Drug Evaluation Committee 2007-19 Who to Re-consent when a Substitute Consent is Obtained
Related classification: Obtaining consent
Initial release date: Jan. 2008
Revised publication date: Mar 2021
Question
If consent was originally obtained from a person other than the subject himself/herself (i.e., a surrogate), is it necessary to explain additional information and obtain written consent from the same surrogate as for the initial consent?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
A surrogate consentor is a person who is deemed legitimate to give consent with or on behalf of the subject when the subject himself/herself does not have sufficient capacity to give consent, and must be a person who can serve the subject's best interests in terms of the substance of life and the psychological relationship between the two (GCP Article 2 Guidance 14). In addition, if the explanatory document is revised during the clinical trial, consent for continued participation in the clinical trial must be obtained from the subject or a surrogate (GCP Article 54, Paragraph 2/3, Guidance 1).
Therefore, if consent can be obtained only from the subject himself/herself, a surrogate is not required. Please confirm whether or not the case in question falls under the category of a substitute consentor in light of Article 2, Paragraph 25 of the GCP. In some cases, such as pediatric clinical trials, the consent of a surrogate is required and the consent of the subject himself/herself (assent) is also obtained. I will answer on the assumption that the case in question is such a case.
GCP does not stipulate that the consent obtained from the substitute must be the same as that of the first time consent. However, if a person who has not received the initial explanation receives only additional safety information, it is fragmentary information and may not be considered as a true understanding of the safety of the clinical trial in question.
Therefore, from the viewpoint of ensuring that the patient agrees to continue to participate in the clinical trial after fully understanding the information about the clinical trial, it is desirable to obtain a second consent from the same surrogate as the first consent.
Reason for revision of opinion
In accordance with the revision of the GCP Ministerial Ordinance (Ministry of Health, Labor and Welfare Ordinance No. 155, August 31, 2020) and the revision of the GCP Guidance (Pharmaceutical Affairs Agency Announcement No. 0831-15, August 31, 2020), the referenced provisions have been changed.