the protocol, will it no longer be necessary to obtain the consent of a surrogate from subjects who are 18 or 19 years old?
I know that there is already a Clinical Trial 119 ( 2019-56 ) that is related to the above question, but I would appreciate your opinion on obtaining consent from subjects who are 18 or 19 years old in general, with no special circumstances such as divorce experience among the subjects.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The age of majority will be lowered from 20 to 18 according to the revised Civil Code, which will go into effect on April 1, 2022. Accordingly, when obtaining consent for participation in a clinical trial after April 1, 2022, we believe that consent from a surrogate will no longer be required as long as the subject is at least 18 years of age and capable of giving consent.
In addition, in accordance with "2. Ethical Considerations" of "Addendum to the Guidance on Clinical Trials for Drug Development in Pediatric Populations" (NHI Drugs and Pharmaceuticals Regulation No. 1227-5, December 27, 2009), if a subject in a clinical trial becomes of age on or after April 1, 2022 and is capable of giving consent, the consent for continued participation in the clinical trial is not required from the subject. (2) Ethical Considerations", it is recommended that consent for continued participation in the clinical trial be obtained from the subject himself/herself.