Drug Evaluation Committee 2013-36 Confirmation of being a "legal guardian
Related classification: Obtaining consent
Initial release date: November 2013
Revised release date: March 2021
Question
Recently, an initial review of a clinical trial involving pediatric patients was conducted by the investigational new drug review board (IRB) that we support.
At that time, one of the IRB members asked us, "Since the consent document for this clinical trial clearly states 'legal guardian other than parents,' if a legal guardian other than parents signs the document, isn't it necessary to confirm in some official document that he or she is a legally authorized guardian?" He commented. If the case was completed without any problems after participating in a clinical trial, it would be fine, but in case some problems occurred during the trial, it would be necessary to have a firm official written confirmation, not only verbal confirmation.
When we asked the sponsor, they told us that it is rare for a legal guardian other than the parents to sign as a surrogate consentor and that they do not know because there is no precedent for this. In accordance with the "Guidance on Clinical Studies of Drugs in Pediatric Populations" (Notification of the Director, Evaluation and Management Division, Pharmaceutical Safety Bureau, Ministry of Health and Welfare, December 15, 2000), the term "legal guardian" was used for the surrogate.
The above guidance states that "sufficient informed consent should be obtained from the legal guardian in accordance with the laws and regulations of each country. Please explain the following two points.
Question 1
In Japan, "legal guardian other than parents" is defined in GCP Article 2 Guidance 14 as "a person who is justified in giving consent with or on behalf of the subject and who has parental authority over the subject, spouse, guardian, or other similar person, and who has the best interests of the subject in view of the substance of their lives and their common psychological relationship. Is it correct to take it as "a person who is capable of looking out for the best interests of the subject in terms of the substance of their lives and their common mental relationship"?
Question 2
If a "legal guardian other than the parents" is the surrogate, is official written confirmation not required (is verbal confirmation by the investigator sufficient)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
The "legal guardian" described in the "Guidance for Clinical Trials of Medicinal Products in Pediatric Populations" and the corresponding ICH E11 Guidance is the same as the "legally acceptable representative" in ICH-GCP, but is the "legal guardian" in ICH-GCP the same as the "legal representative" in ICH-GCP? However, it is not exactly the same as a "legal representative" as defined in Article 2 of the GCP Ordinance. Legal guardians and legal representatives, etc. have the right of legal representation. On the other hand, although careful judgment is required in each case, a person can be a surrogate even if he/she does not necessarily have the legal authority to act on behalf of the subject, as long as he/she is "a person who can serve the best interests of the subject in terms of the substance of their lives and their common spiritual relationship.
Therefore, we recommend that you confirm with the sponsor whether the person who expresses consent on behalf of the subject needs to have the legal authority to act on the subject's behalf.
Please also refer to previous Opinions (4) and 2013-32 regarding the scope of a substitute consentor.
Question 2
GCP does not stipulate the need to confirm official documentation to prove that a person is qualified to act as a surrogate. Whether or not official documentation is required is a matter for the investigator or subinvestigator to decide, depending on the circumstances of each case.
Reason for revision of opinion
With the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Bureau of Japan, No. 0831-15), we have made minor changes to the questions.