Drug Evaluation Committee 2013-32 Scope of Substitute Consentor (Part 2)
Related classification: Obtaining consent
Initial release date: Sep. 2013
Revised publication date: Mar 2021
Question
Please tell me about the surrogate consentor. The subject's parents are alive and well, but he lives with his grandparents. The grandparents accompany the subject to the hospital and take care of the subject at home. In this case, can't we consider "a person who is justified in giving consent with or on behalf of the subject, and who has custody of the subject, spouse, guardian, or other similar person who can serve the best interests of the subject in view of the substance of their lives and their common mental relationship"? Can't we regard them as "a person who has parental authority, a spouse, a guardian, or any other similar person who has the best interests of the subject in view of the substance of their life and their mental relationship?
Pharmaceutical Cooperative Opinion
Article 2, Paragraph 25 of the GCP defines a "surrogate" as "a person who has parental authority over the subject, a spouse, a guardian, or any other person equivalent thereto. The term "parental authority" is held by the parents.
Since "parental authority" is held by the parents, it is considered basic to obtain consent from the parents. However, Guidance 14 of the same article defines "'Substitute Consenting Party' in Paragraph 25 means a person who, when the subject lacks sufficient capacity to consent to participation in a clinical trial, is deemed legitimate to give consent with or on behalf of the subject, and who has parental authority over the subject, spouse, guardian, or other person equivalent thereto, and who is able to give consent in a way that is compatible with the realities of both subjects' lives. The person who has parental authority over the subject, spouse, guardian, or other equivalent person who, in view of the substance of their lives and their common spiritual relationship, is able to serve the best interests of the subject. Therefore, if the relationship between the subject and his/her grandparents can be considered as "a person who can serve the best interest of the subject," then there is a possibility that he/she can be a surrogate.
In the case of your question, the investigator or subinvestigator needs to carefully judge whether the grandparents can be a surrogate consentor or not in light of the above GCP provisions.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020), minor changes have been made to the description.