Drug Evaluation Committee 2021-44 Substitution of a person equivalent to a legal guardian for the consent document
Related classification: Obtaining consent
First published: Jan. 2022
Question
I have a question about GCP.
The subject read the explanatory document and consented to the clinical trial, but due to paralysis caused by his illness (cerebral infarction), he was unable to hold a pen and sign the document. The subject's wife, who was present at the explanation and consent, became an impartial witness, and she signed the impartial witness signature column of the consent document, leaving the subject's signature and the alternate's signature columns blank.
Up to now, I have handled the above, but please point out if I have handled it incorrectly, and I would like to ask if this will be a record deficiency in the future in light of the July 30, 2021 guidance.
Article 52.1.3 "A person equivalent to a substitute consents to the consent document and enters the circumstances and the relationship with the subject" has been added.
(1) Since the subject was able to read the explanatory document, is the wife's position not that of a fair witness?
(2) What should "to that effect" be written?
(iii) What is the minimum required in the "Background" section?
(4) As for the wife's signature, should we prepare a "signature line for a person equivalent to a substitute" in the consent document, and should it be separate from that of an impartial witness?
Please explain the above four points.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 2, Guidance 18 (5) of the GCP, an impartial witness is not a person who gives consent on behalf of the subject or the surrogate, but a person who attests that the consent was obtained properly. Therefore, the signature of the subject or the surrogate is required even before the GCP Guidance (Pharmaceutical Affairs Bureau of Japan, No. 0730-3), which was revised on July 30, 2021. In addition, the wife of the subject can usually be a surrogate (or so-called surrogate author after the revision of this guidance).
Regarding your question, our view after the revision of this guidance is as follows
(i) We believe that the subject's wife is a substitute author.
(2) "To that effect" should be a statement that the person to be the subject verbally consented to participate in the clinical trial.
(iii) "Background" should be a fact that the person who is to be the subject is able to read and understand the explanatory document, but is unable to sign and date the consent document due to illness, etc., and that the substitute writer filled in the form on his/her behalf, together with the relationship between the substitute writer and the subject. We believe that it is sufficient to enter the fact that the substitute writer signed the consent document on behalf of the subject because the subject was unable to sign the document and enter the date, together with the relationship between the substitute writer and the subject.
(iv) We believe that the method of filling in the signature line of the consent document should be determined by the medical institution. If it is unavoidable for a person who is not equivalent to a substitute author to fill in the consent document as a substitute author, the signature of an impartial witness is required together with that of a substitute author who is not equivalent to a substitute author (GCP Article 52, Paragraph 1, Guidance 3). Therefore, if the position of the signatory is clearly indicated in advance, the signature fields for the alternate author and the impartial witness should be separated.