Drug Evaluation Committee 2019-56 Obtaining Consent from Minor Subjects Who Have Been Divorced
Related classification: Obtaining consent
Date of first publication: 03/2020
Question
Under the current Civil Code, the age of majority is 20 years old. However, it is stipulated that when a minor marries, he/she is deemed to have reached the age of majority upon marriage even if he/she is under 20 years old (Article 753, Pseudo-maturity by Marriage). However, under the revised Civil Code to be enforced from April 1, 2022, the age of majority will be changed to 18 years of age, and this "legal age of majority by marriage" provision will be eliminated.
Therefore, when obtaining consent from a woman who was married at the age of 16 just before the enforcement of the revised Civil Code and divorced at the age of 17 immediately after the enforcement, should we bring in the Civil Code and deal with her at the time of initial consent and at the time of obtaining consent again at the time of revision of the explanatory document during the clinical trial in accordance with the current common theory that "the legal age of majority does not disappear even after divorce"? Is this correct?
- 1)Is it correct to assume that a "surrogate consentor" is not needed all the time?
- 2)Is it acceptable to respect all human rights of the subject and always obtain the written consent of a "surrogate" regardless of marital status?
- 3)Is it acceptable to stipulate in advance in the SOP that written consent must also be obtained from a "surrogate" when consent is obtained from a person under 18 years of age, regardless of marital status?
Please let us know how best to respond to this question.
Opinion of the Pharmaceutical Cooperative Association
Even if a 16-year-old woman gets married and divorced before the enforcement of the revised Civil Code (April 2022), for example, she is still considered to be an adult according to Article 753 of the current Civil Code (legal age by marriage). If she is deemed to be an adult before the enforcement of the amendment, she will continue to be deemed to be an adult after the amendment according to Article 2, Paragraph 3 of the Supplementary Provision of the amended Civil Code (Law No. 59, 2008) (Transitional Measures Concerning Adulthood).
Therefore, there should be no problem in obtaining consent for participation in a clinical trial and consent for continued participation in a clinical trial (reconsent) only from the subject himself/herself, as long as the subject himself/herself is capable of understanding the explanation. It is important to record the background and history so that it can be explained that there is no problem only with the subject's consent.
Regarding your question about the SOP provision, as long as the subjects are legally recognized as adults, their rights should be respected, and the need to uniformly stipulate that consent should be obtained from the surrogate should be carefully considered within the hospital.
Reasons for the revision of the opinion
Added a statement that the subject himself/herself has the capacity to give consent.