Drug Evaluation Committee 2016-58 Substitute Consenters for Minor Subjects
Related classification: Obtaining consent
Initial Publication Date: 03/2017
Revised publication date: Mar 2021
Question
Please tell us about the surrogate consentor for minor subjects.
According to the GCP ordinance, the person who performs parental authority falls under this category, but is consent from two parents necessary?
Legally, the person who has parental authority over a minor is generally the parents, although there are some differences from case to case.
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(1)A child who has not reached the age of majority shall be subject to the parental authority of the parents.
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(2)If the child is adopted, he/she shall be subject to the parental authority of the adoptive parents.
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(3)(2) Parental authority shall be exercised jointly by the parents during their marriage. However, if one of the parents is unable to exercise parental authority, the other parent shall do so.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 2, Paragraph 25 of GCP, "A surrogate is a person who has parental authority over the subject, spouse, guardian, or other person equivalent thereto." The same Guidance 14 states, "(omitted) A person who has custody of the subject, spouse, guardian, or other similar person, who is able to serve the best interests of the subject in terms of the substance of their lives and their common emotional relationship. The following is an explanation of the definition of a "minor surrogate".
As a surrogate for the minor in question, "a person who has parental authority over the subject" is considered applicable, but GCP does not stipulate whether or not it is necessary to obtain consent from both parents (two persons). Therefore, we believe that obtaining consent from one parent (one person) who has received sufficient explanation is acceptable. However, it is desirable that both parents sign the consent form after the investigator confirms that they are satisfied with the agreement, so that there will be no discrepancies in intent between the parents.
Reason for revision of opinion
(Minor revisions have been made in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).